id	sid	tid	token	lemma	pos
globalce-322	1	1	47	47	NUM
globalce-322	1	2	j	j	PROPN
globalce-322	1	3	global	global	ADJ
globalce-322	1	4	clinical	clinical	ADJ
globalce-322	1	5	engineering	engineering	NOUN
globalce-322	1	6	vol.7	vol.7	PROPN
globalce-322	1	7	issue	issue	NOUN
globalce-322	1	8	3	3	NUM
globalce-322	1	9	:	:	SYM
globalce-322	1	10	2025	2025	NUM
globalce-322	1	11	received	receive	VERB
globalce-322	1	12	april	april	PROPN
globalce-322	1	13	23	23	NUM
globalce-322	1	14	,	,	PUNCT
globalce-322	1	15	2024	2024	NUM
globalce-322	1	16	,	,	PUNCT
globalce-322	1	17	accepted	accept	VERB
globalce-322	1	18	june	june	PROPN
globalce-322	1	19	2	2	NUM
globalce-322	1	20	,	,	PUNCT
globalce-322	1	21	2025	2025	NUM
globalce-322	1	22	,	,	PUNCT
globalce-322	1	23	date	date	NOUN
globalce-322	1	24	of	of	ADP
globalce-322	1	25	publication	publication	NOUN
globalce-322	1	26	september	september	PROPN
globalce-322	1	27	10	10	NUM
globalce-322	1	28	,	,	PUNCT
globalce-322	1	29	2025	2025	NUM
globalce-322	1	30	.	.	PUNCT
globalce-322	2	1	review	review	NOUN
globalce-322	2	2	catchment	catchment	NOUN
globalce-322	2	3	of	of	ADP
globalce-322	2	4	the	the	DET
globalce-322	2	5	test	test	NOUN
globalce-322	2	6	license	license	NOUN
globalce-322	2	7	for	for	ADP
globalce-322	2	8	the	the	DET
globalce-322	2	9	regulation	regulation	NOUN
globalce-322	2	10	of	of	ADP
globalce-322	2	11	medical	medical	ADJ
globalce-322	2	12	devices	device	NOUN
globalce-322	2	13	in	in	ADP
globalce-322	2	14	india	india	PROPN
globalce-322	2	15	rupak	rupak	PROPN
globalce-322	2	16	kumar	kumar	PROPN
globalce-322	2	17	*	*	PROPN
globalce-322	2	18	,	,	PUNCT
globalce-322	2	19	deepak	deepak	PROPN
globalce-322	2	20	k.	k.	PROPN
globalce-322	2	21	gupta	gupta	PROPN
globalce-322	2	22	,	,	PUNCT
globalce-322	2	23	jyoti	jyoti	PROPN
globalce-322	2	24	batra	batra	PROPN
globalce-322	2	25	,	,	PUNCT
globalce-322	2	26	aarti	aarti	PROPN
globalce-322	2	27	sahu	sahu	PROPN
globalce-322	2	28	and	and	CCONJ
globalce-322	2	29	suchita	suchita	PROPN
globalce-322	2	30	markan	markan	PROPN
globalce-322	2	31	indian	indian	PROPN
globalce-322	2	32	council	council	PROPN
globalce-322	2	33	of	of	ADP
globalce-322	2	34	medical	medical	ADJ
globalce-322	2	35	research	research	NOUN
globalce-322	2	36	(	(	PUNCT
globalce-322	2	37	icmr	icmr	PROPN
globalce-322	2	38	)	)	PUNCT
globalce-322	2	39	,	,	PUNCT
globalce-322	2	40	new	new	PROPN
globalce-322	2	41	delhi	delhi	PROPN
globalce-322	2	42	,	,	PUNCT
globalce-322	2	43	india	india	PROPN
globalce-322	2	44	.	.	PUNCT
globalce-322	3	1	*	*	PUNCT
globalce-322	3	2	corresponding	correspond	VERB
globalce-322	3	3	author	author	NOUN
globalce-322	3	4	email	email	NOUN
globalce-322	3	5	:	:	PUNCT
globalce-322	3	6	rupakraman@gmail.com	rupakraman@gmail.com	X
globalce-322	4	1	abstract	abstract	ADJ
globalce-322	4	2	the	the	DET
globalce-322	4	3	medical	medical	ADJ
globalce-322	4	4	device	device	NOUN
globalce-322	4	5	industry	industry	NOUN
globalce-322	4	6	in	in	ADP
globalce-322	4	7	india	india	PROPN
globalce-322	4	8	is	be	AUX
globalce-322	4	9	gaining	gain	VERB
globalce-322	4	10	momentum	momentum	NOUN
globalce-322	4	11	and	and	CCONJ
globalce-322	4	12	is	be	AUX
globalce-322	4	13	expected	expect	VERB
globalce-322	4	14	to	to	PART
globalce-322	4	15	grow	grow	VERB
globalce-322	4	16	rapidly	rapidly	ADV
globalce-322	4	17	.	.	PUNCT
globalce-322	5	1	given	give	VERB
globalce-322	5	2	the	the	DET
globalce-322	5	3	significant	significant	ADJ
globalce-322	5	4	impact	impact	NOUN
globalce-322	5	5	of	of	ADP
globalce-322	5	6	medical	medical	ADJ
globalce-322	5	7	devices	device	NOUN
globalce-322	5	8	(	(	PUNCT
globalce-322	5	9	md	md	PROPN
globalce-322	5	10	)	)	PUNCT
globalce-322	5	11	on	on	ADP
globalce-322	5	12	patient	patient	ADJ
globalce-322	5	13	health	health	NOUN
globalce-322	5	14	,	,	PUNCT
globalce-322	5	15	a	a	DET
globalce-322	5	16	robust	robust	ADJ
globalce-322	5	17	regulatory	regulatory	ADJ
globalce-322	5	18	framework	framework	NOUN
globalce-322	5	19	that	that	PRON
globalce-322	5	20	combines	combine	VERB
globalce-322	5	21	policies	policy	NOUN
globalce-322	5	22	,	,	PUNCT
globalce-322	5	23	laws	law	NOUN
globalce-322	5	24	,	,	PUNCT
globalce-322	5	25	regulations	regulation	NOUN
globalce-322	5	26	,	,	PUNCT
globalce-322	5	27	and	and	CCONJ
globalce-322	5	28	approvals	approval	NOUN
globalce-322	5	29	is	be	AUX
globalce-322	5	30	necessary	necessary	ADJ
globalce-322	5	31	to	to	PART
globalce-322	5	32	ensure	ensure	VERB
globalce-322	5	33	adherence	adherence	NOUN
globalce-322	5	34	to	to	ADP
globalce-322	5	35	standards	standard	NOUN
globalce-322	5	36	before	before	ADP
globalce-322	5	37	market	market	NOUN
globalce-322	5	38	entry	entry	NOUN
globalce-322	5	39	.	.	PUNCT
globalce-322	6	1	to	to	PART
globalce-322	6	2	initiate	initiate	VERB
globalce-322	6	3	regulatory	regulatory	ADJ
globalce-322	6	4	approval	approval	NOUN
globalce-322	6	5	,	,	PUNCT
globalce-322	6	6	test	test	NOUN
globalce-322	6	7	license	license	NOUN
globalce-322	6	8	is	be	AUX
globalce-322	6	9	the	the	DET
globalce-322	6	10	preliminary	preliminary	ADJ
globalce-322	6	11	step	step	NOUN
globalce-322	6	12	.	.	PUNCT
globalce-322	7	1	it	it	PRON
globalce-322	7	2	is	be	AUX
globalce-322	7	3	required	require	VERB
globalce-322	7	4	to	to	PART
globalce-322	7	5	manufacture	manufacture	VERB
globalce-322	7	6	or	or	CCONJ
globalce-322	7	7	import	import	NOUN
globalce-322	7	8	materials	material	NOUN
globalce-322	7	9	in	in	ADP
globalce-322	7	10	small	small	ADJ
globalce-322	7	11	quantities	quantity	NOUN
globalce-322	7	12	for	for	ADP
globalce-322	7	13	specified	specified	ADJ
globalce-322	7	14	purposes	purpose	NOUN
globalce-322	7	15	;	;	PUNCT
globalce-322	7	16	for	for	ADP
globalce-322	7	17	example	example	NOUN
globalce-322	7	18	,	,	PUNCT
globalce-322	7	19	testing	testing	NOUN
globalce-322	7	20	,	,	PUNCT
globalce-322	7	21	training	training	NOUN
globalce-322	7	22	,	,	PUNCT
globalce-322	7	23	examination	examination	NOUN
globalce-322	7	24	,	,	PUNCT
globalce-322	7	25	evaluation	evaluation	NOUN
globalce-322	7	26	,	,	PUNCT
globalce-322	7	27	demonstration	demonstration	NOUN
globalce-322	7	28	,	,	PUNCT
globalce-322	7	29	and	and	CCONJ
globalce-322	7	30	clinical	clinical	ADJ
globalce-322	7	31	investigation	investigation	NOUN
globalce-322	7	32	under	under	ADP
globalce-322	7	33	india	india	PROPN
globalce-322	7	34	’s	’s	PART
globalce-322	7	35	medical	medical	ADJ
globalce-322	7	36	devices	device	NOUN
globalce-322	7	37	rules	rule	NOUN
globalce-322	7	38	(	(	PUNCT
globalce-322	7	39	mdr	mdr	PROPN
globalce-322	7	40	)	)	PUNCT
globalce-322	7	41	2017	2017	NUM
globalce-322	7	42	.	.	PUNCT
globalce-322	8	1	in	in	ADP
globalce-322	8	2	general	general	ADJ
globalce-322	8	3	,	,	PUNCT
globalce-322	8	4	as	as	ADP
globalce-322	8	5	the	the	DET
globalce-322	8	6	associated	associated	ADJ
globalce-322	8	7	risk	risk	NOUN
globalce-322	8	8	of	of	ADP
globalce-322	8	9	the	the	DET
globalce-322	8	10	device	device	NOUN
globalce-322	8	11	increases	increase	VERB
globalce-322	8	12	,	,	PUNCT
globalce-322	8	13	the	the	DET
globalce-322	8	14	testing	testing	NOUN
globalce-322	8	15	or	or	CCONJ
globalce-322	8	16	evaluation	evaluation	NOUN
globalce-322	8	17	parameters	parameter	NOUN
globalce-322	8	18	required	require	VERB
globalce-322	8	19	to	to	PART
globalce-322	8	20	establish	establish	VERB
globalce-322	8	21	its	its	PRON
globalce-322	8	22	safety	safety	NOUN
globalce-322	8	23	and	and	CCONJ
globalce-322	8	24	efficacy	efficacy	NOUN
globalce-322	8	25	also	also	ADV
globalce-322	8	26	increases	increase	VERB
globalce-322	8	27	.	.	PUNCT
globalce-322	9	1	in	in	ADP
globalce-322	9	2	this	this	DET
globalce-322	9	3	regard	regard	NOUN
globalce-322	9	4	,	,	PUNCT
globalce-322	9	5	test	test	NOUN
globalce-322	9	6	license	license	NOUN
globalce-322	9	7	is	be	AUX
globalce-322	9	8	introduced	introduce	VERB
globalce-322	9	9	so	so	SCONJ
globalce-322	9	10	that	that	SCONJ
globalce-322	9	11	manufacturers	manufacturer	NOUN
globalce-322	9	12	or	or	CCONJ
globalce-322	9	13	importers	importer	NOUN
globalce-322	9	14	must	must	AUX
globalce-322	9	15	navigate	navigate	VERB
globalce-322	9	16	to	to	PART
globalce-322	9	17	ensure	ensure	VERB
globalce-322	9	18	compliance	compliance	NOUN
globalce-322	9	19	for	for	ADP
globalce-322	9	20	the	the	DET
globalce-322	9	21	generation	generation	NOUN
globalce-322	9	22	of	of	ADP
globalce-322	9	23	data	datum	NOUN
globalce-322	9	24	,	,	PUNCT
globalce-322	9	25	particularly	particularly	ADV
globalce-322	9	26	in	in	ADP
globalce-322	9	27	the	the	DET
globalce-322	9	28	context	context	NOUN
globalce-322	9	29	of	of	ADP
globalce-322	9	30	quality	quality	NOUN
globalce-322	9	31	aspects	aspect	NOUN
globalce-322	9	32	of	of	ADP
globalce-322	9	33	a	a	DET
globalce-322	9	34	md	md	PROPN
globalce-322	9	35	or	or	CCONJ
globalce-322	9	36	in	in	ADP
globalce-322	9	37	vitro	vitro	X
globalce-322	9	38	diagnostics	diagnostic	NOUN
globalce-322	9	39	(	(	PUNCT
globalce-322	9	40	ivd	ivd	NOUN
globalce-322	9	41	)	)	PUNCT
globalce-322	9	42	,	,	PUNCT
globalce-322	9	43	such	such	ADJ
globalce-322	9	44	as	as	ADP
globalce-322	9	45	its	its	PRON
globalce-322	9	46	design	design	NOUN
globalce-322	9	47	verification	verification	NOUN
globalce-322	9	48	and	and	CCONJ
globalce-322	9	49	validation	validation	NOUN
globalce-322	9	50	,	,	PUNCT
globalce-322	9	51	material	material	NOUN
globalce-322	9	52	of	of	ADP
globalce-322	9	53	construction	construction	NOUN
globalce-322	9	54	,	,	PUNCT
globalce-322	9	55	testing	testing	NOUN
globalce-322	9	56	,	,	PUNCT
globalce-322	9	57	functionality	functionality	NOUN
globalce-322	9	58	,	,	PUNCT
globalce-322	9	59	durability	durability	NOUN
globalce-322	9	60	,	,	PUNCT
globalce-322	9	61	sterility	sterility	NOUN
globalce-322	9	62	,	,	PUNCT
globalce-322	9	63	biocompatibility	biocompatibility	NOUN
globalce-322	9	64	,	,	PUNCT
globalce-322	9	65	electrical	electrical	ADJ
globalce-322	9	66	safety	safety	NOUN
globalce-322	9	67	,	,	PUNCT
globalce-322	9	68	usability	usability	NOUN
globalce-322	9	69	,	,	PUNCT
globalce-322	9	70	and	and	CCONJ
globalce-322	9	71	many	many	ADJ
globalce-322	9	72	more	more	ADJ
globalce-322	9	73	.	.	PUNCT
globalce-322	10	1	therefore	therefore	ADV
globalce-322	10	2	,	,	PUNCT
globalce-322	10	3	the	the	DET
globalce-322	10	4	present	present	ADJ
globalce-322	10	5	paper	paper	NOUN
globalce-322	10	6	deals	deal	NOUN
globalce-322	10	7	with	with	ADP
globalce-322	10	8	the	the	DET
globalce-322	10	9	basic	basic	ADJ
globalce-322	10	10	requirement	requirement	NOUN
globalce-322	10	11	and	and	CCONJ
globalce-322	10	12	the	the	DET
globalce-322	10	13	details	detail	NOUN
globalce-322	10	14	of	of	ADP
globalce-322	10	15	the	the	DET
globalce-322	10	16	requisite	requisite	ADJ
globalce-322	10	17	documents	document	NOUN
globalce-322	10	18	for	for	ADP
globalce-322	10	19	the	the	DET
globalce-322	10	20	grant	grant	NOUN
globalce-322	10	21	of	of	ADP
globalce-322	10	22	test	test	NOUN
globalce-322	10	23	license	license	NOUN
globalce-322	10	24	for	for	ADP
globalce-322	10	25	the	the	DET
globalce-322	10	26	aforementioned	aforementioned	ADJ
globalce-322	10	27	purposes	purpose	NOUN
globalce-322	10	28	.	.	PUNCT
globalce-322	11	1	it	it	PRON
globalce-322	11	2	also	also	ADV
globalce-322	11	3	aims	aim	VERB
globalce-322	11	4	to	to	PART
globalce-322	11	5	address	address	VERB
globalce-322	11	6	the	the	DET
globalce-322	11	7	challenges	challenge	NOUN
globalce-322	11	8	so	so	SCONJ
globalce-322	11	9	as	as	SCONJ
globalce-322	11	10	to	to	PART
globalce-322	11	11	reduce	reduce	VERB
globalce-322	11	12	the	the	DET
globalce-322	11	13	time	time	NOUN
globalce-322	11	14	-	-	PUNCT
globalce-322	11	15	lapsed	lapse	VERB
globalce-322	11	16	,	,	PUNCT
globalce-322	11	17	effort	effort	NOUN
globalce-322	11	18	,	,	PUNCT
globalce-322	11	19	and	and	CCONJ
globalce-322	11	20	financial	financial	ADJ
globalce-322	11	21	burden	burden	NOUN
globalce-322	11	22	to	to	ADP
globalce-322	11	23	the	the	DET
globalce-322	11	24	applicant	applicant	NOUN
globalce-322	11	25	.	.	PUNCT
globalce-322	12	1	keywords	keyword	NOUN
globalce-322	12	2	—	—	PUNCT
globalce-322	12	3	medical	medical	ADJ
globalce-322	12	4	device	device	NOUN
globalce-322	12	5	,	,	PUNCT
globalce-322	12	6	in	in	ADP
globalce-322	12	7	vitro	vitro	X
globalce-322	12	8	diagnostics	diagnostic	NOUN
globalce-322	12	9	,	,	PUNCT
globalce-322	12	10	test	test	NOUN
globalce-322	12	11	license	license	NOUN
globalce-322	12	12	,	,	PUNCT
globalce-322	12	13	medical	medical	ADJ
globalce-322	12	14	device	device	NOUN
globalce-322	12	15	rules	rule	NOUN
globalce-322	12	16	,	,	PUNCT
globalce-322	12	17	testing	testing	NOUN
globalce-322	12	18	,	,	PUNCT
globalce-322	12	19	evaluation	evaluation	NOUN
globalce-322	12	20	.	.	PUNCT
globalce-322	13	1	copyright	copyright	NOUN
globalce-322	13	2	©	©	PROPN
globalce-322	13	3	2025	2025	NUM
globalce-322	13	4	.	.	PUNCT
globalce-322	14	1	this	this	PRON
globalce-322	14	2	is	be	AUX
globalce-322	14	3	an	an	DET
globalce-322	14	4	open	open	ADJ
globalce-322	14	5	-	-	PUNCT
globalce-322	14	6	access	access	NOUN
globalce-322	14	7	article	article	NOUN
globalce-322	14	8	distributed	distribute	VERB
globalce-322	14	9	under	under	ADP
globalce-322	14	10	the	the	DET
globalce-322	14	11	terms	term	NOUN
globalce-322	14	12	of	of	ADP
globalce-322	14	13	the	the	DET
globalce-322	14	14	creative	creative	ADJ
globalce-322	14	15	commons	common	NOUN
globalce-322	14	16	attribution	attribution	NOUN
globalce-322	14	17	license	license	NOUN
globalce-322	14	18	(	(	PUNCT
globalce-322	14	19	cc	cc	NOUN
globalce-322	14	20	by	by	ADV
globalce-322	14	21	):	):	PUNCT
globalce-322	14	22	creative	creative	ADJ
globalce-322	14	23	commons	common	NOUN
globalce-322	14	24	attribution	attribution	NOUN
globalce-322	14	25	4.0	4.0	NUM
globalce-322	14	26	international	international	NOUN
globalce-322	14	27	cc	cc	NOUN
globalce-322	14	28	by	by	ADP
globalce-322	14	29	4.0	4.0	NUM
globalce-322	14	30	.	.	PUNCT
globalce-322	15	1	the	the	DET
globalce-322	15	2	use	use	NOUN
globalce-322	15	3	,	,	PUNCT
globalce-322	15	4	distribution	distribution	NOUN
globalce-322	15	5	or	or	CCONJ
globalce-322	15	6	reproduction	reproduction	NOUN
globalce-322	15	7	in	in	ADP
globalce-322	15	8	other	other	ADJ
globalce-322	15	9	forums	forum	NOUN
globalce-322	15	10	is	be	AUX
globalce-322	15	11	permitted	permit	VERB
globalce-322	15	12	,	,	PUNCT
globalce-322	15	13	provided	provide	VERB
globalce-322	15	14	the	the	DET
globalce-322	15	15	original	original	ADJ
globalce-322	15	16	author(s	author(s	NOUN
globalce-322	15	17	)	)	PUNCT
globalce-322	15	18	and	and	CCONJ
globalce-322	15	19	the	the	DET
globalce-322	15	20	copyright	copyright	NOUN
globalce-322	15	21	owner(s	owner(s	NOUN
globalce-322	15	22	)	)	PUNCT
globalce-322	15	23	are	be	AUX
globalce-322	15	24	credited	credit	VERB
globalce-322	15	25	and	and	CCONJ
globalce-322	15	26	that	that	SCONJ
globalce-322	15	27	the	the	DET
globalce-322	15	28	original	original	ADJ
globalce-322	15	29	publication	publication	NOUN
globalce-322	15	30	in	in	ADP
globalce-322	15	31	this	this	DET
globalce-322	15	32	journal	journal	NOUN
globalce-322	15	33	is	be	AUX
globalce-322	15	34	cited	cite	VERB
globalce-322	15	35	,	,	PUNCT
globalce-322	15	36	in	in	ADP
globalce-322	15	37	accordance	accordance	NOUN
globalce-322	15	38	with	with	ADP
globalce-322	15	39	accepted	accept	VERB
globalce-322	15	40	academic	academic	ADJ
globalce-322	15	41	practice	practice	NOUN
globalce-322	15	42	.	.	PUNCT
globalce-322	16	1	no	no	DET
globalce-322	16	2	use	use	NOUN
globalce-322	16	3	,	,	PUNCT
globalce-322	16	4	distribution	distribution	NOUN
globalce-322	16	5	or	or	CCONJ
globalce-322	16	6	reproduction	reproduction	NOUN
globalce-322	16	7	is	be	AUX
globalce-322	16	8	permitted	permit	VERB
globalce-322	16	9	which	which	PRON
globalce-322	16	10	does	do	AUX
globalce-322	16	11	not	not	PART
globalce-322	16	12	comply	comply	VERB
globalce-322	16	13	with	with	ADP
globalce-322	16	14	these	these	DET
globalce-322	16	15	terms	term	NOUN
globalce-322	16	16	.	.	PUNCT
globalce-322	16	17	http://www.globalce.org	http://www.globalce.org	PUNCT
globalce-322	17	1	http://globalce.org	http://globalce.org	PROPN
globalce-322	17	2	http://globalce.org	http://globalce.org	PROPN
globalce-322	17	3	mailto:rupakraman@gmail.com	mailto:rupakraman@gmail.com	X
globalce-322	17	4	mailto:mulugetamideksa@gmail.com	mailto:mulugetamideksa@gmail.com	PROPN
globalce-322	17	5	mailto:mulugetamideksa@gmail.com	mailto:mulugetamideksa@gmail.com	PROPN
globalce-322	17	6	mailto:mulugetamideksa@gmail.com	mailto:mulugetamideksa@gmail.com	PROPN
globalce-322	17	7	https://creativecommons.org/licenses/by/4.0/	https://creativecommons.org/licenses/by/4.0/	PROPN
globalce-322	17	8	https://creativecommons.org/licenses/by/4.0/	https://creativecommons.org/licenses/by/4.0/	PROPN
globalce-322	17	9	kumar	kumar	PROPN
globalce-322	17	10	,	,	PUNCT
globalce-322	17	11	gupta	gupta	PROPN
globalce-322	17	12	,	,	PUNCT
globalce-322	17	13	batra	batra	PROPN
globalce-322	17	14	,	,	PUNCT
globalce-322	17	15	sahu	sahu	PROPN
globalce-322	17	16	and	and	CCONJ
globalce-322	17	17	markan	markan	PROPN
globalce-322	17	18	:	:	PUNCT
globalce-322	17	19	catchment	catchment	NOUN
globalce-322	17	20	of	of	ADP
globalce-322	17	21	the	the	DET
globalce-322	17	22	test	test	NOUN
globalce-322	17	23	license	license	NOUN
globalce-322	17	24	for	for	ADP
globalce-322	17	25	the	the	DET
globalce-322	17	26	regulation	regulation	NOUN
globalce-322	17	27	of	of	ADP
globalce-322	17	28	medical	medical	ADJ
globalce-322	17	29	devices	device	NOUN
globalce-322	17	30	in	in	ADP
globalce-322	17	31	india	india	PROPN
globalce-322	17	32	j	j	PROPN
globalce-322	17	33	global	global	ADJ
globalce-322	17	34	clinical	clinical	ADJ
globalce-322	17	35	engineering	engineering	NOUN
globalce-322	17	36	vol.7	vol.7	PROPN
globalce-322	17	37	issue	issue	NOUN
globalce-322	17	38	3	3	NUM
globalce-322	17	39	:	:	SYM
globalce-322	17	40	2025	2025	NUM
globalce-322	17	41	48	48	NUM
globalce-322	17	42	introduction	introduction	NOUN
globalce-322	17	43	the	the	DET
globalce-322	17	44	medical	medical	ADJ
globalce-322	17	45	device	device	NOUN
globalce-322	17	46	sector	sector	NOUN
globalce-322	17	47	in	in	ADP
globalce-322	17	48	india	india	PROPN
globalce-322	17	49	is	be	AUX
globalce-322	17	50	the	the	DET
globalce-322	17	51	fourth	fourth	ADV
globalce-322	17	52	largest	large	ADJ
globalce-322	17	53	medical	medical	ADJ
globalce-322	17	54	devices	device	NOUN
globalce-322	17	55	(	(	PUNCT
globalce-322	17	56	md	md	PROPN
globalce-322	17	57	)	)	PUNCT
globalce-322	17	58	market	market	NOUN
globalce-322	17	59	in	in	ADP
globalce-322	17	60	asia	asia	PROPN
globalce-322	17	61	after	after	ADP
globalce-322	17	62	japan	japan	PROPN
globalce-322	17	63	,	,	PUNCT
globalce-322	17	64	china	china	PROPN
globalce-322	17	65	,	,	PUNCT
globalce-322	17	66	and	and	CCONJ
globalce-322	17	67	south	south	PROPN
globalce-322	17	68	korea	korea	PROPN
globalce-322	17	69	,	,	PUNCT
globalce-322	17	70	and	and	CCONJ
globalce-322	17	71	is	be	AUX
globalce-322	17	72	among	among	ADP
globalce-322	17	73	the	the	DET
globalce-322	17	74	top	top	NOUN
globalce-322	17	75	twenty	twenty	NUM
globalce-322	17	76	globally	globally	ADV
globalce-322	17	77	because	because	SCONJ
globalce-322	17	78	of	of	ADP
globalce-322	17	79	its	its	PRON
globalce-322	17	80	growth	growth	NOUN
globalce-322	17	81	potential	potential	NOUN
globalce-322	17	82	driven	drive	VERB
globalce-322	17	83	by	by	ADP
globalce-322	17	84	the	the	DET
globalce-322	17	85	country	country	NOUN
globalce-322	17	86	’s	’s	PART
globalce-322	17	87	increasing	increase	VERB
globalce-322	17	88	healthcare	healthcare	NOUN
globalce-322	17	89	demands	demand	NOUN
globalce-322	17	90	,	,	PUNCT
globalce-322	17	91	technological	technological	ADJ
globalce-322	17	92	advancement	advancement	NOUN
globalce-322	17	93	,	,	PUNCT
globalce-322	17	94	innovations	innovation	NOUN
globalce-322	17	95	,	,	PUNCT
globalce-322	17	96	and	and	CCONJ
globalce-322	17	97	government	government	NOUN
globalce-322	17	98	support	support	NOUN
globalce-322	17	99	through	through	ADP
globalce-322	17	100	various	various	ADJ
globalce-322	17	101	initiatives	initiative	NOUN
globalce-322	17	102	or	or	CCONJ
globalce-322	17	103	incentive	incentive	NOUN
globalce-322	17	104	opportunities.1	opportunities.1	PROPN
globalce-322	17	105	as	as	SCONJ
globalce-322	17	106	md	md	PROPN
globalce-322	17	107	have	have	VERB
globalce-322	17	108	a	a	DET
globalce-322	17	109	significant	significant	ADJ
globalce-322	17	110	potential	potential	NOUN
globalce-322	17	111	for	for	ADP
globalce-322	17	112	hazards	hazard	NOUN
globalce-322	17	113	,	,	PUNCT
globalce-322	17	114	it	it	PRON
globalce-322	17	115	should	should	AUX
globalce-322	17	116	be	be	AUX
globalce-322	17	117	ensured	ensure	VERB
globalce-322	17	118	that	that	SCONJ
globalce-322	17	119	they	they	PRON
globalce-322	17	120	are	be	AUX
globalce-322	17	121	safe	safe	ADJ
globalce-322	17	122	and	and	CCONJ
globalce-322	17	123	effective	effective	ADJ
globalce-322	17	124	before	before	ADP
globalce-322	17	125	being	be	AUX
globalce-322	17	126	marketed	market	VERB
globalce-322	17	127	.	.	PUNCT
globalce-322	18	1	thus	thus	ADV
globalce-322	18	2	,	,	PUNCT
globalce-322	18	3	govt	govt	PROPN
globalce-322	18	4	.	.	PUNCT
globalce-322	19	1	of	of	ADP
globalce-322	19	2	india	india	PROPN
globalce-322	19	3	(	(	PUNCT
globalce-322	19	4	goi	goi	PROPN
globalce-322	19	5	)	)	PUNCT
globalce-322	19	6	,	,	PUNCT
globalce-322	19	7	ministry	ministry	PROPN
globalce-322	19	8	of	of	ADP
globalce-322	19	9	health	health	PROPN
globalce-322	19	10	and	and	CCONJ
globalce-322	19	11	family	family	NOUN
globalce-322	19	12	welfare	welfare	NOUN
globalce-322	19	13	’s	’s	PART
globalce-322	19	14	central	central	ADJ
globalce-322	19	15	drugs	drug	NOUN
globalce-322	19	16	standard	standard	PROPN
globalce-322	19	17	control	control	PROPN
globalce-322	19	18	organization	organization	PROPN
globalce-322	19	19	(	(	PUNCT
globalce-322	19	20	cdsco	cdsco	PROPN
globalce-322	19	21	)	)	PUNCT
globalce-322	19	22	headed	head	VERB
globalce-322	19	23	by	by	ADP
globalce-322	19	24	the	the	DET
globalce-322	19	25	drug	drug	NOUN
globalce-322	19	26	controller	controller	NOUN
globalce-322	19	27	general	general	NOUN
globalce-322	19	28	of	of	ADP
globalce-322	19	29	india	india	PROPN
globalce-322	19	30	(	(	PUNCT
globalce-322	19	31	dcgi	dcgi	PROPN
globalce-322	19	32	)	)	PUNCT
globalce-322	19	33	,	,	PUNCT
globalce-322	19	34	who	who	PRON
globalce-322	19	35	is	be	AUX
globalce-322	19	36	the	the	DET
globalce-322	19	37	central	central	ADJ
globalce-322	19	38	licensing	licensing	NOUN
globalce-322	19	39	authority	authority	NOUN
globalce-322	19	40	(	(	PUNCT
globalce-322	19	41	cla	cla	PROPN
globalce-322	19	42	)	)	PUNCT
globalce-322	19	43	,	,	PUNCT
globalce-322	19	44	has	have	AUX
globalce-322	19	45	notified	notify	VERB
globalce-322	19	46	medical	medical	ADJ
globalce-322	19	47	devices	device	NOUN
globalce-322	19	48	rules	rule	NOUN
globalce-322	19	49	(	(	PUNCT
globalce-322	19	50	mdr	mdr	PROPN
globalce-322	19	51	)	)	PUNCT
globalce-322	19	52	,	,	PUNCT
globalce-322	19	53	2017	2017	NUM
globalce-322	19	54	,	,	PUNCT
globalce-322	19	55	vide	vide	NOUN
globalce-322	19	56	gsr	gsr	NOUN
globalce-322	19	57	78(e	78(e	NUM
globalce-322	19	58	)	)	PUNCT
globalce-322	19	59	,	,	PUNCT
globalce-322	19	60	dated	date	VERB
globalce-322	19	61	31st	31st	ADJ
globalce-322	19	62	january	january	NOUN
globalce-322	19	63	2017	2017	NUM
globalce-322	19	64	,	,	PUNCT
globalce-322	19	65	effective	effective	ADJ
globalce-322	19	66	from	from	ADP
globalce-322	19	67	1st	1st	ADJ
globalce-322	19	68	january	january	PROPN
globalce-322	19	69	,	,	PUNCT
globalce-322	19	70	2018	2018	NUM
globalce-322	19	71	,	,	PUNCT
globalce-322	19	72	and	and	CCONJ
globalce-322	19	73	its	its	PRON
globalce-322	19	74	amendment	amendment	NOUN
globalce-322	19	75	came	come	VERB
globalce-322	19	76	into	into	ADP
globalce-322	19	77	effect	effect	NOUN
globalce-322	19	78	as	as	SCONJ
globalce-322	19	79	medical	medical	ADJ
globalce-322	19	80	devices	device	NOUN
globalce-322	19	81	(	(	PUNCT
globalce-322	19	82	amendment	amendment	NOUN
globalce-322	19	83	)	)	PUNCT
globalce-322	19	84	rules	rule	NOUN
globalce-322	19	85	,	,	PUNCT
globalce-322	19	86	2020	2020	NUM
globalce-322	19	87	vide	vide	NOUN
globalce-322	19	88	gsr	gsr	PROPN
globalce-322	19	89	777(e	777(e	PROPN
globalce-322	19	90	)	)	PUNCT
globalce-322	19	91	dated	date	VERB
globalce-322	19	92	14th	14th	ADJ
globalce-322	19	93	october	october	PROPN
globalce-322	19	94	,	,	PUNCT
globalce-322	19	95	2022	2022	NUM
globalce-322	19	96	,	,	PUNCT
globalce-322	19	97	effective	effective	ADJ
globalce-322	19	98	from	from	ADP
globalce-322	19	99	14th	14th	ADJ
globalce-322	19	100	october	october	PROPN
globalce-322	19	101	,	,	PUNCT
globalce-322	19	102	2022	2022	NUM
globalce-322	19	103	,	,	PUNCT
globalce-322	19	104	to	to	PART
globalce-322	19	105	have	have	VERB
globalce-322	19	106	specific	specific	ADJ
globalce-322	19	107	requirements	requirement	NOUN
globalce-322	19	108	for	for	ADP
globalce-322	19	109	md	md	PROPN
globalce-322	19	110	that	that	PRON
globalce-322	19	111	have	have	AUX
globalce-322	19	112	been	be	AUX
globalce-322	19	113	framed	frame	VERB
globalce-322	19	114	in	in	ADP
globalce-322	19	115	conformity	conformity	NOUN
globalce-322	19	116	with	with	ADP
globalce-322	19	117	the	the	DET
globalce-322	19	118	global	global	ADJ
globalce-322	19	119	harmonization	harmonization	PROPN
globalce-322	19	120	task	task	PROPN
globalce-322	19	121	force	force	NOUN
globalce-322	19	122	(	(	PUNCT
globalce-322	19	123	ghtf	ghtf	PROPN
globalce-322	19	124	)	)	PUNCT
globalce-322	19	125	framework	framework	NOUN
globalce-322	19	126	in	in	ADP
globalce-322	19	127	order	order	NOUN
globalce-322	19	128	to	to	PART
globalce-322	19	129	align	align	VERB
globalce-322	19	130	with	with	ADP
globalce-322	19	131	the	the	DET
globalce-322	19	132	best	good	ADJ
globalce-322	19	133	international	international	ADJ
globalce-322	19	134	practices	practice	NOUN
globalce-322	19	135	wherein	wherein	SCONJ
globalce-322	19	136	the	the	DET
globalce-322	19	137	requirements	requirement	NOUN
globalce-322	19	138	for	for	ADP
globalce-322	19	139	import	import	NOUN
globalce-322	19	140	,	,	PUNCT
globalce-322	19	141	manufacture	manufacture	NOUN
globalce-322	19	142	,	,	PUNCT
globalce-322	19	143	clinical	clinical	ADJ
globalce-322	19	144	investigation	investigation	NOUN
globalce-322	19	145	/	/	SYM
globalce-322	19	146	performance	performance	NOUN
globalce-322	19	147	,	,	PUNCT
globalce-322	19	148	sale	sale	NOUN
globalce-322	19	149	and	and	CCONJ
globalce-322	19	150	distribution	distribution	NOUN
globalce-322	19	151	of	of	ADP
globalce-322	19	152	md	md	NOUN
globalce-322	19	153	including	include	VERB
globalce-322	19	154	in	in	ADP
globalce-322	19	155	vitro	vitro	X
globalce-322	19	156	diagnostics	diagnostic	NOUN
globalce-322	19	157	(	(	PUNCT
globalce-322	19	158	ivd	ivd	NOUN
globalce-322	19	159	)	)	PUNCT
globalce-322	19	160	have	have	AUX
globalce-322	19	161	been	be	AUX
globalce-322	19	162	prescribed.2	prescribed.2	NOUN
globalce-322	19	163	as	as	SCONJ
globalce-322	19	164	india	india	PROPN
globalce-322	19	165	recently	recently	ADV
globalce-322	19	166	joined	join	VERB
globalce-322	19	167	the	the	DET
globalce-322	19	168	international	international	ADJ
globalce-322	19	169	medical	medical	ADJ
globalce-322	19	170	device	device	NOUN
globalce-322	19	171	regulators	regulator	NOUN
globalce-322	19	172	forum	forum	NOUN
globalce-322	19	173	(	(	PUNCT
globalce-322	19	174	imdrf	imdrf	PROPN
globalce-322	19	175	)	)	PUNCT
globalce-322	19	176	on	on	ADP
globalce-322	19	177	3rd	3rd	PROPN
globalce-322	19	178	october	october	PROPN
globalce-322	19	179	,	,	PUNCT
globalce-322	19	180	2024	2024	NUM
globalce-322	19	181	,	,	PUNCT
globalce-322	19	182	as	as	SCONJ
globalce-322	19	183	an	an	DET
globalce-322	19	184	affiliate	affiliate	NOUN
globalce-322	19	185	member	member	NOUN
globalce-322	19	186	to	to	PART
globalce-322	19	187	accelerate	accelerate	VERB
globalce-322	19	188	global	global	ADJ
globalce-322	19	189	collaboration	collaboration	NOUN
globalce-322	19	190	,	,	PUNCT
globalce-322	19	191	harmonization	harmonization	NOUN
globalce-322	19	192	,	,	PUNCT
globalce-322	19	193	and	and	CCONJ
globalce-322	19	194	convergence	convergence	NOUN
globalce-322	19	195	in	in	ADP
globalce-322	19	196	medical	medical	ADJ
globalce-322	19	197	device	device	NOUN
globalce-322	19	198	regulations	regulation	NOUN
globalce-322	19	199	,	,	PUNCT
globalce-322	19	200	the	the	DET
globalce-322	19	201	importance	importance	NOUN
globalce-322	19	202	of	of	ADP
globalce-322	19	203	test	test	NOUN
globalce-322	19	204	license	license	NOUN
globalce-322	19	205	significantly	significantly	ADV
globalce-322	19	206	helps	help	VERB
globalce-322	19	207	to	to	PART
globalce-322	19	208	protect	protect	VERB
globalce-322	19	209	public	public	ADJ
globalce-322	19	210	health.3	health.3	NOUN
globalce-322	19	211	at	at	ADP
globalce-322	19	212	present	present	ADJ
globalce-322	19	213	,	,	PUNCT
globalce-322	19	214	38	38	NUM
globalce-322	19	215	categories	category	NOUN
globalce-322	19	216	of	of	ADP
globalce-322	19	217	md	md	PROPN
globalce-322	19	218	have	have	AUX
globalce-322	19	219	been	be	AUX
globalce-322	19	220	notified	notify	VERB
globalce-322	19	221	and	and	CCONJ
globalce-322	19	222	regulated	regulate	VERB
globalce-322	19	223	;	;	PUNCT
globalce-322	19	224	the	the	DET
globalce-322	19	225	current	current	ADJ
globalce-322	19	226	regulatory	regulatory	ADJ
globalce-322	19	227	practices	practice	NOUN
globalce-322	19	228	in	in	ADP
globalce-322	19	229	india	india	PROPN
globalce-322	19	230	are	be	AUX
globalce-322	19	231	fully	fully	ADV
globalce-322	19	232	geared	gear	VERB
globalce-322	19	233	to	to	PART
globalce-322	19	234	meet	meet	VERB
globalce-322	19	235	the	the	DET
globalce-322	19	236	requirements	requirement	NOUN
globalce-322	19	237	to	to	PART
globalce-322	19	238	introduce	introduce	VERB
globalce-322	19	239	in	in	ADP
globalce-322	19	240	the	the	DET
globalce-322	19	241	country.4	country.4	NOUN
globalce-322	19	242	the	the	DET
globalce-322	19	243	present	present	ADJ
globalce-322	19	244	study	study	NOUN
globalce-322	19	245	provides	provide	VERB
globalce-322	19	246	a	a	DET
globalce-322	19	247	critical	critical	ADJ
globalce-322	19	248	explanation	explanation	NOUN
globalce-322	19	249	and	and	CCONJ
globalce-322	19	250	significance	significance	NOUN
globalce-322	19	251	of	of	ADP
globalce-322	19	252	the	the	DET
globalce-322	19	253	regulatory	regulatory	ADJ
globalce-322	19	254	framework	framework	NOUN
globalce-322	19	255	’s	’s	PART
globalce-322	19	256	initiation	initiation	NOUN
globalce-322	19	257	,	,	PUNCT
globalce-322	19	258	that	that	ADV
globalce-322	19	259	is	is	ADV
globalce-322	19	260	,	,	PUNCT
globalce-322	19	261	commencement	commencement	NOUN
globalce-322	19	262	of	of	ADP
globalce-322	19	263	test	test	NOUN
globalce-322	19	264	license	license	NOUN
globalce-322	19	265	governing	govern	VERB
globalce-322	19	266	md	md	PROPN
globalce-322	19	267	,	,	PUNCT
globalce-322	19	268	aiming	aim	VERB
globalce-322	19	269	to	to	PART
globalce-322	19	270	annotate	annotate	VERB
globalce-322	19	271	how	how	SCONJ
globalce-322	19	272	such	such	ADJ
globalce-322	19	273	pivotal	pivotal	ADJ
globalce-322	19	274	approvals	approval	NOUN
globalce-322	19	275	have	have	AUX
globalce-322	19	276	shaped	shape	VERB
globalce-322	19	277	the	the	DET
globalce-322	19	278	current	current	ADJ
globalce-322	19	279	regulatory	regulatory	ADJ
globalce-322	19	280	landscape	landscape	NOUN
globalce-322	19	281	and	and	CCONJ
globalce-322	19	282	influenced	influence	VERB
globalce-322	19	283	the	the	DET
globalce-322	19	284	md	md	PROPN
globalce-322	19	285	industry	industry	NOUN
globalce-322	19	286	in	in	ADP
globalce-322	19	287	india	india	PROPN
globalce-322	19	288	.	.	PUNCT
globalce-322	20	1	it	it	PRON
globalce-322	20	2	is	be	AUX
globalce-322	20	3	mandatory	mandatory	ADJ
globalce-322	20	4	that	that	SCONJ
globalce-322	20	5	,	,	PUNCT
globalce-322	20	6	an	an	DET
globalce-322	20	7	applicant	applicant	NOUN
globalce-322	20	8	shall	shall	AUX
globalce-322	20	9	apply	apply	VERB
globalce-322	20	10	for	for	ADP
globalce-322	20	11	test	test	NOUN
globalce-322	20	12	license	license	NOUN
globalce-322	20	13	for	for	ADP
globalce-322	20	14	manufacturing	manufacturing	NOUN
globalce-322	20	15	or	or	CCONJ
globalce-322	20	16	importing	import	VERB
globalce-322	20	17	a	a	DET
globalce-322	20	18	small	small	ADJ
globalce-322	20	19	quantity	quantity	NOUN
globalce-322	20	20	of	of	ADP
globalce-322	20	21	md	md	PROPN
globalce-322	20	22	/	/	SYM
globalce-322	20	23	ivd	ivd	PROPN
globalce-322	20	24	(	(	PUNCT
globalce-322	20	25	in	in	ADP
globalce-322	20	26	case	case	NOUN
globalce-322	20	27	of	of	ADP
globalce-322	20	28	both	both	DET
globalce-322	20	29	availability	availability	NOUN
globalce-322	20	30	and	and	CCONJ
globalce-322	20	31	unavailability	unavailability	NOUN
globalce-322	20	32	of	of	ADP
globalce-322	20	33	predicate	predicate	NOUN
globalce-322	20	34	device	device	NOUN
globalce-322	20	35	in	in	ADP
globalce-322	20	36	india	india	PROPN
globalce-322	20	37	)	)	PUNCT
globalce-322	20	38	to	to	PART
globalce-322	20	39	manufacture/	manufacture/	VERB
globalce-322	20	40	import	import	NOUN
globalce-322	20	41	three	three	NUM
globalce-322	20	42	consecutive	consecutive	ADJ
globalce-322	20	43	test	test	NOUN
globalce-322	20	44	batches	batch	NOUN
globalce-322	20	45	accompanied	accompany	VERB
globalce-322	20	46	with	with	ADP
globalce-322	20	47	a	a	DET
globalce-322	20	48	fee	fee	NOUN
globalce-322	20	49	,	,	PUNCT
globalce-322	20	50	as	as	SCONJ
globalce-322	20	51	specified	specify	VERB
globalce-322	20	52	in	in	ADP
globalce-322	20	53	the	the	DET
globalce-322	20	54	second	second	ADJ
globalce-322	20	55	schedule	schedule	NOUN
globalce-322	20	56	of	of	ADP
globalce-322	20	57	mdr-2017	mdr-2017	NOUN
globalce-322	20	58	having	have	VERB
globalce-322	20	59	a	a	DET
globalce-322	20	60	validity	validity	NOUN
globalce-322	20	61	of	of	ADP
globalce-322	20	62	three	three	NUM
globalce-322	20	63	years	year	NOUN
globalce-322	20	64	.	.	PUNCT
globalce-322	21	1	a	a	DET
globalce-322	21	2	predicate	predicate	NOUN
globalce-322	21	3	device	device	NOUN
globalce-322	21	4	is	be	AUX
globalce-322	21	5	an	an	DET
globalce-322	21	6	approved	approved	ADJ
globalce-322	21	7	md	md	PROPN
globalce-322	21	8	(	(	PUNCT
globalce-322	21	9	manufacture	manufacture	NOUN
globalce-322	21	10	/	/	SYM
globalce-322	21	11	import	import	NOUN
globalce-322	21	12	)	)	PUNCT
globalce-322	21	13	that	that	PRON
globalce-322	21	14	may	may	AUX
globalce-322	21	15	be	be	AUX
globalce-322	21	16	legally	legally	ADV
globalce-322	21	17	marketed	market	VERB
globalce-322	21	18	in	in	ADP
globalce-322	21	19	the	the	DET
globalce-322	21	20	country	country	NOUN
globalce-322	21	21	of	of	ADP
globalce-322	21	22	origin	origin	NOUN
globalce-322	21	23	or	or	CCONJ
globalce-322	21	24	globally	globally	ADV
globalce-322	21	25	and	and	CCONJ
globalce-322	21	26	used	use	VERB
globalce-322	21	27	as	as	ADP
globalce-322	21	28	a	a	DET
globalce-322	21	29	point	point	NOUN
globalce-322	21	30	of	of	ADP
globalce-322	21	31	comparison	comparison	NOUN
globalce-322	21	32	for	for	ADP
globalce-322	21	33	new	new	ADJ
globalce-322	21	34	ivd	ivd	PROPN
globalce-322	21	35	/	/	SYM
globalce-322	21	36	investigational	investigational	ADJ
globalce-322	21	37	md	md	NOUN
globalce-322	21	38	seeking	seek	VERB
globalce-322	21	39	approval	approval	NOUN
globalce-322	21	40	through	through	ADP
globalce-322	21	41	cdsco	cdsco	PROPN
globalce-322	21	42	.	.	PUNCT
globalce-322	22	1	an	an	DET
globalce-322	22	2	applicant	applicant	NOUN
globalce-322	22	3	can	can	AUX
globalce-322	22	4	choose	choose	VERB
globalce-322	22	5	the	the	DET
globalce-322	22	6	right	right	ADJ
globalce-322	22	7	predicate	predicate	NOUN
globalce-322	22	8	device	device	NOUN
globalce-322	22	9	that	that	PRON
globalce-322	22	10	is	be	AUX
globalce-322	22	11	similar/	similar/	NUM
globalce-322	22	12	subsequent	subsequent	ADJ
globalce-322	22	13	equivalence	equivalence	NOUN
globalce-322	22	14	to	to	ADP
globalce-322	22	15	the	the	DET
globalce-322	22	16	subject	subject	ADJ
globalce-322	22	17	device	device	NOUN
globalce-322	22	18	with	with	ADP
globalce-322	22	19	regard	regard	NOUN
globalce-322	22	20	to	to	ADP
globalce-322	22	21	indications	indication	NOUN
globalce-322	22	22	for	for	ADP
globalce-322	22	23	use	use	NOUN
globalce-322	22	24	(	(	PUNCT
globalce-322	22	25	disease	disease	NOUN
globalce-322	22	26	treatment	treatment	NOUN
globalce-322	22	27	/	/	SYM
globalce-322	22	28	screening	screening	NOUN
globalce-322	22	29	/	/	SYM
globalce-322	22	30	diagnosis/	diagnosis/	NUM
globalce-322	22	31	management	management	NOUN
globalce-322	22	32	)	)	PUNCT
globalce-322	22	33	,	,	PUNCT
globalce-322	22	34	material	material	NOUN
globalce-322	22	35	of	of	ADP
globalce-322	22	36	construction	construction	NOUN
globalce-322	22	37	(	(	PUNCT
globalce-322	22	38	moc	moc	NOUN
globalce-322	22	39	)	)	PUNCT
globalce-322	22	40	,	,	PUNCT
globalce-322	22	41	design	design	NOUN
globalce-322	22	42	and	and	CCONJ
globalce-322	22	43	technological	technological	ADJ
globalce-322	22	44	characteristics	characteristic	NOUN
globalce-322	22	45	/	/	SYM
globalce-322	22	46	underlying	underlie	VERB
globalce-322	22	47	principle	principle	NOUN
globalce-322	22	48	,	,	PUNCT
globalce-322	22	49	and	and	CCONJ
globalce-322	22	50	types	type	NOUN
globalce-322	22	51	of	of	ADP
globalce-322	22	52	specimen	speciman	NOUN
globalce-322	22	53	.	.	PUNCT
globalce-322	23	1	any	any	DET
globalce-322	23	2	remarkable	remarkable	ADJ
globalce-322	23	3	change	change	NOUN
globalce-322	23	4	in	in	ADP
globalce-322	23	5	the	the	DET
globalce-322	23	6	said	say	VERB
globalce-322	23	7	features	feature	NOUN
globalce-322	23	8	that	that	PRON
globalce-322	23	9	does	do	AUX
globalce-322	23	10	not	not	PART
globalce-322	23	11	come	come	VERB
globalce-322	23	12	under	under	ADP
globalce-322	23	13	the	the	DET
globalce-322	23	14	predicate	predicate	NOUN
globalce-322	23	15	device	device	NOUN
globalce-322	23	16	are	be	AUX
globalce-322	23	17	supposed	suppose	VERB
globalce-322	23	18	to	to	PART
globalce-322	23	19	be	be	AUX
globalce-322	23	20	investigational	investigational	ADJ
globalce-322	23	21	md	md	PROPN
globalce-322	23	22	/	/	SYM
globalce-322	23	23	new	new	PROPN
globalce-322	23	24	ivd	ivd	NOUN
globalce-322	23	25	.	.	PUNCT
globalce-322	24	1	moreover	moreover	ADV
globalce-322	24	2	,	,	PUNCT
globalce-322	24	3	if	if	SCONJ
globalce-322	24	4	no	no	DET
globalce-322	24	5	such	such	ADJ
globalce-322	24	6	predicate	predicate	NOUN
globalce-322	24	7	device	device	NOUN
globalce-322	24	8	is	be	AUX
globalce-322	24	9	available	available	ADJ
globalce-322	24	10	in	in	ADP
globalce-322	24	11	india	india	PROPN
globalce-322	24	12	against	against	ADP
globalce-322	24	13	the	the	DET
globalce-322	24	14	proposed	propose	VERB
globalce-322	24	15	device	device	NOUN
globalce-322	24	16	,	,	PUNCT
globalce-322	24	17	meaning	mean	VERB
globalce-322	24	18	that	that	SCONJ
globalce-322	24	19	it	it	PRON
globalce-322	24	20	comes	come	VERB
globalce-322	24	21	under	under	ADP
globalce-322	24	22	the	the	DET
globalce-322	24	23	scope	scope	NOUN
globalce-322	24	24	of	of	ADP
globalce-322	24	25	investigational	investigational	ADJ
globalce-322	24	26	md	md	NOUN
globalce-322	24	27	or	or	CCONJ
globalce-322	24	28	new	new	PROPN
globalce-322	24	29	ivd	ivd	PROPN
globalce-322	24	30	,	,	PUNCT
globalce-322	24	31	the	the	DET
globalce-322	24	32	applicant	applicant	NOUN
globalce-322	24	33	must	must	AUX
globalce-322	24	34	also	also	ADV
globalce-322	24	35	initiate	initiate	VERB
globalce-322	24	36	the	the	DET
globalce-322	24	37	regulatory	regulatory	ADJ
globalce-322	24	38	approval	approval	NOUN
globalce-322	24	39	by	by	ADP
globalce-322	24	40	applying	apply	VERB
globalce-322	24	41	for	for	ADP
globalce-322	24	42	test	test	NOUN
globalce-322	24	43	license	license	NOUN
globalce-322	24	44	.	.	PUNCT
globalce-322	25	1	initiation	initiation	NOUN
globalce-322	25	2	of	of	ADP
globalce-322	25	3	test	test	NOUN
globalce-322	25	4	license	license	NOUN
globalce-322	25	5	a	a	DET
globalce-322	25	6	test	test	NOUN
globalce-322	25	7	license	license	NOUN
globalce-322	25	8	is	be	AUX
globalce-322	25	9	required	require	VERB
globalce-322	25	10	to	to	PART
globalce-322	25	11	ensure	ensure	VERB
globalce-322	25	12	that	that	SCONJ
globalce-322	25	13	md	md	PROPN
globalce-322	25	14	/	/	SYM
globalce-322	25	15	ivd	ivd	PROPN
globalce-322	25	16	is	be	AUX
globalce-322	25	17	safe	safe	ADJ
globalce-322	25	18	,	,	PUNCT
globalce-322	25	19	effective	effective	ADJ
globalce-322	25	20	,	,	PUNCT
globalce-322	25	21	and	and	CCONJ
globalce-322	25	22	meets	meet	VERB
globalce-322	25	23	quality	quality	NOUN
globalce-322	25	24	standards	standard	NOUN
globalce-322	25	25	before	before	SCONJ
globalce-322	25	26	they	they	PRON
globalce-322	25	27	are	be	AUX
globalce-322	25	28	sold	sell	VERB
globalce-322	25	29	or	or	CCONJ
globalce-322	25	30	used	use	VERB
globalce-322	25	31	.	.	PUNCT
globalce-322	26	1	test	test	NOUN
globalce-322	26	2	license	license	NOUN
globalce-322	26	3	is	be	AUX
globalce-322	26	4	a	a	DET
globalce-322	26	5	type	type	NOUN
globalce-322	26	6	of	of	ADP
globalce-322	26	7	approval	approval	NOUN
globalce-322	26	8	from	from	ADP
globalce-322	26	9	cla	cla	PROPN
globalce-322	26	10	that	that	PRON
globalce-322	26	11	allows	allow	VERB
globalce-322	26	12	an	an	DET
globalce-322	26	13	applicant	applicant	ADJ
globalce-322	26	14	(	(	PUNCT
globalce-322	26	15	person	person	NOUN
globalce-322	26	16	/	/	SYM
globalce-322	26	17	firm	firm	NOUN
globalce-322	26	18	/	/	SYM
globalce-322	26	19	organization/	organization/	NUM
globalce-322	26	20	startup	startup	NOUN
globalce-322	26	21	/	/	SYM
globalce-322	26	22	innovator	innovator	NOUN
globalce-322	26	23	/	/	SYM
globalce-322	26	24	institute	institute	PROPN
globalce-322	26	25	/	/	SYM
globalce-322	26	26	sole	sole	ADJ
globalce-322	26	27	proprietor	proprietor	NOUN
globalce-322	26	28	/	/	SYM
globalce-322	26	29	limited	limit	VERB
globalce-322	26	30	liability	liability	NOUN
globalce-322	26	31	partnership	partnership	NOUN
globalce-322	26	32	/	/	SYM
globalce-322	26	33	others	other	NOUN
globalce-322	26	34	)	)	PUNCT
globalce-322	26	35	as	as	SCONJ
globalce-322	26	36	manufacturer	manufacturer	NOUN
globalce-322	26	37	or	or	CCONJ
globalce-322	26	38	importer	importer	NOUN
globalce-322	26	39	for	for	ADP
globalce-322	26	40	all	all	DET
globalce-322	26	41	risk	risk	NOUN
globalce-322	26	42	-	-	PUNCT
globalce-322	26	43	based	base	VERB
globalce-322	26	44	classification	classification	NOUN
globalce-322	26	45	to	to	PART
globalce-322	26	46	make	make	VERB
globalce-322	26	47	or	or	CCONJ
globalce-322	26	48	import	import	VERB
globalce-322	26	49	a	a	DET
globalce-322	26	50	test	test	NOUN
globalce-322	26	51	device	device	NOUN
globalce-322	26	52	or	or	CCONJ
globalce-322	26	53	ivd	ivd	VERB
globalce-322	26	54	in	in	ADP
globalce-322	26	55	a	a	DET
globalce-322	26	56	small	small	ADJ
globalce-322	26	57	quantity	quantity	NOUN
globalce-322	26	58	(	(	PUNCT
globalce-322	26	59	figures	figure	NOUN
globalce-322	26	60	1a	1a	NOUN
globalce-322	26	61	and	and	CCONJ
globalce-322	26	62	1b	1b	NUM
globalce-322	26	63	)	)	PUNCT
globalce-322	26	64	on	on	ADP
globalce-322	26	65	the	the	DET
globalce-322	26	66	digital	digital	ADJ
globalce-322	26	67	platform	platform	NOUN
globalce-322	26	68	—	—	PUNCT
globalce-322	26	69	a	a	DET
globalce-322	26	70	government	government	NOUN
globalce-322	26	71	initiative	initiative	NOUN
globalce-322	26	72	of	of	ADP
globalce-322	26	73	national	national	ADJ
globalce-322	26	74	single	single	ADJ
globalce-322	26	75	window	window	NOUN
globalce-322	26	76	system	system	NOUN
globalce-322	26	77	(	(	PUNCT
globalce-322	26	78	nsws	nsws	ADJ
globalce-322	26	79	)	)	PUNCT
globalce-322	26	80	for	for	ADP
globalce-322	26	81	any	any	PRON
globalce-322	26	82	of	of	ADP
globalce-322	26	83	the	the	DET
globalce-322	26	84	following	follow	VERB
globalce-322	26	85	conditions	condition	NOUN
globalce-322	26	86	in	in	ADP
globalce-322	26	87	form	form	NOUN
globalce-322	26	88	md-12	md-12	NOUN
globalce-322	26	89	(	(	PUNCT
globalce-322	26	90	for	for	ADP
globalce-322	26	91	manufacture	manufacture	NOUN
globalce-322	26	92	)	)	PUNCT
globalce-322	26	93	or	or	CCONJ
globalce-322	26	94	form	form	NOUN
globalce-322	26	95	md-16	md-16	NOUN
globalce-322	26	96	(	(	PUNCT
globalce-322	26	97	for	for	ADP
globalce-322	26	98	import).5	import).5	PROPN
globalce-322	26	99	•	•	ADJ
globalce-322	26	100	proof	proof	NOUN
globalce-322	26	101	of	of	ADP
globalce-322	26	102	concept	concept	NOUN
globalce-322	26	103	is	be	AUX
globalce-322	26	104	validated	validate	VERB
globalce-322	26	105	with	with	ADP
globalce-322	26	106	working	working	NOUN
globalce-322	26	107	prototype	prototype	NOUN
globalce-322	26	108	,	,	PUNCT
globalce-322	26	109	and	and	CCONJ
globalce-322	26	110	the	the	DET
globalce-322	26	111	design	design	NOUN
globalce-322	26	112	is	be	AUX
globalce-322	26	113	finalized	finalize	VERB
globalce-322	26	114	.	.	PUNCT
globalce-322	27	1	•	•	NUM
globalce-322	27	2	md	md	PROPN
globalce-322	27	3	/	/	SYM
globalce-322	27	4	ivd	ivd	PROPN
globalce-322	27	5	should	should	AUX
globalce-322	27	6	be	be	AUX
globalce-322	27	7	already	already	ADV
globalce-322	27	8	approved	approve	VERB
globalce-322	27	9	(	(	PUNCT
globalce-322	27	10	either	either	CCONJ
globalce-322	27	11	manufacture	manufacture	NOUN
globalce-322	27	12	/	/	SYM
globalce-322	27	13	imported	import	VERB
globalce-322	27	14	)	)	PUNCT
globalce-322	27	15	in	in	ADP
globalce-322	27	16	india	india	PROPN
globalce-322	27	17	.	.	PUNCT
globalce-322	28	1	•	•	NUM
globalce-322	28	2	investigational	investigational	ADJ
globalce-322	28	3	md	md	PROPN
globalce-322	28	4	/	/	SYM
globalce-322	28	5	new	new	ADJ
globalce-322	28	6	ivd	ivd	NOUN
globalce-322	28	7	in	in	ADP
globalce-322	28	8	case	case	NOUN
globalce-322	28	9	no	no	DET
globalce-322	28	10	such	such	ADJ
globalce-322	28	11	approved	approve	VERB
globalce-322	28	12	devices	device	NOUN
globalce-322	28	13	are	be	AUX
globalce-322	28	14	available	available	ADJ
globalce-322	28	15	in	in	ADP
globalce-322	28	16	india	india	PROPN
globalce-322	28	17	.	.	PROPN
globalce-322	29	1	•	•	NUM
globalce-322	29	2	for	for	ADP
globalce-322	29	3	all	all	DET
globalce-322	29	4	risk	risk	NOUN
globalce-322	29	5	-	-	PUNCT
globalce-322	29	6	based	base	VERB
globalce-322	29	7	classification	classification	NOUN
globalce-322	29	8	of	of	ADP
globalce-322	29	9	md	md	PROPN
globalce-322	29	10	/	/	SYM
globalce-322	29	11	ivd	ivd	PROPN
globalce-322	29	12	(	(	PUNCT
globalce-322	29	13	except	except	SCONJ
globalce-322	29	14	risk	risk	NOUN
globalce-322	29	15	-	-	PUNCT
globalce-322	29	16	based	base	VERB
globalce-322	29	17	class	class	NOUN
globalce-322	29	18	a	a	NOUN
globalce-322	29	19	—	—	PUNCT
globalce-322	29	20	non	non	X
globalce-322	29	21	sterile	sterile	ADJ
globalce-322	29	22	and	and	CCONJ
globalce-322	29	23	non	non	ADJ
globalce-322	29	24	measuring	measure	VERB
globalce-322	29	25	)	)	PUNCT
globalce-322	29	26	.	.	PUNCT
globalce-322	30	1	49	49	NUM
globalce-322	30	2	j	j	PROPN
globalce-322	30	3	global	global	ADJ
globalce-322	30	4	clinical	clinical	ADJ
globalce-322	30	5	engineering	engineering	NOUN
globalce-322	30	6	vol.7	vol.7	PROPN
globalce-322	30	7	issue	issue	NOUN
globalce-322	30	8	3	3	NUM
globalce-322	30	9	:	:	SYM
globalce-322	30	10	2025	2025	NUM
globalce-322	30	11	kumar	kumar	PROPN
globalce-322	30	12	,	,	PUNCT
globalce-322	30	13	gupta	gupta	PROPN
globalce-322	30	14	,	,	PUNCT
globalce-322	30	15	batra	batra	PROPN
globalce-322	30	16	,	,	PUNCT
globalce-322	30	17	sahu	sahu	PROPN
globalce-322	30	18	and	and	CCONJ
globalce-322	30	19	markan	markan	PROPN
globalce-322	30	20	:	:	PUNCT
globalce-322	30	21	catchment	catchment	NOUN
globalce-322	30	22	of	of	ADP
globalce-322	30	23	the	the	DET
globalce-322	30	24	test	test	NOUN
globalce-322	30	25	license	license	NOUN
globalce-322	30	26	for	for	ADP
globalce-322	30	27	the	the	DET
globalce-322	30	28	regulation	regulation	NOUN
globalce-322	30	29	of	of	ADP
globalce-322	30	30	medical	medical	ADJ
globalce-322	30	31	devices	device	NOUN
globalce-322	30	32	in	in	ADP
globalce-322	30	33	india	india	PROPN
globalce-322	30	34	•	•	ADV
globalce-322	30	35	before	before	ADP
globalce-322	30	36	conducting	conduct	VERB
globalce-322	30	37	any	any	DET
globalce-322	30	38	preclinical	preclinical	ADJ
globalce-322	30	39	/	/	SYM
globalce-322	30	40	clinical	clinical	ADJ
globalce-322	30	41	studies	study	NOUN
globalce-322	30	42	,	,	PUNCT
globalce-322	30	43	it	it	PRON
globalce-322	30	44	is	be	AUX
globalce-322	30	45	mandatory	mandatory	ADJ
globalce-322	30	46	to	to	PART
globalce-322	30	47	obtain	obtain	VERB
globalce-322	30	48	the	the	DET
globalce-322	30	49	approval	approval	NOUN
globalce-322	30	50	for	for	ADP
globalce-322	30	51	test	test	NOUN
globalce-322	30	52	license	license	NOUN
globalce-322	30	53	.	.	PUNCT
globalce-322	31	1	all	all	DET
globalce-322	31	2	data	datum	NOUN
globalce-322	31	3	obtained	obtain	VERB
globalce-322	31	4	prior	prior	ADV
globalce-322	31	5	to	to	ADP
globalce-322	31	6	granting	grant	VERB
globalce-322	31	7	of	of	ADP
globalce-322	31	8	test	test	NOUN
globalce-322	31	9	license	license	NOUN
globalce-322	31	10	is	be	AUX
globalce-322	31	11	not	not	PART
globalce-322	31	12	considered	consider	VERB
globalce-322	31	13	for	for	ADP
globalce-322	31	14	regulatory	regulatory	ADJ
globalce-322	31	15	approval	approval	NOUN
globalce-322	31	16	of	of	ADP
globalce-322	31	17	md	md	PROPN
globalce-322	31	18	/	/	SYM
globalce-322	31	19	ivd	ivd	PROPN
globalce-322	31	20	.	.	PUNCT
globalce-322	32	1	the	the	DET
globalce-322	32	2	specific	specific	ADJ
globalce-322	32	3	process	process	NOUN
globalce-322	32	4	for	for	ADP
globalce-322	32	5	obtaining	obtain	VERB
globalce-322	32	6	a	a	DET
globalce-322	32	7	test	test	NOUN
globalce-322	32	8	license	license	NOUN
globalce-322	32	9	for	for	ADP
globalce-322	32	10	the	the	DET
globalce-322	32	11	proposed	propose	VERB
globalce-322	32	12	md	md	PROPN
globalce-322	32	13	/	/	SYM
globalce-322	32	14	ivd	ivd	PROPN
globalce-322	32	15	in	in	ADP
globalce-322	32	16	india	india	PROPN
globalce-322	32	17	involves	involve	VERB
globalce-322	32	18	several	several	ADJ
globalce-322	32	19	steps	step	NOUN
globalce-322	32	20	,	,	PUNCT
globalce-322	32	21	as	as	SCONJ
globalce-322	32	22	outlined	outline	VERB
globalce-322	32	23	in	in	ADP
globalce-322	32	24	figure	figure	NOUN
globalce-322	32	25	1c	1c	NOUN
globalce-322	32	26	(	(	PUNCT
globalce-322	32	27	for	for	ADP
globalce-322	32	28	manufacture	manufacture	NOUN
globalce-322	32	29	in	in	ADP
globalce-322	32	30	form	form	NOUN
globalce-322	32	31	md-12	md-12	NOUN
globalce-322	32	32	)	)	PUNCT
globalce-322	32	33	and	and	CCONJ
globalce-322	32	34	figure	figure	VERB
globalce-322	32	35	1d	1d	NUM
globalce-322	32	36	(	(	PUNCT
globalce-322	32	37	for	for	ADP
globalce-322	32	38	import	import	NOUN
globalce-322	32	39	in	in	ADP
globalce-322	32	40	form	form	NOUN
globalce-322	32	41	md-16	md-16	NUM
globalce-322	32	42	)	)	PUNCT
globalce-322	32	43	.	.	PUNCT
globalce-322	33	1	purpose	purpose	NOUN
globalce-322	33	2	of	of	ADP
globalce-322	33	3	test	test	NOUN
globalce-322	33	4	license	license	NOUN
globalce-322	33	5	test	test	NOUN
globalce-322	33	6	license	license	NOUN
globalce-322	33	7	is	be	AUX
globalce-322	33	8	granted	grant	VERB
globalce-322	33	9	(	(	PUNCT
globalce-322	33	10	form	form	NOUN
globalce-322	33	11	md-13	md-13	NUM
globalce-322	33	12	)	)	PUNCT
globalce-322	33	13	in	in	ADP
globalce-322	33	14	order	order	NOUN
globalce-322	33	15	to	to	PART
globalce-322	33	16	manufacture	manufacture	VERB
globalce-322	33	17	and	and	CCONJ
globalce-322	33	18	import	import	VERB
globalce-322	33	19	small	small	ADJ
globalce-322	33	20	quantities	quantity	NOUN
globalce-322	33	21	of	of	ADP
globalce-322	33	22	md	md	PROPN
globalce-322	33	23	or	or	CCONJ
globalce-322	33	24	ivd	ivd	PROPN
globalce-322	33	25	(	(	PUNCT
globalce-322	33	26	either	either	CCONJ
globalce-322	33	27	earlier	early	ADV
globalce-322	33	28	approved	approve	VERB
globalce-322	33	29	/	/	SYM
globalce-322	33	30	investigational	investigational	ADJ
globalce-322	33	31	medical	medical	ADJ
globalce-322	33	32	device/	device/	NUM
globalce-322	33	33	new	new	ADJ
globalce-322	33	34	ivd	ivd	NOUN
globalce-322	33	35	)	)	PUNCT
globalce-322	33	36	for	for	ADP
globalce-322	33	37	any	any	PRON
globalce-322	33	38	of	of	ADP
globalce-322	33	39	the	the	DET
globalce-322	33	40	following	follow	VERB
globalce-322	33	41	purposes	purpose	NOUN
globalce-322	33	42	at	at	ADP
globalce-322	33	43	a	a	DET
globalce-322	33	44	time	time	NOUN
globalce-322	33	45	:	:	PUNCT
globalce-322	33	46	testing	testing	NOUN
globalce-322	33	47	,	,	PUNCT
globalce-322	33	48	evaluation	evaluation	NOUN
globalce-322	33	49	,	,	PUNCT
globalce-322	33	50	clinical	clinical	ADJ
globalce-322	33	51	investigation	investigation	NOUN
globalce-322	33	52	,	,	PUNCT
globalce-322	33	53	examination	examination	NOUN
globalce-322	33	54	,	,	PUNCT
globalce-322	33	55	demonstration	demonstration	NOUN
globalce-322	33	56	,	,	PUNCT
globalce-322	33	57	and	and	CCONJ
globalce-322	33	58	training	training	NOUN
globalce-322	33	59	.	.	PUNCT
globalce-322	34	1	the	the	DET
globalce-322	34	2	purpose	purpose	NOUN
globalce-322	34	3	of	of	ADP
globalce-322	34	4	applying	apply	VERB
globalce-322	34	5	for	for	ADP
globalce-322	34	6	the	the	DET
globalce-322	34	7	test	test	NOUN
globalce-322	34	8	license	license	NOUN
globalce-322	34	9	should	should	AUX
globalce-322	34	10	be	be	AUX
globalce-322	34	11	very	very	ADV
globalce-322	34	12	specific	specific	ADJ
globalce-322	34	13	in	in	ADP
globalce-322	34	14	nature	nature	NOUN
globalce-322	34	15	,	,	PUNCT
globalce-322	34	16	as	as	SCONJ
globalce-322	34	17	only	only	ADV
globalce-322	34	18	one	one	NUM
globalce-322	34	19	option	option	NOUN
globalce-322	34	20	of	of	ADP
globalce-322	34	21	purpose	purpose	NOUN
globalce-322	34	22	is	be	AUX
globalce-322	34	23	available	available	ADJ
globalce-322	34	24	while	while	SCONJ
globalce-322	34	25	filling	fill	VERB
globalce-322	34	26	the	the	DET
globalce-322	34	27	form	form	NOUN
globalce-322	34	28	md-12	md-12	NOUN
globalce-322	34	29	on	on	ADP
globalce-322	34	30	the	the	DET
globalce-322	34	31	nsws	nsws	ADJ
globalce-322	34	32	portal	portal	NOUN
globalce-322	34	33	.	.	PUNCT
globalce-322	35	1	in	in	ADP
globalce-322	35	2	addition	addition	NOUN
globalce-322	35	3	,	,	PUNCT
globalce-322	35	4	when	when	SCONJ
globalce-322	35	5	a	a	DET
globalce-322	35	6	particular	particular	ADJ
globalce-322	35	7	purpose	purpose	NOUN
globalce-322	35	8	of	of	ADP
globalce-322	35	9	applying	apply	VERB
globalce-322	35	10	the	the	DET
globalce-322	35	11	test	test	NOUN
globalce-322	35	12	license	license	NOUN
globalce-322	35	13	is	be	AUX
globalce-322	35	14	changed	change	VERB
globalce-322	35	15	,	,	PUNCT
globalce-322	35	16	a	a	DET
globalce-322	35	17	fresh	fresh	ADJ
globalce-322	35	18	application	application	NOUN
globalce-322	35	19	must	must	AUX
globalce-322	35	20	be	be	AUX
globalce-322	35	21	submitted	submit	VERB
globalce-322	35	22	.	.	PUNCT
globalce-322	36	1	a	a	DET
globalce-322	36	2	brief	brief	ADJ
globalce-322	36	3	illustration	illustration	NOUN
globalce-322	36	4	of	of	ADP
globalce-322	36	5	a	a	DET
globalce-322	36	6	specific	specific	ADJ
globalce-322	36	7	purpose	purpose	NOUN
globalce-322	36	8	for	for	ADP
globalce-322	36	9	the	the	DET
globalce-322	36	10	grant	grant	NOUN
globalce-322	36	11	of	of	ADP
globalce-322	36	12	test	test	NOUN
globalce-322	36	13	license	license	NOUN
globalce-322	36	14	is	be	AUX
globalce-322	36	15	given	give	VERB
globalce-322	36	16	below	below	ADV
globalce-322	36	17	.	.	PUNCT
globalce-322	37	1	demonstration	demonstration	NOUN
globalce-322	37	2	the	the	DET
globalce-322	37	3	proposed	propose	VERB
globalce-322	37	4	device	device	NOUN
globalce-322	37	5	(	(	PUNCT
globalce-322	37	6	either	either	CCONJ
globalce-322	37	7	earlier	early	ADV
globalce-322	37	8	approved	approve	VERB
globalce-322	37	9	/	/	SYM
globalce-322	37	10	investigational	investigational	ADJ
globalce-322	37	11	/	/	SYM
globalce-322	37	12	new	new	ADJ
globalce-322	37	13	)	)	PUNCT
globalce-322	37	14	is	be	AUX
globalce-322	37	15	manufactured	manufacture	VERB
globalce-322	37	16	or	or	CCONJ
globalce-322	37	17	imported	import	VERB
globalce-322	37	18	for	for	ADP
globalce-322	37	19	the	the	DET
globalce-322	37	20	purpose	purpose	NOUN
globalce-322	37	21	of	of	ADP
globalce-322	37	22	showcasing	showcase	VERB
globalce-322	37	23	the	the	DET
globalce-322	37	24	said	said	ADJ
globalce-322	37	25	device	device	NOUN
globalce-322	37	26	at	at	ADP
globalce-322	37	27	a	a	DET
globalce-322	37	28	national	national	ADJ
globalce-322	37	29	or	or	CCONJ
globalce-322	37	30	international	international	ADJ
globalce-322	37	31	platform	platform	NOUN
globalce-322	37	32	/	/	SYM
globalce-322	37	33	forum	forum	PROPN
globalce-322	37	34	.	.	PUNCT
globalce-322	38	1	training	train	VERB
globalce-322	38	2	the	the	DET
globalce-322	38	3	proposed	propose	VERB
globalce-322	38	4	device	device	NOUN
globalce-322	38	5	(	(	PUNCT
globalce-322	38	6	either	either	CCONJ
globalce-322	38	7	earlier	early	ADV
globalce-322	38	8	approved	approve	VERB
globalce-322	38	9	/	/	SYM
globalce-322	38	10	investigational	investigational	ADJ
globalce-322	38	11	/	/	SYM
globalce-322	38	12	new	new	ADJ
globalce-322	38	13	)	)	PUNCT
globalce-322	38	14	is	be	AUX
globalce-322	38	15	manufactured	manufacture	VERB
globalce-322	38	16	or	or	CCONJ
globalce-322	38	17	imported	import	VERB
globalce-322	38	18	for	for	ADP
globalce-322	38	19	the	the	DET
globalce-322	38	20	purpose	purpose	NOUN
globalce-322	38	21	of	of	ADP
globalce-322	38	22	training	training	NOUN
globalce-322	38	23	for	for	ADP
globalce-322	38	24	process	process	NOUN
globalce-322	38	25	/	/	SYM
globalce-322	38	26	method	method	NOUN
globalce-322	38	27	or	or	CCONJ
globalce-322	38	28	learning	learn	VERB
globalce-322	38	29	any	any	DET
globalce-322	38	30	skills	skill	NOUN
globalce-322	38	31	on	on	ADP
globalce-322	38	32	the	the	DET
globalce-322	38	33	said	say	VERB
globalce-322	38	34	device	device	NOUN
globalce-322	38	35	.	.	PUNCT
globalce-322	39	1	examination	examination	NOUN
globalce-322	39	2	the	the	DET
globalce-322	39	3	proposed	propose	VERB
globalce-322	39	4	device	device	NOUN
globalce-322	39	5	(	(	PUNCT
globalce-322	39	6	either	either	CCONJ
globalce-322	39	7	earlier	early	ADV
globalce-322	39	8	approved	approve	VERB
globalce-322	39	9	/	/	SYM
globalce-322	39	10	investigational	investigational	ADJ
globalce-322	39	11	/	/	SYM
globalce-322	39	12	new	new	ADJ
globalce-322	39	13	)	)	PUNCT
globalce-322	39	14	is	be	AUX
globalce-322	39	15	manufactured	manufacture	VERB
globalce-322	39	16	or	or	CCONJ
globalce-322	39	17	imported	import	VERB
globalce-322	39	18	for	for	ADP
globalce-322	39	19	the	the	DET
globalce-322	39	20	purpose	purpose	NOUN
globalce-322	39	21	of	of	ADP
globalce-322	39	22	conducting	conduct	VERB
globalce-322	39	23	an	an	DET
globalce-322	39	24	examination	examination	NOUN
globalce-322	39	25	to	to	PART
globalce-322	39	26	understand	understand	VERB
globalce-322	39	27	the	the	DET
globalce-322	39	28	technology	technology	NOUN
globalce-322	39	29	,	,	PUNCT
globalce-322	39	30	familiarity	familiarity	NOUN
globalce-322	39	31	,	,	PUNCT
globalce-322	39	32	or	or	CCONJ
globalce-322	39	33	proficiency	proficiency	NOUN
globalce-322	39	34	on	on	ADP
globalce-322	39	35	the	the	DET
globalce-322	39	36	said	say	VERB
globalce-322	39	37	device	device	NOUN
globalce-322	39	38	.	.	PUNCT
globalce-322	40	1	figure	figure	NOUN
globalce-322	40	2	1	1	NUM
globalce-322	40	3	.	.	PUNCT
globalce-322	41	1	(	(	PUNCT
globalce-322	41	2	a	a	X
globalce-322	41	3	)	)	PUNCT
globalce-322	41	4	an	an	DET
globalce-322	41	5	overview	overview	NOUN
globalce-322	41	6	to	to	PART
globalce-322	41	7	apply	apply	VERB
globalce-322	41	8	for	for	ADP
globalce-322	41	9	a	a	DET
globalce-322	41	10	test	test	NOUN
globalce-322	41	11	license	license	NOUN
globalce-322	41	12	for	for	ADP
globalce-322	41	13	the	the	DET
globalce-322	41	14	manufacture	manufacture	NOUN
globalce-322	41	15	or	or	CCONJ
globalce-322	41	16	import	import	NOUN
globalce-322	41	17	of	of	ADP
globalce-322	41	18	md	md	PROPN
globalce-322	41	19	/	/	SYM
globalce-322	41	20	ivd	ivd	PROPN
globalce-322	41	21	.	.	PUNCT
globalce-322	42	1	(	(	PUNCT
globalce-322	42	2	b	b	X
globalce-322	42	3	)	)	PUNCT
globalce-322	42	4	a	a	DET
globalce-322	42	5	process	process	NOUN
globalce-322	42	6	flow	flow	NOUN
globalce-322	42	7	to	to	PART
globalce-322	42	8	grant	grant	VERB
globalce-322	42	9	a	a	DET
globalce-322	42	10	test	test	NOUN
globalce-322	42	11	license	license	NOUN
globalce-322	42	12	.	.	PUNCT
globalce-322	43	1	serial	serial	ADJ
globalce-322	43	2	numbers	number	NOUN
globalce-322	43	3	1	1	NUM
globalce-322	43	4	to	to	PART
globalce-322	43	5	4	4	NUM
globalce-322	43	6	indicate	indicate	VERB
globalce-322	43	7	the	the	DET
globalce-322	43	8	prerequisites	prerequisite	NOUN
globalce-322	43	9	to	to	PART
globalce-322	43	10	apply	apply	VERB
globalce-322	43	11	for	for	ADP
globalce-322	43	12	test	test	NOUN
globalce-322	43	13	license	license	NOUN
globalce-322	43	14	,	,	PUNCT
globalce-322	43	15	and	and	CCONJ
globalce-322	43	16	serial	serial	ADJ
globalce-322	43	17	numbers	number	NOUN
globalce-322	43	18	5	5	NUM
globalce-322	43	19	to	to	PART
globalce-322	43	20	9	9	NUM
globalce-322	43	21	mention	mention	VERB
globalce-322	43	22	the	the	DET
globalce-322	43	23	respective	respective	ADJ
globalce-322	43	24	steps	step	NOUN
globalce-322	43	25	to	to	PART
globalce-322	43	26	grant	grant	VERB
globalce-322	43	27	approval	approval	NOUN
globalce-322	43	28	for	for	ADP
globalce-322	43	29	test	test	NOUN
globalce-322	43	30	license	license	NOUN
globalce-322	43	31	.	.	PUNCT
globalce-322	44	1	(	(	PUNCT
globalce-322	44	2	c	c	X
globalce-322	44	3	)	)	PUNCT
globalce-322	44	4	the	the	DET
globalce-322	44	5	process	process	NOUN
globalce-322	44	6	of	of	ADP
globalce-322	44	7	obtaining	obtain	VERB
globalce-322	44	8	manufacture	manufacture	NOUN
globalce-322	44	9	test	test	NOUN
globalce-322	44	10	license	license	NOUN
globalce-322	44	11	(	(	PUNCT
globalce-322	44	12	form	form	NOUN
globalce-322	44	13	md-12	md-12	NOUN
globalce-322	44	14	)	)	PUNCT
globalce-322	44	15	in	in	ADP
globalce-322	44	16	india	india	PROPN
globalce-322	44	17	.	.	PUNCT
globalce-322	45	1	(	(	PUNCT
globalce-322	45	2	d	d	X
globalce-322	45	3	)	)	PUNCT
globalce-322	45	4	the	the	DET
globalce-322	45	5	process	process	NOUN
globalce-322	45	6	of	of	ADP
globalce-322	45	7	obtaining	obtain	VERB
globalce-322	45	8	import	import	NOUN
globalce-322	45	9	test	test	NOUN
globalce-322	45	10	license	license	NOUN
globalce-322	45	11	(	(	PUNCT
globalce-322	45	12	form	form	NOUN
globalce-322	45	13	md-16	md-16	NOUN
globalce-322	45	14	)	)	PUNCT
globalce-322	45	15	in	in	ADP
globalce-322	45	16	india	india	PROPN
globalce-322	45	17	.	.	PUNCT
globalce-322	46	1	kumar	kumar	PROPN
globalce-322	46	2	,	,	PUNCT
globalce-322	46	3	gupta	gupta	PROPN
globalce-322	46	4	,	,	PUNCT
globalce-322	46	5	batra	batra	PROPN
globalce-322	46	6	,	,	PUNCT
globalce-322	46	7	sahu	sahu	PROPN
globalce-322	46	8	and	and	CCONJ
globalce-322	46	9	markan	markan	PROPN
globalce-322	46	10	:	:	PUNCT
globalce-322	46	11	catchment	catchment	NOUN
globalce-322	46	12	of	of	ADP
globalce-322	46	13	the	the	DET
globalce-322	46	14	test	test	NOUN
globalce-322	46	15	license	license	NOUN
globalce-322	46	16	for	for	ADP
globalce-322	46	17	the	the	DET
globalce-322	46	18	regulation	regulation	NOUN
globalce-322	46	19	of	of	ADP
globalce-322	46	20	medical	medical	ADJ
globalce-322	46	21	devices	device	NOUN
globalce-322	46	22	in	in	ADP
globalce-322	46	23	india	india	PROPN
globalce-322	46	24	j	j	PROPN
globalce-322	46	25	global	global	ADJ
globalce-322	46	26	clinical	clinical	ADJ
globalce-322	46	27	engineering	engineering	NOUN
globalce-322	46	28	vol.7	vol.7	PROPN
globalce-322	46	29	issue	issue	NOUN
globalce-322	46	30	3	3	NUM
globalce-322	46	31	:	:	SYM
globalce-322	46	32	2025	2025	NUM
globalce-322	46	33	50	50	NUM
globalce-322	46	34	the	the	DET
globalce-322	46	35	validity	validity	NOUN
globalce-322	46	36	of	of	ADP
globalce-322	46	37	the	the	DET
globalce-322	46	38	finding	finding	NOUN
globalce-322	46	39	)	)	PUNCT
globalce-322	46	40	.	.	PUNCT
globalce-322	47	1	analytical	analytical	ADJ
globalce-322	47	2	performance	performance	NOUN
globalce-322	47	3	of	of	ADP
globalce-322	47	4	an	an	DET
globalce-322	47	5	ivd	ivd	NOUN
globalce-322	47	6	is	be	AUX
globalce-322	47	7	the	the	DET
globalce-322	47	8	ability	ability	NOUN
globalce-322	47	9	to	to	PART
globalce-322	47	10	measure	measure	VERB
globalce-322	47	11	or	or	CCONJ
globalce-322	47	12	detect	detect	VERB
globalce-322	47	13	a	a	DET
globalce-322	47	14	specific	specific	ADJ
globalce-322	47	15	analyte	analyte	NOUN
globalce-322	47	16	accurately	accurately	ADV
globalce-322	47	17	and	and	CCONJ
globalce-322	47	18	reliably	reliably	ADV
globalce-322	47	19	.	.	PUNCT
globalce-322	48	1	these	these	DET
globalce-322	48	2	studies	study	NOUN
globalce-322	48	3	demonstrate	demonstrate	VERB
globalce-322	48	4	the	the	DET
globalce-322	48	5	analytical	analytical	ADJ
globalce-322	48	6	performance	performance	NOUN
globalce-322	48	7	of	of	ADP
globalce-322	48	8	an	an	DET
globalce-322	48	9	ivd	ivd	NOUN
globalce-322	48	10	that	that	PRON
globalce-322	48	11	includes	include	VERB
globalce-322	48	12	device	device	NOUN
globalce-322	48	13	specification	specification	NOUN
globalce-322	48	14	,	,	PUNCT
globalce-322	48	15	accuracy	accuracy	NOUN
globalce-322	48	16	,	,	PUNCT
globalce-322	48	17	precision	precision	NOUN
globalce-322	48	18	,	,	PUNCT
globalce-322	48	19	linearity	linearity	NOUN
globalce-322	48	20	,	,	PUNCT
globalce-322	48	21	detection	detection	NOUN
globalce-322	48	22	limit	limit	NOUN
globalce-322	48	23	,	,	PUNCT
globalce-322	48	24	quantitation	quantitation	NOUN
globalce-322	48	25	limit	limit	NOUN
globalce-322	48	26	,	,	PUNCT
globalce-322	48	27	cross	cross	NOUN
globalce-322	48	28	reactivity	reactivity	NOUN
globalce-322	48	29	,	,	PUNCT
globalce-322	48	30	specificity	specificity	NOUN
globalce-322	48	31	,	,	PUNCT
globalce-322	48	32	sensitivity	sensitivity	NOUN
globalce-322	48	33	,	,	PUNCT
globalce-322	48	34	either	either	CCONJ
globalce-322	48	35	qualitative	qualitative	ADJ
globalce-322	48	36	or	or	CCONJ
globalce-322	48	37	quantitative	quantitative	ADJ
globalce-322	48	38	,	,	PUNCT
globalce-322	48	39	and	and	CCONJ
globalce-322	48	40	range	range	NOUN
globalce-322	48	41	.	.	PUNCT
globalce-322	49	1	however	however	ADV
globalce-322	49	2	,	,	PUNCT
globalce-322	49	3	clinical	clinical	ADJ
globalce-322	49	4	performance	performance	NOUN
globalce-322	49	5	is	be	AUX
globalce-322	49	6	the	the	DET
globalce-322	49	7	output	output	NOUN
globalce-322	49	8	of	of	ADP
globalce-322	49	9	a	a	DET
globalce-322	49	10	device	device	NOUN
globalce-322	49	11	to	to	PART
globalce-322	49	12	yield	yield	VERB
globalce-322	49	13	results	result	NOUN
globalce-322	49	14	that	that	PRON
globalce-322	49	15	are	be	AUX
globalce-322	49	16	correlated	correlate	VERB
globalce-322	49	17	with	with	ADP
globalce-322	49	18	a	a	DET
globalce-322	49	19	particular	particular	ADJ
globalce-322	49	20	clinical	clinical	ADJ
globalce-322	49	21	condition	condition	NOUN
globalce-322	49	22	based	base	VERB
globalce-322	49	23	on	on	ADP
globalce-322	49	24	sample	sample	NOUN
globalce-322	49	25	size	size	NOUN
globalce-322	49	26	,	,	PUNCT
globalce-322	49	27	diagnostic	diagnostic	ADJ
globalce-322	49	28	sensitivity	sensitivity	NOUN
globalce-322	49	29	,	,	PUNCT
globalce-322	49	30	diagnostic	diagnostic	ADJ
globalce-322	49	31	accuracy	accuracy	NOUN
globalce-322	49	32	,	,	PUNCT
globalce-322	49	33	diagnostic	diagnostic	ADJ
globalce-322	49	34	specificity	specificity	NOUN
globalce-322	49	35	,	,	PUNCT
globalce-322	49	36	ppv	ppv	NOUN
globalce-322	49	37	,	,	PUNCT
globalce-322	49	38	npv	npv	NOUN
globalce-322	49	39	,	,	PUNCT
globalce-322	49	40	likelihood	likelihood	NOUN
globalce-322	49	41	ratio	ratio	NOUN
globalce-322	49	42	,	,	PUNCT
globalce-322	49	43	and	and	CCONJ
globalce-322	49	44	expected	expect	VERB
globalce-322	49	45	values	value	NOUN
globalce-322	49	46	in	in	ADP
globalce-322	49	47	normal	normal	ADJ
globalce-322	49	48	and	and	CCONJ
globalce-322	49	49	affected	affect	VERB
globalce-322	49	50	populations.8	populations.8	PROPN
globalce-322	49	51	performance	performance	NOUN
globalce-322	49	52	evaluation	evaluation	NOUN
globalce-322	49	53	reports	report	NOUN
globalce-322	49	54	(	(	PUNCT
globalce-322	49	55	per	per	ADP
globalce-322	49	56	)	)	PUNCT
globalce-322	49	57	,	,	PUNCT
globalce-322	49	58	which	which	PRON
globalce-322	49	59	are	be	AUX
globalce-322	49	60	essential	essential	ADJ
globalce-322	49	61	technical	technical	ADJ
globalce-322	49	62	documents	document	NOUN
globalce-322	49	63	for	for	ADP
globalce-322	49	64	the	the	DET
globalce-322	49	65	regulatory	regulatory	ADJ
globalce-322	49	66	approval	approval	NOUN
globalce-322	49	67	of	of	ADP
globalce-322	49	68	the	the	DET
globalce-322	49	69	subject	subject	PROPN
globalce-322	49	70	ivd	ivd	PROPN
globalce-322	49	71	,	,	PUNCT
globalce-322	49	72	include	include	VERB
globalce-322	49	73	clinical	clinical	ADJ
globalce-322	49	74	performance	performance	NOUN
globalce-322	49	75	reports	report	NOUN
globalce-322	49	76	as	as	ADP
globalce-322	49	77	a	a	DET
globalce-322	49	78	key	key	ADJ
globalce-322	49	79	component	component	NOUN
globalce-322	49	80	.	.	PUNCT
globalce-322	50	1	clinical	clinical	ADJ
globalce-322	50	2	investigation	investigation	NOUN
globalce-322	50	3	/	/	SYM
globalce-322	50	4	clinical	clinical	ADJ
globalce-322	50	5	performance	performance	NOUN
globalce-322	50	6	evaluation	evaluation	NOUN
globalce-322	50	7	clinical	clinical	ADJ
globalce-322	50	8	trials	trial	NOUN
globalce-322	50	9	using	use	VERB
globalce-322	50	10	md	md	PROPN
globalce-322	50	11	are	be	AUX
globalce-322	50	12	referred	refer	VERB
globalce-322	50	13	as	as	ADP
globalce-322	50	14	clinical	clinical	ADJ
globalce-322	50	15	investigations	investigation	NOUN
globalce-322	50	16	.	.	PUNCT
globalce-322	51	1	the	the	DET
globalce-322	51	2	purpose	purpose	NOUN
globalce-322	51	3	of	of	ADP
globalce-322	51	4	a	a	DET
globalce-322	51	5	clinical	clinical	ADJ
globalce-322	51	6	investigation	investigation	NOUN
globalce-322	51	7	is	be	AUX
globalce-322	51	8	to	to	PART
globalce-322	51	9	answer	answer	VERB
globalce-322	51	10	important	important	ADJ
globalce-322	51	11	scientific	scientific	ADJ
globalce-322	51	12	questions	question	NOUN
globalce-322	51	13	.	.	PUNCT
globalce-322	52	1	it	it	PRON
globalce-322	52	2	must	must	AUX
globalce-322	52	3	follow	follow	VERB
globalce-322	52	4	strict	strict	ADJ
globalce-322	52	5	scientific	scientific	ADJ
globalce-322	52	6	standards	standard	NOUN
globalce-322	52	7	(	(	PUNCT
globalce-322	52	8	iso	iso	NOUN
globalce-322	52	9	-	-	PUNCT
globalce-322	52	10	international	international	ADJ
globalce-322	52	11	organization	organization	NOUN
globalce-322	52	12	for	for	ADP
globalce-322	52	13	standardization	standardization	NOUN
globalce-322	52	14	14155:2020	14155:2020	NUM
globalce-322	52	15	—	—	PUNCT
globalce-322	52	16	clinical	clinical	ADJ
globalce-322	52	17	investigation	investigation	NOUN
globalce-322	52	18	of	of	ADP
globalce-322	52	19	md	md	PROPN
globalce-322	52	20	for	for	ADP
globalce-322	52	21	human	human	ADJ
globalce-322	52	22	subjects	subject	NOUN
globalce-322	52	23	)	)	PUNCT
globalce-322	52	24	,	,	PUNCT
globalce-322	52	25	which	which	PRON
globalce-322	52	26	can	can	AUX
globalce-322	52	27	protect	protect	VERB
globalce-322	52	28	patients	patient	NOUN
globalce-322	52	29	and	and	CCONJ
globalce-322	52	30	produce	produce	VERB
globalce-322	52	31	reliable	reliable	ADJ
globalce-322	52	32	scientific	scientific	ADJ
globalce-322	52	33	outcomes	outcome	NOUN
globalce-322	52	34	.	.	PUNCT
globalce-322	53	1	one	one	NUM
globalce-322	53	2	of	of	ADP
globalce-322	53	3	the	the	DET
globalce-322	53	4	purposes	purpose	NOUN
globalce-322	53	5	of	of	ADP
globalce-322	53	6	a	a	DET
globalce-322	53	7	clinical	clinical	ADJ
globalce-322	53	8	investigation	investigation	NOUN
globalce-322	53	9	could	could	AUX
globalce-322	53	10	be	be	AUX
globalce-322	53	11	to	to	PART
globalce-322	53	12	establish	establish	VERB
globalce-322	53	13	and	and	CCONJ
globalce-322	53	14	verify	verify	VERB
globalce-322	53	15	clinical	clinical	ADJ
globalce-322	53	16	safety	safety	NOUN
globalce-322	53	17	,	,	PUNCT
globalce-322	53	18	meaning	mean	VERB
globalce-322	53	19	to	to	PART
globalce-322	53	20	understand	understand	VERB
globalce-322	53	21	how	how	SCONJ
globalce-322	53	22	testing	testing	NOUN
globalce-322	53	23	in	in	ADP
globalce-322	53	24	general	general	ADJ
globalce-322	53	25	,	,	PUNCT
globalce-322	53	26	medical	medical	ADJ
globalce-322	53	27	device	device	NOUN
globalce-322	53	28	testing	testing	NOUN
globalce-322	53	29	is	be	AUX
globalce-322	53	30	the	the	DET
globalce-322	53	31	process	process	NOUN
globalce-322	53	32	of	of	ADP
globalce-322	53	33	demonstrating	demonstrate	VERB
globalce-322	53	34	that	that	SCONJ
globalce-322	53	35	the	the	DET
globalce-322	53	36	device	device	NOUN
globalce-322	53	37	will	will	AUX
globalce-322	53	38	reliably	reliably	ADV
globalce-322	53	39	perform	perform	VERB
globalce-322	53	40	safely	safely	ADV
globalce-322	53	41	in	in	ADP
globalce-322	53	42	use	use	NOUN
globalce-322	53	43	.	.	PUNCT
globalce-322	54	1	it	it	PRON
globalce-322	54	2	is	be	AUX
globalce-322	54	3	used	use	VERB
globalce-322	54	4	if	if	SCONJ
globalce-322	54	5	the	the	DET
globalce-322	54	6	proposed	propose	VERB
globalce-322	54	7	device	device	NOUN
globalce-322	54	8	(	(	PUNCT
globalce-322	54	9	either	either	CCONJ
globalce-322	54	10	approved/	approved/	NUM
globalce-322	54	11	investigational	investigational	ADJ
globalce-322	54	12	/	/	SYM
globalce-322	54	13	new	new	ADJ
globalce-322	54	14	)	)	PUNCT
globalce-322	54	15	is	be	AUX
globalce-322	54	16	manufactured	manufacture	VERB
globalce-322	54	17	or	or	CCONJ
globalce-322	54	18	imported	import	VERB
globalce-322	54	19	for	for	ADP
globalce-322	54	20	the	the	DET
globalce-322	54	21	purpose	purpose	NOUN
globalce-322	54	22	of	of	ADP
globalce-322	54	23	assessing	assess	VERB
globalce-322	54	24	various	various	ADJ
globalce-322	54	25	quality	quality	NOUN
globalce-322	54	26	aspects	aspect	NOUN
globalce-322	54	27	of	of	ADP
globalce-322	54	28	a	a	DET
globalce-322	54	29	device	device	NOUN
globalce-322	54	30	,	,	PUNCT
globalce-322	54	31	such	such	ADJ
globalce-322	54	32	as	as	ADP
globalce-322	54	33	its	its	PRON
globalce-322	54	34	design	design	NOUN
globalce-322	54	35	verification	verification	NOUN
globalce-322	54	36	and	and	CCONJ
globalce-322	54	37	validation	validation	NOUN
globalce-322	54	38	,	,	PUNCT
globalce-322	54	39	material	material	NOUN
globalce-322	54	40	testing	testing	NOUN
globalce-322	54	41	,	,	PUNCT
globalce-322	54	42	mechanical	mechanical	ADJ
globalce-322	54	43	test	test	NOUN
globalce-322	54	44	,	,	PUNCT
globalce-322	54	45	reliability	reliability	NOUN
globalce-322	54	46	test	test	NOUN
globalce-322	54	47	,	,	PUNCT
globalce-322	54	48	functionality	functionality	NOUN
globalce-322	54	49	,	,	PUNCT
globalce-322	54	50	durability	durability	NOUN
globalce-322	54	51	,	,	PUNCT
globalce-322	54	52	sterility	sterility	NOUN
globalce-322	54	53	,	,	PUNCT
globalce-322	54	54	stability	stability	NOUN
globalce-322	54	55	,	,	PUNCT
globalce-322	54	56	biocompatibility	biocompatibility	NOUN
globalce-322	54	57	(	(	PUNCT
globalce-322	54	58	iso	iso	NOUN
globalce-322	54	59	-	-	PUNCT
globalce-322	54	60	international	international	ADJ
globalce-322	54	61	organization	organization	NOUN
globalce-322	54	62	for	for	ADP
globalce-322	54	63	standardization	standardization	NOUN
globalce-322	54	64	10993	10993	NUM
globalce-322	54	65	standard	standard	NOUN
globalce-322	54	66	for	for	ADP
globalce-322	54	67	evaluating	evaluate	VERB
globalce-322	54	68	the	the	DET
globalce-322	54	69	biocompatibility	biocompatibility	NOUN
globalce-322	54	70	of	of	ADP
globalce-322	54	71	md	md	PROPN
globalce-322	54	72	)	)	PUNCT
globalce-322	54	73	,	,	PUNCT
globalce-322	54	74	electrical	electrical	ADJ
globalce-322	54	75	safety	safety	NOUN
globalce-322	54	76	and	and	CCONJ
globalce-322	54	77	usability	usability	NOUN
globalce-322	54	78	,	,	PUNCT
globalce-322	54	79	ex	ex	X
globalce-322	54	80	vivo	vivo	NOUN
globalce-322	54	81	(	(	PUNCT
globalce-322	54	82	animal	animal	NOUN
globalce-322	54	83	performance	performance	NOUN
globalce-322	54	84	study	study	NOUN
globalce-322	54	85	)	)	PUNCT
globalce-322	54	86	,	,	PUNCT
globalce-322	54	87	and	and	CCONJ
globalce-322	54	88	software	software	NOUN
globalce-322	54	89	verification	verification	NOUN
globalce-322	54	90	and	and	CCONJ
globalce-322	54	91	validation	validation	NOUN
globalce-322	54	92	(	(	PUNCT
globalce-322	54	93	for	for	ADP
globalce-322	54	94	any	any	DET
globalce-322	54	95	software	software	NOUN
globalce-322	54	96	components	component	NOUN
globalce-322	54	97	)	)	PUNCT
globalce-322	54	98	.	.	PUNCT
globalce-322	55	1	evaluation	evaluation	NOUN
globalce-322	55	2	/	/	SYM
globalce-322	55	3	performance	performance	NOUN
globalce-322	55	4	evaluation	evaluation	NOUN
globalce-322	55	5	predominantly	predominantly	ADV
globalce-322	55	6	,	,	PUNCT
globalce-322	55	7	it	it	PRON
globalce-322	55	8	is	be	AUX
globalce-322	55	9	the	the	DET
globalce-322	55	10	theoretical	theoretical	ADJ
globalce-322	55	11	assessment	assessment	NOUN
globalce-322	55	12	of	of	ADP
globalce-322	55	13	evaluating	evaluate	VERB
globalce-322	55	14	the	the	DET
globalce-322	55	15	safety	safety	NOUN
globalce-322	55	16	,	,	PUNCT
globalce-322	55	17	effectiveness	effectiveness	NOUN
globalce-322	55	18	,	,	PUNCT
globalce-322	55	19	and	and	CCONJ
globalce-322	55	20	performance	performance	NOUN
globalce-322	55	21	of	of	ADP
globalce-322	55	22	md	md	PROPN
globalce-322	55	23	that	that	PRON
globalce-322	55	24	should	should	AUX
globalce-322	55	25	start	start	VERB
globalce-322	55	26	even	even	ADV
globalce-322	55	27	before	before	SCONJ
globalce-322	55	28	the	the	DET
globalce-322	55	29	product	product	NOUN
globalce-322	55	30	is	be	AUX
globalce-322	55	31	marketed	market	VERB
globalce-322	55	32	.	.	PUNCT
globalce-322	56	1	if	if	SCONJ
globalce-322	56	2	the	the	DET
globalce-322	56	3	proposed	propose	VERB
globalce-322	56	4	device	device	NOUN
globalce-322	56	5	(	(	PUNCT
globalce-322	56	6	whether	whether	SCONJ
globalce-322	56	7	approved	approve	VERB
globalce-322	56	8	,	,	PUNCT
globalce-322	56	9	investigational	investigational	ADJ
globalce-322	56	10	,	,	PUNCT
globalce-322	56	11	or	or	CCONJ
globalce-322	56	12	new	new	ADJ
globalce-322	56	13	)	)	PUNCT
globalce-322	56	14	is	be	AUX
globalce-322	56	15	manufactured	manufacture	VERB
globalce-322	56	16	or	or	CCONJ
globalce-322	56	17	imported	import	VERB
globalce-322	56	18	for	for	ADP
globalce-322	56	19	the	the	DET
globalce-322	56	20	said	said	ADJ
globalce-322	56	21	purpose	purpose	NOUN
globalce-322	56	22	that	that	PRON
globalce-322	56	23	include	include	VERB
globalce-322	56	24	physical	physical	ADJ
globalce-322	56	25	(	(	PUNCT
globalce-322	56	26	mechanical	mechanical	ADJ
globalce-322	56	27	,	,	PUNCT
globalce-322	56	28	electrical	electrical	ADJ
globalce-322	56	29	)	)	PUNCT
globalce-322	56	30	,	,	PUNCT
globalce-322	56	31	analytical	analytical	ADJ
globalce-322	56	32	(	(	PUNCT
globalce-322	56	33	sensitivity	sensitivity	NOUN
globalce-322	56	34	,	,	PUNCT
globalce-322	56	35	specificity	specificity	NOUN
globalce-322	56	36	,	,	PUNCT
globalce-322	56	37	toxicity	toxicity	NOUN
globalce-322	56	38	,	,	PUNCT
globalce-322	56	39	stability	stability	NOUN
globalce-322	56	40	,	,	PUNCT
globalce-322	56	41	linearity	linearity	NOUN
globalce-322	56	42	,	,	PUNCT
globalce-322	56	43	limit	limit	NOUN
globalce-322	56	44	of	of	ADP
globalce-322	56	45	detection	detection	NOUN
globalce-322	56	46	,	,	PUNCT
globalce-322	56	47	positive	positive	ADJ
globalce-322	56	48	predictive	predictive	ADJ
globalce-322	56	49	value	value	NOUN
globalce-322	56	50	-	-	PUNCT
globalce-322	56	51	ppv	ppv	NOUN
globalce-322	56	52	,	,	PUNCT
globalce-322	56	53	negative	negative	ADJ
globalce-322	56	54	predictive	predictive	ADJ
globalce-322	56	55	value	value	NOUN
globalce-322	56	56	-	-	PUNCT
globalce-322	56	57	npv	npv	NOUN
globalce-322	56	58	)	)	PUNCT
globalce-322	56	59	,	,	PUNCT
globalce-322	56	60	biological	biological	ADJ
globalce-322	56	61	(	(	PUNCT
globalce-322	56	62	biocompatibility	biocompatibility	NOUN
globalce-322	56	63	)	)	PUNCT
globalce-322	56	64	and	and	CCONJ
globalce-322	56	65	other	other	ADJ
globalce-322	56	66	parameters	parameter	NOUN
globalce-322	56	67	(	(	PUNCT
globalce-322	56	68	sometimes	sometimes	ADV
globalce-322	56	69	,	,	PUNCT
globalce-322	56	70	clinical	clinical	ADJ
globalce-322	56	71	samples	sample	NOUN
globalce-322	56	72	/	/	PUNCT
globalce-322	56	73	left	leave	VERB
globalce-322	56	74	over	over	ADP
globalce-322	56	75	samples	sample	NOUN
globalce-322	56	76	are	be	AUX
globalce-322	56	77	also	also	ADV
globalce-322	56	78	used	use	VERB
globalce-322	56	79	)	)	PUNCT
globalce-322	56	80	assessment	assessment	NOUN
globalce-322	56	81	to	to	PART
globalce-322	56	82	evaluate	evaluate	VERB
globalce-322	56	83	its	its	PRON
globalce-322	56	84	functions	function	NOUN
globalce-322	56	85	as	as	ADP
globalce-322	56	86	intended	intend	VERB
globalce-322	56	87	use	use	NOUN
globalce-322	56	88	and	and	CCONJ
globalce-322	56	89	does	do	AUX
globalce-322	56	90	n’t	not	PART
globalce-322	56	91	provide	provide	VERB
globalce-322	56	92	any	any	DET
globalce-322	56	93	faulty	faulty	ADJ
globalce-322	56	94	information	information	NOUN
globalce-322	56	95	.	.	PUNCT
globalce-322	57	1	particularly	particularly	ADV
globalce-322	57	2	,	,	PUNCT
globalce-322	57	3	performance	performance	NOUN
globalce-322	57	4	evaluation	evaluation	NOUN
globalce-322	57	5	is	be	AUX
globalce-322	57	6	carried	carry	VERB
globalce-322	57	7	out	out	ADP
globalce-322	57	8	specifically	specifically	ADV
globalce-322	57	9	for	for	ADP
globalce-322	57	10	ivd	ivd	NOUN
globalce-322	57	11	,	,	PUNCT
globalce-322	57	12	irrespective	irrespective	ADV
globalce-322	57	13	of	of	ADP
globalce-322	57	14	either	either	CCONJ
globalce-322	57	15	new	new	ADJ
globalce-322	57	16	or	or	CCONJ
globalce-322	57	17	earlier	early	ADV
globalce-322	57	18	approved	approve	VERB
globalce-322	57	19	devices	device	NOUN
globalce-322	57	20	at	at	ADP
globalce-322	57	21	cdsco	cdsco	PROPN
globalce-322	57	22	designated	designate	VERB
globalce-322	57	23	lab	lab	NOUN
globalce-322	57	24	under	under	ADP
globalce-322	57	25	subrule	subrule	NOUN
globalce-322	57	26	(	(	PUNCT
globalce-322	57	27	1	1	NUM
globalce-322	57	28	)	)	PUNCT
globalce-322	57	29	of	of	ADP
globalce-322	57	30	rule	rule	NOUN
globalce-322	57	31	19	19	NUM
globalce-322	57	32	of	of	ADP
globalce-322	57	33	mdr-2017/	mdr-2017/	PROPN
globalce-322	57	34	national	national	ADJ
globalce-322	57	35	accreditation	accreditation	PROPN
globalce-322	57	36	board	board	NOUN
globalce-322	57	37	for	for	SCONJ
globalce-322	57	38	testing	testing	NOUN
globalce-322	57	39	and	and	CCONJ
globalce-322	57	40	calibration	calibration	NOUN
globalce-322	57	41	laboratories	laboratory	NOUN
globalce-322	57	42	(	(	PUNCT
globalce-322	57	43	nabl	nabl	NOUN
globalce-322	57	44	)	)	PUNCT
globalce-322	57	45	accredited	accredit	VERB
globalce-322	57	46	lab	lab	NOUN
globalce-322	57	47	/	/	SYM
globalce-322	57	48	govt	govt	NOUN
globalce-322	57	49	.	.	PUNCT
globalce-322	58	1	lab	lab	NOUN
globalce-322	58	2	/	/	SYM
globalce-322	58	3	in	in	ADP
globalce-322	58	4	-	-	PUNCT
globalce-322	58	5	house	house	NOUN
globalce-322	58	6	lab	lab	NOUN
globalce-322	58	7	(	(	PUNCT
globalce-322	58	8	in	in	ADP
globalce-322	58	9	case	case	NOUN
globalce-322	58	10	of	of	ADP
globalce-322	58	11	unavailability	unavailability	NOUN
globalce-322	58	12	of	of	ADP
globalce-322	58	13	these	these	DET
globalce-322	58	14	labs	lab	NOUN
globalce-322	58	15	with	with	ADP
globalce-322	58	16	prior	prior	ADJ
globalce-322	58	17	approval	approval	NOUN
globalce-322	58	18	from	from	ADP
globalce-322	58	19	cdsco).6	cdsco).6	PROPN
globalce-322	58	20	it	it	PRON
globalce-322	58	21	mainly	mainly	ADV
globalce-322	58	22	covers	cover	VERB
globalce-322	58	23	three	three	NUM
globalce-322	58	24	major	major	ADJ
globalce-322	58	25	parameters	parameter	NOUN
globalce-322	58	26	,	,	PUNCT
globalce-322	58	27	namely	namely	ADV
globalce-322	58	28	,	,	PUNCT
globalce-322	58	29	scientific	scientific	ADJ
globalce-322	58	30	validity	validity	NOUN
globalce-322	58	31	,	,	PUNCT
globalce-322	58	32	analytical	analytical	ADJ
globalce-322	58	33	performance	performance	NOUN
globalce-322	58	34	,	,	PUNCT
globalce-322	58	35	and	and	CCONJ
globalce-322	58	36	clinical	clinical	ADJ
globalce-322	58	37	performance	performance	NOUN
globalce-322	58	38	(	(	PUNCT
globalce-322	58	39	figure	figure	NOUN
globalce-322	58	40	2).7	2).7	NUM
globalce-322	58	41	scientific	scientific	ADJ
globalce-322	58	42	validity	validity	NOUN
globalce-322	58	43	covers	cover	VERB
globalce-322	58	44	the	the	DET
globalce-322	58	45	degree	degree	NOUN
globalce-322	58	46	to	to	PART
globalce-322	58	47	which	which	PRON
globalce-322	58	48	a	a	DET
globalce-322	58	49	study	study	NOUN
globalce-322	58	50	or	or	CCONJ
globalce-322	58	51	test	test	NOUN
globalce-322	58	52	accurately	accurately	ADV
globalce-322	58	53	measures	measure	VERB
globalce-322	58	54	what	what	PRON
globalce-322	58	55	it	it	PRON
globalce-322	58	56	is	be	AUX
globalce-322	58	57	intended	intend	VERB
globalce-322	58	58	to	to	PART
globalce-322	58	59	measure	measure	VERB
globalce-322	58	60	in	in	ADP
globalce-322	58	61	a	a	DET
globalce-322	58	62	broader	broad	ADJ
globalce-322	58	63	population	population	NOUN
globalce-322	58	64	.	.	PUNCT
globalce-322	59	1	it	it	PRON
globalce-322	59	2	is	be	AUX
globalce-322	59	3	achieved	achieve	VERB
globalce-322	59	4	by	by	ADP
globalce-322	59	5	defining	define	VERB
globalce-322	59	6	research	research	NOUN
globalce-322	59	7	objectives	objective	NOUN
globalce-322	59	8	(	(	PUNCT
globalce-322	59	9	to	to	PART
globalce-322	59	10	accomplish	accomplish	VERB
globalce-322	59	11	)	)	PUNCT
globalce-322	59	12	,	,	PUNCT
globalce-322	59	13	choosing	choose	VERB
globalce-322	59	14	appropriate	appropriate	ADJ
globalce-322	59	15	methods	method	NOUN
globalce-322	59	16	(	(	PUNCT
globalce-322	59	17	to	to	PART
globalce-322	59	18	collect	collect	VERB
globalce-322	59	19	and	and	CCONJ
globalce-322	59	20	analyze	analyze	VERB
globalce-322	59	21	data	datum	NOUN
globalce-322	59	22	)	)	PUNCT
globalce-322	59	23	,	,	PUNCT
globalce-322	59	24	using	use	VERB
globalce-322	59	25	rigorous	rigorous	ADJ
globalce-322	59	26	methods	method	NOUN
globalce-322	59	27	(	(	PUNCT
globalce-322	59	28	to	to	PART
globalce-322	59	29	apply	apply	VERB
globalce-322	59	30	strict	strict	ADJ
globalce-322	59	31	techniques	technique	NOUN
globalce-322	59	32	to	to	PART
globalce-322	59	33	ensure	ensure	VERB
globalce-322	59	34	the	the	DET
globalce-322	59	35	data	datum	NOUN
globalce-322	59	36	are	be	AUX
globalce-322	59	37	accurate	accurate	ADJ
globalce-322	59	38	)	)	PUNCT
globalce-322	59	39	,	,	PUNCT
globalce-322	59	40	and	and	CCONJ
globalce-322	59	41	evaluating	evaluate	VERB
globalce-322	59	42	the	the	DET
globalce-322	59	43	results	result	NOUN
globalce-322	59	44	(	(	PUNCT
globalce-322	59	45	to	to	PART
globalce-322	59	46	assess	assess	VERB
globalce-322	59	47	figure	figure	NOUN
globalce-322	59	48	2	2	NUM
globalce-322	59	49	.	.	PUNCT
globalce-322	59	50	performance	performance	NOUN
globalce-322	59	51	evaluation	evaluation	NOUN
globalce-322	59	52	of	of	ADP
globalce-322	59	53	the	the	DET
globalce-322	59	54	ivd	ivd	NOUN
globalce-322	59	55	with	with	ADP
globalce-322	59	56	three	three	NUM
globalce-322	59	57	major	major	ADJ
globalce-322	59	58	parameters	parameter	NOUN
globalce-322	59	59	.	.	PUNCT
globalce-322	60	1	51	51	NUM
globalce-322	60	2	j	j	PROPN
globalce-322	60	3	global	global	ADJ
globalce-322	60	4	clinical	clinical	ADJ
globalce-322	60	5	engineering	engineering	NOUN
globalce-322	60	6	vol.7	vol.7	PROPN
globalce-322	60	7	issue	issue	NOUN
globalce-322	60	8	3	3	NUM
globalce-322	60	9	:	:	SYM
globalce-322	60	10	2025	2025	NUM
globalce-322	60	11	kumar	kumar	PROPN
globalce-322	60	12	,	,	PUNCT
globalce-322	60	13	gupta	gupta	PROPN
globalce-322	60	14	,	,	PUNCT
globalce-322	60	15	batra	batra	PROPN
globalce-322	60	16	,	,	PUNCT
globalce-322	60	17	sahu	sahu	PROPN
globalce-322	60	18	and	and	CCONJ
globalce-322	60	19	markan	markan	PROPN
globalce-322	60	20	:	:	PUNCT
globalce-322	60	21	catchment	catchment	NOUN
globalce-322	60	22	of	of	ADP
globalce-322	60	23	the	the	DET
globalce-322	60	24	test	test	NOUN
globalce-322	60	25	license	license	NOUN
globalce-322	60	26	for	for	ADP
globalce-322	60	27	the	the	DET
globalce-322	60	28	regulation	regulation	NOUN
globalce-322	60	29	of	of	ADP
globalce-322	60	30	medical	medical	ADJ
globalce-322	60	31	devices	device	NOUN
globalce-322	60	32	in	in	ADP
globalce-322	60	33	india	india	PROPN
globalce-322	60	34	to	to	PART
globalce-322	60	35	prevent	prevent	VERB
globalce-322	60	36	and	and	CCONJ
globalce-322	60	37	reduce	reduce	VERB
globalce-322	60	38	risks	risk	NOUN
globalce-322	60	39	,	,	PUNCT
globalce-322	60	40	errors	error	NOUN
globalce-322	60	41	,	,	PUNCT
globalce-322	60	42	and	and	CCONJ
globalce-322	60	43	harm	harm	NOUN
globalce-322	60	44	that	that	PRON
globalce-322	60	45	may	may	AUX
globalce-322	60	46	happen	happen	VERB
globalce-322	60	47	to	to	ADP
globalce-322	60	48	patients	patient	NOUN
globalce-322	60	49	/	/	SYM
globalce-322	60	50	end	end	NOUN
globalce-322	60	51	users	user	NOUN
globalce-322	60	52	.	.	PUNCT
globalce-322	61	1	furthermore	furthermore	ADV
globalce-322	61	2	,	,	PUNCT
globalce-322	61	3	the	the	DET
globalce-322	61	4	purpose	purpose	NOUN
globalce-322	61	5	of	of	ADP
globalce-322	61	6	a	a	DET
globalce-322	61	7	clinical	clinical	ADJ
globalce-322	61	8	investigation	investigation	NOUN
globalce-322	61	9	is	be	AUX
globalce-322	61	10	to	to	PART
globalce-322	61	11	establish	establish	VERB
globalce-322	61	12	and	and	CCONJ
globalce-322	61	13	verify	verify	VERB
globalce-322	61	14	the	the	DET
globalce-322	61	15	performance	performance	NOUN
globalce-322	61	16	of	of	ADP
globalce-322	61	17	a	a	DET
globalce-322	61	18	device	device	NOUN
globalce-322	61	19	in	in	ADP
globalce-322	61	20	human	human	ADJ
globalce-322	61	21	subjects	subject	NOUN
globalce-322	61	22	.	.	PUNCT
globalce-322	62	1	broadly	broadly	ADV
globalce-322	62	2	,	,	PUNCT
globalce-322	62	3	it	it	PRON
globalce-322	62	4	focuses	focus	VERB
globalce-322	62	5	on	on	ADP
globalce-322	62	6	good	good	ADJ
globalce-322	62	7	clinical	clinical	ADJ
globalce-322	62	8	practice	practice	NOUN
globalce-322	62	9	(	(	PUNCT
globalce-322	62	10	gcp	gcp	NOUN
globalce-322	62	11	)	)	PUNCT
globalce-322	62	12	for	for	ADP
globalce-322	62	13	the	the	DET
globalce-322	62	14	design	design	NOUN
globalce-322	62	15	,	,	PUNCT
globalce-322	62	16	conduct	conduct	NOUN
globalce-322	62	17	,	,	PUNCT
globalce-322	62	18	recording	recording	NOUN
globalce-322	62	19	,	,	PUNCT
globalce-322	62	20	and	and	CCONJ
globalce-322	62	21	reporting	reporting	NOUN
globalce-322	62	22	of	of	ADP
globalce-322	62	23	the	the	DET
globalce-322	62	24	adverse	adverse	ADJ
globalce-322	62	25	events	event	NOUN
globalce-322	62	26	of	of	ADP
globalce-322	62	27	clinical	clinical	ADJ
globalce-322	62	28	investigations	investigation	NOUN
globalce-322	62	29	carried	carry	VERB
globalce-322	62	30	out	out	ADP
globalce-322	62	31	on	on	ADP
globalce-322	62	32	human	human	ADJ
globalce-322	62	33	subjects	subject	NOUN
globalce-322	62	34	to	to	PART
globalce-322	62	35	assess	assess	VERB
globalce-322	62	36	the	the	DET
globalce-322	62	37	clinical	clinical	ADJ
globalce-322	62	38	effectiveness	effectiveness	NOUN
globalce-322	62	39	and	and	CCONJ
globalce-322	62	40	safety	safety	NOUN
globalce-322	62	41	of	of	ADP
globalce-322	62	42	md	md	PROPN
globalce-322	62	43	as	as	ADP
globalce-322	62	44	per	per	ADP
globalce-322	62	45	the	the	DET
globalce-322	62	46	seventh	seventh	ADJ
globalce-322	62	47	schedule	schedule	NOUN
globalce-322	62	48	of	of	ADP
globalce-322	62	49	mdr-2017	mdr-2017	NOUN
globalce-322	62	50	.	.	PUNCT
globalce-322	63	1	this	this	PRON
globalce-322	63	2	means	mean	VERB
globalce-322	63	3	checking	check	VERB
globalce-322	63	4	the	the	DET
globalce-322	63	5	ability	ability	NOUN
globalce-322	63	6	(	(	PUNCT
globalce-322	63	7	or	or	CCONJ
globalce-322	63	8	capability	capability	NOUN
globalce-322	63	9	)	)	PUNCT
globalce-322	63	10	of	of	ADP
globalce-322	63	11	a	a	DET
globalce-322	63	12	device	device	NOUN
globalce-322	63	13	to	to	PART
globalce-322	63	14	perform	perform	VERB
globalce-322	63	15	as	as	ADP
globalce-322	63	16	per	per	ADP
globalce-322	63	17	intended	intended	ADJ
globalce-322	63	18	use	use	NOUN
globalce-322	63	19	until	until	ADP
globalce-322	63	20	the	the	DET
globalce-322	63	21	specified	specified	ADJ
globalce-322	63	22	period	period	NOUN
globalce-322	63	23	/	/	SYM
globalce-322	63	24	duration	duration	NOUN
globalce-322	63	25	.	.	PUNCT
globalce-322	64	1	it	it	PRON
globalce-322	64	2	needs	need	VERB
globalce-322	64	3	to	to	PART
globalce-322	64	4	be	be	AUX
globalce-322	64	5	verified	verify	VERB
globalce-322	64	6	whether	whether	SCONJ
globalce-322	64	7	it	it	PRON
globalce-322	64	8	enables	enable	VERB
globalce-322	64	9	the	the	DET
globalce-322	64	10	manufacturer	manufacturer	NOUN
globalce-322	64	11	to	to	PART
globalce-322	64	12	achieve	achieve	VERB
globalce-322	64	13	the	the	DET
globalce-322	64	14	intended	intended	ADJ
globalce-322	64	15	purpose	purpose	NOUN
globalce-322	64	16	of	of	ADP
globalce-322	64	17	the	the	DET
globalce-322	64	18	device	device	NOUN
globalce-322	64	19	leading	lead	VERB
globalce-322	64	20	to	to	ADP
globalce-322	64	21	clinical	clinical	ADJ
globalce-322	64	22	benefits	benefit	NOUN
globalce-322	64	23	for	for	ADP
globalce-322	64	24	patients.9	patients.9	NOUN
globalce-322	64	25	moreover	moreover	ADV
globalce-322	64	26	,	,	PUNCT
globalce-322	64	27	evaluation	evaluation	NOUN
globalce-322	64	28	of	of	ADP
globalce-322	64	29	clinical	clinical	ADJ
globalce-322	64	30	performance	performance	NOUN
globalce-322	64	31	is	be	AUX
globalce-322	64	32	the	the	DET
globalce-322	64	33	systematic	systematic	ADJ
globalce-322	64	34	study	study	NOUN
globalce-322	64	35	that	that	PRON
globalce-322	64	36	can	can	AUX
globalce-322	64	37	be	be	AUX
globalce-322	64	38	used	use	VERB
globalce-322	64	39	to	to	PART
globalce-322	64	40	diagnose	diagnose	VERB
globalce-322	64	41	and	and	CCONJ
globalce-322	64	42	treat	treat	VERB
globalce-322	64	43	diseases	disease	NOUN
globalce-322	64	44	in	in	ADP
globalce-322	64	45	vitro	vitro	X
globalce-322	64	46	.	.	PUNCT
globalce-322	65	1	broadly	broadly	ADV
globalce-322	65	2	speaking	speak	VERB
globalce-322	65	3	,	,	PUNCT
globalce-322	65	4	it	it	PRON
globalce-322	65	5	is	be	AUX
globalce-322	65	6	the	the	DET
globalce-322	65	7	assessment	assessment	NOUN
globalce-322	65	8	of	of	ADP
globalce-322	65	9	an	an	DET
globalce-322	65	10	ivd	ivd	NOUN
globalce-322	65	11	using	use	VERB
globalce-322	65	12	a	a	DET
globalce-322	65	13	specimen	speciman	NOUN
globalce-322	65	14	taken	take	VERB
globalce-322	65	15	from	from	ADP
globalce-322	65	16	humans	human	NOUN
globalce-322	65	17	to	to	PART
globalce-322	65	18	evaluate	evaluate	VERB
globalce-322	65	19	its	its	PRON
globalce-322	65	20	performance	performance	NOUN
globalce-322	65	21	when	when	SCONJ
globalce-322	65	22	used	use	VERB
globalce-322	65	23	as	as	SCONJ
globalce-322	65	24	intended	intend	VERB
globalce-322	65	25	by	by	ADP
globalce-322	65	26	the	the	DET
globalce-322	65	27	manufacturer	manufacturer	NOUN
globalce-322	65	28	.	.	PUNCT
globalce-322	66	1	ivds	ivds	PROPN
globalce-322	66	2	are	be	AUX
globalce-322	66	3	designed	design	VERB
globalce-322	66	4	to	to	PART
globalce-322	66	5	extract	extract	VERB
globalce-322	66	6	information	information	NOUN
globalce-322	66	7	from	from	ADP
globalce-322	66	8	human	human	ADJ
globalce-322	66	9	samples	sample	NOUN
globalce-322	66	10	,	,	PUNCT
globalce-322	66	11	such	such	ADJ
globalce-322	66	12	as	as	ADP
globalce-322	66	13	blood	blood	NOUN
globalce-322	66	14	,	,	PUNCT
globalce-322	66	15	tissues	tissue	NOUN
globalce-322	66	16	,	,	PUNCT
globalce-322	66	17	and	and	CCONJ
globalce-322	66	18	biological	biological	ADJ
globalce-322	66	19	fluids	fluid	NOUN
globalce-322	66	20	that	that	PRON
globalce-322	66	21	can	can	AUX
globalce-322	66	22	allow	allow	VERB
globalce-322	66	23	for	for	ADP
globalce-322	66	24	drawing	drawing	NOUN
globalce-322	66	25	of	of	ADP
globalce-322	66	26	conclusions	conclusion	NOUN
globalce-322	66	27	,	,	PUNCT
globalce-322	66	28	such	such	ADJ
globalce-322	66	29	as	as	ADP
globalce-322	66	30	physiological	physiological	ADJ
globalce-322	66	31	or	or	CCONJ
globalce-322	66	32	pathological	pathological	ADJ
globalce-322	66	33	changes	change	NOUN
globalce-322	66	34	in	in	ADP
globalce-322	66	35	the	the	DET
globalce-322	66	36	body	body	NOUN
globalce-322	66	37	.	.	PUNCT
globalce-322	67	1	clinical	clinical	ADJ
globalce-322	67	2	performance	performance	NOUN
globalce-322	67	3	evaluations	evaluation	NOUN
globalce-322	67	4	may	may	AUX
globalce-322	67	5	include	include	VERB
globalce-322	67	6	:	:	PUNCT
globalce-322	67	7	•	•	NUM
globalce-322	67	8	testing	testing	NOUN
globalce-322	67	9	for	for	ADP
globalce-322	67	10	sensitivity	sensitivity	NOUN
globalce-322	67	11	,	,	PUNCT
globalce-322	67	12	specificity	specificity	NOUN
globalce-322	67	13	,	,	PUNCT
globalce-322	67	14	accuracy	accuracy	NOUN
globalce-322	67	15	,	,	PUNCT
globalce-322	67	16	precision	precision	NOUN
globalce-322	67	17	,	,	PUNCT
globalce-322	67	18	and	and	CCONJ
globalce-322	67	19	clinical	clinical	ADJ
globalce-322	67	20	validity	validity	NOUN
globalce-322	67	21	.	.	PUNCT
globalce-322	68	1	•	•	NUM
globalce-322	68	2	using	use	VERB
globalce-322	68	3	clinical	clinical	ADJ
globalce-322	68	4	performance	performance	NOUN
globalce-322	68	5	evaluation	evaluation	NOUN
globalce-322	68	6	plan	plan	NOUN
globalce-322	68	7	in	in	ADP
globalce-322	68	8	human	human	ADJ
globalce-322	68	9	specimens	specimen	NOUN
globalce-322	68	10	.	.	PUNCT
globalce-322	68	11	•	•	NUM
globalce-322	68	12	analyzing	analyze	VERB
globalce-322	68	13	and	and	CCONJ
globalce-322	68	14	summarizing	summarize	VERB
globalce-322	68	15	clinical	clinical	ADJ
globalce-322	68	16	data	datum	NOUN
globalce-322	68	17	.	.	PUNCT
globalce-322	69	1	•	•	NOUN
globalce-322	69	2	demonstrating	demonstrate	VERB
globalce-322	69	3	scientific	scientific	ADJ
globalce-322	69	4	validity	validity	NOUN
globalce-322	69	5	.	.	PUNCT
globalce-322	70	1	•	•	NOUN
globalce-322	70	2	demonstrating	demonstrate	VERB
globalce-322	70	3	analytical	analytical	ADJ
globalce-322	70	4	performance	performance	NOUN
globalce-322	70	5	.	.	PUNCT
globalce-322	71	1	for	for	ADP
globalce-322	71	2	applying	apply	VERB
globalce-322	71	3	for	for	ADP
globalce-322	71	4	a	a	DET
globalce-322	71	5	test	test	NOUN
globalce-322	71	6	license	license	NOUN
globalce-322	71	7	(	(	PUNCT
globalce-322	71	8	manufacturer	manufacturer	NOUN
globalce-322	71	9	)	)	PUNCT
globalce-322	71	10	for	for	ADP
globalce-322	71	11	clinical	clinical	ADJ
globalce-322	71	12	investigation	investigation	NOUN
globalce-322	71	13	of	of	ADP
globalce-322	71	14	md	md	PROPN
globalce-322	71	15	,	,	PUNCT
globalce-322	71	16	a	a	DET
globalce-322	71	17	copy	copy	NOUN
globalce-322	71	18	of	of	ADP
globalce-322	71	19	the	the	DET
globalce-322	71	20	grant	grant	NOUN
globalce-322	71	21	of	of	ADP
globalce-322	71	22	permission	permission	NOUN
globalce-322	71	23	is	be	AUX
globalce-322	71	24	to	to	PART
globalce-322	71	25	be	be	AUX
globalce-322	71	26	provided	provide	VERB
globalce-322	71	27	(	(	PUNCT
globalce-322	71	28	in	in	ADP
globalce-322	71	29	form	form	NOUN
globalce-322	71	30	md-23	md-23	NOUN
globalce-322	71	31	,	,	PUNCT
globalce-322	71	32	whether	whether	SCONJ
globalce-322	71	33	it	it	PRON
globalce-322	71	34	is	be	AUX
globalce-322	71	35	for	for	ADP
globalce-322	71	36	pilot/	pilot/	ADJ
globalce-322	71	37	pivotal	pivotal	ADJ
globalce-322	71	38	/	/	SYM
globalce-322	71	39	post	post	ADJ
globalce-322	71	40	-	-	ADJ
globalce-322	71	41	marketing	marketing	ADJ
globalce-322	71	42	clinical	clinical	ADJ
globalce-322	71	43	study	study	NOUN
globalce-322	71	44	)	)	PUNCT
globalce-322	71	45	.	.	PUNCT
globalce-322	72	1	conditional	conditional	ADJ
globalce-322	72	2	approval	approval	NOUN
globalce-322	72	3	of	of	ADP
globalce-322	72	4	test	test	NOUN
globalce-322	72	5	license	license	NOUN
globalce-322	72	6	may	may	AUX
globalce-322	72	7	be	be	AUX
globalce-322	72	8	granted	grant	VERB
globalce-322	72	9	in	in	ADP
globalce-322	72	10	absentia	absentia	NOUN
globalce-322	72	11	of	of	ADP
globalce-322	72	12	form	form	NOUN
globalce-322	72	13	md-23	md-23	NOUN
globalce-322	72	14	.	.	PUNCT
globalce-322	73	1	however	however	ADV
globalce-322	73	2	,	,	PUNCT
globalce-322	73	3	for	for	ADP
globalce-322	73	4	permission	permission	NOUN
globalce-322	73	5	to	to	PART
globalce-322	73	6	conduct	conduct	VERB
globalce-322	73	7	clinical	clinical	ADJ
globalce-322	73	8	investigation	investigation	NOUN
globalce-322	73	9	for	for	ADP
globalce-322	73	10	an	an	DET
globalce-322	73	11	earlier	early	ADV
globalce-322	73	12	approved	approve	VERB
globalce-322	73	13	medical	medical	ADJ
globalce-322	73	14	device	device	NOUN
globalce-322	73	15	,	,	PUNCT
globalce-322	73	16	valid	valid	ADJ
globalce-322	73	17	approval	approval	NOUN
globalce-322	73	18	from	from	ADP
globalce-322	73	19	the	the	DET
globalce-322	73	20	ethics	ethic	NOUN
globalce-322	73	21	committee	committee	PROPN
globalce-322	73	22	is	be	AUX
globalce-322	73	23	required	require	VERB
globalce-322	73	24	(	(	PUNCT
globalce-322	73	25	table	table	NOUN
globalce-322	73	26	1	1	NUM
globalce-322	73	27	)	)	PUNCT
globalce-322	73	28	.	.	PUNCT
globalce-322	74	1	on	on	ADP
globalce-322	74	2	the	the	DET
globalce-322	74	3	other	other	ADJ
globalce-322	74	4	hand	hand	NOUN
globalce-322	74	5	,	,	PUNCT
globalce-322	74	6	for	for	ADP
globalce-322	74	7	applying	apply	VERB
globalce-322	74	8	for	for	ADP
globalce-322	74	9	a	a	DET
globalce-322	74	10	test	test	NOUN
globalce-322	74	11	license	license	NOUN
globalce-322	74	12	(	(	PUNCT
globalce-322	74	13	manufacturer	manufacturer	NOUN
globalce-322	74	14	)	)	PUNCT
globalce-322	74	15	for	for	ADP
globalce-322	74	16	the	the	DET
globalce-322	74	17	evaluation	evaluation	NOUN
globalce-322	74	18	of	of	ADP
globalce-322	74	19	the	the	DET
globalce-322	74	20	clinical	clinical	ADJ
globalce-322	74	21	performance	performance	NOUN
globalce-322	74	22	of	of	ADP
globalce-322	74	23	a	a	DET
globalce-322	74	24	new	new	ADJ
globalce-322	74	25	ivd	ivd	NOUN
globalce-322	74	26	,	,	PUNCT
globalce-322	74	27	a	a	DET
globalce-322	74	28	copy	copy	NOUN
globalce-322	74	29	of	of	ADP
globalce-322	74	30	the	the	DET
globalce-322	74	31	grant	grant	NOUN
globalce-322	74	32	of	of	ADP
globalce-322	74	33	permission	permission	NOUN
globalce-322	74	34	is	be	AUX
globalce-322	74	35	required	require	VERB
globalce-322	74	36	(	(	PUNCT
globalce-322	74	37	in	in	ADP
globalce-322	74	38	form	form	NOUN
globalce-322	74	39	md-25	md-25	ADV
globalce-322	74	40	)	)	PUNCT
globalce-322	74	41	.	.	PUNCT
globalce-322	75	1	conditional	conditional	ADJ
globalce-322	75	2	approval	approval	NOUN
globalce-322	75	3	of	of	ADP
globalce-322	75	4	test	test	NOUN
globalce-322	75	5	license	license	NOUN
globalce-322	75	6	may	may	AUX
globalce-322	75	7	be	be	AUX
globalce-322	75	8	granted	grant	VERB
globalce-322	75	9	in	in	ADP
globalce-322	75	10	absentia	absentia	NOUN
globalce-322	75	11	of	of	ADP
globalce-322	75	12	form	form	NOUN
globalce-322	75	13	md-25	md-25	ADV
globalce-322	75	14	with	with	ADP
globalce-322	75	15	prior	prior	ADJ
globalce-322	75	16	submission	submission	NOUN
globalce-322	75	17	of	of	ADP
globalce-322	75	18	the	the	DET
globalce-322	75	19	clinical	clinical	ADJ
globalce-322	75	20	investigation	investigation	NOUN
globalce-322	75	21	plan	plan	NOUN
globalce-322	75	22	and	and	CCONJ
globalce-322	75	23	approval	approval	NOUN
globalce-322	75	24	from	from	ADP
globalce-322	75	25	the	the	DET
globalce-322	75	26	institutional	institutional	ADJ
globalce-322	75	27	ethics	ethic	NOUN
globalce-322	75	28	committee	committee	PROPN
globalce-322	75	29	(	(	PUNCT
globalce-322	75	30	iec	iec	PROPN
globalce-322	75	31	)	)	PUNCT
globalce-322	75	32	.	.	PUNCT
globalce-322	76	1	however	however	ADV
globalce-322	76	2	,	,	PUNCT
globalce-322	76	3	for	for	ADP
globalce-322	76	4	permission	permission	NOUN
globalce-322	76	5	to	to	PART
globalce-322	76	6	conduct	conduct	VERB
globalce-322	76	7	evaluation	evaluation	NOUN
globalce-322	76	8	of	of	ADP
globalce-322	76	9	clinical	clinical	ADJ
globalce-322	76	10	performance	performance	NOUN
globalce-322	76	11	of	of	ADP
globalce-322	76	12	an	an	DET
globalce-322	76	13	earlier	early	ADV
globalce-322	76	14	approved	approve	VERB
globalce-322	76	15	ivd	ivd	NOUN
globalce-322	76	16	,	,	PUNCT
globalce-322	76	17	valid	valid	ADJ
globalce-322	76	18	approval	approval	NOUN
globalce-322	76	19	from	from	ADP
globalce-322	76	20	the	the	DET
globalce-322	76	21	ethics	ethic	NOUN
globalce-322	76	22	committee	committee	PROPN
globalce-322	76	23	is	be	AUX
globalce-322	76	24	required	require	VERB
globalce-322	76	25	(	(	PUNCT
globalce-322	76	26	table	table	NOUN
globalce-322	76	27	2	2	NUM
globalce-322	76	28	)	)	PUNCT
globalce-322	76	29	.	.	PUNCT
globalce-322	77	1	in	in	ADP
globalce-322	77	2	addition	addition	NOUN
globalce-322	77	3	,	,	PUNCT
globalce-322	77	4	if	if	SCONJ
globalce-322	77	5	a	a	DET
globalce-322	77	6	certain	certain	ADJ
globalce-322	77	7	medical	medical	ADJ
globalce-322	77	8	device	device	NOUN
globalce-322	77	9	/	/	SYM
globalce-322	77	10	ivd	ivd	NOUN
globalce-322	77	11	is	be	AUX
globalce-322	77	12	imported	import	VERB
globalce-322	77	13	for	for	ADP
globalce-322	77	14	the	the	DET
globalce-322	77	15	purpose	purpose	NOUN
globalce-322	77	16	of	of	ADP
globalce-322	77	17	clinical	clinical	ADJ
globalce-322	77	18	investigation	investigation	NOUN
globalce-322	77	19	/	/	SYM
globalce-322	77	20	clinical	clinical	ADJ
globalce-322	77	21	performance	performance	NOUN
globalce-322	77	22	evaluation	evaluation	NOUN
globalce-322	77	23	from	from	ADP
globalce-322	77	24	the	the	DET
globalce-322	77	25	usa	usa	PROPN
globalce-322	77	26	,	,	PUNCT
globalce-322	77	27	britain	britain	PROPN
globalce-322	77	28	,	,	PUNCT
globalce-322	77	29	the	the	DET
globalce-322	77	30	united	united	PROPN
globalce-322	77	31	kingdom	kingdom	PROPN
globalce-322	77	32	,	,	PUNCT
globalce-322	77	33	japan	japan	PROPN
globalce-322	77	34	,	,	PUNCT
globalce-322	77	35	the	the	DET
globalce-322	77	36	european	european	PROPN
globalce-322	77	37	union	union	PROPN
globalce-322	77	38	,	,	PUNCT
globalce-322	77	39	australia	australia	PROPN
globalce-322	77	40	,	,	PUNCT
globalce-322	77	41	and	and	CCONJ
globalce-322	77	42	canada	canada	PROPN
globalce-322	77	43	(	(	PUNCT
globalce-322	77	44	with	with	ADP
globalce-322	77	45	a	a	DET
globalce-322	77	46	condition	condition	NOUN
globalce-322	77	47	that	that	SCONJ
globalce-322	77	48	the	the	DET
globalce-322	77	49	product	product	NOUN
globalce-322	77	50	has	have	AUX
globalce-322	77	51	already	already	ADV
globalce-322	77	52	been	be	AUX
globalce-322	77	53	marketed	market	VERB
globalce-322	77	54	for	for	ADP
globalce-322	77	55	at	at	ADV
globalce-322	77	56	least	least	ADV
globalce-322	77	57	2	2	NUM
globalce-322	77	58	years	year	NOUN
globalce-322	77	59	in	in	ADP
globalce-322	77	60	these	these	DET
globalce-322	77	61	territories	territory	NOUN
globalce-322	77	62	,	,	PUNCT
globalce-322	77	63	and	and	CCONJ
globalce-322	77	64	the	the	DET
globalce-322	77	65	cla	cla	NOUN
globalce-322	77	66	is	be	AUX
globalce-322	77	67	satisfied	satisfied	ADJ
globalce-322	77	68	with	with	ADP
globalce-322	77	69	the	the	DET
globalce-322	77	70	data	datum	NOUN
globalce-322	77	71	of	of	ADP
globalce-322	77	72	safety	safety	NOUN
globalce-322	77	73	,	,	PUNCT
globalce-322	77	74	performance	performance	NOUN
globalce-322	77	75	,	,	PUNCT
globalce-322	77	76	and	and	CCONJ
globalce-322	77	77	pharmacovigilance	pharmacovigilance	NOUN
globalce-322	77	78	of	of	ADP
globalce-322	77	79	the	the	DET
globalce-322	77	80	said	say	VERB
globalce-322	77	81	device	device	NOUN
globalce-322	77	82	)	)	PUNCT
globalce-322	77	83	,	,	PUNCT
globalce-322	77	84	the	the	DET
globalce-322	77	85	requirement	requirement	NOUN
globalce-322	77	86	to	to	PART
globalce-322	77	87	apply	apply	VERB
globalce-322	77	88	for	for	ADP
globalce-322	77	89	test	test	NOUN
globalce-322	77	90	license	license	NOUN
globalce-322	77	91	to	to	PART
globalce-322	77	92	conduct	conduct	VERB
globalce-322	77	93	clinical	clinical	ADJ
globalce-322	77	94	investigation	investigation	NOUN
globalce-322	77	95	/	/	SYM
globalce-322	77	96	evaluation	evaluation	NOUN
globalce-322	77	97	of	of	ADP
globalce-322	77	98	clinical	clinical	ADJ
globalce-322	77	99	performance	performance	NOUN
globalce-322	77	100	is	be	AUX
globalce-322	77	101	waived	waive	VERB
globalce-322	77	102	off	off	ADP
globalce-322	77	103	.	.	PUNCT
globalce-322	78	1	however	however	ADV
globalce-322	78	2	,	,	PUNCT
globalce-322	78	3	if	if	SCONJ
globalce-322	78	4	medical	medical	ADJ
globalce-322	78	5	device	device	NOUN
globalce-322	78	6	/	/	SYM
globalce-322	78	7	ivd	ivd	NOUN
globalce-322	78	8	is	be	AUX
globalce-322	78	9	approved	approve	VERB
globalce-322	78	10	and	and	CCONJ
globalce-322	78	11	marketed	market	VERB
globalce-322	78	12	in	in	ADP
globalce-322	78	13	places	place	NOUN
globalce-322	78	14	other	other	ADJ
globalce-322	78	15	than	than	ADP
globalce-322	78	16	these	these	DET
globalce-322	78	17	territories	territory	NOUN
globalce-322	78	18	,	,	PUNCT
globalce-322	78	19	proof	proof	NOUN
globalce-322	78	20	of	of	ADP
globalce-322	78	21	grant	grant	NOUN
globalce-322	78	22	of	of	ADP
globalce-322	78	23	permission	permission	NOUN
globalce-322	78	24	to	to	PART
globalce-322	78	25	conduct	conduct	VERB
globalce-322	78	26	clinical	clinical	ADJ
globalce-322	78	27	investigation	investigation	NOUN
globalce-322	78	28	/	/	SYM
globalce-322	78	29	evaluation	evaluation	NOUN
globalce-322	78	30	of	of	ADP
globalce-322	78	31	clinical	clinical	ADJ
globalce-322	78	32	performance	performance	NOUN
globalce-322	78	33	(	(	PUNCT
globalce-322	78	34	form	form	NOUN
globalce-322	78	35	md-23/	md-23/	PROPN
globalce-322	78	36	form	form	NOUN
globalce-322	78	37	md-25	md-25	ADV
globalce-322	78	38	)	)	PUNCT
globalce-322	78	39	is	be	AUX
globalce-322	78	40	required	require	VERB
globalce-322	78	41	in	in	ADP
globalce-322	78	42	accordance	accordance	NOUN
globalce-322	78	43	with	with	ADP
globalce-322	78	44	the	the	DET
globalce-322	78	45	test	test	NOUN
globalce-322	78	46	license	license	NOUN
globalce-322	78	47	(	(	PUNCT
globalce-322	78	48	table	table	NOUN
globalce-322	78	49	1	1	NUM
globalce-322	78	50	)	)	PUNCT
globalce-322	78	51	.	.	PUNCT
globalce-322	79	1	consequent	consequent	ADJ
globalce-322	79	2	attributes	attribute	NOUN
globalce-322	79	3	after	after	ADP
globalce-322	79	4	test	test	NOUN
globalce-322	79	5	license	license	NOUN
globalce-322	79	6	once	once	ADV
globalce-322	79	7	test	test	NOUN
globalce-322	79	8	license	license	NOUN
globalce-322	79	9	has	have	AUX
globalce-322	79	10	been	be	AUX
globalce-322	79	11	granted	grant	VERB
globalce-322	79	12	for	for	ADP
globalce-322	79	13	any	any	PRON
globalce-322	79	14	of	of	ADP
globalce-322	79	15	the	the	DET
globalce-322	79	16	aforesaid	aforesaid	ADJ
globalce-322	79	17	purposes	purpose	NOUN
globalce-322	79	18	,	,	PUNCT
globalce-322	79	19	the	the	DET
globalce-322	79	20	applicant	applicant	NOUN
globalce-322	79	21	may	may	AUX
globalce-322	79	22	prepare	prepare	VERB
globalce-322	79	23	/	/	SYM
globalce-322	79	24	import	import	NOUN
globalce-322	79	25	at	at	ADV
globalce-322	79	26	least	least	ADV
globalce-322	79	27	three	three	NUM
globalce-322	79	28	test	test	NOUN
globalce-322	79	29	batches	batch	NOUN
globalce-322	79	30	of	of	ADP
globalce-322	79	31	the	the	DET
globalce-322	79	32	said	said	ADJ
globalce-322	79	33	device	device	NOUN
globalce-322	79	34	in	in	ADP
globalce-322	79	35	statistically	statistically	ADV
globalce-322	79	36	significant	significant	ADJ
globalce-322	79	37	quantities	quantity	NOUN
globalce-322	79	38	at	at	ADP
globalce-322	79	39	the	the	DET
globalce-322	79	40	manufacturing	manufacturing	NOUN
globalce-322	79	41	site	site	NOUN
globalce-322	79	42	(	(	PUNCT
globalce-322	79	43	in	in	ADP
globalce-322	79	44	-	-	PUNCT
globalce-322	79	45	house	house	NOUN
globalce-322	79	46	)	)	PUNCT
globalce-322	79	47	to	to	PART
globalce-322	79	48	generate	generate	VERB
globalce-322	79	49	quality	quality	NOUN
globalce-322	79	50	control	control	NOUN
globalce-322	79	51	(	(	PUNCT
globalce-322	79	52	qc	qc	PROPN
globalce-322	79	53	)	)	PUNCT
globalce-322	79	54	data	datum	NOUN
globalce-322	79	55	that	that	PRON
globalce-322	79	56	comply	comply	VERB
globalce-322	79	57	with	with	ADP
globalce-322	79	58	the	the	DET
globalce-322	79	59	essential	essential	ADJ
globalce-322	79	60	principles	principle	NOUN
globalce-322	79	61	of	of	ADP
globalce-322	79	62	safety	safety	NOUN
globalce-322	79	63	and	and	CCONJ
globalce-322	79	64	performance	performance	NOUN
globalce-322	79	65	of	of	ADP
globalce-322	79	66	the	the	DET
globalce-322	79	67	proposed	propose	VERB
globalce-322	79	68	device	device	NOUN
globalce-322	79	69	.	.	PUNCT
globalce-322	80	1	in	in	ADP
globalce-322	80	2	addition	addition	NOUN
globalce-322	80	3	,	,	PUNCT
globalce-322	80	4	these	these	DET
globalce-322	80	5	data	datum	NOUN
globalce-322	80	6	should	should	AUX
globalce-322	80	7	also	also	ADV
globalce-322	80	8	be	be	AUX
globalce-322	80	9	generated	generate	VERB
globalce-322	80	10	at	at	ADP
globalce-322	80	11	the	the	DET
globalce-322	80	12	testing	testing	NOUN
globalce-322	80	13	site	site	NOUN
globalce-322	80	14	that	that	PRON
globalce-322	80	15	may	may	AUX
globalce-322	80	16	be	be	AUX
globalce-322	80	17	comparable	comparable	ADJ
globalce-322	80	18	enough	enough	ADV
globalce-322	80	19	with	with	ADP
globalce-322	80	20	the	the	DET
globalce-322	80	21	in	in	ADP
globalce-322	80	22	-	-	PUNCT
globalce-322	80	23	house	house	NOUN
globalce-322	80	24	data	datum	NOUN
globalce-322	80	25	.	.	PUNCT
globalce-322	81	1	however	however	ADV
globalce-322	81	2	,	,	PUNCT
globalce-322	81	3	in	in	ADP
globalce-322	81	4	the	the	DET
globalce-322	81	5	case	case	NOUN
globalce-322	81	6	of	of	ADP
globalce-322	81	7	manufacture	manufacture	NOUN
globalce-322	81	8	/	/	SYM
globalce-322	81	9	import	import	NOUN
globalce-322	81	10	of	of	ADP
globalce-322	81	11	ivd	ivd	PROPN
globalce-322	81	12	,	,	PUNCT
globalce-322	81	13	per	per	ADP
globalce-322	81	14	that	that	PRON
globalce-322	81	15	would	would	AUX
globalce-322	81	16	be	be	AUX
globalce-322	81	17	generated	generate	VERB
globalce-322	81	18	at	at	ADP
globalce-322	81	19	designated	designate	VERB
globalce-322	81	20	labs	lab	NOUN
globalce-322	81	21	(	(	PUNCT
globalce-322	81	22	specific	specific	ADJ
globalce-322	81	23	for	for	ADP
globalce-322	81	24	a	a	DET
globalce-322	81	25	particular	particular	ADJ
globalce-322	81	26	ivd	ivd	NOUN
globalce-322	81	27	)	)	PUNCT
globalce-322	81	28	should	should	AUX
globalce-322	81	29	be	be	AUX
globalce-322	81	30	compared	compare	VERB
globalce-322	81	31	with	with	ADP
globalce-322	81	32	the	the	DET
globalce-322	81	33	in	in	ADP
globalce-322	81	34	-	-	PUNCT
globalce-322	81	35	house	house	NOUN
globalce-322	81	36	data	datum	NOUN
globalce-322	81	37	generated	generate	VERB
globalce-322	81	38	.	.	PUNCT
globalce-322	82	1	these	these	DET
globalce-322	82	2	data	datum	NOUN
globalce-322	82	3	are	be	AUX
globalce-322	82	4	further	far	ADV
globalce-322	82	5	used	use	VERB
globalce-322	82	6	in	in	ADP
globalce-322	82	7	the	the	DET
globalce-322	82	8	next	next	ADJ
globalce-322	82	9	regulatory	regulatory	ADJ
globalce-322	82	10	application	application	NOUN
globalce-322	82	11	in	in	ADP
globalce-322	82	12	order	order	NOUN
globalce-322	82	13	to	to	PART
globalce-322	82	14	get	get	VERB
globalce-322	82	15	the	the	DET
globalce-322	82	16	final	final	ADJ
globalce-322	82	17	approval	approval	NOUN
globalce-322	82	18	of	of	ADP
globalce-322	82	19	the	the	DET
globalce-322	82	20	device	device	NOUN
globalce-322	82	21	/	/	SYM
globalce-322	82	22	ivd	ivd	NOUN
globalce-322	82	23	for	for	ADP
globalce-322	82	24	sale	sale	NOUN
globalce-322	82	25	and	and	CCONJ
globalce-322	82	26	distribution	distribution	NOUN
globalce-322	82	27	in	in	ADP
globalce-322	82	28	the	the	DET
globalce-322	82	29	market	market	NOUN
globalce-322	82	30	.	.	PUNCT
globalce-322	83	1	kumar	kumar	PROPN
globalce-322	83	2	,	,	PUNCT
globalce-322	83	3	gupta	gupta	PROPN
globalce-322	83	4	,	,	PUNCT
globalce-322	83	5	batra	batra	PROPN
globalce-322	83	6	,	,	PUNCT
globalce-322	83	7	sahu	sahu	PROPN
globalce-322	83	8	and	and	CCONJ
globalce-322	83	9	markan	markan	PROPN
globalce-322	83	10	:	:	PUNCT
globalce-322	83	11	catchment	catchment	NOUN
globalce-322	83	12	of	of	ADP
globalce-322	83	13	the	the	DET
globalce-322	83	14	test	test	NOUN
globalce-322	83	15	license	license	NOUN
globalce-322	83	16	for	for	ADP
globalce-322	83	17	the	the	DET
globalce-322	83	18	regulation	regulation	NOUN
globalce-322	83	19	of	of	ADP
globalce-322	83	20	medical	medical	ADJ
globalce-322	83	21	devices	device	NOUN
globalce-322	83	22	in	in	ADP
globalce-322	83	23	india	india	PROPN
globalce-322	83	24	j	j	PROPN
globalce-322	83	25	global	global	ADJ
globalce-322	83	26	clinical	clinical	ADJ
globalce-322	83	27	engineering	engineering	NOUN
globalce-322	83	28	vol.7	vol.7	PROPN
globalce-322	83	29	issue	issue	NOUN
globalce-322	83	30	3	3	NUM
globalce-322	83	31	:	:	SYM
globalce-322	83	32	2025	2025	NUM
globalce-322	83	33	52	52	NUM
globalce-322	83	34	moreover	moreover	ADV
globalce-322	83	35	,	,	PUNCT
globalce-322	83	36	it	it	PRON
globalce-322	83	37	has	have	AUX
globalce-322	83	38	been	be	AUX
globalce-322	83	39	noticed	notice	VERB
globalce-322	83	40	that	that	SCONJ
globalce-322	83	41	at	at	ADP
globalce-322	83	42	the	the	DET
globalce-322	83	43	time	time	NOUN
globalce-322	83	44	of	of	ADP
globalce-322	83	45	applying	apply	VERB
globalce-322	83	46	for	for	ADP
globalce-322	83	47	the	the	DET
globalce-322	83	48	test	test	NOUN
globalce-322	83	49	license	license	NOUN
globalce-322	83	50	,	,	PUNCT
globalce-322	83	51	it	it	PRON
globalce-322	83	52	is	be	AUX
globalce-322	83	53	not	not	PART
globalce-322	83	54	mandatory	mandatory	ADJ
globalce-322	83	55	that	that	SCONJ
globalce-322	83	56	the	the	DET
globalce-322	83	57	manufacturing	manufacturing	NOUN
globalce-322	83	58	site	site	NOUN
globalce-322	83	59	should	should	AUX
globalce-322	83	60	comply	comply	VERB
globalce-322	83	61	with	with	ADP
globalce-322	83	62	the	the	DET
globalce-322	83	63	quality	quality	NOUN
globalce-322	83	64	management	management	NOUN
globalce-322	83	65	system	system	NOUN
globalce-322	83	66	(	(	PUNCT
globalce-322	83	67	qms	qms	NOUN
globalce-322	83	68	)	)	PUNCT
globalce-322	83	69	as	as	ADP
globalce-322	83	70	per	per	ADP
globalce-322	83	71	the	the	DET
globalce-322	83	72	fifth	fifth	ADJ
globalce-322	83	73	schedule	schedule	NOUN
globalce-322	83	74	of	of	ADP
globalce-322	83	75	mdr-2017	mdr-2017	NOUN
globalce-322	83	76	and	and	CCONJ
globalce-322	83	77	the	the	DET
globalce-322	83	78	subject	subject	ADJ
globalce-322	83	79	device	device	NOUN
globalce-322	83	80	should	should	AUX
globalce-322	83	81	adhere	adhere	VERB
globalce-322	83	82	with	with	ADP
globalce-322	83	83	applicable	applicable	ADJ
globalce-322	83	84	bureau	bureau	NOUN
globalce-322	83	85	of	of	ADP
globalce-322	83	86	indian	indian	PROPN
globalce-322	83	87	standards	standard	NOUN
globalce-322	83	88	(	(	PUNCT
globalce-322	83	89	bis)/iso	bis)/iso	NOUN
globalce-322	83	90	/	/	SYM
globalce-322	83	91	international	international	ADJ
globalce-322	83	92	electrotechnical	electrotechnical	ADJ
globalce-322	83	93	commission	commission	NOUN
globalce-322	83	94	(	(	PUNCT
globalce-322	83	95	iec)/pharmacopeial	iec)/pharmacopeial	ADJ
globalce-322	83	96	standards	standard	NOUN
globalce-322	83	97	)	)	PUNCT
globalce-322	83	98	.	.	PUNCT
globalce-322	84	1	but	but	CCONJ
globalce-322	84	2	,	,	PUNCT
globalce-322	84	3	while	while	SCONJ
globalce-322	84	4	applying	apply	VERB
globalce-322	84	5	for	for	ADP
globalce-322	84	6	the	the	DET
globalce-322	84	7	commercial	commercial	ADJ
globalce-322	84	8	manufacturing	manufacturing	NOUN
globalce-322	84	9	license	license	NOUN
globalce-322	84	10	,	,	PUNCT
globalce-322	84	11	the	the	DET
globalce-322	84	12	manufacturing	manufacturing	NOUN
globalce-322	84	13	facility	facility	NOUN
globalce-322	84	14	must	must	AUX
globalce-322	84	15	comply	comply	VERB
globalce-322	84	16	with	with	ADP
globalce-322	84	17	qms	qms	NOUN
globalce-322	84	18	or	or	CCONJ
globalce-322	84	19	have	have	VERB
globalce-322	84	20	iso	iso	NOUN
globalce-322	84	21	13485	13485	NUM
globalce-322	84	22	,	,	PUNCT
globalce-322	84	23	which	which	PRON
globalce-322	84	24	may	may	AUX
globalce-322	84	25	be	be	AUX
globalce-322	84	26	audited	audit	VERB
globalce-322	84	27	later	later	ADV
globalce-322	84	28	by	by	ADP
globalce-322	84	29	the	the	DET
globalce-322	84	30	concern	concern	NOUN
globalce-322	84	31	notified	notify	VERB
globalce-322	84	32	body	body	NOUN
globalce-322	84	33	(	(	PUNCT
globalce-322	84	34	in	in	ADP
globalce-322	84	35	the	the	DET
globalce-322	84	36	case	case	NOUN
globalce-322	84	37	of	of	ADP
globalce-322	84	38	risk	risk	NOUN
globalce-322	84	39	-	-	PUNCT
globalce-322	84	40	based	base	VERB
globalce-322	84	41	class	class	NOUN
globalce-322	84	42	of	of	ADP
globalce-322	84	43	a	a	PRON
globalce-322	84	44	and	and	CCONJ
globalce-322	84	45	b	b	NOUN
globalce-322	84	46	by	by	ADP
globalce-322	84	47	the	the	DET
globalce-322	84	48	state	state	NOUN
globalce-322	84	49	licensing	licensing	NOUN
globalce-322	84	50	authority	authority	NOUN
globalce-322	84	51	)	)	PUNCT
globalce-322	84	52	or	or	CCONJ
globalce-322	84	53	by	by	ADP
globalce-322	84	54	a	a	DET
globalce-322	84	55	medical	medical	ADJ
globalce-322	84	56	device	device	NOUN
globalce-322	84	57	officer	officer	NOUN
globalce-322	84	58	(	(	PUNCT
globalce-322	84	59	in	in	ADP
globalce-322	84	60	the	the	DET
globalce-322	84	61	case	case	NOUN
globalce-322	84	62	of	of	ADP
globalce-322	84	63	risk	risk	NOUN
globalce-322	84	64	-	-	PUNCT
globalce-322	84	65	based	base	VERB
globalce-322	84	66	class	class	NOUN
globalce-322	84	67	of	of	ADP
globalce-322	84	68	c	c	PROPN
globalce-322	84	69	and	and	CCONJ
globalce-322	84	70	d	d	NOUN
globalce-322	84	71	by	by	ADP
globalce-322	84	72	the	the	DET
globalce-322	84	73	cla	cla	NOUN
globalce-322	84	74	)	)	PUNCT
globalce-322	84	75	,	,	PUNCT
globalce-322	84	76	and	and	CCONJ
globalce-322	84	77	the	the	DET
globalce-322	84	78	proposed	propose	VERB
globalce-322	84	79	device	device	NOUN
globalce-322	84	80	must	must	AUX
globalce-322	84	81	follow	follow	VERB
globalce-322	84	82	the	the	DET
globalce-322	84	83	respective	respective	ADJ
globalce-322	84	84	standards	standard	NOUN
globalce-322	84	85	.	.	PUNCT
globalce-322	85	1	all	all	DET
globalce-322	85	2	the	the	DET
globalce-322	85	3	data	datum	NOUN
globalce-322	85	4	obtained	obtain	VERB
globalce-322	85	5	prior	prior	ADV
globalce-322	85	6	to	to	ADP
globalce-322	85	7	granting	grant	VERB
globalce-322	85	8	of	of	ADP
globalce-322	85	9	the	the	DET
globalce-322	85	10	test	test	NOUN
globalce-322	85	11	license	license	NOUN
globalce-322	85	12	is	be	AUX
globalce-322	85	13	not	not	PART
globalce-322	85	14	to	to	PART
globalce-322	85	15	be	be	AUX
globalce-322	85	16	considered	consider	VERB
globalce-322	85	17	for	for	ADP
globalce-322	85	18	regulatory	regulatory	ADJ
globalce-322	85	19	approval	approval	NOUN
globalce-322	85	20	of	of	ADP
globalce-322	85	21	medical	medical	ADJ
globalce-322	85	22	device	device	NOUN
globalce-322	85	23	/	/	SYM
globalce-322	85	24	ivd	ivd	NOUN
globalce-322	85	25	(	(	PUNCT
globalce-322	85	26	figures	figure	NOUN
globalce-322	85	27	3	3	NUM
globalce-322	85	28	and	and	CCONJ
globalce-322	85	29	4	4	NUM
globalce-322	85	30	)	)	PUNCT
globalce-322	85	31	.	.	PUNCT
globalce-322	86	1	in	in	ADP
globalce-322	86	2	this	this	DET
globalce-322	86	3	regard	regard	NOUN
globalce-322	86	4	,	,	PUNCT
globalce-322	86	5	it	it	PRON
globalce-322	86	6	is	be	AUX
globalce-322	86	7	advisable	advisable	ADJ
globalce-322	86	8	that	that	SCONJ
globalce-322	86	9	the	the	DET
globalce-322	86	10	innovator	innovator	NOUN
globalce-322	86	11	may	may	AUX
globalce-322	86	12	refer	refer	VERB
globalce-322	86	13	to	to	ADP
globalce-322	86	14	the	the	DET
globalce-322	86	15	regulatory	regulatory	ADJ
globalce-322	86	16	pathway	pathway	NOUN
globalce-322	86	17	for	for	ADP
globalce-322	86	18	md	md	PROPN
globalce-322	86	19	/	/	SYM
globalce-322	86	20	ivd	ivd	PROPN
globalce-322	86	21	given	give	VERB
globalce-322	86	22	on	on	ADP
globalce-322	86	23	the	the	DET
globalce-322	86	24	cdsco	cdsco	PROPN
globalce-322	86	25	website.10	website.10	VERB
globalce-322	86	26	document	document	NOUN
globalce-322	86	27	underlying	underlie	VERB
globalce-322	86	28	for	for	ADP
globalce-322	86	29	applying	apply	VERB
globalce-322	86	30	the	the	DET
globalce-322	86	31	test	test	NOUN
globalce-322	86	32	license	license	NOUN
globalce-322	86	33	there	there	PRON
globalce-322	86	34	are	be	VERB
globalce-322	86	35	a	a	DET
globalce-322	86	36	certain	certain	ADJ
globalce-322	86	37	set	set	NOUN
globalce-322	86	38	of	of	ADP
globalce-322	86	39	documents	document	NOUN
globalce-322	86	40	for	for	ADP
globalce-322	86	41	applying	apply	VERB
globalce-322	86	42	for	for	ADP
globalce-322	86	43	test	test	NOUN
globalce-322	86	44	license	license	NOUN
globalce-322	86	45	against	against	ADP
globalce-322	86	46	the	the	DET
globalce-322	86	47	proposed	propose	VERB
globalce-322	86	48	device	device	NOUN
globalce-322	86	49	/	/	SYM
globalce-322	86	50	ivd	ivd	NOUN
globalce-322	86	51	as	as	ADP
globalce-322	86	52	per	per	ADP
globalce-322	86	53	form	form	NOUN
globalce-322	86	54	mdr-2017.2	mdr-2017.2	VERB
globalce-322	86	55	a	a	DET
globalce-322	86	56	brief	brief	ADJ
globalce-322	86	57	overview	overview	NOUN
globalce-322	86	58	of	of	ADP
globalce-322	86	59	each	each	DET
globalce-322	86	60	document	document	NOUN
globalce-322	86	61	is	be	AUX
globalce-322	86	62	herewith	herewith	NOUN
globalce-322	86	63	discussed	discuss	VERB
globalce-322	86	64	and	and	CCONJ
globalce-322	86	65	summarized	summarize	VERB
globalce-322	86	66	in	in	ADP
globalce-322	86	67	table	table	NOUN
globalce-322	86	68	2	2	NUM
globalce-322	86	69	.	.	NOUN
globalce-322	86	70	1	1	NUM
globalce-322	86	71	.	.	X
globalce-322	86	72	covering	cover	VERB
globalce-322	86	73	letter	letter	NOUN
globalce-322	86	74	mentioning	mention	VERB
globalce-322	86	75	the	the	DET
globalce-322	86	76	objective	objective	NOUN
globalce-322	86	77	of	of	ADP
globalce-322	86	78	the	the	DET
globalce-322	86	79	test	test	NOUN
globalce-322	86	80	license	license	NOUN
globalce-322	86	81	specifically	specifically	ADV
globalce-322	86	82	details	detail	VERB
globalce-322	86	83	the	the	DET
globalce-322	86	84	purpose	purpose	NOUN
globalce-322	86	85	,	,	PUNCT
globalce-322	86	86	intended	intended	ADJ
globalce-322	86	87	use	use	NOUN
globalce-322	86	88	,	,	PUNCT
globalce-322	86	89	justification	justification	NOUN
globalce-322	86	90	of	of	ADP
globalce-322	86	91	quantity	quantity	NOUN
globalce-322	86	92	,	,	PUNCT
globalce-322	86	93	and	and	CCONJ
globalce-322	86	94	regulatory	regulatory	ADJ
globalce-322	86	95	status	status	NOUN
globalce-322	86	96	(	(	PUNCT
globalce-322	86	97	i.e.	i.e.	X
globalce-322	86	98	,	,	PUNCT
globalce-322	86	99	availability	availability	NOUN
globalce-322	86	100	of	of	ADP
globalce-322	86	101	predicate	predicate	NOUN
globalce-322	86	102	device	device	NOUN
globalce-322	86	103	in	in	ADP
globalce-322	86	104	india	india	PROPN
globalce-322	86	105	and	and	CCONJ
globalce-322	86	106	approval	approval	NOUN
globalce-322	86	107	status	status	NOUN
globalce-322	86	108	in	in	ADP
globalce-322	86	109	other	other	ADJ
globalce-322	86	110	countries	country	NOUN
globalce-322	86	111	)	)	PUNCT
globalce-322	86	112	,	,	PUNCT
globalce-322	86	113	and	and	CCONJ
globalce-322	86	114	detail	detail	NOUN
globalce-322	86	115	of	of	ADP
globalce-322	86	116	manufacturing	manufacturing	NOUN
globalce-322	86	117	and	and	CCONJ
globalce-322	86	118	testing/	testing/	NUM
globalce-322	86	119	evaluation	evaluation	NOUN
globalce-322	86	120	site	site	NOUN
globalce-322	86	121	.	.	PUNCT
globalce-322	87	1	2	2	X
globalce-322	87	2	.	.	X
globalce-322	87	3	brief	brief	ADJ
globalce-322	87	4	description	description	NOUN
globalce-322	87	5	of	of	ADP
globalce-322	87	6	applied	apply	VERB
globalce-322	87	7	md	md	PROPN
globalce-322	87	8	/	/	SYM
globalce-322	87	9	ivd	ivd	PROPN
globalce-322	87	10	including	include	VERB
globalce-322	87	11	intended	intend	VERB
globalce-322	87	12	use	use	NOUN
globalce-322	87	13	,	,	PUNCT
globalce-322	87	14	material	material	NOUN
globalce-322	87	15	of	of	ADP
globalce-322	87	16	construction	construction	NOUN
globalce-322	87	17	(	(	PUNCT
globalce-322	87	18	moc	moc	NOUN
globalce-322	87	19	,	,	PUNCT
globalce-322	87	20	design	design	NOUN
globalce-322	87	21	,	,	PUNCT
globalce-322	87	22	label	label	NOUN
globalce-322	87	23	,	,	PUNCT
globalce-322	87	24	specimen	speciman	NOUN
globalce-322	87	25	used	use	VERB
globalce-322	87	26	for	for	ADP
globalce-322	87	27	testing	testing	NOUN
globalce-322	87	28	(	(	PUNCT
globalce-322	87	29	human	human	NOUN
globalce-322	87	30	/	/	SYM
globalce-322	87	31	animal	animal	NOUN
globalce-322	87	32	)	)	PUNCT
globalce-322	87	33	,	,	PUNCT
globalce-322	87	34	type	type	NOUN
globalce-322	87	35	of	of	ADP
globalce-322	87	36	specimen	speciman	NOUN
globalce-322	87	37	(	(	PUNCT
globalce-322	87	38	blood	blood	NOUN
globalce-322	87	39	,	,	PUNCT
globalce-322	87	40	serum	serum	NOUN
globalce-322	87	41	,	,	PUNCT
globalce-322	87	42	plasma	plasma	NOUN
globalce-322	87	43	,	,	PUNCT
globalce-322	87	44	etc	etc	X
globalce-322	87	45	.	.	X
globalce-322	87	46	)	)	PUNCT
globalce-322	87	47	.	.	PUNCT
globalce-322	88	1	if	if	SCONJ
globalce-322	88	2	a	a	DET
globalce-322	88	3	predicate	predicate	NOUN
globalce-322	88	4	device	device	NOUN
globalce-322	88	5	is	be	AUX
globalce-322	88	6	available	available	ADJ
globalce-322	88	7	,	,	PUNCT
globalce-322	88	8	the	the	DET
globalce-322	88	9	applicant	applicant	NOUN
globalce-322	88	10	needs	need	VERB
globalce-322	88	11	to	to	PART
globalce-322	88	12	submit	submit	VERB
globalce-322	88	13	the	the	DET
globalce-322	88	14	substantial	substantial	ADJ
globalce-322	88	15	equivalence	equivalence	NOUN
globalce-322	88	16	evaluation	evaluation	NOUN
globalce-322	88	17	along	along	ADP
globalce-322	88	18	with	with	ADP
globalce-322	88	19	relevant	relevant	ADJ
globalce-322	88	20	published	publish	VERB
globalce-322	88	21	literature	literature	NOUN
globalce-322	88	22	,	,	PUNCT
globalce-322	88	23	that	that	ADV
globalce-322	88	24	is	is	ADV
globalce-322	88	25	,	,	PUNCT
globalce-322	88	26	comparative	comparative	ADJ
globalce-322	88	27	analysis	analysis	NOUN
globalce-322	88	28	to	to	PART
globalce-322	88	29	prove	prove	VERB
globalce-322	88	30	substantial	substantial	ADJ
globalce-322	88	31	equivalence	equivalence	NOUN
globalce-322	88	32	to	to	ADP
globalce-322	88	33	the	the	DET
globalce-322	88	34	predicate	predicate	NOUN
globalce-322	88	35	device(s	device(s	NOUN
globalce-322	88	36	)	)	PUNCT
globalce-322	88	37	as	as	SCONJ
globalce-322	88	38	claimed	claim	VERB
globalce-322	88	39	with	with	ADP
globalce-322	88	40	respect	respect	NOUN
globalce-322	88	41	to	to	ADP
globalce-322	88	42	intended	intended	ADJ
globalce-322	88	43	use	use	NOUN
globalce-322	88	44	,	,	PUNCT
globalce-322	88	45	moc	moc	NOUN
globalce-322	88	46	,	,	PUNCT
globalce-322	88	47	design	design	NOUN
globalce-322	88	48	characteristics	characteristic	NOUN
globalce-322	88	49	,	,	PUNCT
globalce-322	88	50	mechanism	mechanism	NOUN
globalce-322	88	51	,	,	PUNCT
globalce-322	88	52	principal	principal	NOUN
globalce-322	88	53	of	of	ADP
globalce-322	88	54	operation	operation	NOUN
globalce-322	88	55	,	,	PUNCT
globalce-322	88	56	etc	etc	X
globalce-322	88	57	.	.	X
globalce-322	88	58	table	table	NOUN
globalce-322	88	59	1	1	NUM
globalce-322	88	60	.	.	PUNCT
globalce-322	88	61	requirement	requirement	NOUN
globalce-322	88	62	for	for	ADP
globalce-322	88	63	the	the	DET
globalce-322	88	64	application	application	NOUN
globalce-322	88	65	of	of	ADP
globalce-322	88	66	test	test	NOUN
globalce-322	88	67	license	license	NOUN
globalce-322	88	68	with	with	ADP
globalce-322	88	69	the	the	DET
globalce-322	88	70	purpose	purpose	NOUN
globalce-322	88	71	of	of	ADP
globalce-322	88	72	clinical	clinical	ADJ
globalce-322	88	73	investigation	investigation	NOUN
globalce-322	88	74	/	/	SYM
globalce-322	88	75	evaluation	evaluation	NOUN
globalce-322	88	76	of	of	ADP
globalce-322	88	77	clinical	clinical	ADJ
globalce-322	88	78	performance	performance	NOUN
globalce-322	88	79	.	.	PUNCT
globalce-322	89	1	objective	objective	ADJ
globalce-322	89	2	test	test	NOUN
globalce-322	89	3	license	license	NOUN
globalce-322	89	4	for	for	ADP
globalce-322	89	5	md	md	PROPN
globalce-322	89	6	/	/	SYM
globalce-322	89	7	ivd	ivd	PROPN
globalce-322	89	8	manufacture	manufacture	VERB
globalce-322	89	9	investigational	investigational	ADJ
globalce-322	89	10	md	md	PROPN
globalce-322	89	11	/	/	SYM
globalce-322	89	12	new	new	ADJ
globalce-322	89	13	ivd	ivd	NOUN
globalce-322	89	14	proof	proof	NOUN
globalce-322	89	15	of	of	ADP
globalce-322	89	16	grant	grant	NOUN
globalce-322	89	17	of	of	ADP
globalce-322	89	18	permission	permission	NOUN
globalce-322	89	19	to	to	PART
globalce-322	89	20	conduct	conduct	VERB
globalce-322	89	21	clinical	clinical	ADJ
globalce-322	89	22	investigation	investigation	NOUN
globalce-322	89	23	/	/	SYM
globalce-322	89	24	evaluation	evaluation	NOUN
globalce-322	89	25	of	of	ADP
globalce-322	89	26	clinical	clinical	ADJ
globalce-322	89	27	performance	performance	NOUN
globalce-322	89	28	(	(	PUNCT
globalce-322	89	29	form	form	NOUN
globalce-322	89	30	md-23	md-23	NOUN
globalce-322	89	31	for	for	ADP
globalce-322	89	32	md	md	PROPN
globalce-322	89	33	)	)	PUNCT
globalce-322	89	34	,	,	PUNCT
globalce-322	89	35	(	(	PUNCT
globalce-322	89	36	form	form	NOUN
globalce-322	89	37	md-25	md-25	X
globalce-322	89	38	for	for	ADP
globalce-322	89	39	ivd	ivd	NOUN
globalce-322	89	40	)	)	PUNCT
globalce-322	89	41	.	.	PUNCT
globalce-322	90	1	earlier	early	ADV
globalce-322	90	2	approved	approve	VERB
globalce-322	90	3	in	in	ADP
globalce-322	90	4	india	india	PROPN
globalce-322	90	5	ethics	ethics	PROPN
globalce-322	90	6	committee	committee	PROPN
globalce-322	90	7	(	(	PUNCT
globalce-322	90	8	ec	ec	PROPN
globalce-322	90	9	)	)	PUNCT
globalce-322	90	10	approval	approval	NOUN
globalce-322	90	11	import	import	NOUN
globalce-322	90	12	investigational	investigational	ADJ
globalce-322	90	13	md	md	PROPN
globalce-322	90	14	/	/	SYM
globalce-322	90	15	new	new	PROPN
globalce-322	90	16	ivd	ivd	NOUN
globalce-322	90	17	in	in	ADP
globalce-322	90	18	the	the	DET
globalce-322	90	19	country	country	NOUN
globalce-322	90	20	of	of	ADP
globalce-322	90	21	origin	origin	NOUN
globalce-322	90	22	•	•	NOUN
globalce-322	90	23	waive	waive	VERB
globalce-322	90	24	off	off	ADP
globalce-322	90	25	if	if	SCONJ
globalce-322	90	26	:	:	PUNCT
globalce-322	90	27	•	•	NUM
globalce-322	90	28	medical	medical	ADJ
globalce-322	90	29	device	device	NOUN
globalce-322	90	30	imported	import	VERB
globalce-322	90	31	from	from	ADP
globalce-322	90	32	the	the	DET
globalce-322	90	33	united	united	PROPN
globalce-322	90	34	states	states	PROPN
globalce-322	90	35	,	,	PUNCT
globalce-322	90	36	britain	britain	PROPN
globalce-322	90	37	,	,	PUNCT
globalce-322	90	38	the	the	DET
globalce-322	90	39	united	united	PROPN
globalce-322	90	40	kingdom	kingdom	PROPN
globalce-322	90	41	,	,	PUNCT
globalce-322	90	42	japan	japan	PROPN
globalce-322	90	43	,	,	PUNCT
globalce-322	90	44	the	the	DET
globalce-322	90	45	european	european	PROPN
globalce-322	90	46	union	union	PROPN
globalce-322	90	47	,	,	PUNCT
globalce-322	90	48	australia	australia	PROPN
globalce-322	90	49	,	,	PUNCT
globalce-322	90	50	and	and	CCONJ
globalce-322	90	51	canada	canada	PROPN
globalce-322	90	52	.	.	PUNCT
globalce-322	91	1	•	•	NUM
globalce-322	91	2	already	already	ADV
globalce-322	91	3	marketed	market	VERB
globalce-322	91	4	for	for	ADP
globalce-322	91	5	at	at	ADV
globalce-322	91	6	least	least	ADV
globalce-322	91	7	2	2	NUM
globalce-322	91	8	years	year	NOUN
globalce-322	91	9	in	in	ADP
globalce-322	91	10	these	these	DET
globalce-322	91	11	territories	territory	NOUN
globalce-322	91	12	.	.	PUNCT
globalce-322	92	1	•	•	NUM
globalce-322	92	2	cla	cla	NOUN
globalce-322	92	3	is	be	AUX
globalce-322	92	4	satisfied	satisfied	ADJ
globalce-322	92	5	with	with	ADP
globalce-322	92	6	the	the	DET
globalce-322	92	7	data	datum	NOUN
globalce-322	92	8	of	of	ADP
globalce-322	92	9	safety	safety	NOUN
globalce-322	92	10	,	,	PUNCT
globalce-322	92	11	performance	performance	NOUN
globalce-322	92	12	,	,	PUNCT
globalce-322	92	13	and	and	CCONJ
globalce-322	92	14	pharmacovigilance	pharmacovigilance	NOUN
globalce-322	92	15	of	of	ADP
globalce-322	92	16	the	the	DET
globalce-322	92	17	said	say	VERB
globalce-322	92	18	device*,2	device*,2	PROPN
globalce-322	92	19	however	however	ADV
globalce-322	92	20	,	,	PUNCT
globalce-322	92	21	if	if	SCONJ
globalce-322	92	22	medical	medical	ADJ
globalce-322	92	23	device	device	NOUN
globalce-322	92	24	/	/	SYM
globalce-322	92	25	ivd	ivd	NOUN
globalce-322	92	26	is	be	AUX
globalce-322	92	27	approved	approve	VERB
globalce-322	92	28	and	and	CCONJ
globalce-322	92	29	marketed	market	VERB
globalce-322	92	30	in	in	ADP
globalce-322	92	31	places	place	NOUN
globalce-322	92	32	other	other	ADJ
globalce-322	92	33	than	than	ADP
globalce-322	92	34	these	these	DET
globalce-322	92	35	countries	country	NOUN
globalce-322	92	36	,	,	PUNCT
globalce-322	92	37	proof	proof	NOUN
globalce-322	92	38	of	of	ADP
globalce-322	92	39	grant	grant	NOUN
globalce-322	92	40	of	of	ADP
globalce-322	92	41	permission	permission	NOUN
globalce-322	92	42	to	to	PART
globalce-322	92	43	conduct	conduct	VERB
globalce-322	92	44	clinical	clinical	ADJ
globalce-322	92	45	investigation/	investigation/	NUM
globalce-322	92	46	evaluation	evaluation	NOUN
globalce-322	92	47	of	of	ADP
globalce-322	92	48	clinical	clinical	ADJ
globalce-322	92	49	performance	performance	NOUN
globalce-322	92	50	(	(	PUNCT
globalce-322	92	51	form	form	NOUN
globalce-322	92	52	md-23	md-23	NOUN
globalce-322	92	53	for	for	ADP
globalce-322	92	54	md	md	PROPN
globalce-322	92	55	)	)	PUNCT
globalce-322	92	56	,	,	PUNCT
globalce-322	92	57	(	(	PUNCT
globalce-322	92	58	form	form	NOUN
globalce-322	92	59	md-25	md-25	X
globalce-322	92	60	for	for	ADP
globalce-322	92	61	ivd	ivd	PROPN
globalce-322	92	62	)	)	PUNCT
globalce-322	92	63	is	be	AUX
globalce-322	92	64	required	require	VERB
globalce-322	92	65	.	.	PUNCT
globalce-322	93	1	earlier	early	ADV
globalce-322	93	2	approved	approve	VERB
globalce-322	93	3	in	in	ADP
globalce-322	93	4	the	the	DET
globalce-322	93	5	country	country	NOUN
globalce-322	93	6	of	of	ADP
globalce-322	93	7	origin	origin	PROPN
globalce-322	93	8	md	md	PROPN
globalce-322	93	9	:	:	PUNCT
globalce-322	93	10	medical	medical	ADJ
globalce-322	93	11	device	device	NOUN
globalce-322	93	12	,	,	PUNCT
globalce-322	93	13	ivd	ivd	NOUN
globalce-322	93	14	:	:	PUNCT
globalce-322	93	15	in	in	ADP
globalce-322	93	16	vitro	vitro	X
globalce-322	93	17	diagnostics	diagnostic	NOUN
globalce-322	93	18	.	.	PUNCT
globalce-322	94	1	*	*	PUNCT
globalce-322	94	2	subject	subject	ADJ
globalce-322	94	3	to	to	ADP
globalce-322	94	4	approval	approval	NOUN
globalce-322	94	5	from	from	ADP
globalce-322	94	6	the	the	DET
globalce-322	94	7	cla	cla	NOUN
globalce-322	94	8	.	.	PROPN
globalce-322	95	1	53	53	NUM
globalce-322	95	2	j	j	PROPN
globalce-322	95	3	global	global	ADJ
globalce-322	95	4	clinical	clinical	ADJ
globalce-322	95	5	engineering	engineering	NOUN
globalce-322	95	6	vol.7	vol.7	PROPN
globalce-322	95	7	issue	issue	NOUN
globalce-322	95	8	3	3	NUM
globalce-322	95	9	:	:	SYM
globalce-322	95	10	2025	2025	NUM
globalce-322	95	11	kumar	kumar	PROPN
globalce-322	95	12	,	,	PUNCT
globalce-322	95	13	gupta	gupta	PROPN
globalce-322	95	14	,	,	PUNCT
globalce-322	95	15	batra	batra	PROPN
globalce-322	95	16	,	,	PUNCT
globalce-322	95	17	sahu	sahu	PROPN
globalce-322	95	18	and	and	CCONJ
globalce-322	95	19	markan	markan	PROPN
globalce-322	95	20	:	:	PUNCT
globalce-322	95	21	catchment	catchment	NOUN
globalce-322	95	22	of	of	ADP
globalce-322	95	23	the	the	DET
globalce-322	95	24	test	test	NOUN
globalce-322	95	25	license	license	NOUN
globalce-322	95	26	for	for	ADP
globalce-322	95	27	the	the	DET
globalce-322	95	28	regulation	regulation	NOUN
globalce-322	95	29	of	of	ADP
globalce-322	95	30	medical	medical	ADJ
globalce-322	95	31	devices	device	NOUN
globalce-322	95	32	in	in	ADP
globalce-322	95	33	india	india	PROPN
globalce-322	95	34	figure	figure	NOUN
globalce-322	95	35	3	3	NUM
globalce-322	95	36	.	.	PUNCT
globalce-322	95	37	road	road	NOUN
globalce-322	95	38	map	map	NOUN
globalce-322	95	39	to	to	PART
globalce-322	95	40	apply	apply	VERB
globalce-322	95	41	test	test	NOUN
globalce-322	95	42	license	license	NOUN
globalce-322	95	43	(	(	PUNCT
globalce-322	95	44	form	form	NOUN
globalce-322	95	45	md-12	md-12	NOUN
globalce-322	95	46	)	)	PUNCT
globalce-322	95	47	for	for	ADP
globalce-322	95	48	md	md	PROPN
globalce-322	95	49	with	with	ADP
globalce-322	95	50	the	the	DET
globalce-322	95	51	purpose	purpose	NOUN
globalce-322	95	52	of	of	ADP
globalce-322	95	53	testing	testing	NOUN
globalce-322	95	54	.	.	PUNCT
globalce-322	96	1	figure	figure	VERB
globalce-322	96	2	4	4	NUM
globalce-322	96	3	.	.	PUNCT
globalce-322	96	4	road	road	NOUN
globalce-322	96	5	map	map	NOUN
globalce-322	96	6	to	to	PART
globalce-322	96	7	apply	apply	VERB
globalce-322	96	8	test	test	NOUN
globalce-322	96	9	license	license	NOUN
globalce-322	96	10	(	(	PUNCT
globalce-322	96	11	form	form	NOUN
globalce-322	96	12	md-12	md-12	NOUN
globalce-322	96	13	)	)	PUNCT
globalce-322	96	14	for	for	ADP
globalce-322	96	15	ivd	ivd	NOUN
globalce-322	96	16	with	with	ADP
globalce-322	96	17	the	the	DET
globalce-322	96	18	purpose	purpose	NOUN
globalce-322	96	19	of	of	ADP
globalce-322	96	20	evaluation	evaluation	NOUN
globalce-322	96	21	/	/	SYM
globalce-322	96	22	performance	performance	NOUN
globalce-322	96	23	evaluation	evaluation	NOUN
globalce-322	96	24	.	.	PUNCT
globalce-322	97	1	kumar	kumar	PROPN
globalce-322	97	2	,	,	PUNCT
globalce-322	97	3	gupta	gupta	PROPN
globalce-322	97	4	,	,	PUNCT
globalce-322	97	5	batra	batra	PROPN
globalce-322	97	6	,	,	PUNCT
globalce-322	97	7	sahu	sahu	PROPN
globalce-322	97	8	and	and	CCONJ
globalce-322	97	9	markan	markan	PROPN
globalce-322	97	10	:	:	PUNCT
globalce-322	97	11	catchment	catchment	NOUN
globalce-322	97	12	of	of	ADP
globalce-322	97	13	the	the	DET
globalce-322	97	14	test	test	NOUN
globalce-322	97	15	license	license	NOUN
globalce-322	97	16	for	for	ADP
globalce-322	97	17	the	the	DET
globalce-322	97	18	regulation	regulation	NOUN
globalce-322	97	19	of	of	ADP
globalce-322	97	20	medical	medical	ADJ
globalce-322	97	21	devices	device	NOUN
globalce-322	97	22	in	in	ADP
globalce-322	97	23	india	india	PROPN
globalce-322	97	24	j	j	PROPN
globalce-322	97	25	global	global	ADJ
globalce-322	97	26	clinical	clinical	ADJ
globalce-322	97	27	engineering	engineering	NOUN
globalce-322	97	28	vol.7	vol.7	PROPN
globalce-322	97	29	issue	issue	NOUN
globalce-322	97	30	3	3	NUM
globalce-322	97	31	:	:	SYM
globalce-322	97	32	2025	2025	NUM
globalce-322	97	33	54	54	NUM
globalce-322	97	34	3	3	NUM
globalce-322	97	35	.	.	PUNCT
globalce-322	97	36	undertaking	undertake	VERB
globalce-322	97	37	stating	state	VERB
globalce-322	97	38	that	that	SCONJ
globalce-322	97	39	the	the	DET
globalce-322	97	40	required	require	VERB
globalce-322	97	41	facilities	facility	NOUN
globalce-322	97	42	including	include	VERB
globalce-322	97	43	equipment	equipment	NOUN
globalce-322	97	44	,	,	PUNCT
globalce-322	97	45	instruments	instrument	NOUN
globalce-322	97	46	,	,	PUNCT
globalce-322	97	47	and	and	CCONJ
globalce-322	97	48	personnel	personnel	NOUN
globalce-322	97	49	have	have	AUX
globalce-322	97	50	been	be	AUX
globalce-322	97	51	provided	provide	VERB
globalce-322	97	52	to	to	PART
globalce-322	97	53	manufacture	manufacture	VERB
globalce-322	97	54	such	such	ADJ
globalce-322	97	55	md	md	PROPN
globalce-322	97	56	/	/	SYM
globalce-322	97	57	ivd	ivd	PROPN
globalce-322	97	58	on	on	ADP
globalce-322	97	59	the	the	DET
globalce-322	97	60	letterhead	letterhead	NOUN
globalce-322	97	61	with	with	ADP
globalce-322	97	62	a	a	DET
globalce-322	97	63	stamp	stamp	NOUN
globalce-322	97	64	and	and	CCONJ
globalce-322	97	65	signed	sign	VERB
globalce-322	97	66	.	.	PUNCT
globalce-322	98	1	however	however	ADV
globalce-322	98	2	,	,	PUNCT
globalce-322	98	3	in	in	ADP
globalce-322	98	4	the	the	DET
globalce-322	98	5	case	case	NOUN
globalce-322	98	6	of	of	ADP
globalce-322	98	7	import	import	NOUN
globalce-322	98	8	of	of	ADP
globalce-322	98	9	md	md	PROPN
globalce-322	98	10	/	/	SYM
globalce-322	98	11	ivd	ivd	PROPN
globalce-322	98	12	in	in	ADP
globalce-322	98	13	small	small	ADJ
globalce-322	98	14	quantities	quantity	NOUN
globalce-322	98	15	,	,	PUNCT
globalce-322	98	16	2	2	NUM
globalce-322	98	17	undertakings	undertaking	NOUN
globalce-322	98	18	are	be	AUX
globalce-322	98	19	required	require	VERB
globalce-322	98	20	,	,	PUNCT
globalce-322	98	21	namely	namely	ADV
globalce-322	98	22	:	:	PUNCT
globalce-322	98	23	•	•	ADP
globalce-322	98	24	an	an	DET
globalce-322	98	25	undertaking	undertaking	NOUN
globalce-322	98	26	stating	state	VERB
globalce-322	98	27	that	that	SCONJ
globalce-322	98	28	the	the	DET
globalce-322	98	29	md	md	PROPN
globalce-322	98	30	/	/	SYM
globalce-322	98	31	ivd	ivd	PROPN
globalce-322	98	32	proposed	propose	VERB
globalce-322	98	33	to	to	PART
globalce-322	98	34	be	be	AUX
globalce-322	98	35	imported	import	VERB
globalce-322	98	36	is	be	AUX
globalce-322	98	37	to	to	PART
globalce-322	98	38	be	be	AUX
globalce-322	98	39	used	use	VERB
globalce-322	98	40	exclusively	exclusively	ADV
globalce-322	98	41	for	for	ADP
globalce-322	98	42	the	the	DET
globalce-322	98	43	specified	specified	ADJ
globalce-322	98	44	purpose	purpose	NOUN
globalce-322	98	45	and	and	CCONJ
globalce-322	98	46	not	not	PART
globalce-322	98	47	for	for	ADP
globalce-322	98	48	commercial	commercial	ADJ
globalce-322	98	49	purpose	purpose	NOUN
globalce-322	98	50	.	.	PUNCT
globalce-322	99	1	•	•	NOUN
globalce-322	99	2	an	an	DET
globalce-322	99	3	undertaking	undertaking	NOUN
globalce-322	99	4	stating	state	VERB
globalce-322	99	5	that	that	SCONJ
globalce-322	99	6	required	require	VERB
globalce-322	99	7	facilities	facility	NOUN
globalce-322	99	8	including	include	VERB
globalce-322	99	9	equipment	equipment	NOUN
globalce-322	99	10	,	,	PUNCT
globalce-322	99	11	instrument	instrument	NOUN
globalce-322	99	12	,	,	PUNCT
globalce-322	99	13	and	and	CCONJ
globalce-322	99	14	personnel	personnel	NOUN
globalce-322	99	15	will	will	AUX
globalce-322	99	16	be	be	AUX
globalce-322	99	17	provided	provide	VERB
globalce-322	99	18	to	to	PART
globalce-322	99	19	test	test	VERB
globalce-322	99	20	or	or	CCONJ
globalce-322	99	21	evaluate	evaluate	VERB
globalce-322	99	22	the	the	DET
globalce-322	99	23	medical	medical	ADJ
globalce-322	99	24	device	device	NOUN
globalce-322	99	25	.	.	PUNCT
globalce-322	100	1	4	4	X
globalce-322	100	2	.	.	X
globalce-322	100	3	list	list	NOUN
globalce-322	100	4	of	of	ADP
globalce-322	100	5	equipment	equipment	NOUN
globalce-322	100	6	,	,	PUNCT
globalce-322	100	7	instruments	instrument	NOUN
globalce-322	100	8	for	for	ADP
globalce-322	100	9	manufacturing	manufacturing	NOUN
globalce-322	100	10	and	and	CCONJ
globalce-322	100	11	testing	testing	NOUN
globalce-322	100	12	/	/	SYM
globalce-322	100	13	evaluation	evaluation	NOUN
globalce-322	100	14	of	of	ADP
globalce-322	100	15	applied	apply	VERB
globalce-322	100	16	md	md	PROPN
globalce-322	100	17	/	/	SYM
globalce-322	100	18	ivd	ivd	PROPN
globalce-322	100	19	(	(	PUNCT
globalce-322	100	20	not	not	PART
globalce-322	100	21	applicable	applicable	ADJ
globalce-322	100	22	for	for	ADP
globalce-322	100	23	the	the	DET
globalce-322	100	24	import	import	NOUN
globalce-322	100	25	of	of	ADP
globalce-322	100	26	md	md	PROPN
globalce-322	100	27	/	/	SYM
globalce-322	100	28	ivd	ivd	PROPN
globalce-322	100	29	)	)	PUNCT
globalce-322	100	30	.	.	PUNCT
globalce-322	101	1	5	5	X
globalce-322	101	2	.	.	X
globalce-322	101	3	list	list	NOUN
globalce-322	101	4	of	of	ADP
globalce-322	101	5	qualified	qualified	ADJ
globalce-322	101	6	personnel	personnel	NOUN
globalce-322	101	7	for	for	ADP
globalce-322	101	8	manufacturing	manufacturing	NOUN
globalce-322	101	9	and	and	CCONJ
globalce-322	101	10	testing	testing	NOUN
globalce-322	101	11	of	of	ADP
globalce-322	101	12	applied	apply	VERB
globalce-322	101	13	md	md	PROPN
globalce-322	101	14	/	/	SYM
globalce-322	101	15	ivd	ivd	PROPN
globalce-322	101	16	in	in	ADP
globalce-322	101	17	tabular	tabular	NOUN
globalce-322	101	18	form	form	NOUN
globalce-322	101	19	under	under	ADP
globalce-322	101	20	whose	whose	DET
globalce-322	101	21	direction	direction	NOUN
globalce-322	101	22	and	and	CCONJ
globalce-322	101	23	supervision	supervision	NOUN
globalce-322	101	24	the	the	DET
globalce-322	101	25	test	test	NOUN
globalce-322	101	26	batches	batch	NOUN
globalce-322	101	27	’	'	PUNCT
globalce-322	101	28	manufacturing	manufacturing	NOUN
globalce-322	101	29	activity	activity	NOUN
globalce-322	101	30	,	,	PUNCT
globalce-322	101	31	testing	testing	NOUN
globalce-322	101	32	,	,	PUNCT
globalce-322	101	33	and	and	CCONJ
globalce-322	101	34	evaluation	evaluation	NOUN
globalce-322	101	35	of	of	ADP
globalce-322	101	36	a	a	DET
globalce-322	101	37	medical	medical	ADJ
globalce-322	101	38	device	device	NOUN
globalce-322	101	39	shall	shall	AUX
globalce-322	101	40	be	be	AUX
globalce-322	101	41	undertaken	undertake	VERB
globalce-322	101	42	(	(	PUNCT
globalce-322	101	43	not	not	PART
globalce-322	101	44	applicable	applicable	ADJ
globalce-322	101	45	for	for	ADP
globalce-322	101	46	the	the	DET
globalce-322	101	47	import	import	NOUN
globalce-322	101	48	of	of	ADP
globalce-322	101	49	md	md	PROPN
globalce-322	101	50	/	/	SYM
globalce-322	101	51	ivd	ivd	PROPN
globalce-322	101	52	)	)	PUNCT
globalce-322	101	53	6	6	NUM
globalce-322	101	54	.	.	PUNCT
globalce-322	101	55	justification	justification	NOUN
globalce-322	101	56	of	of	ADP
globalce-322	101	57	quantity	quantity	NOUN
globalce-322	101	58	proposed	propose	VERB
globalce-322	101	59	to	to	PART
globalce-322	101	60	be	be	AUX
globalce-322	101	61	manufactured	manufacture	VERB
globalce-322	101	62	along	along	ADP
globalce-322	101	63	with	with	ADP
globalce-322	101	64	its	its	PRON
globalce-322	101	65	utilization	utilization	NOUN
globalce-322	101	66	breakup	breakup	NOUN
globalce-322	101	67	mentioning	mentioning	NOUN
globalce-322	101	68	testing	testing	NOUN
globalce-322	101	69	parameters	parameter	NOUN
globalce-322	101	70	with	with	ADP
globalce-322	101	71	quantity	quantity	NOUN
globalce-322	101	72	required	require	VERB
globalce-322	101	73	for	for	ADP
globalce-322	101	74	the	the	DET
globalce-322	101	75	applied	apply	VERB
globalce-322	101	76	quantity	quantity	NOUN
globalce-322	101	77	,	,	PUNCT
globalce-322	101	78	mentioning	mention	VERB
globalce-322	101	79	both	both	CCONJ
globalce-322	101	80	internal	internal	ADJ
globalce-322	101	81	and	and	CCONJ
globalce-322	101	82	external	external	ADJ
globalce-322	101	83	evaluations	evaluation	NOUN
globalce-322	101	84	(	(	PUNCT
globalce-322	101	85	if	if	SCONJ
globalce-322	101	86	applicable	applicable	ADJ
globalce-322	101	87	)	)	PUNCT
globalce-322	101	88	.	.	PUNCT
globalce-322	102	1	moreover	moreover	ADV
globalce-322	102	2	,	,	PUNCT
globalce-322	102	3	the	the	DET
globalce-322	102	4	same	same	ADJ
globalce-322	102	5	implies	imply	VERB
globalce-322	102	6	for	for	ADP
globalce-322	102	7	ivd	ivd	NOUN
globalce-322	102	8	with	with	ADP
globalce-322	102	9	quantity	quantity	NOUN
globalce-322	102	10	required	require	VERB
globalce-322	102	11	for	for	ADP
globalce-322	102	12	evaluating	evaluate	VERB
globalce-322	102	13	at	at	ADP
globalce-322	102	14	both	both	CCONJ
globalce-322	102	15	internal	internal	ADJ
globalce-322	102	16	and	and	CCONJ
globalce-322	102	17	external	external	ADJ
globalce-322	102	18	evaluation	evaluation	NOUN
globalce-322	102	19	sites	site	NOUN
globalce-322	102	20	(	(	PUNCT
globalce-322	102	21	if	if	SCONJ
globalce-322	102	22	applicable	applicable	ADJ
globalce-322	102	23	)	)	PUNCT
globalce-322	102	24	.	.	PUNCT
globalce-322	103	1	however	however	ADV
globalce-322	103	2	,	,	PUNCT
globalce-322	103	3	in	in	ADP
globalce-322	103	4	the	the	DET
globalce-322	103	5	case	case	NOUN
globalce-322	103	6	of	of	ADP
globalce-322	103	7	import	import	NOUN
globalce-322	103	8	of	of	ADP
globalce-322	103	9	md	md	PROPN
globalce-322	103	10	/	/	SYM
globalce-322	103	11	ivd	ivd	PROPN
globalce-322	103	12	in	in	ADP
globalce-322	103	13	small	small	ADJ
globalce-322	103	14	quantities	quantity	NOUN
globalce-322	103	15	,	,	PUNCT
globalce-322	103	16	the	the	DET
globalce-322	103	17	applicant	applicant	NOUN
globalce-322	103	18	can	can	AUX
globalce-322	103	19	give	give	VERB
globalce-322	103	20	the	the	DET
globalce-322	103	21	proper	proper	ADJ
globalce-322	103	22	justification	justification	NOUN
globalce-322	103	23	of	of	ADP
globalce-322	103	24	the	the	DET
globalce-322	103	25	quantity	quantity	NOUN
globalce-322	103	26	proposed	propose	VERB
globalce-322	103	27	to	to	PART
globalce-322	103	28	be	be	AUX
globalce-322	103	29	imported	import	VERB
globalce-322	103	30	with	with	ADP
globalce-322	103	31	its	its	PRON
globalce-322	103	32	utilization	utilization	NOUN
globalce-322	103	33	breakup	breakup	NOUN
globalce-322	103	34	.	.	PUNCT
globalce-322	104	1	7	7	X
globalce-322	104	2	.	.	PUNCT
globalce-322	104	3	test	test	NOUN
globalce-322	104	4	specification	specification	NOUN
globalce-322	104	5	and	and	CCONJ
globalce-322	104	6	protocol	protocol	NOUN
globalce-322	104	7	along	along	ADP
globalce-322	104	8	with	with	ADP
globalce-322	104	9	applicable	applicable	ADJ
globalce-322	104	10	standards	standard	NOUN
globalce-322	104	11	that	that	PRON
globalce-322	104	12	provide	provide	VERB
globalce-322	104	13	the	the	DET
globalce-322	104	14	testing	testing	NOUN
globalce-322	104	15	protocol	protocol	NOUN
globalce-322	104	16	or	or	CCONJ
globalce-322	104	17	any	any	DET
globalce-322	104	18	other	other	ADJ
globalce-322	104	19	protocol	protocol	NOUN
globalce-322	104	20	specific	specific	ADJ
globalce-322	104	21	to	to	ADP
globalce-322	104	22	the	the	DET
globalce-322	104	23	device	device	NOUN
globalce-322	104	24	/	/	SYM
globalce-322	104	25	ivd	ivd	PROPN
globalce-322	104	26	.	.	PUNCT
globalce-322	105	1	approved	approve	VERB
globalce-322	105	2	clinical	clinical	ADJ
globalce-322	105	3	study	study	NOUN
globalce-322	105	4	protocol	protocol	NOUN
globalce-322	105	5	or	or	CCONJ
globalce-322	105	6	approval	approval	NOUN
globalce-322	105	7	copy	copy	NOUN
globalce-322	105	8	of	of	ADP
globalce-322	105	9	form	form	NOUN
globalce-322	105	10	md-23	md-23	NOUN
globalce-322	105	11	or	or	CCONJ
globalce-322	105	12	form	form	NOUN
globalce-322	105	13	md-25	md-25	ADV
globalce-322	105	14	will	will	AUX
globalce-322	105	15	be	be	AUX
globalce-322	105	16	required	require	VERB
globalce-322	105	17	if	if	SCONJ
globalce-322	105	18	the	the	DET
globalce-322	105	19	selected	select	VERB
globalce-322	105	20	purpose	purpose	NOUN
globalce-322	105	21	of	of	ADP
globalce-322	105	22	applying	apply	VERB
globalce-322	105	23	for	for	ADP
globalce-322	105	24	the	the	DET
globalce-322	105	25	test	test	NOUN
globalce-322	105	26	license	license	NOUN
globalce-322	105	27	is	be	AUX
globalce-322	105	28	for	for	ADP
globalce-322	105	29	clinical	clinical	ADJ
globalce-322	105	30	investigation	investigation	NOUN
globalce-322	105	31	or	or	CCONJ
globalce-322	105	32	evaluation	evaluation	NOUN
globalce-322	105	33	of	of	ADP
globalce-322	105	34	clinical	clinical	ADJ
globalce-322	105	35	performance	performance	NOUN
globalce-322	105	36	.	.	PUNCT
globalce-322	106	1	it	it	PRON
globalce-322	106	2	is	be	AUX
globalce-322	106	3	also	also	ADV
globalce-322	106	4	applicable	applicable	ADJ
globalce-322	106	5	for	for	ADP
globalce-322	106	6	the	the	DET
globalce-322	106	7	import	import	NOUN
globalce-322	106	8	of	of	ADP
globalce-322	106	9	md	md	PROPN
globalce-322	106	10	/	/	SYM
globalce-322	106	11	ivd	ivd	PROPN
globalce-322	106	12	in	in	ADP
globalce-322	106	13	small	small	ADJ
globalce-322	106	14	quantities	quantity	NOUN
globalce-322	106	15	.	.	PUNCT
globalce-322	107	1	8	8	X
globalce-322	107	2	.	.	X
globalce-322	107	3	brief	brief	ADJ
globalce-322	107	4	description	description	NOUN
globalce-322	107	5	of	of	ADP
globalce-322	107	6	the	the	DET
globalce-322	107	7	manufacturing	manufacturing	NOUN
globalce-322	107	8	and	and	CCONJ
globalce-322	107	9	testing	testing	NOUN
globalce-322	107	10	process	process	NOUN
globalce-322	107	11	and	and	CCONJ
globalce-322	107	12	flowchart	flowchart	NOUN
globalce-322	107	13	that	that	PRON
globalce-322	107	14	includes	include	VERB
globalce-322	107	15	each	each	DET
globalce-322	107	16	process	process	NOUN
globalce-322	107	17	step	step	NOUN
globalce-322	107	18	of	of	ADP
globalce-322	107	19	manufacturing	manufacturing	NOUN
globalce-322	107	20	of	of	ADP
globalce-322	107	21	the	the	DET
globalce-322	107	22	subject	subject	ADJ
globalce-322	107	23	device	device	NOUN
globalce-322	107	24	/	/	SYM
globalce-322	107	25	ivd	ivd	NOUN
globalce-322	107	26	.	.	PUNCT
globalce-322	108	1	9	9	X
globalce-322	108	2	.	.	X
globalce-322	108	3	copy	copy	NOUN
globalce-322	108	4	of	of	ADP
globalce-322	108	5	the	the	DET
globalce-322	108	6	manufacturing	manufacturing	NOUN
globalce-322	108	7	license	license	NOUN
globalce-322	108	8	of	of	ADP
globalce-322	108	9	the	the	DET
globalce-322	108	10	premises	premise	NOUN
globalce-322	108	11	where	where	SCONJ
globalce-322	108	12	the	the	DET
globalce-322	108	13	development	development	NOUN
globalce-322	108	14	/	/	SYM
globalce-322	108	15	testing	testing	NOUN
globalce-322	108	16	activity	activity	NOUN
globalce-322	108	17	is	be	AUX
globalce-322	108	18	to	to	PART
globalce-322	108	19	be	be	AUX
globalce-322	108	20	carried	carry	VERB
globalce-322	108	21	out	out	ADP
globalce-322	108	22	,	,	PUNCT
globalce-322	108	23	under	under	ADP
globalce-322	108	24	these	these	DET
globalce-322	108	25	rules	rule	NOUN
globalce-322	108	26	,	,	PUNCT
globalce-322	108	27	if	if	SCONJ
globalce-322	108	28	any	any	PRON
globalce-322	108	29	.	.	PUNCT
globalce-322	109	1	it	it	PRON
globalce-322	109	2	is	be	AUX
globalce-322	109	3	applicable	applicable	ADJ
globalce-322	109	4	only	only	ADV
globalce-322	109	5	to	to	ADP
globalce-322	109	6	existing	exist	VERB
globalce-322	109	7	manufacturers	manufacturer	NOUN
globalce-322	109	8	who	who	PRON
globalce-322	109	9	have	have	AUX
globalce-322	109	10	been	be	AUX
globalce-322	109	11	previously	previously	ADV
globalce-322	109	12	issued	issue	VERB
globalce-322	109	13	a	a	DET
globalce-322	109	14	license	license	NOUN
globalce-322	109	15	;	;	PUNCT
globalce-322	109	16	otherwise	otherwise	ADV
globalce-322	109	17	,	,	PUNCT
globalce-322	109	18	this	this	PRON
globalce-322	109	19	does	do	AUX
globalce-322	109	20	not	not	PART
globalce-322	109	21	apply	apply	VERB
globalce-322	109	22	.	.	PUNCT
globalce-322	110	1	please	please	INTJ
globalce-322	110	2	upload	upload	VERB
globalce-322	110	3	a	a	DET
globalce-322	110	4	declaration	declaration	NOUN
globalce-322	110	5	confirming	confirm	VERB
globalce-322	110	6	this	this	PRON
globalce-322	110	7	.	.	PUNCT
globalce-322	111	1	10	10	NUM
globalce-322	111	2	.	.	PUNCT
globalce-322	111	3	approval	approval	NOUN
globalce-322	111	4	letter	letter	NOUN
globalce-322	111	5	authorizing	authorize	VERB
globalce-322	111	6	to	to	PART
globalce-322	111	7	undertake	undertake	VERB
globalce-322	111	8	research	research	NOUN
globalce-322	111	9	and	and	CCONJ
globalce-322	111	10	development	development	NOUN
globalce-322	111	11	activities	activity	NOUN
globalce-322	111	12	issued	issue	VERB
globalce-322	111	13	by	by	ADP
globalce-322	111	14	a	a	DET
globalce-322	111	15	government	government	NOUN
globalce-322	111	16	organization	organization	NOUN
globalce-322	111	17	,	,	PUNCT
globalce-322	111	18	if	if	SCONJ
globalce-322	111	19	any	any	PRON
globalce-322	111	20	.	.	PUNCT
globalce-322	112	1	any	any	DET
globalce-322	112	2	approval	approval	NOUN
globalce-322	112	3	from	from	ADP
globalce-322	112	4	agencies	agency	NOUN
globalce-322	112	5	funding	fund	VERB
globalce-322	112	6	research	research	NOUN
globalce-322	112	7	internally	internally	ADV
globalce-322	112	8	or	or	CCONJ
globalce-322	112	9	externally	externally	ADV
globalce-322	112	10	11	11	NUM
globalce-322	112	11	.	.	PUNCT
globalce-322	113	1	other	other	ADJ
globalce-322	113	2	documents	document	NOUN
globalce-322	113	3	,	,	PUNCT
globalce-322	113	4	if	if	SCONJ
globalce-322	113	5	any	any	PRON
globalce-322	113	6	.	.	PUNCT
globalce-322	114	1	it	it	PRON
globalce-322	114	2	may	may	AUX
globalce-322	114	3	include	include	VERB
globalce-322	114	4	publication/	publication/	NUM
globalce-322	114	5	research	research	NOUN
globalce-322	114	6	paper	paper	NOUN
globalce-322	114	7	in	in	ADP
globalce-322	114	8	support	support	NOUN
globalce-322	114	9	of	of	ADP
globalce-322	114	10	intended	intend	VERB
globalce-322	114	11	claims	claim	NOUN
globalce-322	114	12	,	,	PUNCT
globalce-322	114	13	design	design	NOUN
globalce-322	114	14	,	,	PUNCT
globalce-322	114	15	principal	principal	NOUN
globalce-322	114	16	of	of	ADP
globalce-322	114	17	operation	operation	NOUN
globalce-322	114	18	,	,	PUNCT
globalce-322	114	19	moc	moc	PROPN
globalce-322	114	20	,	,	PUNCT
globalce-322	114	21	etc	etc	X
globalce-322	114	22	.	.	X
globalce-322	114	23	12	12	NUM
globalce-322	114	24	.	.	PUNCT
globalce-322	114	25	fee	fee	NOUN
globalce-322	114	26	challan	challan	NOUN
globalce-322	114	27	that	that	PRON
globalce-322	114	28	will	will	AUX
globalce-322	114	29	be	be	AUX
globalce-322	114	30	paid	pay	VERB
globalce-322	114	31	online	online	ADV
globalce-322	114	32	via	via	ADP
globalce-322	114	33	the	the	DET
globalce-322	114	34	bharat	bharat	PROPN
globalce-322	114	35	kosh	kosh	PROPN
globalce-322	114	36	portal	portal	PROPN
globalce-322	114	37	(	(	PUNCT
globalce-322	114	38	https://bharatkosh.gov.in/	https://bharatkosh.gov.in/	PROPN
globalce-322	114	39	)	)	PUNCT
globalce-322	114	40	directed	direct	VERB
globalce-322	114	41	through	through	ADP
globalce-322	114	42	the	the	DET
globalce-322	114	43	nsws	nsws	ADJ
globalce-322	114	44	portal	portal	NOUN
globalce-322	114	45	.	.	PUNCT
globalce-322	115	1	the	the	DET
globalce-322	115	2	fee	fee	NOUN
globalce-322	115	3	amount	amount	NOUN
globalce-322	115	4	is	be	AUX
globalce-322	115	5	subjective	subjective	ADJ
globalce-322	115	6	and	and	CCONJ
globalce-322	115	7	is	be	AUX
globalce-322	115	8	calculated	calculate	VERB
globalce-322	115	9	automatically	automatically	ADV
globalce-322	115	10	by	by	ADP
globalce-322	115	11	the	the	DET
globalce-322	115	12	system	system	NOUN
globalce-322	115	13	based	base	VERB
globalce-322	115	14	on	on	ADP
globalce-322	115	15	the	the	DET
globalce-322	115	16	device	device	NOUN
globalce-322	115	17	applied	apply	VERB
globalce-322	115	18	(	(	PUNCT
globalce-322	115	19	as	as	ADP
globalce-322	115	20	per	per	ADP
globalce-322	115	21	second	second	ADJ
globalce-322	115	22	schedule	schedule	NOUN
globalce-322	115	23	of	of	ADP
globalce-322	115	24	mdr-2017	mdr-2017	NOUN
globalce-322	115	25	)	)	PUNCT
globalce-322	115	26	.	.	PUNCT
globalce-322	116	1	it	it	PRON
globalce-322	116	2	is	be	AUX
globalce-322	116	3	advisable	advisable	ADJ
globalce-322	116	4	not	not	PART
globalce-322	116	5	to	to	PART
globalce-322	116	6	pay	pay	VERB
globalce-322	116	7	the	the	DET
globalce-322	116	8	respective	respective	ADJ
globalce-322	116	9	amount	amount	NOUN
globalce-322	116	10	directly	directly	ADV
globalce-322	116	11	through	through	ADP
globalce-322	116	12	the	the	DET
globalce-322	116	13	bharat	bharat	PROPN
globalce-322	116	14	kosh	kosh	PROPN
globalce-322	116	15	portal	portal	PROPN
globalce-322	116	16	.	.	PUNCT
globalce-322	117	1	13	13	NUM
globalce-322	117	2	.	.	PUNCT
globalce-322	117	3	legal	legal	ADJ
globalce-322	117	4	form	form	NOUN
globalce-322	117	5	.	.	PUNCT
globalce-322	118	1	it	it	PRON
globalce-322	118	2	is	be	AUX
globalce-322	118	3	a	a	DET
globalce-322	118	4	system	system	NOUN
globalce-322	118	5	-	-	PUNCT
globalce-322	118	6	generated	generate	VERB
globalce-322	118	7	filled	fill	VERB
globalce-322	118	8	form	form	NOUN
globalce-322	118	9	of	of	ADP
globalce-322	118	10	md-12	md-12	NOUN
globalce-322	118	11	application	application	NOUN
globalce-322	118	12	that	that	PRON
globalce-322	118	13	should	should	AUX
globalce-322	118	14	be	be	AUX
globalce-322	118	15	submitted	submit	VERB
globalce-322	118	16	after	after	ADP
globalce-322	118	17	being	be	AUX
globalce-322	118	18	digitally	digitally	ADV
globalce-322	118	19	signed	sign	VERB
globalce-322	118	20	with	with	ADP
globalce-322	118	21	the	the	DET
globalce-322	118	22	digital	digital	ADJ
globalce-322	118	23	signature	signature	NOUN
globalce-322	118	24	certificate	certificate	NOUN
globalce-322	118	25	(	(	PUNCT
globalce-322	118	26	dsc	dsc	NOUN
globalce-322	118	27	)	)	PUNCT
globalce-322	118	28	of	of	ADP
globalce-322	118	29	an	an	DET
globalce-322	118	30	authorized	authorized	ADJ
globalce-322	118	31	signatory	signatory	NOUN
globalce-322	118	32	.	.	PUNCT
globalce-322	119	1	in	in	ADP
globalce-322	119	2	addition	addition	NOUN
globalce-322	119	3	,	,	PUNCT
globalce-322	119	4	the	the	DET
globalce-322	119	5	following	follow	VERB
globalce-322	119	6	documents	document	NOUN
globalce-322	119	7	are	be	AUX
globalce-322	119	8	used	use	VERB
globalce-322	119	9	exclusively	exclusively	ADV
globalce-322	119	10	for	for	ADP
globalce-322	119	11	the	the	DET
globalce-322	119	12	import	import	NOUN
globalce-322	119	13	of	of	ADP
globalce-322	119	14	md	md	PROPN
globalce-322	119	15	/	/	SYM
globalce-322	119	16	ivd	ivd	PROPN
globalce-322	119	17	in	in	ADP
globalce-322	119	18	small	small	ADJ
globalce-322	119	19	quantities	quantity	NOUN
globalce-322	119	20	:	:	PUNCT
globalce-322	119	21	•	•	NUM
globalce-322	119	22	quality	quality	NOUN
globalce-322	119	23	certificates	certificate	NOUN
globalce-322	119	24	like	like	ADP
globalce-322	119	25	qms	qms	PROPN
globalce-322	119	26	,	,	PUNCT
globalce-322	119	27	etc	etc	X
globalce-322	119	28	.	.	X
globalce-322	119	29	,	,	PUNCT
globalce-322	119	30	of	of	ADP
globalce-322	119	31	the	the	DET
globalce-322	119	32	manufacturer	manufacturer	NOUN
globalce-322	119	33	,	,	PUNCT
globalce-322	119	34	if	if	SCONJ
globalce-322	119	35	any	any	PRON
globalce-322	119	36	.	.	PUNCT
globalce-322	120	1	manufacturing	manufacturing	NOUN
globalce-322	120	2	site	site	NOUN
globalce-322	120	3	should	should	AUX
globalce-322	120	4	comply	comply	VERB
globalce-322	120	5	with	with	ADP
globalce-322	120	6	qms	qms	PROPN
globalce-322	120	7	as	as	ADP
globalce-322	120	8	per	per	ADP
globalce-322	120	9	the	the	DET
globalce-322	120	10	fifth	fifth	ADJ
globalce-322	120	11	schedule	schedule	NOUN
globalce-322	120	12	of	of	ADP
globalce-322	120	13	mdr-2017	mdr-2017	NOUN
globalce-322	120	14	or	or	CCONJ
globalce-322	120	15	iso	iso	NOUN
globalce-322	120	16	13485	13485	NUM
globalce-322	120	17	.	.	PUNCT
globalce-322	121	1	•	•	NOUN
globalce-322	121	2	labels	label	NOUN
globalce-322	121	3	and	and	CCONJ
globalce-322	121	4	instructions	instruction	NOUN
globalce-322	121	5	for	for	ADP
globalce-322	121	6	use	use	NOUN
globalce-322	121	7	(	(	PUNCT
globalce-322	121	8	ifu	ifu	NOUN
globalce-322	121	9	)	)	PUNCT
globalce-322	121	10	,	,	PUNCT
globalce-322	121	11	as	as	ADP
globalce-322	121	12	per	per	ADP
globalce-322	121	13	rule	rule	NOUN
globalce-322	121	14	44	44	NUM
globalce-322	121	15	of	of	ADP
globalce-322	121	16	mdr-2017	mdr-2017	NOUN
globalce-322	121	17	.	.	PUNCT
globalce-322	122	1	labelling	labelling	NOUN
globalce-322	122	2	of	of	ADP
globalce-322	122	3	md	md	PROPN
globalce-322	122	4	needs	need	VERB
globalce-322	122	5	particulars	particular	NOUN
globalce-322	122	6	such	such	ADJ
globalce-322	122	7	as	as	ADP
globalce-322	122	8	name	name	NOUN
globalce-322	122	9	of	of	ADP
globalce-322	122	10	the	the	DET
globalce-322	122	11	medical	medical	ADJ
globalce-322	122	12	device	device	NOUN
globalce-322	122	13	;	;	PUNCT
globalce-322	122	14	the	the	DET
globalce-322	122	15	details	detail	NOUN
globalce-322	122	16	necessary	necessary	ADJ
globalce-322	122	17	for	for	SCONJ
globalce-322	122	18	the	the	DET
globalce-322	122	19	user	user	NOUN
globalce-322	122	20	to	to	PART
globalce-322	122	21	identify	identify	VERB
globalce-322	122	22	the	the	DET
globalce-322	122	23	device	device	NOUN
globalce-322	122	24	and	and	CCONJ
globalce-322	122	25	its	its	PRON
globalce-322	122	26	use	use	NOUN
globalce-322	122	27	;	;	PUNCT
globalce-322	122	28	the	the	DET
globalce-322	122	29	name	name	NOUN
globalce-322	122	30	of	of	ADP
globalce-322	122	31	the	the	DET
globalce-322	122	32	manufacturer	manufacturer	NOUN
globalce-322	122	33	and	and	CCONJ
globalce-322	122	34	the	the	DET
globalce-322	122	35	address	address	NOUN
globalce-322	122	36	of	of	ADP
globalce-322	122	37	the	the	DET
globalce-322	122	38	manufacturing	manufacturing	NOUN
globalce-322	122	39	premises	premise	NOUN
globalce-322	122	40	;	;	PUNCT
globalce-322	122	41	the	the	DET
globalce-322	122	42	correct	correct	ADJ
globalce-322	122	43	statement	statement	NOUN
globalce-322	122	44	about	about	ADP
globalce-322	122	45	the	the	DET
globalce-322	122	46	net	net	ADJ
globalce-322	122	47	quantity	quantity	NOUN
globalce-322	122	48	in	in	ADP
globalce-322	122	49	terms	term	NOUN
globalce-322	122	50	of	of	ADP
globalce-322	122	51	weight	weight	NOUN
globalce-322	122	52	,	,	PUNCT
globalce-322	122	53	measure	measure	NOUN
globalce-322	122	54	,	,	PUNCT
globalce-322	122	55	volume	volume	NOUN
globalce-322	122	56	,	,	PUNCT
globalce-322	122	57	number	number	NOUN
globalce-322	122	58	of	of	ADP
globalce-322	122	59	units	unit	NOUN
globalce-322	122	60	,	,	PUNCT
globalce-322	122	61	as	as	SCONJ
globalce-322	122	62	the	the	DET
globalce-322	122	63	case	case	NOUN
globalce-322	122	64	may	may	AUX
globalce-322	122	65	be	be	AUX
globalce-322	122	66	;	;	PUNCT
globalce-322	122	67	and	and	CCONJ
globalce-322	122	68	the	the	DET
globalce-322	122	69	number	number	NOUN
globalce-322	122	70	of	of	ADP
globalce-322	122	71	the	the	DET
globalce-322	122	72	devices	device	NOUN
globalce-322	122	73	contained	contain	VERB
globalce-322	122	74	in	in	ADP
globalce-322	122	75	the	the	DET
globalce-322	122	76	package	package	NOUN
globalce-322	122	77	expressed	express	VERB
globalce-322	122	78	in	in	ADP
globalce-322	122	79	the	the	DET
globalce-322	122	80	metric	metric	ADJ
globalce-322	122	81	system	system	NOUN
globalce-322	122	82	;	;	PUNCT
globalce-322	122	83	the	the	DET
globalce-322	122	84	month	month	NOUN
globalce-322	122	85	and	and	CCONJ
globalce-322	122	86	year	year	NOUN
globalce-322	122	87	of	of	ADP
globalce-322	122	88	manufacture	manufacture	NOUN
globalce-322	122	89	and	and	CCONJ
globalce-322	122	90	expiry	expiry	NOUN
globalce-322	122	91	(	(	PUNCT
globalce-322	122	92	the	the	DET
globalce-322	122	93	label	label	NOUN
globalce-322	122	94	may	may	AUX
globalce-322	122	95	indicate	indicate	VERB
globalce-322	122	96	the	the	DET
globalce-322	122	97	product	product	NOUN
globalce-322	122	98	's	's	PART
globalce-322	122	99	shelf	shelf	NOUN
globalce-322	122	100	life	life	NOUN
globalce-322	122	101	.	.	PUNCT
globalce-322	123	1	for	for	ADP
globalce-322	123	2	sterile	sterile	ADJ
globalce-322	123	3	devices	device	NOUN
globalce-322	123	4	composed	compose	VERB
globalce-322	123	5	of	of	ADP
globalce-322	123	6	stable	stable	ADJ
globalce-322	123	7	materials	material	NOUN
globalce-322	123	8	such	such	ADJ
globalce-322	123	9	as	as	ADP
globalce-322	123	10	stainless	stainless	ADJ
globalce-322	123	11	steel	steel	NOUN
globalce-322	123	12	or	or	CCONJ
globalce-322	123	13	55	55	NUM
globalce-322	123	14	j	j	PROPN
globalce-322	123	15	global	global	ADJ
globalce-322	123	16	clinical	clinical	ADJ
globalce-322	123	17	engineering	engineering	NOUN
globalce-322	123	18	vol.7	vol.7	PROPN
globalce-322	123	19	issue	issue	NOUN
globalce-322	123	20	3	3	NUM
globalce-322	123	21	:	:	SYM
globalce-322	123	22	2025	2025	NUM
globalce-322	123	23	kumar	kumar	PROPN
globalce-322	123	24	,	,	PUNCT
globalce-322	123	25	gupta	gupta	PROPN
globalce-322	123	26	,	,	PUNCT
globalce-322	123	27	batra	batra	PROPN
globalce-322	123	28	,	,	PUNCT
globalce-322	123	29	sahu	sahu	PROPN
globalce-322	123	30	and	and	CCONJ
globalce-322	123	31	markan	markan	PROPN
globalce-322	123	32	:	:	PUNCT
globalce-322	123	33	catchment	catchment	NOUN
globalce-322	123	34	of	of	ADP
globalce-322	123	35	the	the	DET
globalce-322	123	36	test	test	NOUN
globalce-322	123	37	license	license	NOUN
globalce-322	123	38	for	for	ADP
globalce-322	123	39	the	the	DET
globalce-322	123	40	regulation	regulation	NOUN
globalce-322	123	41	of	of	ADP
globalce-322	123	42	medical	medical	ADJ
globalce-322	123	43	devices	device	NOUN
globalce-322	123	44	in	in	ADP
globalce-322	123	45	india	india	PROPN
globalce-322	123	46	titanium	titanium	NOUN
globalce-322	123	47	,	,	PUNCT
globalce-322	123	48	and	and	CCONJ
globalce-322	123	49	supplied	supply	VERB
globalce-322	123	50	non	non	ADJ
globalce-322	123	51	-	-	ADJ
globalce-322	123	52	sterile	sterile	ADJ
globalce-322	123	53	,	,	PUNCT
globalce-322	123	54	the	the	DET
globalce-322	123	55	date	date	NOUN
globalce-322	123	56	of	of	ADP
globalce-322	123	57	sterilization	sterilization	NOUN
globalce-322	123	58	may	may	AUX
globalce-322	123	59	be	be	AUX
globalce-322	123	60	treated	treat	VERB
globalce-322	123	61	as	as	ADP
globalce-322	123	62	the	the	DET
globalce-322	123	63	manufacturing	manufacturing	NOUN
globalce-322	123	64	date	date	NOUN
globalce-322	123	65	.	.	PUNCT
globalce-322	124	1	in	in	ADP
globalce-322	124	2	the	the	DET
globalce-322	124	3	case	case	NOUN
globalce-322	124	4	of	of	ADP
globalce-322	124	5	medical	medical	ADJ
globalce-322	124	6	equipment	equipment	NOUN
globalce-322	124	7	,	,	PUNCT
globalce-322	124	8	instruments	instrument	NOUN
globalce-322	124	9	,	,	PUNCT
globalce-322	124	10	or	or	CCONJ
globalce-322	124	11	apparatus	apparatus	NOUN
globalce-322	124	12	,	,	PUNCT
globalce-322	124	13	it	it	PRON
globalce-322	124	14	may	may	AUX
globalce-322	124	15	not	not	PART
globalce-322	124	16	be	be	AUX
globalce-322	124	17	necessary	necessary	ADJ
globalce-322	124	18	to	to	PART
globalce-322	124	19	specify	specify	VERB
globalce-322	124	20	an	an	DET
globalce-322	124	21	expiry	expiry	NOUN
globalce-322	124	22	date	date	NOUN
globalce-322	124	23	)	)	PUNCT
globalce-322	124	24	on	on	ADP
globalce-322	124	25	the	the	DET
globalce-322	124	26	shelf	shelf	NOUN
globalce-322	124	27	pack	pack	NOUN
globalce-322	124	28	of	of	ADP
globalce-322	124	29	the	the	DET
globalce-322	124	30	md	md	PROPN
globalce-322	124	31	or	or	CCONJ
globalce-322	124	32	on	on	ADP
globalce-322	124	33	the	the	DET
globalce-322	124	34	outer	outer	ADJ
globalce-322	124	35	cover	cover	NOUN
globalce-322	124	36	of	of	ADP
globalce-322	124	37	the	the	DET
globalce-322	124	38	md	md	PROPN
globalce-322	124	39	that	that	PRON
globalce-322	124	40	shall	shall	AUX
globalce-322	124	41	be	be	AUX
globalce-322	124	42	printed	print	VERB
globalce-322	124	43	in	in	ADP
globalce-322	124	44	indelible	indelible	ADJ
globalce-322	124	45	ink	ink	NOUN
globalce-322	124	46	on	on	ADP
globalce-322	124	47	the	the	DET
globalce-322	124	48	label	label	NOUN
globalce-322	124	49	,	,	PUNCT
globalce-322	124	50	whereas	whereas	SCONJ
globalce-322	124	51	the	the	DET
globalce-322	124	52	intended	intend	VERB
globalce-322	124	53	use	use	NOUN
globalce-322	124	54	of	of	ADP
globalce-322	124	55	a	a	DET
globalce-322	124	56	medical	medical	ADJ
globalce-322	124	57	device	device	NOUN
globalce-322	124	58	is	be	AUX
globalce-322	124	59	clearly	clearly	ADV
globalce-322	124	60	communicated	communicate	VERB
globalce-322	124	61	in	in	ADP
globalce-322	124	62	the	the	DET
globalce-322	124	63	ifu	ifu	NOUN
globalce-322	124	64	.	.	PUNCT
globalce-322	125	1	the	the	DET
globalce-322	125	2	ifu	ifu	PROPN
globalce-322	125	3	(	(	PUNCT
globalce-322	125	4	or	or	CCONJ
globalce-322	125	5	electronic	electronic	ADJ
globalce-322	125	6	ifu	ifu	NOUN
globalce-322	125	7	)	)	PUNCT
globalce-322	125	8	is	be	AUX
globalce-322	125	9	a	a	DET
globalce-322	125	10	set	set	NOUN
globalce-322	125	11	of	of	ADP
globalce-322	125	12	instructions	instruction	NOUN
globalce-322	125	13	that	that	PRON
globalce-322	125	14	are	be	AUX
globalce-322	125	15	legally	legally	ADV
globalce-322	125	16	required	require	VERB
globalce-322	125	17	for	for	SCONJ
globalce-322	125	18	md	md	PROPN
globalce-322	125	19	to	to	PART
globalce-322	125	20	be	be	AUX
globalce-322	125	21	sold	sell	VERB
globalce-322	125	22	and	and	CCONJ
globalce-322	125	23	are	be	AUX
globalce-322	125	24	intended	intend	VERB
globalce-322	125	25	to	to	PART
globalce-322	125	26	ensure	ensure	VERB
globalce-322	125	27	the	the	DET
globalce-322	125	28	safe	safe	ADJ
globalce-322	125	29	and	and	CCONJ
globalce-322	125	30	effective	effective	ADJ
globalce-322	125	31	use	use	NOUN
globalce-322	125	32	of	of	ADP
globalce-322	125	33	the	the	DET
globalce-322	125	34	device	device	NOUN
globalce-322	125	35	.	.	PUNCT
globalce-322	126	1	it	it	PRON
globalce-322	126	2	should	should	AUX
globalce-322	126	3	include	include	VERB
globalce-322	126	4	:	:	PUNCT
globalce-322	126	5	•	•	NUM
globalce-322	126	6	intended	intend	VERB
globalce-322	126	7	use	use	NOUN
globalce-322	126	8	:	:	PUNCT
globalce-322	126	9	the	the	DET
globalce-322	126	10	specific	specific	ADJ
globalce-322	126	11	intended	intended	ADJ
globalce-322	126	12	use	use	NOUN
globalce-322	126	13	of	of	ADP
globalce-322	126	14	the	the	DET
globalce-322	126	15	device	device	NOUN
globalce-322	126	16	.	.	PUNCT
globalce-322	127	1	•	•	NUM
globalce-322	127	2	precautions	precaution	NOUN
globalce-322	127	3	:	:	PUNCT
globalce-322	127	4	any	any	DET
globalce-322	127	5	precautions	precaution	NOUN
globalce-322	127	6	or	or	CCONJ
globalce-322	127	7	warnings	warning	NOUN
globalce-322	127	8	that	that	PRON
globalce-322	127	9	should	should	AUX
globalce-322	127	10	be	be	AUX
globalce-322	127	11	considered	consider	VERB
globalce-322	127	12	while	while	SCONJ
globalce-322	127	13	using	use	VERB
globalce-322	127	14	the	the	DET
globalce-322	127	15	device	device	NOUN
globalce-322	127	16	.	.	PUNCT
globalce-322	128	1	•	•	NUM
globalce-322	128	2	preparation	preparation	NOUN
globalce-322	128	3	:	:	PUNCT
globalce-322	128	4	how	how	SCONJ
globalce-322	128	5	to	to	PART
globalce-322	128	6	prepare	prepare	VERB
globalce-322	128	7	the	the	DET
globalce-322	128	8	device	device	NOUN
globalce-322	128	9	for	for	ADP
globalce-322	128	10	use	use	NOUN
globalce-322	128	11	,	,	PUNCT
globalce-322	128	12	such	such	ADJ
globalce-322	128	13	as	as	ADP
globalce-322	128	14	sterilization	sterilization	NOUN
globalce-322	128	15	,	,	PUNCT
globalce-322	128	16	assembly	assembly	NOUN
globalce-322	128	17	,	,	PUNCT
globalce-322	128	18	or	or	CCONJ
globalce-322	128	19	calibration	calibration	NOUN
globalce-322	128	20	.	.	PUNCT
globalce-322	129	1	•	•	NUM
globalce-322	129	2	disposal	disposal	NOUN
globalce-322	129	3	:	:	PUNCT
globalce-322	129	4	how	how	SCONJ
globalce-322	129	5	to	to	PART
globalce-322	129	6	dispose	dispose	VERB
globalce-322	129	7	of	of	ADP
globalce-322	129	8	the	the	DET
globalce-322	129	9	device	device	NOUN
globalce-322	129	10	.	.	PUNCT
globalce-322	130	1	•	•	NUM
globalce-322	130	2	other	other	ADJ
globalce-322	130	3	information	information	NOUN
globalce-322	130	4	:	:	PUNCT
globalce-322	130	5	the	the	DET
globalce-322	130	6	name	name	NOUN
globalce-322	130	7	of	of	ADP
globalce-322	130	8	the	the	DET
globalce-322	130	9	device	device	NOUN
globalce-322	130	10	,	,	PUNCT
globalce-322	130	11	manufacturer	manufacturer	NOUN
globalce-322	130	12	’s	’s	PART
globalce-322	130	13	address	address	NOUN
globalce-322	130	14	,	,	PUNCT
globalce-322	130	15	shelf	shelf	NOUN
globalce-322	130	16	-	-	PUNCT
globalce-322	130	17	life	life	NOUN
globalce-322	130	18	,	,	PUNCT
globalce-322	130	19	storage	storage	NOUN
globalce-322	130	20	requirements	requirement	NOUN
globalce-322	130	21	,	,	PUNCT
globalce-322	130	22	and	and	CCONJ
globalce-322	130	23	technical	technical	ADJ
globalce-322	130	24	specifications	specification	NOUN
globalce-322	130	25	.	.	PUNCT
globalce-322	131	1	in	in	ADP
globalce-322	131	2	cases	case	NOUN
globalce-322	131	3	where	where	SCONJ
globalce-322	131	4	certain	certain	ADJ
globalce-322	131	5	requisite	requisite	ADJ
globalce-322	131	6	documents	document	NOUN
globalce-322	131	7	are	be	AUX
globalce-322	131	8	not	not	PART
globalce-322	131	9	applicable	applicable	ADJ
globalce-322	131	10	to	to	ADP
globalce-322	131	11	a	a	DET
globalce-322	131	12	particular	particular	ADJ
globalce-322	131	13	device	device	NOUN
globalce-322	131	14	or	or	CCONJ
globalce-322	131	15	ivd	ivd	NOUN
globalce-322	131	16	,	,	PUNCT
globalce-322	131	17	the	the	DET
globalce-322	131	18	applicant	applicant	NOUN
globalce-322	131	19	must	must	AUX
globalce-322	131	20	provide	provide	VERB
globalce-322	131	21	a	a	DET
globalce-322	131	22	proper	proper	ADJ
globalce-322	131	23	justification	justification	NOUN
globalce-322	131	24	and	and	CCONJ
globalce-322	131	25	upload	upload	VERB
globalce-322	131	26	the	the	DET
globalce-322	131	27	same	same	ADJ
globalce-322	131	28	on	on	ADP
globalce-322	131	29	the	the	DET
globalce-322	131	30	portal	portal	NOUN
globalce-322	131	31	.	.	PUNCT
globalce-322	132	1	exclusion	exclusion	NOUN
globalce-322	132	2	of	of	ADP
globalce-322	132	3	the	the	DET
globalce-322	132	4	test	test	NOUN
globalce-322	132	5	license	license	NOUN
globalce-322	132	6	a	a	DET
globalce-322	132	7	test	test	NOUN
globalce-322	132	8	license	license	NOUN
globalce-322	132	9	is	be	AUX
globalce-322	132	10	not	not	PART
globalce-322	132	11	required	require	VERB
globalce-322	132	12	to	to	PART
globalce-322	132	13	apply	apply	VERB
globalce-322	132	14	for	for	ADP
globalce-322	132	15	all	all	DET
globalce-322	132	16	md	md	PROPN
globalce-322	132	17	in	in	ADP
globalce-322	132	18	india	india	PROPN
globalce-322	132	19	,	,	PUNCT
globalce-322	132	20	but	but	CCONJ
globalce-322	132	21	it	it	PRON
globalce-322	132	22	depends	depend	VERB
globalce-322	132	23	on	on	ADP
globalce-322	132	24	the	the	DET
globalce-322	132	25	risk	risk	NOUN
globalce-322	132	26	-	-	PUNCT
globalce-322	132	27	based	base	VERB
globalce-322	132	28	class	class	NOUN
globalce-322	132	29	of	of	ADP
globalce-322	132	30	device	device	NOUN
globalce-322	132	31	,	,	PUNCT
globalce-322	132	32	usability	usability	NOUN
globalce-322	132	33	,	,	PUNCT
globalce-322	132	34	and	and	CCONJ
globalce-322	132	35	the	the	DET
globalce-322	132	36	purpose	purpose	NOUN
globalce-322	132	37	in	in	ADP
globalce-322	132	38	certain	certain	ADJ
globalce-322	132	39	conditions	condition	NOUN
globalce-322	132	40	as	as	SCONJ
globalce-322	132	41	follows	follow	VERB
globalce-322	132	42	:	:	PUNCT
globalce-322	132	43	manufacture	manufacture	NOUN
globalce-322	132	44	/	/	SYM
globalce-322	132	45	import	import	NOUN
globalce-322	132	46	of	of	ADP
globalce-322	132	47	class	class	NOUN
globalce-322	132	48	a	a	DET
globalce-322	132	49	nonsterile	nonsterile	NOUN
globalce-322	132	50	and	and	CCONJ
globalce-322	132	51	nonmeasuring	nonmeasure	VERB
globalce-322	132	52	device	device	NOUN
globalce-322	132	53	consequent	consequent	ADJ
globalce-322	132	54	to	to	ADP
globalce-322	132	55	the	the	DET
globalce-322	132	56	implementation	implementation	NOUN
globalce-322	132	57	of	of	ADP
globalce-322	132	58	the	the	DET
globalce-322	132	59	notification	notification	NOUN
globalce-322	132	60	g.s.r	g.s.r	NOUN
globalce-322	132	61	.	.	PROPN
globalce-322	133	1	102	102	NUM
globalce-322	133	2	(	(	PUNCT
globalce-322	133	3	e	e	NOUN
globalce-322	133	4	)	)	PUNCT
globalce-322	133	5	dated	date	VERB
globalce-322	133	6	11th	11th	ADJ
globalce-322	133	7	feb	feb	NOUN
globalce-322	133	8	,	,	PUNCT
globalce-322	133	9	2020	2020	NUM
globalce-322	133	10	,	,	PUNCT
globalce-322	133	11	all	all	DET
globalce-322	133	12	md	md	NOUN
globalce-322	133	13	are	be	AUX
globalce-322	133	14	under	under	ADP
globalce-322	133	15	the	the	DET
globalce-322	133	16	licensing	licensing	NOUN
globalce-322	133	17	regime	regime	NOUN
globalce-322	133	18	(	(	PUNCT
globalce-322	133	19	except	except	SCONJ
globalce-322	133	20	for	for	ADP
globalce-322	133	21	class	class	NOUN
globalce-322	133	22	a	a	PRON
globalce-322	133	23	—	—	PUNCT
globalce-322	133	24	non	non	ADJ
globalce-322	133	25	-	-	ADJ
globalce-322	133	26	sterile	sterile	ADJ
globalce-322	133	27	and	and	CCONJ
globalce-322	133	28	non	non	ADJ
globalce-322	133	29	-	-	ADJ
globalce-322	133	30	measuring	measuring	ADJ
globalce-322	133	31	md	md	NOUN
globalce-322	133	32	)	)	PUNCT
globalce-322	133	33	,	,	PUNCT
globalce-322	133	34	and	and	CCONJ
globalce-322	133	35	license	license	NOUN
globalce-322	133	36	is	be	AUX
globalce-322	133	37	required	require	VERB
globalce-322	133	38	for	for	ADP
globalce-322	133	39	the	the	DET
globalce-322	133	40	import	import	NOUN
globalce-322	133	41	/	/	SYM
globalce-322	133	42	manufacture	manufacture	NOUN
globalce-322	133	43	of	of	ADP
globalce-322	133	44	md	md	PROPN
globalce-322	133	45	in	in	ADP
globalce-322	133	46	the	the	DET
globalce-322	133	47	country.11	country.11	NOUN
globalce-322	133	48	these	these	DET
globalce-322	133	49	devices	device	NOUN
globalce-322	133	50	such	such	ADJ
globalce-322	133	51	as	as	ADP
globalce-322	133	52	scalpels	scalpel	NOUN
globalce-322	133	53	,	,	PUNCT
globalce-322	133	54	scissors	scissor	NOUN
globalce-322	133	55	,	,	PUNCT
globalce-322	133	56	walking	walking	NOUN
globalce-322	133	57	sticks	stick	NOUN
globalce-322	133	58	,	,	PUNCT
globalce-322	133	59	eyeglasses	eyeglass	NOUN
globalce-322	133	60	,	,	PUNCT
globalce-322	133	61	and	and	CCONJ
globalce-322	133	62	wheelchairs	wheelchairs	NOUN
globalce-322	133	63	do	do	AUX
globalce-322	133	64	not	not	PART
globalce-322	133	65	require	require	VERB
globalce-322	133	66	a	a	DET
globalce-322	133	67	license	license	NOUN
globalce-322	133	68	,	,	PUNCT
globalce-322	133	69	but	but	CCONJ
globalce-322	133	70	they	they	PRON
globalce-322	133	71	do	do	AUX
globalce-322	133	72	need	need	VERB
globalce-322	133	73	to	to	PART
globalce-322	133	74	be	be	AUX
globalce-322	133	75	registered	register	VERB
globalce-322	133	76	on	on	ADP
globalce-322	133	77	“	"	PUNCT
globalce-322	133	78	online	online	ADJ
globalce-322	133	79	system	system	NOUN
globalce-322	133	80	for	for	ADP
globalce-322	133	81	medical	medical	ADJ
globalce-322	133	82	devices	device	NOUN
globalce-322	133	83	”	"	PUNCT
globalce-322	133	84	established	establish	VERB
globalce-322	133	85	by	by	ADP
globalce-322	133	86	cdsco	cdsco	NOUN
globalce-322	133	87	for	for	ADP
globalce-322	133	88	this	this	DET
globalce-322	133	89	purpose.12	purpose.12	NOUN
globalce-322	133	90	the	the	DET
globalce-322	133	91	registration	registration	NOUN
globalce-322	133	92	number	number	NOUN
globalce-322	133	93	obtained	obtain	VERB
globalce-322	133	94	shall	shall	AUX
globalce-322	133	95	not	not	PART
globalce-322	133	96	be	be	AUX
globalce-322	133	97	considered	consider	VERB
globalce-322	133	98	as	as	ADP
globalce-322	133	99	a	a	DET
globalce-322	133	100	regulatory	regulatory	ADJ
globalce-322	133	101	approval	approval	NOUN
globalce-322	133	102	for	for	ADP
globalce-322	133	103	the	the	DET
globalce-322	133	104	manufacture	manufacture	NOUN
globalce-322	133	105	/	/	SYM
globalce-322	133	106	import	import	NOUN
globalce-322	133	107	of	of	ADP
globalce-322	133	108	devices	device	NOUN
globalce-322	133	109	.	.	PUNCT
globalce-322	134	1	import	import	NOUN
globalce-322	134	2	of	of	ADP
globalce-322	134	3	md	md	PROPN
globalce-322	134	4	/	/	SYM
globalce-322	134	5	ivd	ivd	PROPN
globalce-322	134	6	from	from	ADP
globalce-322	134	7	the	the	DET
globalce-322	134	8	founding	found	VERB
globalce-322	134	9	member	member	NOUN
globalce-322	134	10	countries	country	NOUN
globalce-322	134	11	of	of	ADP
globalce-322	134	12	the	the	DET
globalce-322	134	13	ghtf	ghtf	PROPN
globalce-322	134	14	clinical	clinical	ADJ
globalce-322	134	15	investigation	investigation	NOUN
globalce-322	134	16	will	will	AUX
globalce-322	134	17	be	be	AUX
globalce-322	134	18	waived	waive	VERB
globalce-322	134	19	off	off	ADP
globalce-322	134	20	for	for	ADP
globalce-322	134	21	the	the	DET
globalce-322	134	22	subject	subject	ADJ
globalce-322	134	23	device	device	NOUN
globalce-322	134	24	if	if	SCONJ
globalce-322	134	25	it	it	PRON
globalce-322	134	26	is	be	AUX
globalce-322	134	27	imported	import	VERB
globalce-322	134	28	from	from	ADP
globalce-322	134	29	the	the	DET
globalce-322	134	30	united	united	PROPN
globalce-322	134	31	states	states	PROPN
globalce-322	134	32	,	,	PUNCT
globalce-322	134	33	britain	britain	PROPN
globalce-322	134	34	,	,	PUNCT
globalce-322	134	35	the	the	DET
globalce-322	134	36	united	united	PROPN
globalce-322	134	37	kingdom	kingdom	PROPN
globalce-322	134	38	,	,	PUNCT
globalce-322	134	39	japan	japan	PROPN
globalce-322	134	40	,	,	PUNCT
globalce-322	134	41	the	the	DET
globalce-322	134	42	european	european	PROPN
globalce-322	134	43	union	union	PROPN
globalce-322	134	44	,	,	PUNCT
globalce-322	134	45	australia	australia	PROPN
globalce-322	134	46	,	,	PUNCT
globalce-322	134	47	and	and	CCONJ
globalce-322	134	48	canada	canada	PROPN
globalce-322	134	49	and	and	CCONJ
globalce-322	134	50	remains	remain	VERB
globalce-322	134	51	marketed	market	VERB
globalce-322	134	52	for	for	ADP
globalce-322	134	53	at	at	ADV
globalce-322	134	54	least	least	ADV
globalce-322	134	55	2	2	NUM
globalce-322	134	56	years	year	NOUN
globalce-322	134	57	in	in	ADP
globalce-322	134	58	these	these	DET
globalce-322	134	59	territories	territory	NOUN
globalce-322	134	60	(	(	PUNCT
globalce-322	134	61	table	table	NOUN
globalce-322	134	62	1	1	NUM
globalce-322	134	63	)	)	PUNCT
globalce-322	134	64	.	.	PUNCT
globalce-322	135	1	in	in	ADP
globalce-322	135	2	addition	addition	NOUN
globalce-322	135	3	,	,	PUNCT
globalce-322	135	4	the	the	DET
globalce-322	135	5	cla	cla	NOUN
globalce-322	135	6	is	be	AUX
globalce-322	135	7	satisfied	satisfied	ADJ
globalce-322	135	8	with	with	ADP
globalce-322	135	9	the	the	DET
globalce-322	135	10	data	datum	NOUN
globalce-322	135	11	of	of	ADP
globalce-322	135	12	safety	safety	NOUN
globalce-322	135	13	,	,	PUNCT
globalce-322	135	14	performance	performance	NOUN
globalce-322	135	15	and	and	CCONJ
globalce-322	135	16	pharmacovigilance	pharmacovigilance	NOUN
globalce-322	135	17	of	of	ADP
globalce-322	135	18	the	the	DET
globalce-322	135	19	said	said	ADJ
globalce-322	135	20	device	device	NOUN
globalce-322	135	21	as	as	ADP
globalce-322	135	22	per	per	ADP
globalce-322	135	23	rule	rule	NOUN
globalce-322	135	24	63	63	NUM
globalce-322	135	25	of	of	ADP
globalce-322	135	26	mdr-2017.2	mdr-2017.2	NOUN
globalce-322	135	27	however	however	ADV
globalce-322	135	28	,	,	PUNCT
globalce-322	135	29	it	it	PRON
globalce-322	135	30	is	be	AUX
globalce-322	135	31	subject	subject	ADJ
globalce-322	135	32	to	to	ADP
globalce-322	135	33	approval	approval	NOUN
globalce-322	135	34	from	from	ADP
globalce-322	135	35	the	the	DET
globalce-322	135	36	cdsco	cdsco	NOUN
globalce-322	135	37	on	on	ADP
globalce-322	135	38	a	a	DET
globalce-322	135	39	case	case	NOUN
globalce-322	135	40	basis	basis	NOUN
globalce-322	135	41	.	.	PUNCT
globalce-322	136	1	imported	import	VERB
globalce-322	136	2	for	for	ADP
globalce-322	136	3	personal	personal	ADJ
globalce-322	136	4	use	use	NOUN
globalce-322	136	5	test	test	NOUN
globalce-322	136	6	license	license	NOUN
globalce-322	136	7	is	be	AUX
globalce-322	136	8	not	not	PART
globalce-322	136	9	required	require	VERB
globalce-322	136	10	for	for	ADP
globalce-322	136	11	the	the	DET
globalce-322	136	12	import	import	NOUN
globalce-322	136	13	of	of	ADP
globalce-322	136	14	small	small	ADJ
globalce-322	136	15	quantities	quantity	NOUN
globalce-322	136	16	of	of	ADP
globalce-322	136	17	md	md	PROPN
globalce-322	136	18	/	/	SYM
globalce-322	136	19	ivd	ivd	PROPN
globalce-322	136	20	for	for	ADP
globalce-322	136	21	personal	personal	ADJ
globalce-322	136	22	use	use	NOUN
globalce-322	136	23	(	(	PUNCT
globalce-322	136	24	by	by	ADP
globalce-322	136	25	a	a	DET
globalce-322	136	26	person	person	NOUN
globalce-322	136	27	or	or	CCONJ
globalce-322	136	28	by	by	ADP
globalce-322	136	29	a	a	DET
globalce-322	136	30	government	government	NOUN
globalce-322	136	31	hospital	hospital	NOUN
globalce-322	136	32	or	or	CCONJ
globalce-322	136	33	statutory	statutory	ADJ
globalce-322	136	34	medical	medical	ADJ
globalce-322	136	35	institution	institution	NOUN
globalce-322	136	36	for	for	ADP
globalce-322	136	37	the	the	DET
globalce-322	136	38	treatment	treatment	NOUN
globalce-322	136	39	of	of	ADP
globalce-322	136	40	a	a	DET
globalce-322	136	41	patient	patient	NOUN
globalce-322	136	42	)	)	PUNCT
globalce-322	136	43	,	,	PUNCT
globalce-322	136	44	which	which	PRON
globalce-322	136	45	is	be	AUX
globalce-322	136	46	otherwise	otherwise	ADV
globalce-322	136	47	prohibited	prohibit	VERB
globalce-322	136	48	under	under	ADP
globalce-322	136	49	section	section	NOUN
globalce-322	136	50	10	10	NUM
globalce-322	136	51	of	of	ADP
globalce-322	136	52	the	the	DET
globalce-322	136	53	act	act	NOUN
globalce-322	136	54	.	.	PUNCT
globalce-322	137	1	md	md	PROPN
globalce-322	137	2	/	/	SYM
globalce-322	137	3	ivd	ivd	PROPN
globalce-322	137	4	may	may	AUX
globalce-322	137	5	be	be	AUX
globalce-322	137	6	imported	import	VERB
globalce-322	137	7	for	for	ADP
globalce-322	137	8	personal	personal	ADJ
globalce-322	137	9	use	use	NOUN
globalce-322	137	10	subject	subject	NOUN
globalce-322	137	11	to	to	ADP
globalce-322	137	12	prior	prior	ADJ
globalce-322	137	13	approval	approval	NOUN
globalce-322	137	14	in	in	ADP
globalce-322	137	15	form	form	NOUN
globalce-322	137	16	md-20	md-20	NOUN
globalce-322	138	1	as	as	ADP
globalce-322	138	2	per	per	ADP
globalce-322	138	3	rule	rule	NOUN
globalce-322	138	4	43	43	NUM
globalce-322	138	5	of	of	ADP
globalce-322	138	6	mdr-2017	mdr-2017	NOUN
globalce-322	138	7	accompanied	accompany	VERB
globalce-322	138	8	by	by	ADP
globalce-322	138	9	requisite	requisite	ADJ
globalce-322	138	10	documents	document	NOUN
globalce-322	138	11	and	and	CCONJ
globalce-322	138	12	the	the	DET
globalce-322	138	13	fee	fee	NOUN
globalce-322	138	14	as	as	SCONJ
globalce-322	138	15	specified	specify	VERB
globalce-322	138	16	in	in	ADP
globalce-322	138	17	the	the	DET
globalce-322	138	18	second	second	ADJ
globalce-322	138	19	schedule	schedule	NOUN
globalce-322	138	20	of	of	ADP
globalce-322	138	21	mdr-2017	mdr-2017	NOUN
globalce-322	138	22	on	on	ADP
globalce-322	138	23	the	the	DET
globalce-322	138	24	cited	cite	VERB
globalce-322	138	25	portal.12	portal.12	NOUN
globalce-322	138	26	on	on	ADP
globalce-322	138	27	the	the	DET
globalce-322	138	28	other	other	ADJ
globalce-322	138	29	hand	hand	NOUN
globalce-322	138	30	,	,	PUNCT
globalce-322	138	31	small	small	ADJ
globalce-322	138	32	quantities	quantity	NOUN
globalce-322	138	33	of	of	ADP
globalce-322	138	34	an	an	DET
globalce-322	138	35	investigational	investigational	ADJ
globalce-322	138	36	medical	medical	ADJ
globalce-322	138	37	device	device	NOUN
globalce-322	138	38	,	,	PUNCT
globalce-322	138	39	the	the	DET
globalce-322	138	40	import	import	NOUN
globalce-322	138	41	of	of	ADP
globalce-322	138	42	which	which	PRON
globalce-322	138	43	is	be	AUX
globalce-322	138	44	not	not	PART
globalce-322	138	45	allowed	allow	VERB
globalce-322	138	46	,	,	PUNCT
globalce-322	138	47	but	but	CCONJ
globalce-322	138	48	approved	approve	VERB
globalce-322	138	49	in	in	ADP
globalce-322	138	50	the	the	DET
globalce-322	138	51	country	country	NOUN
globalce-322	138	52	of	of	ADP
globalce-322	138	53	origin	origin	NOUN
globalce-322	138	54	,	,	PUNCT
globalce-322	138	55	may	may	AUX
globalce-322	138	56	be	be	AUX
globalce-322	138	57	allowed	allow	VERB
globalce-322	138	58	to	to	PART
globalce-322	138	59	be	be	AUX
globalce-322	138	60	imported	import	VERB
globalce-322	138	61	by	by	ADP
globalce-322	138	62	the	the	DET
globalce-322	138	63	cla	cla	NOUN
globalce-322	138	64	for	for	ADP
globalce-322	138	65	the	the	DET
globalce-322	138	66	treatment	treatment	NOUN
globalce-322	138	67	of	of	ADP
globalce-322	138	68	a	a	DET
globalce-322	138	69	patient	patient	NOUN
globalce-322	138	70	suffering	suffering	NOUN
globalce-322	138	71	from	from	ADP
globalce-322	138	72	a	a	DET
globalce-322	138	73	life	life	NOUN
globalce-322	138	74	-	-	PUNCT
globalce-322	138	75	threatening	threaten	VERB
globalce-322	138	76	disease	disease	NOUN
globalce-322	138	77	,	,	PUNCT
globalce-322	138	78	or	or	CCONJ
globalce-322	138	79	disease	disease	NOUN
globalce-322	138	80	causing	cause	VERB
globalce-322	138	81	serious	serious	ADJ
globalce-322	138	82	permanent	permanent	ADJ
globalce-322	138	83	disability	disability	NOUN
globalce-322	138	84	,	,	PUNCT
globalce-322	138	85	or	or	CCONJ
globalce-322	138	86	disease	disease	NOUN
globalce-322	138	87	requiring	require	VERB
globalce-322	138	88	therapy	therapy	NOUN
globalce-322	138	89	for	for	ADP
globalce-322	138	90	an	an	DET
globalce-322	138	91	unmet	unmet	NOUN
globalce-322	138	92	medical	medical	ADJ
globalce-322	138	93	need	need	NOUN
globalce-322	138	94	,	,	PUNCT
globalce-322	138	95	on	on	ADP
globalce-322	138	96	an	an	DET
globalce-322	138	97	application	application	NOUN
globalce-322	138	98	made	make	VERB
globalce-322	138	99	by	by	ADP
globalce-322	138	100	a	a	DET
globalce-322	138	101	medical	medical	ADJ
globalce-322	138	102	officer	officer	NOUN
globalce-322	138	103	through	through	ADP
globalce-322	138	104	the	the	DET
globalce-322	138	105	medical	medical	ADJ
globalce-322	138	106	superintendent	superintendent	NOUN
globalce-322	138	107	of	of	ADP
globalce-322	138	108	a	a	DET
globalce-322	138	109	government	government	NOUN
globalce-322	138	110	hospital	hospital	NOUN
globalce-322	138	111	or	or	CCONJ
globalce-322	138	112	a	a	DET
globalce-322	138	113	statutory	statutory	ADJ
globalce-322	138	114	medical	medical	ADJ
globalce-322	138	115	institution	institution	NOUN
globalce-322	138	116	in	in	ADP
globalce-322	138	117	form	form	NOUN
globalce-322	138	118	md-18	md-18	NOUN
globalce-322	138	119	as	as	ADP
globalce-322	138	120	per	per	ADP
globalce-322	138	121	rule	rule	NOUN
globalce-322	138	122	42	42	NUM
globalce-322	138	123	of	of	ADP
globalce-322	138	124	mdr-2017	mdr-2017	NOUN
globalce-322	138	125	accompanied	accompany	VERB
globalce-322	138	126	by	by	ADP
globalce-322	138	127	requisite	requisite	ADJ
globalce-322	138	128	documents	document	NOUN
globalce-322	138	129	required	require	VERB
globalce-322	138	130	and	and	CCONJ
globalce-322	138	131	the	the	DET
globalce-322	138	132	fee	fee	NOUN
globalce-322	138	133	as	as	SCONJ
globalce-322	138	134	specified	specify	VERB
globalce-322	138	135	in	in	ADP
globalce-322	138	136	the	the	DET
globalce-322	138	137	second	second	ADJ
globalce-322	138	138	schedule	schedule	NOUN
globalce-322	138	139	of	of	ADP
globalce-322	138	140	mdr-2017	mdr-2017	NOUN
globalce-322	138	141	on	on	ADP
globalce-322	138	142	the	the	DET
globalce-322	138	143	cited	cite	VERB
globalce-322	138	144	portal	portal	NOUN
globalce-322	138	145	for	for	ADP
globalce-322	138	146	this	this	DET
globalce-322	138	147	purpose.12	purpose.12	NOUN
globalce-322	138	148	manufacturing	manufacturing	NOUN
globalce-322	138	149	of	of	ADP
globalce-322	138	150	custom	custom	ADV
globalce-322	138	151	-	-	PUNCT
globalce-322	138	152	made	make	VERB
globalce-322	138	153	device	device	NOUN
globalce-322	138	154	md	md	NOUN
globalce-322	138	155	that	that	PRON
globalce-322	138	156	are	be	AUX
globalce-322	138	157	made	make	VERB
globalce-322	138	158	specifically	specifically	ADV
globalce-322	138	159	in	in	ADP
globalce-322	138	160	accordance	accordance	NOUN
globalce-322	138	161	with	with	ADP
globalce-322	138	162	a	a	DET
globalce-322	138	163	written	write	VERB
globalce-322	138	164	prescription	prescription	NOUN
globalce-322	138	165	of	of	ADP
globalce-322	138	166	a	a	DET
globalce-322	138	167	registered	register	VERB
globalce-322	138	168	medical	medical	ADJ
globalce-322	138	169	practitioner	practitioner	NOUN
globalce-322	138	170	,	,	PUNCT
globalce-322	138	171	specialized	specialize	VERB
globalce-322	138	172	in	in	ADP
globalce-322	138	173	the	the	DET
globalce-322	138	174	relevant	relevant	ADJ
globalce-322	138	175	area	area	NOUN
globalce-322	138	176	,	,	PUNCT
globalce-322	138	177	under	under	ADP
globalce-322	138	178	his	his	PRON
globalce-322	138	179	/	/	SYM
globalce-322	138	180	her	her	PRON
globalce-322	138	181	responsibility	responsibility	NOUN
globalce-322	138	182	in	in	ADP
globalce-322	138	183	accordance	accordance	NOUN
globalce-322	138	184	with	with	ADP
globalce-322	138	185	a	a	DET
globalce-322	138	186	specific	specific	ADJ
globalce-322	138	187	design	design	NOUN
globalce-322	138	188	,	,	PUNCT
globalce-322	138	189	characteristics	characteristic	NOUN
globalce-322	138	190	,	,	PUNCT
globalce-322	138	191	and	and	CCONJ
globalce-322	138	192	kumar	kumar	PROPN
globalce-322	138	193	,	,	PUNCT
globalce-322	138	194	gupta	gupta	PROPN
globalce-322	138	195	,	,	PUNCT
globalce-322	138	196	batra	batra	PROPN
globalce-322	138	197	,	,	PUNCT
globalce-322	138	198	sahu	sahu	PROPN
globalce-322	138	199	and	and	CCONJ
globalce-322	138	200	markan	markan	PROPN
globalce-322	138	201	:	:	PUNCT
globalce-322	138	202	catchment	catchment	NOUN
globalce-322	138	203	of	of	ADP
globalce-322	138	204	the	the	DET
globalce-322	138	205	test	test	NOUN
globalce-322	138	206	license	license	NOUN
globalce-322	138	207	for	for	ADP
globalce-322	138	208	the	the	DET
globalce-322	138	209	regulation	regulation	NOUN
globalce-322	138	210	of	of	ADP
globalce-322	138	211	medical	medical	ADJ
globalce-322	138	212	devices	device	NOUN
globalce-322	138	213	in	in	ADP
globalce-322	138	214	india	india	PROPN
globalce-322	138	215	j	j	PROPN
globalce-322	138	216	global	global	ADJ
globalce-322	138	217	clinical	clinical	ADJ
globalce-322	138	218	engineering	engineering	NOUN
globalce-322	138	219	vol.7	vol.7	PROPN
globalce-322	138	220	issue	issue	NOUN
globalce-322	138	221	3	3	NUM
globalce-322	138	222	:	:	PUNCT
globalce-322	138	223	2025	2025	NUM
globalce-322	138	224	56	56	NUM
globalce-322	138	225	•	•	NOUN
globalce-322	138	226	role	role	NOUN
globalce-322	138	227	in	in	ADP
globalce-322	138	228	regulatory	regulatory	ADJ
globalce-322	138	229	compliance	compliance	NOUN
globalce-322	138	230	:	:	PUNCT
globalce-322	138	231	obtaining	obtain	VERB
globalce-322	138	232	test	test	NOUN
globalce-322	138	233	license	license	NOUN
globalce-322	138	234	is	be	AUX
globalce-322	138	235	an	an	DET
globalce-322	138	236	important	important	ADJ
globalce-322	138	237	step	step	NOUN
globalce-322	138	238	which	which	PRON
globalce-322	138	239	helps	help	VERB
globalce-322	138	240	in	in	ADP
globalce-322	138	241	ensuring	ensure	VERB
globalce-322	138	242	adherence	adherence	NOUN
globalce-322	138	243	with	with	ADP
globalce-322	138	244	the	the	DET
globalce-322	138	245	existing	exist	VERB
globalce-322	138	246	regulatory	regulatory	ADJ
globalce-322	138	247	framework	framework	NOUN
globalce-322	138	248	so	so	SCONJ
globalce-322	138	249	that	that	SCONJ
globalce-322	138	250	it	it	PRON
globalce-322	138	251	can	can	AUX
globalce-322	138	252	be	be	AUX
globalce-322	138	253	of	of	ADP
globalce-322	138	254	help	help	NOUN
globalce-322	138	255	to	to	PART
globalce-322	138	256	protect	protect	VERB
globalce-322	138	257	public	public	ADJ
globalce-322	138	258	health	health	NOUN
globalce-322	138	259	.	.	PUNCT
globalce-322	139	1	it	it	PRON
globalce-322	139	2	also	also	ADV
globalce-322	139	3	ensures	ensure	VERB
globalce-322	139	4	that	that	SCONJ
globalce-322	139	5	products	product	NOUN
globalce-322	139	6	that	that	PRON
globalce-322	139	7	are	be	AUX
globalce-322	139	8	manufactured	manufacture	VERB
globalce-322	139	9	/	/	SYM
globalce-322	139	10	imported	import	VERB
globalce-322	139	11	in	in	ADP
globalce-322	139	12	small	small	ADJ
globalce-322	139	13	quantities	quantity	NOUN
globalce-322	139	14	after	after	ADP
globalce-322	139	15	obtaining	obtain	VERB
globalce-322	139	16	test	test	NOUN
globalce-322	139	17	license	license	NOUN
globalce-322	139	18	shall	shall	AUX
globalce-322	139	19	be	be	AUX
globalce-322	139	20	used	use	VERB
globalce-322	139	21	only	only	ADV
globalce-322	139	22	for	for	ADP
globalce-322	139	23	specified	specify	VERB
globalce-322	139	24	purposes	purpose	NOUN
globalce-322	139	25	and	and	CCONJ
globalce-322	139	26	not	not	PART
globalce-322	139	27	for	for	ADP
globalce-322	139	28	commercial	commercial	ADJ
globalce-322	139	29	purposes	purpose	NOUN
globalce-322	139	30	.	.	PUNCT
globalce-322	140	1	•	•	NUM
globalce-322	140	2	safety	safety	NOUN
globalce-322	140	3	measures	measure	NOUN
globalce-322	140	4	:	:	PUNCT
globalce-322	140	5	test	test	NOUN
globalce-322	140	6	license	license	NOUN
globalce-322	140	7	granted	grant	VERB
globalce-322	140	8	against	against	ADP
globalce-322	140	9	manufacturing	manufacturing	NOUN
globalce-322	140	10	/	/	SYM
globalce-322	140	11	importing	import	VERB
globalce-322	140	12	the	the	DET
globalce-322	140	13	md	md	PROPN
globalce-322	140	14	/	/	SYM
globalce-322	140	15	ivd	ivd	PROPN
globalce-322	140	16	for	for	ADP
globalce-322	140	17	the	the	DET
globalce-322	140	18	purpose	purpose	NOUN
globalce-322	140	19	of	of	ADP
globalce-322	140	20	testing/	testing/	NUM
globalce-322	140	21	evaluation	evaluation	NOUN
globalce-322	140	22	ensures	ensure	VERB
globalce-322	140	23	that	that	SCONJ
globalce-322	140	24	testing	testing	NOUN
globalce-322	140	25	/	/	SYM
globalce-322	140	26	evaluation	evaluation	NOUN
globalce-322	140	27	carried	carry	VERB
globalce-322	140	28	out	out	ADP
globalce-322	140	29	with	with	ADP
globalce-322	140	30	respect	respect	NOUN
globalce-322	140	31	to	to	ADP
globalce-322	140	32	applicable	applicable	ADJ
globalce-322	140	33	gold	gold	NOUN
globalce-322	140	34	standards	standard	NOUN
globalce-322	140	35	will	will	AUX
globalce-322	140	36	establish	establish	VERB
globalce-322	140	37	that	that	SCONJ
globalce-322	140	38	the	the	DET
globalce-322	140	39	products	product	NOUN
globalce-322	140	40	are	be	AUX
globalce-322	140	41	safe	safe	ADJ
globalce-322	140	42	and	and	CCONJ
globalce-322	140	43	effective	effective	ADJ
globalce-322	140	44	for	for	ADP
globalce-322	140	45	human	human	ADJ
globalce-322	140	46	use	use	NOUN
globalce-322	140	47	.	.	PUNCT
globalce-322	141	1	•	•	NUM
globalce-322	141	2	commercial	commercial	ADJ
globalce-322	141	3	manufacturing	manufacturing	NOUN
globalce-322	141	4	preparedness	preparedness	NOUN
globalce-322	141	5	:	:	PUNCT
globalce-322	141	6	the	the	DET
globalce-322	141	7	grant	grant	NOUN
globalce-322	141	8	of	of	ADP
globalce-322	141	9	a	a	DET
globalce-322	141	10	test	test	NOUN
globalce-322	141	11	license	license	NOUN
globalce-322	141	12	is	be	AUX
globalce-322	141	13	the	the	DET
globalce-322	141	14	preliminary	preliminary	ADJ
globalce-322	141	15	step	step	NOUN
globalce-322	141	16	for	for	ADP
globalce-322	141	17	the	the	DET
globalce-322	141	18	preparedness	preparedness	NOUN
globalce-322	141	19	of	of	ADP
globalce-322	141	20	commercial	commercial	ADJ
globalce-322	141	21	manufacturing	manufacturing	NOUN
globalce-322	141	22	license	license	NOUN
globalce-322	141	23	for	for	ADP
globalce-322	141	24	sale	sale	NOUN
globalce-322	141	25	and	and	CCONJ
globalce-322	141	26	distribution	distribution	NOUN
globalce-322	141	27	of	of	ADP
globalce-322	141	28	md	md	PROPN
globalce-322	141	29	/	/	SYM
globalce-322	141	30	ivd	ivd	PROPN
globalce-322	141	31	in	in	ADP
globalce-322	141	32	the	the	DET
globalce-322	141	33	indian	indian	ADJ
globalce-322	141	34	market	market	NOUN
globalce-322	141	35	,	,	PUNCT
globalce-322	141	36	as	as	SCONJ
globalce-322	141	37	it	it	PRON
globalce-322	141	38	helps	help	VERB
globalce-322	141	39	to	to	PART
globalce-322	141	40	prevent	prevent	VERB
globalce-322	141	41	the	the	DET
globalce-322	141	42	marketing	marketing	NOUN
globalce-322	141	43	of	of	ADP
globalce-322	141	44	unsafe	unsafe	ADJ
globalce-322	141	45	or	or	CCONJ
globalce-322	141	46	ineffective	ineffective	ADJ
globalce-322	141	47	devices	device	NOUN
globalce-322	141	48	.	.	PUNCT
globalce-322	142	1	usually	usually	ADV
globalce-322	142	2	,	,	PUNCT
globalce-322	142	3	it	it	PRON
globalce-322	142	4	is	be	AUX
globalce-322	142	5	applied	apply	VERB
globalce-322	142	6	for	for	ADP
globalce-322	142	7	once	once	ADV
globalce-322	142	8	the	the	DET
globalce-322	142	9	working	work	VERB
globalce-322	142	10	prototype	prototype	NOUN
globalce-322	142	11	is	be	AUX
globalce-322	142	12	ready	ready	ADJ
globalce-322	142	13	,	,	PUNCT
globalce-322	142	14	and	and	CCONJ
globalce-322	142	15	its	its	PRON
globalce-322	142	16	design	design	NOUN
globalce-322	142	17	is	be	AUX
globalce-322	142	18	finalized	finalize	VERB
globalce-322	142	19	in	in	ADP
globalce-322	142	20	the	the	DET
globalce-322	142	21	case	case	NOUN
globalce-322	142	22	of	of	ADP
globalce-322	142	23	investigational	investigational	ADJ
globalce-322	142	24	md	md	PROPN
globalce-322	142	25	/	/	SYM
globalce-322	142	26	new	new	PROPN
globalce-322	142	27	ivd	ivd	PROPN
globalce-322	142	28	.	.	PUNCT
globalce-322	143	1	•	•	NUM
globalce-322	143	2	build	build	PROPN
globalce-322	143	3	trust	trust	NOUN
globalce-322	143	4	:	:	PUNCT
globalce-322	143	5	the	the	DET
globalce-322	143	6	end	end	NOUN
globalce-322	143	7	user	user	NOUN
globalce-322	143	8	can	can	AUX
globalce-322	143	9	build	build	VERB
globalce-322	143	10	trust	trust	NOUN
globalce-322	143	11	in	in	ADP
globalce-322	143	12	the	the	DET
globalce-322	143	13	company	company	NOUN
globalce-322	143	14	’s	’s	PART
globalce-322	143	15	various	various	ADJ
globalce-322	143	16	products	product	NOUN
globalce-322	143	17	of	of	ADP
globalce-322	143	18	md	md	PROPN
globalce-322	143	19	/	/	SYM
globalce-322	143	20	ivd	ivd	PROPN
globalce-322	143	21	for	for	ADP
globalce-322	143	22	which	which	PRON
globalce-322	143	23	the	the	DET
globalce-322	143	24	license	license	NOUN
globalce-322	143	25	has	have	AUX
globalce-322	143	26	been	be	AUX
globalce-322	143	27	granted	grant	VERB
globalce-322	143	28	.	.	PUNCT
globalce-322	144	1	•	•	NUM
globalce-322	144	2	adverse	adverse	ADJ
globalce-322	144	3	event	event	NOUN
globalce-322	144	4	surveillance	surveillance	NOUN
globalce-322	144	5	:	:	PUNCT
globalce-322	144	6	test	test	NOUN
globalce-322	144	7	license	license	NOUN
globalce-322	144	8	encompasses	encompass	VERB
globalce-322	144	9	the	the	DET
globalce-322	144	10	compliance	compliance	NOUN
globalce-322	144	11	of	of	ADP
globalce-322	144	12	regulatory	regulatory	ADJ
globalce-322	144	13	approval	approval	NOUN
globalce-322	144	14	,	,	PUNCT
globalce-322	144	15	identification	identification	NOUN
globalce-322	144	16	of	of	ADP
globalce-322	144	17	all	all	DET
globalce-322	144	18	quality	quality	NOUN
globalce-322	144	19	-	-	PUNCT
globalce-322	144	20	related	relate	VERB
globalce-322	144	21	issues	issue	NOUN
globalce-322	144	22	,	,	PUNCT
globalce-322	144	23	investigation	investigation	NOUN
globalce-322	144	24	of	of	ADP
globalce-322	144	25	the	the	DET
globalce-322	144	26	root	root	NOUN
globalce-322	144	27	cause	cause	NOUN
globalce-322	144	28	,	,	PUNCT
globalce-322	144	29	and	and	CCONJ
globalce-322	144	30	implementation	implementation	NOUN
globalce-322	144	31	of	of	ADP
globalce-322	144	32	necessary	necessary	ADJ
globalce-322	144	33	legal	legal	ADJ
globalce-322	144	34	actions	action	NOUN
globalce-322	144	35	in	in	ADP
globalce-322	144	36	case	case	NOUN
globalce-322	144	37	of	of	ADP
globalce-322	144	38	adverse	adverse	ADJ
globalce-322	144	39	events	event	NOUN
globalce-322	144	40	reported	report	VERB
globalce-322	144	41	(	(	PUNCT
globalce-322	144	42	if	if	SCONJ
globalce-322	144	43	any	any	PRON
globalce-322	144	44	)	)	PUNCT
globalce-322	144	45	of	of	ADP
globalce-322	144	46	the	the	DET
globalce-322	144	47	subject	subject	ADJ
globalce-322	144	48	device	device	NOUN
globalce-322	144	49	.	.	PUNCT
globalce-322	145	1	this	this	PRON
globalce-322	145	2	ensures	ensure	VERB
globalce-322	145	3	that	that	SCONJ
globalce-322	145	4	such	such	ADJ
globalce-322	145	5	problems	problem	NOUN
globalce-322	145	6	do	do	AUX
globalce-322	145	7	not	not	PART
globalce-322	145	8	arise	arise	VERB
globalce-322	145	9	again	again	ADV
globalce-322	145	10	and	and	CCONJ
globalce-322	145	11	develops	develop	VERB
globalce-322	145	12	the	the	DET
globalce-322	145	13	confidence	confidence	NOUN
globalce-322	145	14	of	of	ADP
globalce-322	145	15	users	user	NOUN
globalce-322	145	16	on	on	ADP
globalce-322	145	17	device	device	NOUN
globalce-322	145	18	potentially	potentially	ADV
globalce-322	145	19	,	,	PUNCT
globalce-322	145	20	safety	safety	NOUN
globalce-322	145	21	,	,	PUNCT
globalce-322	145	22	and	and	CCONJ
globalce-322	145	23	effectiveness	effectiveness	NOUN
globalce-322	145	24	of	of	ADP
globalce-322	145	25	use	use	NOUN
globalce-322	145	26	in	in	ADP
globalce-322	145	27	humans	human	NOUN
globalce-322	145	28	.	.	PUNCT
globalce-322	146	1	key	key	ADJ
globalce-322	146	2	challenges	challenge	NOUN
globalce-322	146	3	and	and	CCONJ
globalce-322	146	4	suggestions	suggestion	NOUN
globalce-322	146	5	for	for	ADP
globalce-322	146	6	amelioration	amelioration	NOUN
globalce-322	146	7	test	test	NOUN
globalce-322	146	8	license	license	NOUN
globalce-322	146	9	permits	permit	VERB
globalce-322	146	10	the	the	DET
globalce-322	146	11	manufacturer	manufacturer	NOUN
globalce-322	146	12	/	/	SYM
globalce-322	146	13	importer	importer	NOUN
globalce-322	146	14	to	to	PART
globalce-322	146	15	make	make	VERB
globalce-322	146	16	/	/	SYM
globalce-322	146	17	import	import	VERB
globalce-322	146	18	a	a	DET
globalce-322	146	19	limited	limited	ADJ
globalce-322	146	20	quantity	quantity	NOUN
globalce-322	146	21	of	of	ADP
globalce-322	146	22	md	md	PROPN
globalce-322	146	23	/	/	SYM
globalce-322	146	24	ivd	ivd	PROPN
globalce-322	146	25	falling	fall	VERB
globalce-322	146	26	within	within	ADP
globalce-322	146	27	class	class	NOUN
globalce-322	146	28	a	a	PRON
globalce-322	146	29	(	(	PUNCT
globalce-322	146	30	except	except	SCONJ
globalce-322	146	31	non	non	ADJ
globalce-322	146	32	-	-	ADJ
globalce-322	146	33	sterile	sterile	ADJ
globalce-322	146	34	and	and	CCONJ
globalce-322	146	35	non	non	NOUN
globalce-322	146	36	-	-	NOUN
globalce-322	146	37	measuring)/b	measuring)/b	ADJ
globalce-322	146	38	/	/	SYM
globalce-322	146	39	c	c	NOUN
globalce-322	146	40	/	/	SYM
globalce-322	146	41	d	d	NOUN
globalce-322	146	42	for	for	ADP
globalce-322	146	43	any	any	PRON
globalce-322	146	44	of	of	ADP
globalce-322	146	45	the	the	DET
globalce-322	146	46	aforesaid	aforesaid	ADJ
globalce-322	146	47	purposes	purpose	NOUN
globalce-322	146	48	before	before	ADP
globalce-322	146	49	being	be	AUX
globalce-322	146	50	put	put	VERB
globalce-322	146	51	into	into	ADP
globalce-322	146	52	commercial	commercial	ADJ
globalce-322	146	53	use	use	NOUN
globalce-322	146	54	.	.	PUNCT
globalce-322	147	1	there	there	PRON
globalce-322	147	2	are	be	VERB
globalce-322	147	3	certain	certain	ADJ
globalce-322	147	4	challenges	challenge	NOUN
globalce-322	147	5	with	with	ADP
globalce-322	147	6	regard	regard	NOUN
globalce-322	147	7	to	to	ADP
globalce-322	147	8	applying	apply	VERB
globalce-322	147	9	the	the	DET
globalce-322	147	10	test	test	NOUN
globalce-322	147	11	license	license	NOUN
globalce-322	147	12	and	and	CCONJ
globalce-322	147	13	possible	possible	ADJ
globalce-322	147	14	suggestions	suggestion	NOUN
globalce-322	147	15	,	,	PUNCT
globalce-322	147	16	which	which	PRON
globalce-322	147	17	are	be	AUX
globalce-322	147	18	summarized	summarize	VERB
globalce-322	147	19	below	below	ADP
globalce-322	147	20	.	.	PUNCT
globalce-322	148	1	the	the	DET
globalce-322	148	2	same	same	ADJ
globalce-322	148	3	is	be	AUX
globalce-322	148	4	intended	intend	VERB
globalce-322	148	5	for	for	ADP
globalce-322	148	6	the	the	DET
globalce-322	148	7	sole	sole	ADJ
globalce-322	148	8	use	use	NOUN
globalce-322	148	9	of	of	ADP
globalce-322	148	10	a	a	DET
globalce-322	148	11	particular	particular	ADJ
globalce-322	148	12	patient	patient	NOUN
globalce-322	148	13	,	,	PUNCT
globalce-322	148	14	and	and	CCONJ
globalce-322	148	15	the	the	DET
globalce-322	148	16	label	label	NOUN
globalce-322	148	17	mentions	mention	VERB
globalce-322	148	18	“	"	PUNCT
globalce-322	148	19	for	for	ADP
globalce-322	148	20	the	the	DET
globalce-322	148	21	sole	sole	ADJ
globalce-322	148	22	use	use	NOUN
globalce-322	148	23	of	of	ADP
globalce-322	148	24	a	a	DET
globalce-322	148	25	particular	particular	ADJ
globalce-322	148	26	patient	patient	NOUN
globalce-322	148	27	,	,	PUNCT
globalce-322	148	28	”	"	PUNCT
globalce-322	148	29	and	and	CCONJ
globalce-322	148	30	does	do	AUX
globalce-322	148	31	not	not	PART
globalce-322	148	32	include	include	VERB
globalce-322	148	33	the	the	DET
globalce-322	148	34	mass	mass	ADJ
globalce-322	148	35	production	production	NOUN
globalce-322	148	36	of	of	ADP
globalce-322	148	37	such	such	DET
globalce-322	148	38	a	a	DET
globalce-322	148	39	device	device	NOUN
globalce-322	148	40	.	.	PUNCT
globalce-322	149	1	all	all	DET
globalce-322	149	2	provisions	provision	NOUN
globalce-322	149	3	of	of	ADP
globalce-322	149	4	chapter	chapter	NOUN
globalce-322	149	5	iv	iv	NUM
globalce-322	149	6	(	(	PUNCT
globalce-322	149	7	manufacture	manufacture	NOUN
globalce-322	149	8	of	of	ADP
globalce-322	149	9	md	md	PROPN
globalce-322	149	10	for	for	ADP
globalce-322	149	11	sale	sale	NOUN
globalce-322	149	12	or	or	CCONJ
globalce-322	149	13	for	for	ADP
globalce-322	149	14	distribution	distribution	NOUN
globalce-322	149	15	and	and	CCONJ
globalce-322	149	16	chapter	chapter	NOUN
globalce-322	149	17	v	v	NOUN
globalce-322	149	18	(	(	PUNCT
globalce-322	149	19	import	import	NOUN
globalce-322	149	20	of	of	ADP
globalce-322	149	21	md	md	PROPN
globalce-322	149	22	)	)	PUNCT
globalce-322	149	23	are	be	AUX
globalce-322	149	24	exempted	exempt	VERB
globalce-322	149	25	as	as	ADP
globalce-322	149	26	per	per	ADP
globalce-322	149	27	the	the	DET
globalce-322	149	28	eighth	eighth	ADJ
globalce-322	149	29	schedule	schedule	NOUN
globalce-322	149	30	of	of	ADP
globalce-322	149	31	mdr-2017	mdr-2017	NOUN
globalce-322	149	32	.	.	PUNCT
globalce-322	150	1	withdrawal	withdrawal	NOUN
globalce-322	150	2	,	,	PUNCT
globalce-322	150	3	rejection	rejection	NOUN
globalce-322	150	4	,	,	PUNCT
globalce-322	150	5	and	and	CCONJ
globalce-322	150	6	cancellation	cancellation	NOUN
globalce-322	150	7	of	of	ADP
globalce-322	150	8	test	test	NOUN
globalce-322	150	9	license	license	NOUN
globalce-322	150	10	once	once	SCONJ
globalce-322	150	11	the	the	DET
globalce-322	150	12	test	test	NOUN
globalce-322	150	13	license	license	NOUN
globalce-322	150	14	application	application	NOUN
globalce-322	150	15	is	be	AUX
globalce-322	150	16	submitted	submit	VERB
globalce-322	150	17	successfully	successfully	ADV
globalce-322	150	18	,	,	PUNCT
globalce-322	150	19	there	there	PRON
globalce-322	150	20	is	be	VERB
globalce-322	150	21	no	no	DET
globalce-322	150	22	option	option	NOUN
globalce-322	150	23	to	to	PART
globalce-322	150	24	withdraw	withdraw	VERB
globalce-322	150	25	/	/	SYM
globalce-322	150	26	amend	amend	VERB
globalce-322	150	27	the	the	DET
globalce-322	150	28	submitted	submit	VERB
globalce-322	150	29	test	test	NOUN
globalce-322	150	30	license	license	NOUN
globalce-322	150	31	application	application	NOUN
globalce-322	150	32	on	on	ADP
globalce-322	150	33	the	the	DET
globalce-322	150	34	nsws	nsws	ADJ
globalce-322	150	35	portal	portal	NOUN
globalce-322	150	36	.	.	PUNCT
globalce-322	151	1	however	however	ADV
globalce-322	151	2	,	,	PUNCT
globalce-322	151	3	an	an	DET
globalce-322	151	4	applicant	applicant	NOUN
globalce-322	151	5	can	can	AUX
globalce-322	151	6	request	request	VERB
globalce-322	151	7	the	the	DET
globalce-322	151	8	cla	cla	NOUN
globalce-322	151	9	for	for	ADP
globalce-322	151	10	cancellation	cancellation	NOUN
globalce-322	151	11	with	with	ADP
globalce-322	151	12	a	a	DET
globalce-322	151	13	proper	proper	ADJ
globalce-322	151	14	justification	justification	NOUN
globalce-322	151	15	for	for	ADP
globalce-322	151	16	the	the	DET
globalce-322	151	17	same	same	ADJ
globalce-322	151	18	.	.	PUNCT
globalce-322	152	1	in	in	ADP
globalce-322	152	2	addition	addition	NOUN
globalce-322	152	3	,	,	PUNCT
globalce-322	152	4	after	after	ADP
globalce-322	152	5	obtaining	obtain	VERB
globalce-322	152	6	the	the	DET
globalce-322	152	7	test	test	NOUN
globalce-322	152	8	license	license	NOUN
globalce-322	152	9	in	in	ADP
globalce-322	152	10	form	form	NOUN
globalce-322	152	11	md-13	md-13	PRON
globalce-322	152	12	,	,	PUNCT
globalce-322	152	13	if	if	SCONJ
globalce-322	152	14	an	an	DET
globalce-322	152	15	applicant	applicant	NOUN
globalce-322	152	16	fails	fail	VERB
globalce-322	152	17	to	to	PART
globalce-322	152	18	comply	comply	VERB
globalce-322	152	19	with	with	ADP
globalce-322	152	20	relevant	relevant	ADJ
globalce-322	152	21	provisions	provision	NOUN
globalce-322	152	22	of	of	ADP
globalce-322	152	23	the	the	DET
globalce-322	152	24	mdr-2017	mdr-2017	NOUN
globalce-322	152	25	against	against	ADP
globalce-322	152	26	the	the	DET
globalce-322	152	27	proposed	propose	VERB
globalce-322	152	28	device	device	NOUN
globalce-322	152	29	/	/	SYM
globalce-322	152	30	ivd	ivd	PROPN
globalce-322	152	31	,	,	PUNCT
globalce-322	152	32	the	the	DET
globalce-322	152	33	cla	cla	NOUN
globalce-322	152	34	may	may	AUX
globalce-322	152	35	issue	issue	VERB
globalce-322	152	36	a	a	DET
globalce-322	152	37	show	show	NOUN
globalce-322	152	38	cause	cause	VERB
globalce-322	152	39	notice	notice	NOUN
globalce-322	152	40	for	for	ADP
globalce-322	152	41	cancellation	cancellation	NOUN
globalce-322	152	42	giving	give	VERB
globalce-322	152	43	an	an	DET
globalce-322	152	44	opportunity	opportunity	NOUN
globalce-322	152	45	to	to	PART
globalce-322	152	46	explain	explain	VERB
globalce-322	152	47	in	in	ADP
globalce-322	152	48	writing	write	VERB
globalce-322	152	49	the	the	DET
globalce-322	152	50	licensee	licensee	NOUN
globalce-322	152	51	’s	’s	PART
globalce-322	152	52	defense	defense	NOUN
globalce-322	152	53	against	against	ADP
globalce-322	152	54	an	an	DET
globalce-322	152	55	order	order	NOUN
globalce-322	152	56	for	for	ADP
globalce-322	152	57	cancellation	cancellation	NOUN
globalce-322	152	58	.	.	PUNCT
globalce-322	153	1	the	the	DET
globalce-322	153	2	licensee	licensee	NOUN
globalce-322	153	3	has	have	VERB
globalce-322	153	4	the	the	DET
globalce-322	153	5	right	right	NOUN
globalce-322	153	6	to	to	PART
globalce-322	153	7	appeal	appeal	VERB
globalce-322	153	8	to	to	ADP
globalce-322	153	9	the	the	DET
globalce-322	153	10	central	central	ADJ
globalce-322	153	11	government	government	NOUN
globalce-322	153	12	within	within	ADP
globalce-322	153	13	45	45	NUM
globalce-322	153	14	days	day	NOUN
globalce-322	153	15	from	from	ADP
globalce-322	153	16	the	the	DET
globalce-322	153	17	date	date	NOUN
globalce-322	153	18	of	of	ADP
globalce-322	153	19	cancellation	cancellation	NOUN
globalce-322	153	20	of	of	ADP
globalce-322	153	21	the	the	DET
globalce-322	153	22	order.2	order.2	PROPN
globalce-322	153	23	the	the	DET
globalce-322	153	24	cla	cla	NOUN
globalce-322	153	25	may	may	AUX
globalce-322	153	26	reject	reject	VERB
globalce-322	153	27	the	the	DET
globalce-322	153	28	grant	grant	NOUN
globalce-322	153	29	of	of	ADP
globalce-322	153	30	a	a	DET
globalce-322	153	31	test	test	NOUN
globalce-322	153	32	license	license	NOUN
globalce-322	153	33	in	in	ADP
globalce-322	153	34	form	form	NOUN
globalce-322	153	35	md-17	md-17	ADV
globalce-322	153	36	,	,	PUNCT
globalce-322	153	37	and	and	CCONJ
globalce-322	153	38	the	the	DET
globalce-322	153	39	reasons	reason	NOUN
globalce-322	153	40	,	,	PUNCT
globalce-322	153	41	such	such	ADJ
globalce-322	153	42	as	as	ADP
globalce-322	153	43	the	the	DET
globalce-322	153	44	requirements	requirement	NOUN
globalce-322	153	45	of	of	ADP
globalce-322	153	46	these	these	DET
globalce-322	153	47	rules	rule	NOUN
globalce-322	153	48	are	be	AUX
globalce-322	153	49	not	not	PART
globalce-322	153	50	satisfied	satisfied	ADJ
globalce-322	153	51	by	by	ADP
globalce-322	153	52	the	the	DET
globalce-322	153	53	applicant	applicant	NOUN
globalce-322	153	54	,	,	PUNCT
globalce-322	153	55	are	be	AUX
globalce-322	153	56	to	to	PART
globalce-322	153	57	be	be	AUX
globalce-322	153	58	recorded	record	VERB
globalce-322	153	59	in	in	ADP
globalce-322	153	60	writing	writing	NOUN
globalce-322	153	61	within	within	ADP
globalce-322	153	62	a	a	DET
globalce-322	153	63	period	period	NOUN
globalce-322	153	64	of	of	ADP
globalce-322	153	65	thirty	thirty	NUM
globalce-322	153	66	days	day	NOUN
globalce-322	153	67	from	from	ADP
globalce-322	153	68	the	the	DET
globalce-322	153	69	date	date	NOUN
globalce-322	153	70	of	of	ADP
globalce-322	153	71	the	the	DET
globalce-322	153	72	application	application	NOUN
globalce-322	153	73	under	under	ADP
globalce-322	153	74	sub	sub	NOUN
globalce-322	153	75	-	-	NOUN
globalce-322	153	76	rule	rule	ADJ
globalce-322	153	77	(	(	PUNCT
globalce-322	153	78	2	2	NUM
globalce-322	153	79	)	)	PUNCT
globalce-322	153	80	of	of	ADP
globalce-322	153	81	rule	rule	NOUN
globalce-322	153	82	40	40	NUM
globalce-322	153	83	of	of	ADP
globalce-322	153	84	mdr-2017.2	mdr-2017.2	NOUN
globalce-322	153	85	significance	significance	NOUN
globalce-322	153	86	of	of	ADP
globalce-322	153	87	test	test	NOUN
globalce-322	153	88	license	license	VERB
globalce-322	153	89	the	the	DET
globalce-322	153	90	importance	importance	NOUN
globalce-322	153	91	of	of	ADP
globalce-322	153	92	test	test	NOUN
globalce-322	153	93	license	license	NOUN
globalce-322	153	94	significantly	significantly	ADV
globalce-322	153	95	implies	imply	VERB
globalce-322	153	96	a	a	DET
globalce-322	153	97	quality	quality	NOUN
globalce-322	153	98	of	of	ADP
globalce-322	153	99	md	md	PROPN
globalce-322	153	100	/	/	SYM
globalce-322	153	101	ivd	ivd	PROPN
globalce-322	153	102	that	that	PRON
globalce-322	153	103	should	should	AUX
globalce-322	153	104	make	make	VERB
globalce-322	153	105	it	it	PRON
globalce-322	153	106	worthy	worthy	ADJ
globalce-322	153	107	of	of	ADP
globalce-322	153	108	global	global	ADJ
globalce-322	153	109	acceptance	acceptance	NOUN
globalce-322	153	110	.	.	PUNCT
globalce-322	154	1	within	within	ADP
globalce-322	154	2	a	a	DET
globalce-322	154	3	functioning	function	VERB
globalce-322	154	4	healthcare	healthcare	NOUN
globalce-322	154	5	system	system	NOUN
globalce-322	154	6	,	,	PUNCT
globalce-322	154	7	initiating	initiate	VERB
globalce-322	154	8	the	the	DET
globalce-322	154	9	regulatory	regulatory	ADJ
globalce-322	154	10	application	application	NOUN
globalce-322	154	11	process	process	NOUN
globalce-322	154	12	—	—	PUNCT
globalce-322	154	13	beginning	begin	VERB
globalce-322	154	14	with	with	ADP
globalce-322	154	15	the	the	DET
globalce-322	154	16	issuance	issuance	NOUN
globalce-322	154	17	of	of	ADP
globalce-322	154	18	a	a	DET
globalce-322	154	19	test	test	NOUN
globalce-322	154	20	license	license	NOUN
globalce-322	154	21	—	—	PUNCT
globalce-322	154	22	is	be	AUX
globalce-322	154	23	a	a	DET
globalce-322	154	24	crucial	crucial	ADJ
globalce-322	154	25	first	first	ADJ
globalce-322	154	26	step	step	NOUN
globalce-322	154	27	for	for	ADP
globalce-322	154	28	any	any	DET
globalce-322	154	29	subject	subject	ADJ
globalce-322	154	30	device	device	NOUN
globalce-322	154	31	intended	intend	VERB
globalce-322	154	32	for	for	ADP
globalce-322	154	33	widespread	widespread	ADJ
globalce-322	154	34	use	use	NOUN
globalce-322	154	35	in	in	ADP
globalce-322	154	36	the	the	DET
globalce-322	154	37	prevention	prevention	NOUN
globalce-322	154	38	,	,	PUNCT
globalce-322	154	39	diagnosis	diagnosis	NOUN
globalce-322	154	40	,	,	PUNCT
globalce-322	154	41	treatment	treatment	NOUN
globalce-322	154	42	,	,	PUNCT
globalce-322	154	43	monitoring	monitoring	NOUN
globalce-322	154	44	,	,	PUNCT
globalce-322	154	45	and	and	CCONJ
globalce-322	154	46	rehabilitation	rehabilitation	NOUN
globalce-322	154	47	of	of	ADP
globalce-322	154	48	a	a	DET
globalce-322	154	49	broad	broad	ADJ
globalce-322	154	50	range	range	NOUN
globalce-322	154	51	of	of	ADP
globalce-322	154	52	diseases	disease	NOUN
globalce-322	154	53	and	and	CCONJ
globalce-322	154	54	medical	medical	ADJ
globalce-322	154	55	conditions	condition	NOUN
globalce-322	154	56	.	.	PUNCT
globalce-322	155	1	in	in	ADP
globalce-322	155	2	addition	addition	NOUN
globalce-322	155	3	,	,	PUNCT
globalce-322	155	4	it	it	PRON
globalce-322	155	5	can	can	AUX
globalce-322	155	6	also	also	ADV
globalce-322	155	7	be	be	AUX
globalce-322	155	8	used	use	VERB
globalce-322	155	9	to	to	PART
globalce-322	155	10	monitor	monitor	VERB
globalce-322	155	11	vital	vital	ADJ
globalce-322	155	12	signs	sign	NOUN
globalce-322	155	13	,	,	PUNCT
globalce-322	155	14	deliver	deliver	VERB
globalce-322	155	15	medications	medication	NOUN
globalce-322	155	16	,	,	PUNCT
globalce-322	155	17	remove	remove	VERB
globalce-322	155	18	biological	biological	ADJ
globalce-322	155	19	waste	waste	NOUN
globalce-322	155	20	,	,	PUNCT
globalce-322	155	21	and	and	CCONJ
globalce-322	155	22	support	support	NOUN
globalce-322	155	23	or	or	CCONJ
globalce-322	155	24	replace	replace	VERB
globalce-322	155	25	damaged	damage	VERB
globalce-322	155	26	body	body	NOUN
globalce-322	155	27	parts	part	NOUN
globalce-322	155	28	.	.	PUNCT
globalce-322	156	1	the	the	DET
globalce-322	156	2	important	important	ADJ
globalce-322	156	3	aspects	aspect	NOUN
globalce-322	156	4	of	of	ADP
globalce-322	156	5	test	test	NOUN
globalce-322	156	6	license	license	NOUN
globalce-322	156	7	are	be	AUX
globalce-322	156	8	herewith	herewith	NOUN
globalce-322	156	9	outlined	outline	VERB
globalce-322	156	10	below	below	ADV
globalce-322	156	11	:	:	PUNCT
globalce-322	156	12	57	57	NUM
globalce-322	156	13	j	j	PROPN
globalce-322	156	14	global	global	ADJ
globalce-322	156	15	clinical	clinical	ADJ
globalce-322	156	16	engineering	engineering	NOUN
globalce-322	156	17	vol.7	vol.7	PROPN
globalce-322	156	18	issue	issue	NOUN
globalce-322	156	19	3	3	NUM
globalce-322	156	20	:	:	SYM
globalce-322	156	21	2025	2025	NUM
globalce-322	156	22	kumar	kumar	PROPN
globalce-322	156	23	,	,	PUNCT
globalce-322	156	24	gupta	gupta	PROPN
globalce-322	156	25	,	,	PUNCT
globalce-322	156	26	batra	batra	PROPN
globalce-322	156	27	,	,	PUNCT
globalce-322	156	28	sahu	sahu	PROPN
globalce-322	156	29	and	and	CCONJ
globalce-322	156	30	markan	markan	PROPN
globalce-322	156	31	:	:	PUNCT
globalce-322	156	32	catchment	catchment	NOUN
globalce-322	156	33	of	of	ADP
globalce-322	156	34	the	the	DET
globalce-322	156	35	test	test	NOUN
globalce-322	156	36	license	license	NOUN
globalce-322	156	37	for	for	ADP
globalce-322	156	38	the	the	DET
globalce-322	156	39	regulation	regulation	NOUN
globalce-322	156	40	of	of	ADP
globalce-322	156	41	medical	medical	ADJ
globalce-322	156	42	devices	device	NOUN
globalce-322	156	43	in	in	ADP
globalce-322	156	44	india	india	PROPN
globalce-322	156	45	extended	extend	VERB
globalce-322	156	46	application	application	NOUN
globalce-322	156	47	review	review	NOUN
globalce-322	156	48	period	period	NOUN
globalce-322	156	49	in	in	ADP
globalce-322	156	50	general	general	ADJ
globalce-322	156	51	,	,	PUNCT
globalce-322	156	52	30	30	NUM
globalce-322	156	53	working	work	VERB
globalce-322	156	54	days	day	NOUN
globalce-322	156	55	are	be	AUX
globalce-322	156	56	allocated	allocate	VERB
globalce-322	156	57	to	to	PART
globalce-322	156	58	review	review	VERB
globalce-322	156	59	the	the	DET
globalce-322	156	60	application	application	NOUN
globalce-322	156	61	and	and	CCONJ
globalce-322	156	62	grant	grant	NOUN
globalce-322	156	63	approval	approval	NOUN
globalce-322	156	64	.	.	PUNCT
globalce-322	157	1	however	however	ADV
globalce-322	157	2	,	,	PUNCT
globalce-322	157	3	long	long	ADV
globalce-322	157	4	extended	extended	ADJ
globalce-322	157	5	time	time	NOUN
globalce-322	157	6	has	have	AUX
globalce-322	157	7	been	be	AUX
globalce-322	157	8	utilized	utilize	VERB
globalce-322	157	9	to	to	PART
globalce-322	157	10	review	review	VERB
globalce-322	157	11	the	the	DET
globalce-322	157	12	application	application	NOUN
globalce-322	157	13	because	because	SCONJ
globalce-322	157	14	of	of	ADP
globalce-322	157	15	a	a	DET
globalce-322	157	16	large	large	ADJ
globalce-322	157	17	volume	volume	NOUN
globalce-322	157	18	of	of	ADP
globalce-322	157	19	applications	application	NOUN
globalce-322	157	20	or	or	CCONJ
globalce-322	157	21	insufficient	insufficient	ADJ
globalce-322	157	22	information	information	NOUN
globalce-322	157	23	/	/	SYM
globalce-322	157	24	incorrect	incorrect	ADJ
globalce-322	157	25	documents	document	NOUN
globalce-322	157	26	submitted	submit	VERB
globalce-322	157	27	by	by	ADP
globalce-322	157	28	the	the	DET
globalce-322	157	29	applicants	applicant	NOUN
globalce-322	157	30	.	.	PUNCT
globalce-322	158	1	possible	possible	ADJ
globalce-322	158	2	suggestions	suggestion	NOUN
globalce-322	158	3	inconsistent	inconsistent	ADJ
globalce-322	158	4	testing	testing	NOUN
globalce-322	158	5	standards	standard	NOUN
globalce-322	158	6	there	there	PRON
globalce-322	158	7	may	may	AUX
globalce-322	158	8	be	be	AUX
globalce-322	158	9	inconsistencies	inconsistency	NOUN
globalce-322	158	10	in	in	ADP
globalce-322	158	11	how	how	SCONJ
globalce-322	158	12	different	different	ADJ
globalce-322	158	13	laboratories	laboratory	NOUN
globalce-322	158	14	apply	apply	VERB
globalce-322	158	15	the	the	DET
globalce-322	158	16	standards	standard	NOUN
globalce-322	158	17	,	,	PUNCT
globalce-322	158	18	leading	lead	VERB
globalce-322	158	19	to	to	ADP
globalce-322	158	20	variability	variability	NOUN
globalce-322	158	21	in	in	ADP
globalce-322	158	22	testing/	testing/	NUM
globalce-322	158	23	performance	performance	NOUN
globalce-322	158	24	outcomes	outcome	NOUN
globalce-322	158	25	.	.	PUNCT
globalce-322	159	1	there	there	PRON
globalce-322	159	2	is	be	VERB
globalce-322	159	3	no	no	DET
globalce-322	159	4	harmonization	harmonization	NOUN
globalce-322	159	5	of	of	ADP
globalce-322	159	6	the	the	DET
globalce-322	159	7	analytical	analytical	ADJ
globalce-322	159	8	parameter	parameter	NOUN
globalce-322	159	9	,	,	PUNCT
globalce-322	159	10	which	which	PRON
globalce-322	159	11	is	be	AUX
globalce-322	159	12	established	establish	VERB
globalce-322	159	13	to	to	PART
globalce-322	159	14	conduct	conduct	VERB
globalce-322	159	15	the	the	DET
globalce-322	159	16	performance	performance	NOUN
globalce-322	159	17	evaluation	evaluation	NOUN
globalce-322	159	18	of	of	ADP
globalce-322	159	19	the	the	DET
globalce-322	159	20	subject	subject	NOUN
globalce-322	159	21	ivd	ivd	NOUN
globalce-322	159	22	that	that	PRON
globalce-322	159	23	varies	vary	VERB
globalce-322	159	24	across	across	ADP
globalce-322	159	25	designated	designate	VERB
globalce-322	159	26	labs	lab	NOUN
globalce-322	159	27	.	.	PUNCT
globalce-322	160	1	aligning	align	VERB
globalce-322	160	2	the	the	DET
globalce-322	160	3	harmonized	harmonized	ADJ
globalce-322	160	4	results	result	NOUN
globalce-322	160	5	with	with	ADP
globalce-322	160	6	mdr-2017	mdr-2017	NOUN
globalce-322	160	7	is	be	AUX
globalce-322	160	8	critical	critical	ADJ
globalce-322	160	9	for	for	ADP
globalce-322	160	10	approval	approval	NOUN
globalce-322	160	11	.	.	PUNCT
globalce-322	161	1	emergence	emergence	NOUN
globalce-322	161	2	of	of	ADP
globalce-322	161	3	new	new	ADJ
globalce-322	161	4	technologies	technology	NOUN
globalce-322	161	5	:	:	PUNCT
globalce-322	161	6	emergence	emergence	NOUN
globalce-322	161	7	of	of	ADP
globalce-322	161	8	new	new	ADJ
globalce-322	161	9	technologies	technology	NOUN
globalce-322	161	10	for	for	ADP
globalce-322	161	11	health	health	NOUN
globalce-322	161	12	solutions	solution	NOUN
globalce-322	161	13	require	require	VERB
globalce-322	161	14	new	new	ADJ
globalce-322	161	15	risk	risk	NOUN
globalce-322	161	16	-	-	PUNCT
globalce-322	161	17	based	base	VERB
globalce-322	161	18	classification	classification	NOUN
globalce-322	161	19	under	under	ADP
globalce-322	161	20	either	either	DET
globalce-322	161	21	software	software	NOUN
globalce-322	161	22	integrated	integrate	VERB
globalce-322	161	23	medical	medical	ADJ
globalce-322	161	24	device	device	NOUN
globalce-322	161	25	(	(	PUNCT
globalce-322	161	26	simd	simd	PROPN
globalce-322	161	27	)	)	PUNCT
globalce-322	161	28	or	or	CCONJ
globalce-322	161	29	software	software	NOUN
globalce-322	161	30	as	as	ADP
globalce-322	161	31	medical	medical	ADJ
globalce-322	161	32	device	device	NOUN
globalce-322	161	33	(	(	PUNCT
globalce-322	161	34	samd	samd	NOUN
globalce-322	161	35	)	)	PUNCT
globalce-322	161	36	for	for	ADP
globalce-322	161	37	addressing	address	VERB
globalce-322	161	38	efficacy	efficacy	NOUN
globalce-322	161	39	/	/	SYM
globalce-322	161	40	intended	intend	VERB
globalce-322	161	41	use	use	NOUN
globalce-322	161	42	in	in	ADP
globalce-322	161	43	ways	way	NOUN
globalce-322	161	44	that	that	PRON
globalce-322	161	45	are	be	AUX
globalce-322	161	46	not	not	PART
globalce-322	161	47	previously	previously	ADV
globalce-322	161	48	covered	cover	VERB
globalce-322	161	49	.	.	PUNCT
globalce-322	162	1	an	an	DET
globalce-322	162	2	awareness	awareness	NOUN
globalce-322	162	3	-	-	PUNCT
globalce-322	162	4	strengthening	strengthen	VERB
globalce-322	162	5	regulation	regulation	NOUN
globalce-322	162	6	since	since	SCONJ
globalce-322	162	7	,	,	PUNCT
globalce-322	162	8	there	there	PRON
globalce-322	162	9	is	be	VERB
globalce-322	162	10	an	an	DET
globalce-322	162	11	overall	overall	ADJ
globalce-322	162	12	trend	trend	NOUN
globalce-322	162	13	to	to	PART
globalce-322	162	14	cover	cover	VERB
globalce-322	162	15	all	all	DET
globalce-322	162	16	md	md	PROPN
globalce-322	162	17	/	/	SYM
globalce-322	162	18	ivd	ivd	PROPN
globalce-322	162	19	under	under	ADP
globalce-322	162	20	the	the	DET
globalce-322	162	21	license	license	NOUN
globalce-322	162	22	regime	regime	NOUN
globalce-322	162	23	,	,	PUNCT
globalce-322	162	24	it	it	PRON
globalce-322	162	25	is	be	AUX
globalce-322	162	26	primarily	primarily	ADV
globalce-322	162	27	recommended	recommend	VERB
globalce-322	162	28	as	as	SCONJ
globalce-322	162	29	safety	safety	NOUN
globalce-322	162	30	concern	concern	NOUN
globalce-322	162	31	grows	grow	VERB
globalce-322	162	32	,	,	PUNCT
globalce-322	162	33	to	to	PART
globalce-322	162	34	be	be	AUX
globalce-322	162	35	aware	aware	ADJ
globalce-322	162	36	about	about	ADP
globalce-322	162	37	increased	increase	VERB
globalce-322	162	38	regulation	regulation	NOUN
globalce-322	162	39	over	over	ADP
globalce-322	162	40	previously	previously	ADV
globalce-322	162	41	non	non	ADJ
globalce-322	162	42	-	-	ADJ
globalce-322	162	43	notified	notified	ADJ
globalce-322	162	44	category	category	NOUN
globalce-322	162	45	of	of	ADP
globalce-322	162	46	md	md	PROPN
globalce-322	162	47	/	/	SYM
globalce-322	162	48	ivd	ivd	PROPN
globalce-322	162	49	.	.	PUNCT
globalce-322	163	1	conclusion	conclusion	NOUN
globalce-322	163	2	medtech	medtech	NOUN
globalce-322	163	3	industry	industry	NOUN
globalce-322	163	4	is	be	AUX
globalce-322	163	5	not	not	PART
globalce-322	163	6	just	just	ADV
globalce-322	163	7	a	a	DET
globalce-322	163	8	component	component	NOUN
globalce-322	163	9	of	of	ADP
globalce-322	163	10	healthcare	healthcare	NOUN
globalce-322	163	11	but	but	CCONJ
globalce-322	163	12	is	be	AUX
globalce-322	163	13	the	the	DET
globalce-322	163	14	catalyst	catalyst	NOUN
globalce-322	163	15	that	that	PRON
globalce-322	163	16	links	link	VERB
globalce-322	163	17	patients	patient	NOUN
globalce-322	163	18	,	,	PUNCT
globalce-322	163	19	payors	payor	NOUN
globalce-322	163	20	,	,	PUNCT
globalce-322	163	21	service	service	NOUN
globalce-322	163	22	providers	provider	NOUN
globalce-322	163	23	,	,	PUNCT
globalce-322	163	24	and	and	CCONJ
globalce-322	163	25	regulators	regulator	NOUN
globalce-322	163	26	to	to	PART
globalce-322	163	27	create	create	VERB
globalce-322	163	28	a	a	DET
globalce-322	163	29	stronger	strong	ADJ
globalce-322	163	30	and	and	CCONJ
globalce-322	163	31	more	more	ADV
globalce-322	163	32	equitable	equitable	ADJ
globalce-322	163	33	system	system	NOUN
globalce-322	163	34	in	in	ADP
globalce-322	163	35	a	a	DET
globalce-322	163	36	fast	fast	ADV
globalce-322	163	37	-	-	PUNCT
globalce-322	163	38	paced	pace	VERB
globalce-322	163	39	environment	environment	NOUN
globalce-322	163	40	globally	globally	ADV
globalce-322	163	41	.	.	PUNCT
globalce-322	164	1	in	in	ADP
globalce-322	164	2	this	this	DET
globalce-322	164	3	regard	regard	NOUN
globalce-322	164	4	,	,	PUNCT
globalce-322	164	5	md	md	PROPN
globalce-322	164	6	/	/	SYM
globalce-322	164	7	ivd	ivd	PROPN
globalce-322	164	8	is	be	AUX
globalce-322	164	9	the	the	DET
globalce-322	164	10	unique	unique	ADJ
globalce-322	164	11	positioning	positioning	NOUN
globalce-322	164	12	of	of	ADP
globalce-322	164	13	the	the	DET
globalce-322	164	14	medtech	medtech	NOUN
globalce-322	164	15	sector	sector	NOUN
globalce-322	164	16	that	that	PRON
globalce-322	164	17	holds	hold	VERB
globalce-322	164	18	the	the	DET
globalce-322	164	19	promise	promise	NOUN
globalce-322	164	20	of	of	ADP
globalce-322	164	21	revolutionizing	revolutionize	VERB
globalce-322	164	22	healthcare	healthcare	NOUN
globalce-322	164	23	delivery	delivery	NOUN
globalce-322	164	24	and	and	CCONJ
globalce-322	164	25	outcomes	outcome	NOUN
globalce-322	164	26	,	,	PUNCT
globalce-322	164	27	both	both	CCONJ
globalce-322	164	28	in	in	ADP
globalce-322	164	29	india	india	PROPN
globalce-322	164	30	and	and	CCONJ
globalce-322	164	31	globally	globally	ADV
globalce-322	164	32	.	.	PUNCT
globalce-322	165	1	the	the	DET
globalce-322	165	2	wide	wide	ADJ
globalce-322	165	3	spectrum	spectrum	NOUN
globalce-322	165	4	md	md	PROPN
globalce-322	165	5	/	/	SYM
globalce-322	165	6	ivd	ivd	PROPN
globalce-322	165	7	,	,	PUNCT
globalce-322	165	8	from	from	ADP
globalce-322	165	9	simple	simple	ADJ
globalce-322	165	10	technologies	technology	NOUN
globalce-322	165	11	to	to	PART
globalce-322	165	12	complex	complex	ADJ
globalce-322	165	13	high	high	ADJ
globalce-322	165	14	-	-	PUNCT
globalce-322	165	15	throughput	throughput	NOUN
globalce-322	165	16	systems	system	NOUN
globalce-322	165	17	,	,	PUNCT
globalce-322	165	18	presents	present	VERB
globalce-322	165	19	varying	vary	VERB
globalce-322	165	20	degrees	degree	NOUN
globalce-322	165	21	of	of	ADP
globalce-322	165	22	risk	risk	NOUN
globalce-322	165	23	that	that	PRON
globalce-322	165	24	may	may	AUX
globalce-322	165	25	directly	directly	ADV
globalce-322	165	26	influence	influence	VERB
globalce-322	165	27	patient	patient	ADJ
globalce-322	165	28	health	health	NOUN
globalce-322	165	29	challenges	challenge	NOUN
globalce-322	165	30	faced	face	VERB
globalce-322	165	31	the	the	DET
globalce-322	165	32	dynamic	dynamic	ADJ
globalce-322	165	33	and	and	CCONJ
globalce-322	165	34	complexity	complexity	NOUN
globalce-322	165	35	of	of	ADP
globalce-322	165	36	regulatory	regulatory	ADJ
globalce-322	165	37	compliance	compliance	NOUN
globalce-322	165	38	:	:	PUNCT
globalce-322	165	39	with	with	ADP
globalce-322	165	40	ongoing	ongoing	ADJ
globalce-322	165	41	amendments	amendment	NOUN
globalce-322	165	42	and	and	CCONJ
globalce-322	165	43	regular	regular	ADJ
globalce-322	165	44	updates	update	NOUN
globalce-322	165	45	to	to	PART
globalce-322	165	46	mdr-2017	mdr-2017	VERB
globalce-322	165	47	in	in	ADP
globalce-322	165	48	india	india	PROPN
globalce-322	165	49	,	,	PUNCT
globalce-322	165	50	usually	usually	ADV
globalce-322	165	51	the	the	DET
globalce-322	165	52	applicants	applicant	NOUN
globalce-322	165	53	often	often	ADV
globalce-322	165	54	face	face	VERB
globalce-322	165	55	the	the	DET
globalce-322	165	56	following	follow	VERB
globalce-322	165	57	challenges	challenge	NOUN
globalce-322	165	58	in	in	ADP
globalce-322	165	59	fully	fully	ADV
globalce-322	165	60	understanding	understand	VERB
globalce-322	165	61	the	the	DET
globalce-322	165	62	nuances	nuance	NOUN
globalce-322	165	63	related	relate	VERB
globalce-322	165	64	to	to	ADP
globalce-322	165	65	device	device	NOUN
globalce-322	165	66	/	/	SYM
globalce-322	165	67	ivd	ivd	NOUN
globalce-322	165	68	:	:	PUNCT
globalce-322	165	69	•	•	NUM
globalce-322	165	70	class	class	NOUN
globalce-322	165	71	of	of	ADP
globalce-322	165	72	md	md	PROPN
globalce-322	165	73	/	/	SYM
globalce-322	165	74	ivd	ivd	PROPN
globalce-322	165	75	:	:	PUNCT
globalce-322	165	76	correct	correct	ADJ
globalce-322	165	77	identification	identification	NOUN
globalce-322	165	78	of	of	ADP
globalce-322	165	79	a	a	DET
globalce-322	165	80	risk	risk	NOUN
globalce-322	165	81	-	-	PUNCT
globalce-322	165	82	based	base	VERB
globalce-322	165	83	class	class	NOUN
globalce-322	165	84	of	of	ADP
globalce-322	165	85	the	the	DET
globalce-322	165	86	device	device	NOUN
globalce-322	165	87	.	.	PUNCT
globalce-322	166	1	•	•	NUM
globalce-322	166	2	laboratory	laboratory	NOUN
globalce-322	166	3	for	for	ADP
globalce-322	166	4	conducting	conduct	VERB
globalce-322	166	5	performance	performance	NOUN
globalce-322	166	6	evaluation	evaluation	NOUN
globalce-322	166	7	:	:	PUNCT
globalce-322	166	8	availability	availability	NOUN
globalce-322	166	9	and	and	CCONJ
globalce-322	166	10	identification	identification	NOUN
globalce-322	166	11	of	of	ADP
globalce-322	166	12	cdsco	cdsco	PROPN
globalce-322	166	13	designated	designate	VERB
globalce-322	166	14	labs	lab	NOUN
globalce-322	166	15	under	under	ADP
globalce-322	166	16	sub	sub	NOUN
globalce-322	166	17	-	-	NOUN
globalce-322	166	18	rule	rule	ADJ
globalce-322	166	19	(	(	PUNCT
globalce-322	166	20	1	1	NUM
globalce-322	166	21	)	)	PUNCT
globalce-322	166	22	of	of	ADP
globalce-322	166	23	rule	rule	NOUN
globalce-322	166	24	19	19	NUM
globalce-322	166	25	of	of	ADP
globalce-322	166	26	mdr-2017	mdr-2017	NOUN
globalce-322	166	27	for	for	ADP
globalce-322	166	28	ivd	ivd	PROPN
globalce-322	166	29	.	.	PUNCT
globalce-322	167	1	•	•	NUM
globalce-322	167	2	identification	identification	NOUN
globalce-322	167	3	of	of	ADP
globalce-322	167	4	predicate	predicate	NOUN
globalce-322	167	5	device	device	NOUN
globalce-322	167	6	:	:	PUNCT
globalce-322	167	7	it	it	PRON
globalce-322	167	8	is	be	AUX
globalce-322	167	9	essential	essential	ADJ
globalce-322	167	10	for	for	ADP
globalce-322	167	11	confirmation	confirmation	NOUN
globalce-322	167	12	that	that	SCONJ
globalce-322	167	13	it	it	PRON
globalce-322	167	14	either	either	CCONJ
globalce-322	167	15	falls	fall	VERB
globalce-322	167	16	under	under	ADP
globalce-322	167	17	investigational	investigational	ADJ
globalce-322	167	18	md	md	NOUN
globalce-322	167	19	or	or	CCONJ
globalce-322	167	20	new	new	ADJ
globalce-322	167	21	ivd	ivd	NOUN
globalce-322	167	22	or	or	CCONJ
globalce-322	167	23	subsequent	subsequent	ADJ
globalce-322	167	24	equivalent	equivalent	NOUN
globalce-322	167	25	of	of	ADP
globalce-322	167	26	the	the	DET
globalce-322	167	27	approved	approve	VERB
globalce-322	167	28	device	device	NOUN
globalce-322	167	29	/	/	SYM
globalce-322	167	30	ivd	ivd	NOUN
globalce-322	167	31	.	.	PUNCT
globalce-322	168	1	•	•	NUM
globalce-322	168	2	understanding	understanding	NOUN
globalce-322	168	3	of	of	ADP
globalce-322	168	4	different	different	ADJ
globalce-322	168	5	components	component	NOUN
globalce-322	168	6	/	/	SYM
globalce-322	168	7	accessories/	accessories/	NUM
globalce-322	168	8	consumables	consumable	NOUN
globalce-322	168	9	:	:	PUNCT
globalce-322	168	10	it	it	PRON
globalce-322	168	11	includes	include	VERB
globalce-322	168	12	a	a	DET
globalce-322	168	13	basic	basic	ADJ
globalce-322	168	14	overview	overview	NOUN
globalce-322	168	15	of	of	ADP
globalce-322	168	16	the	the	DET
globalce-322	168	17	device	device	NOUN
globalce-322	168	18	and	and	CCONJ
globalce-322	168	19	its	its	PRON
globalce-322	168	20	parts	part	NOUN
globalce-322	168	21	,	,	PUNCT
globalce-322	168	22	whether	whether	SCONJ
globalce-322	168	23	or	or	CCONJ
globalce-322	168	24	not	not	PART
globalce-322	168	25	consumable	consumable	ADJ
globalce-322	168	26	items	item	NOUN
globalce-322	168	27	are	be	AUX
globalce-322	168	28	included	include	VERB
globalce-322	168	29	—	—	PUNCT
globalce-322	168	30	along	along	ADP
globalce-322	168	31	with	with	ADP
globalce-322	168	32	their	their	PRON
globalce-322	168	33	respective	respective	ADJ
globalce-322	168	34	risk	risk	NOUN
globalce-322	168	35	-	-	PUNCT
globalce-322	168	36	based	base	VERB
globalce-322	168	37	classification	classification	NOUN
globalce-322	168	38	and	and	CCONJ
globalce-322	168	39	intended	intended	ADJ
globalce-322	168	40	use	use	NOUN
globalce-322	168	41	,	,	PUNCT
globalce-322	168	42	is	be	AUX
globalce-322	168	43	not	not	PART
globalce-322	168	44	clearly	clearly	ADV
globalce-322	168	45	explained	explain	VERB
globalce-322	168	46	in	in	ADP
globalce-322	168	47	the	the	DET
globalce-322	168	48	remarks	remark	NOUN
globalce-322	168	49	.	.	PUNCT
globalce-322	169	1	justification	justification	NOUN
globalce-322	169	2	of	of	ADP
globalce-322	169	3	quantity	quantity	NOUN
globalce-322	169	4	to	to	PART
globalce-322	169	5	be	be	AUX
globalce-322	169	6	manufactured	manufacture	VERB
globalce-322	169	7	/	/	SYM
globalce-322	169	8	imported	import	VERB
globalce-322	169	9	for	for	ADP
globalce-322	169	10	different	different	ADJ
globalce-322	169	11	purposes	purpose	NOUN
globalce-322	169	12	and	and	CCONJ
globalce-322	169	13	their	their	PRON
globalce-322	169	14	breakups	breakup	NOUN
globalce-322	169	15	utilization	utilization	NOUN
globalce-322	169	16	.	.	PUNCT
globalce-322	170	1	•	•	NUM
globalce-322	170	2	clarity	clarity	NOUN
globalce-322	170	3	on	on	ADP
globalce-322	170	4	grouping	grouping	NOUN
globalce-322	170	5	of	of	ADP
globalce-322	170	6	md	md	PROPN
globalce-322	170	7	/	/	SYM
globalce-322	170	8	ivd	ivd	PROPN
globalce-322	170	9	;	;	PUNCT
globalce-322	170	10	either	either	CCONJ
globalce-322	170	11	it	it	PRON
globalce-322	170	12	falls	fall	VERB
globalce-322	170	13	under	under	ADP
globalce-322	170	14	the	the	DET
globalce-322	170	15	category	category	NOUN
globalce-322	170	16	of	of	ADP
globalce-322	170	17	single	single	ADJ
globalce-322	170	18	,	,	PUNCT
globalce-322	170	19	system	system	NOUN
globalce-322	170	20	,	,	PUNCT
globalce-322	170	21	group	group	NOUN
globalce-322	170	22	,	,	PUNCT
globalce-322	170	23	family	family	NOUN
globalce-322	170	24	,	,	PUNCT
globalce-322	170	25	or	or	CCONJ
globalce-322	170	26	cluster	cluster	NOUN
globalce-322	170	27	.	.	PUNCT
globalce-322	171	1	•	•	NUM
globalce-322	171	2	identification	identification	NOUN
globalce-322	171	3	of	of	ADP
globalce-322	171	4	test	test	NOUN
globalce-322	171	5	batch	batch	NOUN
globalce-322	171	6	manufacturing	manufacture	VERB
globalce-322	171	7	sites/	sites/	NUM
globalce-322	171	8	testing	testing	NOUN
globalce-322	171	9	sites	site	NOUN
globalce-322	171	10	.	.	PUNCT
globalce-322	172	1	technical	technical	ADJ
globalce-322	172	2	barriers	barrier	NOUN
globalce-322	172	3	on	on	ADP
globalce-322	172	4	the	the	DET
globalce-322	172	5	nsws	nsws	ADJ
globalce-322	172	6	portal	portal	NOUN
globalce-322	172	7	the	the	DET
globalce-322	172	8	nsws	nsws	ADJ
globalce-322	172	9	platform	platform	NOUN
globalce-322	172	10	,	,	PUNCT
globalce-322	172	11	while	while	SCONJ
globalce-322	172	12	designed	design	VERB
globalce-322	172	13	to	to	PART
globalce-322	172	14	simplify	simplify	VERB
globalce-322	172	15	regulatory	regulatory	ADJ
globalce-322	172	16	processes	process	NOUN
globalce-322	172	17	,	,	PUNCT
globalce-322	172	18	can	can	AUX
globalce-322	172	19	present	present	VERB
globalce-322	172	20	technical	technical	ADJ
globalce-322	172	21	barriers	barrier	NOUN
globalce-322	172	22	,	,	PUNCT
globalce-322	172	23	such	such	ADJ
globalce-322	172	24	as	as	ADP
globalce-322	172	25	slow	slow	ADJ
globalce-322	172	26	response	response	NOUN
globalce-322	172	27	times	time	NOUN
globalce-322	172	28	,	,	PUNCT
globalce-322	172	29	connectivity	connectivity	NOUN
globalce-322	172	30	issues	issue	NOUN
globalce-322	172	31	,	,	PUNCT
globalce-322	172	32	or	or	CCONJ
globalce-322	172	33	errors	error	NOUN
globalce-322	172	34	in	in	ADP
globalce-322	172	35	uploading	upload	VERB
globalce-322	172	36	required	require	VERB
globalce-322	172	37	documents	document	NOUN
globalce-322	172	38	along	along	ADP
globalce-322	172	39	with	with	ADP
globalce-322	172	40	login	login	NOUN
globalce-322	172	41	credential	credential	ADJ
globalce-322	172	42	requirements	requirement	NOUN
globalce-322	172	43	of	of	ADP
globalce-322	172	44	mandatory	mandatory	ADJ
globalce-322	172	45	dsc	dsc	NOUN
globalce-322	172	46	,	,	PUNCT
globalce-322	172	47	which	which	PRON
globalce-322	172	48	is	be	AUX
globalce-322	172	49	linked	link	VERB
globalce-322	172	50	to	to	ADP
globalce-322	172	51	the	the	DET
globalce-322	172	52	permanent	permanent	ADJ
globalce-322	172	53	account	account	NOUN
globalce-322	172	54	number	number	NOUN
globalce-322	172	55	(	(	PUNCT
globalce-322	172	56	pan	pan	NOUN
globalce-322	172	57	)	)	PUNCT
globalce-322	172	58	of	of	ADP
globalce-322	172	59	the	the	DET
globalce-322	172	60	business	business	NOUN
globalce-322	172	61	entity	entity	NOUN
globalce-322	172	62	or	or	CCONJ
globalce-322	172	63	signatory	signatory	NOUN
globalce-322	172	64	authority	authority	NOUN
globalce-322	172	65	for	for	ADP
globalce-322	172	66	its	its	PRON
globalce-322	172	67	validation	validation	NOUN
globalce-322	172	68	to	to	PART
globalce-322	172	69	submit	submit	VERB
globalce-322	172	70	the	the	DET
globalce-322	172	71	application	application	NOUN
globalce-322	172	72	as	as	ADV
globalce-322	172	73	well	well	ADV
globalce-322	172	74	as	as	ADP
globalce-322	172	75	approval	approval	NOUN
globalce-322	172	76	.	.	PUNCT
globalce-322	173	1	kumar	kumar	PROPN
globalce-322	173	2	,	,	PUNCT
globalce-322	173	3	gupta	gupta	PROPN
globalce-322	173	4	,	,	PUNCT
globalce-322	173	5	batra	batra	PROPN
globalce-322	173	6	,	,	PUNCT
globalce-322	173	7	sahu	sahu	PROPN
globalce-322	173	8	and	and	CCONJ
globalce-322	173	9	markan	markan	PROPN
globalce-322	173	10	:	:	PUNCT
globalce-322	173	11	catchment	catchment	NOUN
globalce-322	173	12	of	of	ADP
globalce-322	173	13	the	the	DET
globalce-322	173	14	test	test	NOUN
globalce-322	173	15	license	license	NOUN
globalce-322	173	16	for	for	ADP
globalce-322	173	17	the	the	DET
globalce-322	173	18	regulation	regulation	NOUN
globalce-322	173	19	of	of	ADP
globalce-322	173	20	medical	medical	ADJ
globalce-322	173	21	devices	device	NOUN
globalce-322	173	22	in	in	ADP
globalce-322	173	23	india	india	PROPN
globalce-322	173	24	j	j	PROPN
globalce-322	173	25	global	global	ADJ
globalce-322	173	26	clinical	clinical	ADJ
globalce-322	173	27	engineering	engineering	NOUN
globalce-322	173	28	vol.7	vol.7	PROPN
globalce-322	173	29	issue	issue	NOUN
globalce-322	173	30	3	3	NUM
globalce-322	173	31	:	:	SYM
globalce-322	173	32	2025	2025	NUM
globalce-322	173	33	58	58	NUM
globalce-322	173	34	conflicts	conflict	NOUN
globalce-322	173	35	of	of	ADP
globalce-322	173	36	interest	interest	NOUN
globalce-322	173	37	we	we	PRON
globalce-322	173	38	have	have	VERB
globalce-322	173	39	no	no	DET
globalce-322	173	40	conflicts	conflict	NOUN
globalce-322	173	41	of	of	ADP
globalce-322	173	42	interest	interest	NOUN
globalce-322	173	43	to	to	PART
globalce-322	173	44	disclose	disclose	VERB
globalce-322	173	45	.	.	PUNCT
globalce-322	174	1	ethics	ethic	NOUN
globalce-322	174	2	approval	approval	NOUN
globalce-322	174	3	and	and	CCONJ
globalce-322	174	4	consent	consent	NOUN
globalce-322	174	5	to	to	PART
globalce-322	174	6	participate	participate	VERB
globalce-322	174	7	not	not	PART
globalce-322	174	8	applicable	applicable	ADJ
globalce-322	174	9	.	.	PUNCT
globalce-322	175	1	consent	consent	NOUN
globalce-322	175	2	for	for	ADP
globalce-322	175	3	publication	publication	NOUN
globalce-322	175	4	not	not	PART
globalce-322	175	5	applicable	applicable	ADJ
globalce-322	175	6	.	.	PUNCT
globalce-322	176	1	further	further	ADJ
globalce-322	176	2	disclosure	disclosure	NOUN
globalce-322	176	3	not	not	PART
globalce-322	176	4	applicable	applicable	ADJ
globalce-322	176	5	.	.	PUNCT
globalce-322	177	1	references	reference	NOUN
globalce-322	177	2	1	1	NUM
globalce-322	177	3	.	.	PUNCT
globalce-322	177	4	press	press	NOUN
globalce-322	177	5	releases	release	NOUN
globalce-322	177	6	,	,	PUNCT
globalce-322	177	7	ministry	ministry	PROPN
globalce-322	177	8	of	of	ADP
globalce-322	177	9	health	health	PROPN
globalce-322	177	10	and	and	CCONJ
globalce-322	177	11	family	family	NOUN
globalce-322	177	12	welfare	welfare	NOUN
globalce-322	177	13	,	,	PUNCT
globalce-322	177	14	government	government	NOUN
globalce-322	177	15	of	of	ADP
globalce-322	177	16	india	india	PROPN
globalce-322	177	17	.	.	PUNCT
globalce-322	178	1	december	december	PROPN
globalce-322	178	2	19	19	NUM
globalce-322	178	3	,	,	PUNCT
globalce-322	178	4	2024	2024	NUM
globalce-322	178	5	.	.	PUNCT
globalce-322	178	6	available	available	ADJ
globalce-322	178	7	online	online	ADV
globalce-322	178	8	:	:	PUNCT
globalce-322	178	9	https://mohfw.gov.in/press-info/8078	https://mohfw.gov.in/press-info/8078	NOUN
globalce-322	178	10	.	.	NOUN
globalce-322	179	1	2	2	X
globalce-322	179	2	.	.	X
globalce-322	179	3	the	the	DET
globalce-322	179	4	medical	medical	ADJ
globalce-322	179	5	devices	device	NOUN
globalce-322	179	6	rules	rule	NOUN
globalce-322	179	7	,	,	PUNCT
globalce-322	179	8	2017	2017	NUM
globalce-322	179	9	.	.	PUNCT
globalce-322	180	1	available	available	ADJ
globalce-322	180	2	online	online	ADV
globalce-322	180	3	:	:	PUNCT
globalce-322	180	4	https://	https://	PROPN
globalce-322	180	5	cdsco.gov.in/opencms/opencms/system/modules/cdsco	cdsco.gov.in/opencms/opencms/system/modules/cdsco	PROPN
globalce-322	180	6	.	.	PUNCT
globalce-322	181	1	web	web	NOUN
globalce-322	181	2	/	/	SYM
globalce-322	181	3	elements	element	NOUN
globalce-322	181	4	/	/	SYM
globalce-322	181	5	download_file_division.jsp?num_id	download_file_division.jsp?num_id	PROPN
globalce-322	181	6	=	=	SYM
globalce-322	181	7	otg4nq	otg4nq	PROPN
globalce-322	181	8	.	.	NOUN
globalce-322	182	1	3	3	X
globalce-322	182	2	.	.	X
globalce-322	182	3	press	press	NOUN
globalce-322	182	4	releases	release	NOUN
globalce-322	182	5	,	,	PUNCT
globalce-322	182	6	central	central	ADJ
globalce-322	182	7	drugs	drug	NOUN
globalce-322	182	8	standard	standard	PROPN
globalce-322	182	9	control	control	PROPN
globalce-322	182	10	organization	organization	PROPN
globalce-322	182	11	under	under	ADP
globalce-322	182	12	ministry	ministry	PROPN
globalce-322	182	13	of	of	ADP
globalce-322	182	14	health	health	PROPN
globalce-322	182	15	&	&	CCONJ
globalce-322	182	16	family	family	PROPN
globalce-322	182	17	welfare	welfare	NOUN
globalce-322	182	18	,	,	PUNCT
globalce-322	182	19	india	india	PROPN
globalce-322	182	20	becomes	become	VERB
globalce-322	182	21	affiliate	affiliate	NOUN
globalce-322	182	22	member	member	NOUN
globalce-322	182	23	of	of	ADP
globalce-322	182	24	the	the	DET
globalce-322	182	25	international	international	ADJ
globalce-322	182	26	medical	medical	ADJ
globalce-322	182	27	device	device	NOUN
globalce-322	182	28	regulators	regulator	NOUN
globalce-322	182	29	forum	forum	PROPN
globalce-322	182	30	.	.	PUNCT
globalce-322	183	1	october	october	PROPN
globalce-322	183	2	03	03	NUM
globalce-322	183	3	,	,	PUNCT
globalce-322	183	4	2024	2024	NUM
globalce-322	183	5	.	.	PUNCT
globalce-322	184	1	available	available	ADJ
globalce-322	184	2	online	online	ADV
globalce-322	184	3	:	:	PUNCT
globalce-322	184	4	https://	https://	PROPN
globalce-322	184	5	pib.gov.in/pressreleasepage.aspx?prid=2061397	pib.gov.in/pressreleasepage.aspx?prid=2061397	PROPN
globalce-322	184	6	.	.	PROPN
globalce-322	185	1	4	4	NUM
globalce-322	185	2	.	.	X
globalce-322	185	3	india	india	PROPN
globalce-322	185	4	’s	’s	PART
globalce-322	185	5	cdsco	cdsco	PROPN
globalce-322	185	6	extends	extend	VERB
globalce-322	185	7	list	list	NOUN
globalce-322	185	8	of	of	ADP
globalce-322	185	9	notified	notify	VERB
globalce-322	185	10	devices	device	NOUN
globalce-322	185	11	.	.	PUNCT
globalce-322	186	1	january	january	PROPN
globalce-322	186	2	13	13	NUM
globalce-322	186	3	,	,	PUNCT
globalce-322	186	4	2021	2021	NUM
globalce-322	186	5	.	.	PUNCT
globalce-322	187	1	available	available	ADJ
globalce-322	187	2	online	online	ADV
globalce-322	187	3	:	:	PUNCT
globalce-322	187	4	https://asiaactual.com/blog/	https://asiaactual.com/blog/	PUNCT
globalce-322	187	5	indias	indias	PROPN
globalce-322	187	6	-	-	PUNCT
globalce-322	187	7	cdsco	cdsco	NOUN
globalce-322	187	8	-	-	PUNCT
globalce-322	187	9	extends	extend	NOUN
globalce-322	187	10	-	-	PUNCT
globalce-322	187	11	list	list	NOUN
globalce-322	187	12	-	-	PUNCT
globalce-322	187	13	of	of	ADP
globalce-322	187	14	-	-	PUNCT
globalce-322	187	15	notified	notify	VERB
globalce-322	187	16	-	-	PUNCT
globalce-322	187	17	devices/.	devices/.	NOUN
globalce-322	187	18	5	5	NUM
globalce-322	187	19	.	.	PUNCT
globalce-322	188	1	cdsco	cdsco	PROPN
globalce-322	188	2	launched	launch	VERB
globalce-322	188	3	national	national	ADJ
globalce-322	188	4	single	single	ADJ
globalce-322	188	5	window	window	NOUN
globalce-322	188	6	system	system	NOUN
globalce-322	188	7	(	(	PUNCT
globalce-322	188	8	nsws	nsws	ADJ
globalce-322	188	9	)	)	PUNCT
globalce-322	188	10	portal	portal	NOUN
globalce-322	188	11	.	.	PUNCT
globalce-322	189	1	january	january	PROPN
globalce-322	189	2	01	01	NUM
globalce-322	189	3	,	,	PUNCT
globalce-322	189	4	2024	2024	NUM
globalce-322	189	5	.	.	PUNCT
globalce-322	189	6	available	available	ADJ
globalce-322	189	7	online	online	ADV
globalce-322	189	8	:	:	PUNCT
globalce-322	190	1	https://www	https://www	PROPN
globalce-322	190	2	.	.	PUNCT
globalce-322	190	3	nsws.gov.in/.	nsws.gov.in/.	PROPN
globalce-322	190	4	6	6	NUM
globalce-322	190	5	.	.	PUNCT
globalce-322	190	6	guidance	guidance	NOUN
globalce-322	190	7	on	on	ADP
globalce-322	190	8	performance	performance	NOUN
globalce-322	190	9	evaluation	evaluation	NOUN
globalce-322	190	10	of	of	ADP
globalce-322	190	11	in	in	ADP
globalce-322	190	12	-	-	PUNCT
globalce-322	190	13	vitro	vitro	X
globalce-322	190	14	diagnostic	diagnostic	ADJ
globalce-322	190	15	medical	medical	ADJ
globalce-322	190	16	devices	device	NOUN
globalce-322	190	17	.	.	PUNCT
globalce-322	191	1	august	august	PROPN
globalce-322	191	2	7	7	NUM
globalce-322	191	3	,	,	PUNCT
globalce-322	191	4	2018	2018	NUM
globalce-322	191	5	.	.	PUNCT
globalce-322	192	1	available	available	ADJ
globalce-322	192	2	online	online	ADV
globalce-322	192	3	:	:	PUNCT
globalce-322	192	4	https://	https://	PROPN
globalce-322	192	5	cdsco.gov.in/opencms/export/sites/cdsco_web/pdfdocuments/medical-device/guidanceperformanceivd.pdf	cdsco.gov.in/opencms/export/sites/cdsco_web/pdfdocuments/medical-device/guidanceperformanceivd.pdf	NOUN
globalce-322	192	6	.	.	PUNCT
globalce-322	193	1	7	7	X
globalce-322	193	2	.	.	NUM
globalce-322	193	3	ivdr	ivdr	ADJ
globalce-322	193	4	performance	performance	NOUN
globalce-322	193	5	evaluation	evaluation	NOUN
globalce-322	193	6	(	(	PUNCT
globalce-322	193	7	2019–2024	2019–2024	NUM
globalce-322	193	8	)	)	PUNCT
globalce-322	193	9	.	.	PUNCT
globalce-322	194	1	available	available	ADJ
globalce-322	194	2	online	online	ADV
globalce-322	194	3	:	:	PUNCT
globalce-322	194	4	https://www.thinqbetter.com/ivdr-performance-evaluation	https://www.thinqbetter.com/ivdr-performance-evaluation	NOUN
globalce-322	194	5	8	8	X
globalce-322	194	6	.	.	PUNCT
globalce-322	195	1	clinical	clinical	ADJ
globalce-322	195	2	performance	performance	NOUN
globalce-322	195	3	definition	definition	NOUN
globalce-322	195	4	ivdr	ivdr	VERB
globalce-322	195	5	,	,	PUNCT
globalce-322	195	6	celegence	celegence	NOUN
globalce-322	195	7	.	.	PUNCT
globalce-322	196	1	april	april	PROPN
globalce-322	196	2	6	6	NUM
globalce-322	196	3	,	,	PUNCT
globalce-322	196	4	2022	2022	NUM
globalce-322	196	5	.	.	PUNCT
globalce-322	196	6	available	available	ADJ
globalce-322	196	7	online	online	ADV
globalce-322	196	8	:	:	PUNCT
globalce-322	197	1	https://www.celegence.com/	https://www.celegence.com/	NOUN
globalce-322	197	2	clinical	clinical	ADJ
globalce-322	197	3	-	-	PUNCT
globalce-322	197	4	performance	performance	NOUN
globalce-322	197	5	-	-	PUNCT
globalce-322	197	6	ivdr	ivdr	VERB
globalce-322	197	7	/	/	SYM
globalce-322	197	8	jj	jj	PROPN
globalce-322	197	9	.	.	PROPN
globalce-322	197	10	and	and	CCONJ
globalce-322	197	11	safety	safety	NOUN
globalce-322	197	12	.	.	PUNCT
globalce-322	198	1	on	on	ADP
globalce-322	198	2	the	the	DET
globalce-322	198	3	other	other	ADJ
globalce-322	198	4	end	end	NOUN
globalce-322	198	5	,	,	PUNCT
globalce-322	198	6	the	the	DET
globalce-322	198	7	regulatory	regulatory	ADJ
globalce-322	198	8	compliances	compliance	NOUN
globalce-322	198	9	in	in	ADP
globalce-322	198	10	accordance	accordance	NOUN
globalce-322	198	11	of	of	ADP
globalce-322	198	12	risk	risk	NOUN
globalce-322	198	13	-	-	PUNCT
globalce-322	198	14	based	base	VERB
globalce-322	198	15	classification	classification	NOUN
globalce-322	198	16	of	of	ADP
globalce-322	198	17	md	md	PROPN
globalce-322	198	18	/	/	SYM
globalce-322	198	19	ivd	ivd	PROPN
globalce-322	198	20	vary	vary	NOUN
globalce-322	198	21	.	.	PUNCT
globalce-322	199	1	however	however	ADV
globalce-322	199	2	,	,	PUNCT
globalce-322	199	3	test	test	NOUN
globalce-322	199	4	license	license	NOUN
globalce-322	199	5	is	be	AUX
globalce-322	199	6	an	an	DET
globalce-322	199	7	important	important	ADJ
globalce-322	199	8	principal	principal	ADJ
globalce-322	199	9	requirement	requirement	NOUN
globalce-322	199	10	to	to	PART
globalce-322	199	11	get	get	VERB
globalce-322	199	12	the	the	DET
globalce-322	199	13	necessary	necessary	ADJ
globalce-322	199	14	approval	approval	NOUN
globalce-322	199	15	for	for	ADP
globalce-322	199	16	manufacture/	manufacture/	NUM
globalce-322	199	17	import	import	NOUN
globalce-322	199	18	of	of	ADP
globalce-322	199	19	a	a	DET
globalce-322	199	20	small	small	ADJ
globalce-322	199	21	quantity	quantity	NOUN
globalce-322	199	22	of	of	ADP
globalce-322	199	23	md	md	PROPN
globalce-322	199	24	/	/	SYM
globalce-322	199	25	ivd	ivd	PROPN
globalce-322	199	26	for	for	ADP
globalce-322	199	27	the	the	DET
globalce-322	199	28	purpose	purpose	NOUN
globalce-322	199	29	of	of	ADP
globalce-322	199	30	clinical	clinical	ADJ
globalce-322	199	31	investigation	investigation	NOUN
globalce-322	199	32	,	,	PUNCT
globalce-322	199	33	testing	testing	NOUN
globalce-322	199	34	,	,	PUNCT
globalce-322	199	35	evaluation	evaluation	NOUN
globalce-322	199	36	,	,	PUNCT
globalce-322	199	37	examination	examination	NOUN
globalce-322	199	38	,	,	PUNCT
globalce-322	199	39	demonstration	demonstration	NOUN
globalce-322	199	40	,	,	PUNCT
globalce-322	199	41	or	or	CCONJ
globalce-322	199	42	training	training	NOUN
globalce-322	199	43	.	.	PUNCT
globalce-322	200	1	the	the	DET
globalce-322	200	2	process	process	NOUN
globalce-322	200	3	of	of	ADP
globalce-322	200	4	obtaining	obtain	VERB
globalce-322	200	5	test	test	NOUN
globalce-322	200	6	license	license	NOUN
globalce-322	200	7	under	under	ADP
globalce-322	200	8	the	the	DET
globalce-322	200	9	mdr-2017	mdr-2017	NOUN
globalce-322	200	10	in	in	ADP
globalce-322	200	11	india	india	PROPN
globalce-322	200	12	via	via	ADP
globalce-322	200	13	the	the	DET
globalce-322	200	14	nsws	nsws	ADJ
globalce-322	200	15	portal	portal	NOUN
globalce-322	200	16	involves	involve	VERB
globalce-322	200	17	navigating	navigate	VERB
globalce-322	200	18	complex	complex	ADJ
globalce-322	200	19	regulations	regulation	NOUN
globalce-322	200	20	and	and	CCONJ
globalce-322	200	21	ensuring	ensure	VERB
globalce-322	200	22	compliance	compliance	NOUN
globalce-322	200	23	with	with	ADP
globalce-322	200	24	testing	testing	NOUN
globalce-322	200	25	standards	standard	NOUN
globalce-322	200	26	.	.	PUNCT
globalce-322	201	1	the	the	DET
globalce-322	201	2	objective	objective	NOUN
globalce-322	201	3	of	of	ADP
globalce-322	201	4	the	the	DET
globalce-322	201	5	current	current	ADJ
globalce-322	201	6	study	study	NOUN
globalce-322	201	7	is	be	AUX
globalce-322	201	8	to	to	PART
globalce-322	201	9	provide	provide	VERB
globalce-322	201	10	a	a	DET
globalce-322	201	11	significant	significant	ADJ
globalce-322	201	12	overview	overview	NOUN
globalce-322	201	13	of	of	ADP
globalce-322	201	14	the	the	DET
globalce-322	201	15	regulatory	regulatory	ADJ
globalce-322	201	16	framework	framework	NOUN
globalce-322	201	17	that	that	PRON
globalce-322	201	18	brings	bring	VERB
globalce-322	201	19	test	test	NOUN
globalce-322	201	20	license	license	NOUN
globalce-322	201	21	approval	approval	NOUN
globalce-322	201	22	of	of	ADP
globalce-322	201	23	the	the	DET
globalce-322	201	24	md	md	PROPN
globalce-322	201	25	in	in	ADP
globalce-322	201	26	india	india	PROPN
globalce-322	201	27	.	.	PUNCT
globalce-322	202	1	these	these	DET
globalce-322	202	2	approvals	approval	NOUN
globalce-322	202	3	facilitate	facilitate	VERB
globalce-322	202	4	ease	ease	NOUN
globalce-322	202	5	of	of	ADP
globalce-322	202	6	doing	do	VERB
globalce-322	202	7	business	business	NOUN
globalce-322	202	8	,	,	PUNCT
globalce-322	202	9	remove	remove	VERB
globalce-322	202	10	regulatory	regulatory	ADJ
globalce-322	202	11	bottlenecks	bottleneck	NOUN
globalce-322	202	12	to	to	PART
globalce-322	202	13	make	make	VERB
globalce-322	202	14	in	in	ADP
globalce-322	202	15	india	india	PROPN
globalce-322	202	16	,	,	PUNCT
globalce-322	202	17	while	while	SCONJ
globalce-322	202	18	ensuring	ensure	VERB
globalce-322	202	19	availability	availability	NOUN
globalce-322	202	20	of	of	ADP
globalce-322	202	21	better	well	ADJ
globalce-322	202	22	md	md	NOUN
globalce-322	202	23	for	for	ADP
globalce-322	202	24	patient	patient	ADJ
globalce-322	202	25	care	care	NOUN
globalce-322	202	26	and	and	CCONJ
globalce-322	202	27	safety	safety	NOUN
globalce-322	202	28	.	.	PUNCT
globalce-322	203	1	conversely	conversely	ADV
globalce-322	203	2	,	,	PUNCT
globalce-322	203	3	there	there	PRON
globalce-322	203	4	are	be	VERB
globalce-322	203	5	certain	certain	ADJ
globalce-322	203	6	challenges	challenge	NOUN
globalce-322	203	7	that	that	PRON
globalce-322	203	8	significantly	significantly	ADV
globalce-322	203	9	present	present	ADJ
globalce-322	203	10	opportunities	opportunity	NOUN
globalce-322	203	11	for	for	ADP
globalce-322	203	12	improvement	improvement	NOUN
globalce-322	203	13	in	in	ADP
globalce-322	203	14	regulatory	regulatory	ADJ
globalce-322	203	15	frameworks	framework	NOUN
globalce-322	203	16	and	and	CCONJ
globalce-322	203	17	quality	quality	NOUN
globalce-322	203	18	standards	standard	NOUN
globalce-322	203	19	,	,	PUNCT
globalce-322	203	20	potentially	potentially	ADV
globalce-322	203	21	leading	lead	VERB
globalce-322	203	22	to	to	ADP
globalce-322	203	23	a	a	DET
globalce-322	203	24	more	more	ADV
globalce-322	203	25	robust	robust	ADJ
globalce-322	203	26	medical	medical	ADJ
globalce-322	203	27	device	device	NOUN
globalce-322	203	28	market	market	NOUN
globalce-322	203	29	in	in	ADP
globalce-322	203	30	india	india	PROPN
globalce-322	203	31	.	.	PUNCT
globalce-322	204	1	these	these	DET
globalce-322	204	2	insights	insight	NOUN
globalce-322	204	3	may	may	AUX
globalce-322	204	4	be	be	AUX
globalce-322	204	5	relevant	relevant	ADJ
globalce-322	204	6	when	when	SCONJ
globalce-322	204	7	considering	consider	VERB
globalce-322	204	8	the	the	DET
globalce-322	204	9	broader	broad	ADJ
globalce-322	204	10	context	context	NOUN
globalce-322	204	11	of	of	ADP
globalce-322	204	12	md	md	PROPN
globalce-322	204	13	/	/	SYM
globalce-322	204	14	ivd	ivd	PROPN
globalce-322	204	15	testing	testing	NOUN
globalce-322	204	16	and	and	CCONJ
globalce-322	204	17	licensing	licensing	NOUN
globalce-322	204	18	under	under	ADP
globalce-322	204	19	mdr-2017	mdr-2017	NOUN
globalce-322	204	20	.	.	PUNCT
globalce-322	205	1	author	author	NOUN
globalce-322	205	2	contributions	contribution	NOUN
globalce-322	205	3	conceptualization	conceptualization	NOUN
globalce-322	205	4	and	and	CCONJ
globalce-322	205	5	writing	writing	NOUN
globalce-322	205	6	–	–	PUNCT
globalce-322	205	7	review	review	NOUN
globalce-322	205	8	&	&	CCONJ
globalce-322	205	9	editing	editing	PROPN
globalce-322	205	10	,	,	PUNCT
globalce-322	205	11	r.k	r.k	PROPN
globalce-322	205	12	.	.	PROPN
globalce-322	205	13	;	;	PUNCT
globalce-322	205	14	methodology	methodology	NOUN
globalce-322	205	15	,	,	PUNCT
globalce-322	205	16	d.k.g	d.k.g	ADV
globalce-322	205	17	.	.	PUNCT
globalce-322	205	18	;	;	PUNCT
globalce-322	205	19	visualization	visualization	NOUN
globalce-322	205	20	,	,	PUNCT
globalce-322	205	21	j.b	j.b	PROPN
globalce-322	205	22	.	.	PROPN
globalce-322	205	23	;	;	PUNCT
globalce-322	205	24	resources	resource	NOUN
globalce-322	205	25	,	,	PUNCT
globalce-322	205	26	a.s	a.s	PROPN
globalce-322	205	27	.	.	PROPN
globalce-322	205	28	;	;	PUNCT
globalce-322	205	29	supervision	supervision	NOUN
globalce-322	205	30	,	,	PUNCT
globalce-322	205	31	s.m	s.m	PROPN
globalce-322	205	32	.	.	PROPN
globalce-322	205	33	acknowledgments	acknowledgment	NOUN
globalce-322	206	1	i	i	PRON
globalce-322	206	2	greatly	greatly	ADV
globalce-322	206	3	acknowledge	acknowledge	VERB
globalce-322	206	4	icmr	icmr	ADJ
globalce-322	206	5	for	for	ADP
globalce-322	206	6	providing	provide	VERB
globalce-322	206	7	the	the	DET
globalce-322	206	8	necessary	necessary	ADJ
globalce-322	206	9	infrastructure	infrastructure	NOUN
globalce-322	206	10	,	,	PUNCT
globalce-322	206	11	computing	compute	VERB
globalce-322	206	12	resources	resource	NOUN
globalce-322	206	13	,	,	PUNCT
globalce-322	206	14	study	study	NOUN
globalce-322	206	15	materials	material	NOUN
globalce-322	206	16	,	,	PUNCT
globalce-322	206	17	circulars	circular	NOUN
globalce-322	206	18	,	,	PUNCT
globalce-322	206	19	and	and	CCONJ
globalce-322	206	20	documents	document	NOUN
globalce-322	206	21	to	to	PART
globalce-322	206	22	prepare	prepare	VERB
globalce-322	206	23	the	the	DET
globalce-322	206	24	manuscript	manuscript	NOUN
globalce-322	206	25	.	.	PUNCT
globalce-322	207	1	funding	fund	VERB
globalce-322	207	2	this	this	DET
globalce-322	207	3	study	study	NOUN
globalce-322	207	4	received	receive	VERB
globalce-322	207	5	no	no	DET
globalce-322	207	6	funding	funding	NOUN
globalce-322	207	7	.	.	PUNCT
globalce-322	208	1	data	datum	NOUN
globalce-322	208	2	availability	availability	NOUN
globalce-322	208	3	statement	statement	NOUN
globalce-322	208	4	not	not	PART
globalce-322	208	5	applicable	applicable	ADJ
globalce-322	208	6	.	.	PUNCT
globalce-322	209	1	https://mohfw.gov.in/press-info/8078	https://mohfw.gov.in/press-info/8078	PROPN
globalce-322	209	2	https://cdsco.gov.in/opencms/opencms/system/modules/cdsco.web/elements/download_file_division.jsp?num_id=otg4nq	https://cdsco.gov.in/opencms/opencms/system/modules/cdsco.web/elements/download_file_division.jsp?num_id=otg4nq	PROPN
globalce-322	209	3	https://cdsco.gov.in/opencms/opencms/system/modules/cdsco.web/elements/download_file_division.jsp?num_id=otg4nq	https://cdsco.gov.in/opencms/opencms/system/modules/cdsco.web/elements/download_file_division.jsp?num_id=otg4nq	SYM
globalce-322	209	4	https://cdsco.gov.in/opencms/opencms/system/modules/cdsco.web/elements/download_file_division.jsp?num_id=otg4nq	https://cdsco.gov.in/opencms/opencms/system/modules/cdsco.web/elements/download_file_division.jsp?num_id=otg4nq	PROPN
globalce-322	209	5	https://pib.gov.in/pressreleasepage.aspx?prid=2061397	https://pib.gov.in/pressreleasepage.aspx?prid=2061397	NOUN
globalce-322	209	6	https://pib.gov.in/pressreleasepage.aspx?prid=2061397	https://pib.gov.in/pressreleasepage.aspx?prid=2061397	PROPN
globalce-322	209	7	https://asiaactual.com/blog/indias-cdsco-extends-list-of-notified-devices/	https://asiaactual.com/blog/indias-cdsco-extends-list-of-notified-devices/	NOUN
globalce-322	209	8	https://asiaactual.com/blog/indias-cdsco-extends-list-of-notified-devices/	https://asiaactual.com/blog/indias-cdsco-extends-list-of-notified-devices/	ADJ
globalce-322	209	9	https://www.nsws.gov.in/	https://www.nsws.gov.in/	NOUN
globalce-322	209	10	https://www.nsws.gov.in/	https://www.nsws.gov.in/	NOUN
globalce-322	209	11	https://cdsco.gov.in/opencms/export/sites/cdsco_web/pdf-documents/medical-device/guidanceperformanceivd.pdf	https://cdsco.gov.in/opencms/export/sites/cdsco_web/pdf-documents/medical-device/guidanceperformanceivd.pdf	PROPN
globalce-322	209	12	https://cdsco.gov.in/opencms/export/sites/cdsco_web/pdf-documents/medical-device/guidanceperformanceivd.pdf	https://cdsco.gov.in/opencms/export/sites/cdsco_web/pdf-documents/medical-device/guidanceperformanceivd.pdf	PROPN
globalce-322	209	13	https://cdsco.gov.in/opencms/export/sites/cdsco_web/pdf-documents/medical-device/guidanceperformanceivd.pdf	https://cdsco.gov.in/opencms/export/sites/cdsco_web/pdf-documents/medical-device/guidanceperformanceivd.pdf	PROPN
globalce-322	209	14	https://www.celegence.com/clinical-performance-ivdr/jj	https://www.celegence.com/clinical-performance-ivdr/jj	NOUN
globalce-322	209	15	https://www.celegence.com/clinical-performance-ivdr/jj	https://www.celegence.com/clinical-performance-ivdr/jj	NOUN
globalce-322	209	16	59	59	NUM
globalce-322	210	1	j	j	PROPN
globalce-322	210	2	global	global	ADJ
globalce-322	210	3	clinical	clinical	ADJ
globalce-322	210	4	engineering	engineering	NOUN
globalce-322	210	5	vol.7	vol.7	PROPN
globalce-322	210	6	issue	issue	NOUN
globalce-322	210	7	3	3	NUM
globalce-322	210	8	:	:	SYM
globalce-322	210	9	2025	2025	NUM
globalce-322	210	10	kumar	kumar	PROPN
globalce-322	210	11	,	,	PUNCT
globalce-322	210	12	gupta	gupta	PROPN
globalce-322	210	13	,	,	PUNCT
globalce-322	210	14	batra	batra	PROPN
globalce-322	210	15	,	,	PUNCT
globalce-322	210	16	sahu	sahu	PROPN
globalce-322	210	17	and	and	CCONJ
globalce-322	210	18	markan	markan	PROPN
globalce-322	210	19	:	:	PUNCT
globalce-322	210	20	catchment	catchment	NOUN
globalce-322	210	21	of	of	ADP
globalce-322	210	22	the	the	DET
globalce-322	210	23	test	test	NOUN
globalce-322	210	24	license	license	NOUN
globalce-322	210	25	for	for	ADP
globalce-322	210	26	the	the	DET
globalce-322	210	27	regulation	regulation	NOUN
globalce-322	210	28	of	of	ADP
globalce-322	210	29	medical	medical	ADJ
globalce-322	210	30	devices	device	NOUN
globalce-322	210	31	in	in	ADP
globalce-322	210	32	india	india	PROPN
globalce-322	210	33	9	9	NUM
globalce-322	210	34	.	.	PUNCT
globalce-322	211	1	clinical	clinical	ADJ
globalce-322	211	2	investigation	investigation	NOUN
globalce-322	211	3	and	and	CCONJ
globalce-322	211	4	clinical	clinical	ADJ
globalce-322	211	5	evaluation	evaluation	NOUN
globalce-322	211	6	of	of	ADP
globalce-322	211	7	medical	medical	ADJ
globalce-322	211	8	devices	device	NOUN
globalce-322	211	9	.	.	PUNCT
globalce-322	212	1	may	may	AUX
globalce-322	212	2	10	10	NUM
globalce-322	212	3	,	,	PUNCT
globalce-322	212	4	2022	2022	NUM
globalce-322	212	5	.	.	PUNCT
globalce-322	213	1	available	available	ADJ
globalce-322	213	2	online	online	ADV
globalce-322	213	3	:	:	PUNCT
globalce-322	213	4	https://medicaldevicehq	https://medicaldevicehq	X
globalce-322	213	5	.	.	X
globalce-322	213	6	com	com	NOUN
globalce-322	213	7	/	/	SYM
globalce-322	213	8	articles	article	NOUN
globalce-322	213	9	/	/	SYM
globalce-322	213	10	clinical	clinical	NOUN
globalce-322	213	11	-	-	PUNCT
globalce-322	213	12	investigation	investigation	NOUN
globalce-322	213	13	-	-	PUNCT
globalce-322	213	14	and	and	CCONJ
globalce-322	213	15	-	-	PUNCT
globalce-322	213	16	clinical	clinical	NOUN
globalce-322	213	17	-	-	PUNCT
globalce-322	213	18	evaluation/.	evaluation/.	NOUN
globalce-322	213	19	10	10	NUM
globalce-322	213	20	.	.	PUNCT
globalce-322	214	1	regulatory	regulatory	ADJ
globalce-322	214	2	pathway	pathway	NOUN
globalce-322	214	3	to	to	PART
globalce-322	214	4	be	be	AUX
globalce-322	214	5	followed	follow	VERB
globalce-322	214	6	for	for	ADP
globalce-322	214	7	the	the	DET
globalce-322	214	8	medical	medical	ADJ
globalce-322	214	9	device	device	NOUN
globalce-322	214	10	from	from	ADP
globalce-322	214	11	its	its	PRON
globalce-322	214	12	development	development	NOUN
globalce-322	214	13	to	to	ADP
globalce-322	214	14	commercialization	commercialization	NOUN
globalce-322	214	15	under	under	ADP
globalce-322	214	16	medical	medical	ADJ
globalce-322	214	17	devices	device	NOUN
globalce-322	214	18	rules	rule	NOUN
globalce-322	214	19	,	,	PUNCT
globalce-322	214	20	2017	2017	NUM
globalce-322	214	21	.	.	PUNCT
globalce-322	215	1	available	available	ADJ
globalce-322	215	2	online	online	ADV
globalce-322	215	3	:	:	PUNCT
globalce-322	216	1	https://cdsco.gov	https://cdsco.gov	NUM
globalce-322	216	2	.	.	PUNCT
globalce-322	217	1	in	in	ADP
globalce-322	217	2	/	/	SYM
globalce-322	217	3	opencms	opencms	NOUN
globalce-322	217	4	/	/	SYM
globalce-322	217	5	export	export	NOUN
globalce-322	217	6	/	/	SYM
globalce-322	217	7	sites	site	NOUN
globalce-322	217	8	/	/	SYM
globalce-322	217	9	cdsco_web	cdsco_web	NUM
globalce-322	217	10	/	/	SYM
globalce-322	217	11	pdf	pdf	NOUN
globalce-322	217	12	-	-	PUNCT
globalce-322	217	13	documents/	documents/	NOUN
globalce-322	217	14	md123.pdf	md123.pdf	NOUN
globalce-322	217	15	.	.	PUNCT
globalce-322	217	16	11	11	NUM
globalce-322	217	17	.	.	X
globalce-322	218	1	ministry	ministry	PROPN
globalce-322	218	2	of	of	ADP
globalce-322	218	3	health	health	PROPN
globalce-322	218	4	and	and	CCONJ
globalce-322	218	5	family	family	NOUN
globalce-322	218	6	welfare	welfare	NOUN
globalce-322	218	7	(	(	PUNCT
globalce-322	218	8	department	department	NOUN
globalce-322	218	9	of	of	ADP
globalce-322	218	10	health	health	NOUN
globalce-322	218	11	and	and	CCONJ
globalce-322	218	12	family	family	NOUN
globalce-322	218	13	welfare	welfare	NOUN
globalce-322	218	14	)	)	PUNCT
globalce-322	218	15	.	.	PUNCT
globalce-322	219	1	notification	notification	NOUN
globalce-322	219	2	,	,	PUNCT
globalce-322	219	3	g.s.r	g.s.r	NOUN
globalce-322	219	4	.	.	PROPN
globalce-322	219	5	102	102	NUM
globalce-322	219	6	(	(	PUNCT
globalce-322	219	7	e	e	NOUN
globalce-322	219	8	)	)	PUNCT
globalce-322	219	9	dated	date	VERB
globalce-322	219	10	11th	11th	ADJ
globalce-322	219	11	february	february	NOUN
globalce-322	219	12	,	,	PUNCT
globalce-322	219	13	2020	2020	NUM
globalce-322	219	14	.	.	PUNCT
globalce-322	220	1	available	available	ADJ
globalce-322	220	2	online	online	ADV
globalce-322	220	3	:	:	PUNCT
globalce-322	220	4	https://cdsco	https://cdsco	PROPN
globalce-322	220	5	.	.	PROPN
globalce-322	220	6	gov.in/opencms/resources/uploadcdscoweb/2018/uploadgazette_notificationsfiles/gsr102eregistration%20	gov.in/opencms/resources/uploadcdscoweb/2018/uploadgazette_notificationsfiles/gsr102eregistration%20	PROPN
globalce-322	220	7	of%20certain%20medical%20devices.pdf	of%20certain%20medical%20devices.pdf	PROPN
globalce-322	220	8	.	.	PUNCT
globalce-322	221	1	12	12	NUM
globalce-322	221	2	.	.	PUNCT
globalce-322	222	1	online	online	ADJ
globalce-322	222	2	system	system	NOUN
globalce-322	222	3	for	for	ADP
globalce-322	222	4	medical	medical	ADJ
globalce-322	222	5	devices	device	NOUN
globalce-322	222	6	.	.	PUNCT
globalce-322	223	1	available	available	ADJ
globalce-322	223	2	online	online	ADV
globalce-322	223	3	:	:	PUNCT
globalce-322	223	4	https://	https://	PROPN
globalce-322	223	5	cdscomdonline.gov.in/newmeddev/homepage	cdscomdonline.gov.in/newmeddev/homepage	PROPN
globalce-322	223	6	.	.	PUNCT
globalce-322	224	1	https://medicaldevicehq.com/articles/clinical-investigation-and-clinical-evaluation/	https://medicaldevicehq.com/articles/clinical-investigation-and-clinical-evaluation/	PROPN
globalce-322	224	2	https://medicaldevicehq.com/articles/clinical-investigation-and-clinical-evaluation/	https://medicaldevicehq.com/articles/clinical-investigation-and-clinical-evaluation/	PROPN
globalce-322	225	1	https://cdsco.gov.in/opencms/export/sites/cdsco_web/pdf-documents/md123.pdf	https://cdsco.gov.in/opencms/export/sites/cdsco_web/pdf-documents/md123.pdf	PROPN
globalce-322	225	2	https://cdsco.gov.in/opencms/export/sites/cdsco_web/pdf-documents/md123.pdf	https://cdsco.gov.in/opencms/export/sites/cdsco_web/pdf-documents/md123.pdf	PROPN
globalce-322	225	3	https://cdsco.gov.in/opencms/export/sites/cdsco_web/pdf-documents/md123.pdf	https://cdsco.gov.in/opencms/export/sites/cdsco_web/pdf-documents/md123.pdf	PROPN
globalce-322	225	4	https://cdsco.gov.in/opencms/resources/uploadcdscoweb/2018/uploadgazette_notificationsfiles/gsr102eregistration%20of%20certain%20medical%20devices.pdf	https://cdsco.gov.in/opencms/resources/uploadcdscoweb/2018/uploadgazette_notificationsfiles/gsr102eregistration%20of%20certain%20medical%20devices.pdf	PROPN
globalce-322	225	5	https://cdsco.gov.in/opencms/resources/uploadcdscoweb/2018/uploadgazette_notificationsfiles/gsr102eregistration%20of%20certain%20medical%20devices.pdf	https://cdsco.gov.in/opencms/resources/uploadcdscoweb/2018/uploadgazette_notificationsfiles/gsr102eregistration%20of%20certain%20medical%20devices.pdf	PROPN
globalce-322	225	6	https://cdsco.gov.in/opencms/resources/uploadcdscoweb/2018/uploadgazette_notificationsfiles/gsr102eregistration%20of%20certain%20medical%20devices.pdf	https://cdsco.gov.in/opencms/resources/uploadcdscoweb/2018/uploadgazette_notificationsfiles/gsr102eregistration%20of%20certain%20medical%20devices.pdf	X
globalce-322	225	7	https://cdsco.gov.in/opencms/resources/uploadcdscoweb/2018/uploadgazette_notificationsfiles/gsr102eregistration%20of%20certain%20medical%20devices.pdf	https://cdsco.gov.in/opencms/resources/uploadcdscoweb/2018/uploadgazette_notificationsfiles/gsr102eregistration%20of%20certain%20medical%20devices.pdf	X
globalce-322	225	8	https://cdscomdonline.gov.in/newmeddev/homepage	https://cdscomdonline.gov.in/newmeddev/homepage	NUM
globalce-322	225	9	https://cdscomdonline.gov.in/newmeddev/homepage	https://cdscomdonline.gov.in/newmeddev/homepage	X