id	sid	tid	token	lemma	pos
ajlm-123	1	1	article	article	PROPN
ajlm-123	1	2	information	information	NOUN
ajlm-123	1	3	authors	author	NOUN
ajlm-123	1	4	:	:	PUNCT
ajlm-123	1	5	ruth	ruth	PROPN
ajlm-123	1	6	mcnerney1	mcnerney1	NOUN
ajlm-123	1	7	kimberly	kimberly	PROPN
ajlm-123	1	8	sollis1	sollis1	PROPN
ajlm-123	1	9	rosanna	rosanna	PROPN
ajlm-123	1	10	w.	w.	PROPN
ajlm-123	1	11	peeling1	peeling1	PROPN
ajlm-123	1	12	affiliations	affiliation	NOUN
ajlm-123	1	13	:	:	PUNCT
ajlm-123	1	14	1london	1london	NUM
ajlm-123	1	15	school	school	NOUN
ajlm-123	1	16	of	of	ADP
ajlm-123	1	17	hygiene	hygiene	NOUN
ajlm-123	1	18	&	&	CCONJ
ajlm-123	1	19	tropical	tropical	ADJ
ajlm-123	1	20	medicine	medicine	NOUN
ajlm-123	1	21	,	,	PUNCT
ajlm-123	1	22	united	united	ADJ
ajlm-123	1	23	kingdom	kingdom	PROPN
ajlm-123	1	24	correspondence	correspondence	NOUN
ajlm-123	1	25	to	to	ADP
ajlm-123	1	26	:	:	PUNCT
ajlm-123	1	27	ruth	ruth	PROPN
ajlm-123	1	28	mcnerney	mcnerney	PROPN
ajlm-123	1	29	postal	postal	ADJ
ajlm-123	1	30	address	address	PROPN
ajlm-123	1	31	:	:	PUNCT
ajlm-123	1	32	london	london	PROPN
ajlm-123	1	33	school	school	NOUN
ajlm-123	1	34	of	of	ADP
ajlm-123	1	35	hygiene	hygiene	PROPN
ajlm-123	1	36	&	&	CCONJ
ajlm-123	1	37	tropical	tropical	ADJ
ajlm-123	1	38	medicine	medicine	NOUN
ajlm-123	1	39	,	,	PUNCT
ajlm-123	1	40	keppel	keppel	PROPN
ajlm-123	1	41	street	street	PROPN
ajlm-123	1	42	,	,	PUNCT
ajlm-123	1	43	london	london	PROPN
ajlm-123	1	44	wc1e	wc1e	PROPN
ajlm-123	1	45	7ht	7ht	NOUN
ajlm-123	1	46	,	,	PUNCT
ajlm-123	1	47	united	united	ADJ
ajlm-123	1	48	kingdom	kingdom	PROPN
ajlm-123	1	49	dates	date	NOUN
ajlm-123	1	50	:	:	PUNCT
ajlm-123	1	51	received	receive	VERB
ajlm-123	1	52	:	:	PUNCT
ajlm-123	1	53	25	25	NUM
ajlm-123	1	54	june	june	PROPN
ajlm-123	1	55	2013	2013	NUM
ajlm-123	1	56	accepted	accept	VERB
ajlm-123	1	57	:	:	PUNCT
ajlm-123	1	58	15	15	NUM
ajlm-123	1	59	nov	nov	NOUN
ajlm-123	1	60	.	.	PROPN
ajlm-123	1	61	2013	2013	NUM
ajlm-123	1	62	published	publish	VERB
ajlm-123	1	63	:	:	PUNCT
ajlm-123	1	64	04	04	NUM
ajlm-123	1	65	apr	apr	NOUN
ajlm-123	1	66	.	.	PUNCT
ajlm-123	1	67	2014	2014	NUM
ajlm-123	2	1	how	how	SCONJ
ajlm-123	2	2	to	to	PART
ajlm-123	2	3	cite	cite	VERB
ajlm-123	2	4	this	this	DET
ajlm-123	2	5	article	article	NOUN
ajlm-123	2	6	:	:	PUNCT
ajlm-123	2	7	mcnerney	mcnerney	PROPN
ajlm-123	2	8	r	r	PROPN
ajlm-123	2	9	,	,	PUNCT
ajlm-123	2	10	sollis	solli	VERB
ajlm-123	2	11	k	k	NOUN
ajlm-123	2	12	,	,	PUNCT
ajlm-123	2	13	peeling	peel	VERB
ajlm-123	2	14	rw	rw	NOUN
ajlm-123	2	15	.	.	PUNCT
ajlm-123	3	1	improving	improve	VERB
ajlm-123	3	2	access	access	NOUN
ajlm-123	3	3	to	to	ADP
ajlm-123	3	4	new	new	ADJ
ajlm-123	3	5	diagnostics	diagnostic	NOUN
ajlm-123	3	6	through	through	ADP
ajlm-123	3	7	harmonised	harmonise	VERB
ajlm-123	3	8	regulation	regulation	NOUN
ajlm-123	3	9	:	:	PUNCT
ajlm-123	3	10	priorities	priority	NOUN
ajlm-123	3	11	for	for	ADP
ajlm-123	3	12	action	action	NOUN
ajlm-123	3	13	.	.	PUNCT
ajlm-123	4	1	afr	afr	PROPN
ajlm-123	4	2	j	j	PROPN
ajlm-123	4	3	lab	lab	PROPN
ajlm-123	4	4	med	med	PROPN
ajlm-123	4	5	.	.	PUNCT
ajlm-123	4	6	2014;3(1	2014;3(1	NUM
ajlm-123	4	7	)	)	PUNCT
ajlm-123	4	8	,	,	PUNCT
ajlm-123	4	9	art	art	NOUN
ajlm-123	4	10	.	.	PUNCT
ajlm-123	5	1	#	#	SYM
ajlm-123	5	2	123	123	NUM
ajlm-123	5	3	,	,	PUNCT
ajlm-123	5	4	7	7	NUM
ajlm-123	5	5	pages	page	NOUN
ajlm-123	5	6	.	.	PUNCT
ajlm-123	6	1	http://dx.doi.org/10.4102/	http://dx.doi.org/10.4102/	NUM
ajlm-123	6	2	ajlm.v3i1.123	ajlm.v3i1.123	PROPN
ajlm-123	6	3	copyright	copyright	NOUN
ajlm-123	6	4	notice	notice	NOUN
ajlm-123	6	5	:	:	PUNCT
ajlm-123	6	6	©	©	PROPN
ajlm-123	6	7	2013	2013	NUM
ajlm-123	6	8	.	.	PUNCT
ajlm-123	7	1	the	the	DET
ajlm-123	7	2	authors	author	NOUN
ajlm-123	7	3	.	.	PUNCT
ajlm-123	8	1	licensee	licensee	NOUN
ajlm-123	8	2	:	:	PUNCT
ajlm-123	8	3	aosis	aosis	NOUN
ajlm-123	8	4	openjournals	openjournal	NOUN
ajlm-123	8	5	.	.	PUNCT
ajlm-123	9	1	this	this	PRON
ajlm-123	9	2	is	be	AUX
ajlm-123	9	3	an	an	DET
ajlm-123	9	4	open	open	ADJ
ajlm-123	9	5	access	access	NOUN
ajlm-123	9	6	article	article	NOUN
ajlm-123	9	7	distributed	distribute	VERB
ajlm-123	9	8	under	under	ADP
ajlm-123	9	9	the	the	DET
ajlm-123	9	10	terms	term	NOUN
ajlm-123	9	11	of	of	ADP
ajlm-123	9	12	the	the	DET
ajlm-123	9	13	creative	creative	ADJ
ajlm-123	9	14	commons	common	NOUN
ajlm-123	9	15	attribution	attribution	NOUN
ajlm-123	9	16	license	license	NOUN
ajlm-123	9	17	,	,	PUNCT
ajlm-123	9	18	which	which	PRON
ajlm-123	9	19	permits	permit	VERB
ajlm-123	9	20	unrestricted	unrestricted	ADJ
ajlm-123	9	21	use	use	NOUN
ajlm-123	9	22	,	,	PUNCT
ajlm-123	9	23	distribution	distribution	NOUN
ajlm-123	9	24	,	,	PUNCT
ajlm-123	9	25	and	and	CCONJ
ajlm-123	9	26	reproduction	reproduction	NOUN
ajlm-123	9	27	in	in	ADP
ajlm-123	9	28	any	any	DET
ajlm-123	9	29	medium	medium	NOUN
ajlm-123	9	30	,	,	PUNCT
ajlm-123	9	31	provided	provide	VERB
ajlm-123	9	32	the	the	DET
ajlm-123	9	33	original	original	ADJ
ajlm-123	9	34	work	work	NOUN
ajlm-123	9	35	is	be	AUX
ajlm-123	9	36	properly	properly	ADV
ajlm-123	9	37	cited	cite	VERB
ajlm-123	9	38	.	.	PUNCT
ajlm-123	10	1	improving	improve	VERB
ajlm-123	10	2	access	access	NOUN
ajlm-123	10	3	to	to	ADP
ajlm-123	10	4	new	new	ADJ
ajlm-123	10	5	diagnostics	diagnostic	NOUN
ajlm-123	10	6	through	through	ADP
ajlm-123	10	7	harmonised	harmonise	VERB
ajlm-123	10	8	regulation	regulation	NOUN
ajlm-123	10	9	:	:	PUNCT
ajlm-123	10	10	priorities	priority	NOUN
ajlm-123	10	11	for	for	ADP
ajlm-123	10	12	action	action	NOUN
ajlm-123	10	13	in	in	ADP
ajlm-123	10	14	this	this	DET
ajlm-123	10	15	improving	improve	VERB
ajlm-123	10	16	access	access	NOUN
ajlm-123	10	17	to	to	ADP
ajlm-123	10	18	new	new	ADJ
ajlm-123	10	19	diagnostics	diagnostic	NOUN
ajlm-123	10	20	through	through	ADP
ajlm-123	10	21	harmonised	harmonise	VERB
ajlm-123	10	22	regulation	regulation	NOUN
ajlm-123	10	23	:	:	PUNCT
ajlm-123	10	24	priorities	priority	NOUN
ajlm-123	10	25	for	for	ADP
ajlm-123	10	26	action	action	NOUN
ajlm-123	10	27	...	...	PUNCT
ajlm-123	10	28	open	open	ADJ
ajlm-123	10	29	access	access	NOUN
ajlm-123	10	30	•	•	ADP
ajlm-123	10	31	abstract	abstract	ADJ
ajlm-123	10	32	•	•	NUM
ajlm-123	10	33	introduction	introduction	NOUN
ajlm-123	10	34	   	   	SPACE
ajlm-123	10	35	•	•	NOUN
ajlm-123	10	36	regulating	regulate	VERB
ajlm-123	10	37	diagnostic	diagnostic	ADJ
ajlm-123	10	38	devices	device	NOUN
ajlm-123	10	39	   	   	SPACE
ajlm-123	10	40	•	•	NUM
ajlm-123	10	41	risk	risk	NOUN
ajlm-123	10	42	classification	classification	NOUN
ajlm-123	10	43	of	of	ADP
ajlm-123	10	44	in	in	ADP
ajlm-123	10	45	vitro	vitro	X
ajlm-123	10	46	diagnostic	diagnostic	ADJ
ajlm-123	10	47	medical	medical	ADJ
ajlm-123	10	48	devices	device	NOUN
ajlm-123	10	49	   	   	SPACE
ajlm-123	10	50	•	•	ADV
ajlm-123	10	51	harmonising	harmonise	VERB
ajlm-123	10	52	regulation	regulation	NOUN
ajlm-123	10	53	of	of	ADP
ajlm-123	10	54	diagnostic	diagnostic	ADJ
ajlm-123	10	55	devices	device	NOUN
ajlm-123	10	56	•	•	ADP
ajlm-123	10	57	a	a	DET
ajlm-123	10	58	common	common	ADJ
ajlm-123	10	59	submission	submission	NOUN
ajlm-123	10	60	dossier	dossier	NOUN
ajlm-123	10	61	   	   	SPACE
ajlm-123	10	62	•	•	NUM
ajlm-123	10	63	status	status	NOUN
ajlm-123	10	64	quo	quo	NOUN
ajlm-123	10	65	   	   	SPACE
ajlm-123	10	66	•	•	NOUN
ajlm-123	10	67	action	action	NOUN
ajlm-123	10	68	going	go	VERB
ajlm-123	10	69	forward	forward	ADV
ajlm-123	10	70	•	•	NOUN
ajlm-123	10	71	convergence	convergence	NOUN
ajlm-123	10	72	in	in	ADP
ajlm-123	10	73	the	the	DET
ajlm-123	10	74	auditing	auditing	NOUN
ajlm-123	10	75	of	of	ADP
ajlm-123	10	76	quality	quality	NOUN
ajlm-123	10	77	systems	system	NOUN
ajlm-123	10	78	   	   	SPACE
ajlm-123	10	79	•	•	NUM
ajlm-123	10	80	status	status	NOUN
ajlm-123	10	81	quo	quo	NOUN
ajlm-123	10	82	   	   	SPACE
ajlm-123	10	83	•	•	NOUN
ajlm-123	10	84	action	action	NOUN
ajlm-123	10	85	going	go	VERB
ajlm-123	10	86	forward	forward	ADV
ajlm-123	10	87	•	•	ADP
ajlm-123	10	88	reducing	reduce	VERB
ajlm-123	10	89	duplication	duplication	NOUN
ajlm-123	10	90	in	in	ADP
ajlm-123	10	91	studies	study	NOUN
ajlm-123	10	92	of	of	ADP
ajlm-123	10	93	clinical	clinical	ADJ
ajlm-123	10	94	performance	performance	NOUN
ajlm-123	10	95	   	   	SPACE
ajlm-123	10	96	•	•	NUM
ajlm-123	10	97	status	status	NOUN
ajlm-123	10	98	quo	quo	NOUN
ajlm-123	10	99	   	   	SPACE
ajlm-123	10	100	•	•	NOUN
ajlm-123	10	101	action	action	NOUN
ajlm-123	10	102	going	go	VERB
ajlm-123	10	103	forward	forward	ADV
ajlm-123	10	104	•	•	NOUN
ajlm-123	10	105	convergence	convergence	NOUN
ajlm-123	10	106	in	in	ADP
ajlm-123	10	107	post	post	ADJ
ajlm-123	10	108	-	-	ADJ
ajlm-123	10	109	market	market	ADJ
ajlm-123	10	110	surveillance	surveillance	NOUN
ajlm-123	10	111	   	   	SPACE
ajlm-123	10	112	•	•	NUM
ajlm-123	10	113	status	status	NOUN
ajlm-123	10	114	quo	quo	NOUN
ajlm-123	10	115	   	   	SPACE
ajlm-123	10	116	•	•	NOUN
ajlm-123	10	117	action	action	NOUN
ajlm-123	10	118	going	go	VERB
ajlm-123	10	119	forward	forward	ADV
ajlm-123	10	120	•	•	NOUN
ajlm-123	10	121	conclusion	conclusion	NOUN
ajlm-123	10	122	•	•	NUM
ajlm-123	10	123	acknowledgements	acknowledgement	NOUN
ajlm-123	10	124	   	   	SPACE
ajlm-123	10	125	•	•	NOUN
ajlm-123	10	126	competing	compete	VERB
ajlm-123	10	127	interests	interest	NOUN
ajlm-123	10	128	   	   	SPACE
ajlm-123	10	129	•	•	NUM
ajlm-123	10	130	authors	author	NOUN
ajlm-123	10	131	’	'	PUNCT
ajlm-123	10	132	contributions	contribution	NOUN
ajlm-123	10	133	•	•	NUM
ajlm-123	10	134	references	reference	NOUN
ajlm-123	10	135	abstract	abstract	ADJ
ajlm-123	10	136	top	top	NOUN
ajlm-123	10	137	↑	↑	PROPN
ajlm-123	10	138	a	a	DET
ajlm-123	10	139	new	new	ADJ
ajlm-123	10	140	generation	generation	NOUN
ajlm-123	10	141	of	of	ADP
ajlm-123	10	142	diagnostic	diagnostic	ADJ
ajlm-123	10	143	tests	test	NOUN
ajlm-123	10	144	is	be	AUX
ajlm-123	10	145	being	be	AUX
ajlm-123	10	146	developed	develop	VERB
ajlm-123	10	147	for	for	ADP
ajlm-123	10	148	use	use	NOUN
ajlm-123	10	149	at	at	ADP
ajlm-123	10	150	the	the	DET
ajlm-123	10	151	point	point	NOUN
ajlm-123	10	152	of	of	ADP
ajlm-123	10	153	care	care	NOUN
ajlm-123	10	154	that	that	PRON
ajlm-123	10	155	could	could	AUX
ajlm-123	10	156	save	save	VERB
ajlm-123	10	157	lives	life	NOUN
ajlm-123	10	158	and	and	CCONJ
ajlm-123	10	159	reduce	reduce	VERB
ajlm-123	10	160	the	the	DET
ajlm-123	10	161	spread	spread	NOUN
ajlm-123	10	162	of	of	ADP
ajlm-123	10	163	infectious	infectious	ADJ
ajlm-123	10	164	diseases	disease	NOUN
ajlm-123	10	165	through	through	ADP
ajlm-123	10	166	early	early	ADJ
ajlm-123	10	167	detection	detection	NOUN
ajlm-123	10	168	and	and	CCONJ
ajlm-123	10	169	treatment	treatment	NOUN
ajlm-123	10	170	.	.	PUNCT
ajlm-123	11	1	it	it	PRON
ajlm-123	11	2	is	be	AUX
ajlm-123	11	3	important	important	ADJ
ajlm-123	11	4	that	that	SCONJ
ajlm-123	11	5	patients	patient	NOUN
ajlm-123	11	6	in	in	ADP
ajlm-123	11	7	developing	develop	VERB
ajlm-123	11	8	countries	country	NOUN
ajlm-123	11	9	have	have	VERB
ajlm-123	11	10	access	access	NOUN
ajlm-123	11	11	to	to	ADP
ajlm-123	11	12	these	these	DET
ajlm-123	11	13	products	product	NOUN
ajlm-123	11	14	at	at	ADP
ajlm-123	11	15	affordable	affordable	ADJ
ajlm-123	11	16	prices	price	NOUN
ajlm-123	11	17	and	and	CCONJ
ajlm-123	11	18	without	without	ADP
ajlm-123	11	19	delay	delay	NOUN
ajlm-123	11	20	.	.	PUNCT
ajlm-123	12	1	regulation	regulation	NOUN
ajlm-123	12	2	of	of	ADP
ajlm-123	12	3	medical	medical	ADJ
ajlm-123	12	4	products	product	NOUN
ajlm-123	12	5	is	be	AUX
ajlm-123	12	6	intended	intend	VERB
ajlm-123	12	7	to	to	PART
ajlm-123	12	8	ensure	ensure	VERB
ajlm-123	12	9	safety	safety	NOUN
ajlm-123	12	10	and	and	CCONJ
ajlm-123	12	11	quality	quality	NOUN
ajlm-123	12	12	whilst	whilst	SCONJ
ajlm-123	12	13	balancing	balance	VERB
ajlm-123	12	14	the	the	DET
ajlm-123	12	15	need	need	NOUN
ajlm-123	12	16	for	for	ADP
ajlm-123	12	17	timely	timely	ADJ
ajlm-123	12	18	access	access	NOUN
ajlm-123	12	19	to	to	ADP
ajlm-123	12	20	beneficial	beneficial	ADJ
ajlm-123	12	21	new	new	ADJ
ajlm-123	12	22	products	product	NOUN
ajlm-123	12	23	.	.	PUNCT
ajlm-123	13	1	current	current	ADJ
ajlm-123	13	2	regulatory	regulatory	ADJ
ajlm-123	13	3	oversight	oversight	NOUN
ajlm-123	13	4	of	of	ADP
ajlm-123	13	5	diagnostic	diagnostic	ADJ
ajlm-123	13	6	tests	test	NOUN
ajlm-123	13	7	in	in	ADP
ajlm-123	13	8	developing	develop	VERB
ajlm-123	13	9	countries	country	NOUN
ajlm-123	13	10	is	be	AUX
ajlm-123	13	11	highly	highly	ADV
ajlm-123	13	12	variable	variable	ADJ
ajlm-123	13	13	and	and	CCONJ
ajlm-123	13	14	weak	weak	ADJ
ajlm-123	13	15	regulation	regulation	NOUN
ajlm-123	13	16	allows	allow	VERB
ajlm-123	13	17	poor	poor	ADJ
ajlm-123	13	18	-	-	PUNCT
ajlm-123	13	19	quality	quality	NOUN
ajlm-123	13	20	tests	test	NOUN
ajlm-123	13	21	to	to	PART
ajlm-123	13	22	enter	enter	VERB
ajlm-123	13	23	the	the	DET
ajlm-123	13	24	market	market	NOUN
ajlm-123	13	25	.	.	PUNCT
ajlm-123	14	1	however	however	ADV
ajlm-123	14	2	,	,	PUNCT
ajlm-123	14	3	inefficient	inefficient	ADJ
ajlm-123	14	4	or	or	CCONJ
ajlm-123	14	5	overzealous	overzealous	ADJ
ajlm-123	14	6	regulation	regulation	NOUN
ajlm-123	14	7	results	result	NOUN
ajlm-123	14	8	in	in	ADP
ajlm-123	14	9	unnecessary	unnecessary	ADJ
ajlm-123	14	10	delays	delay	NOUN
ajlm-123	14	11	,	,	PUNCT
ajlm-123	14	12	increases	increase	VERB
ajlm-123	14	13	costs	cost	NOUN
ajlm-123	14	14	and	and	CCONJ
ajlm-123	14	15	acts	act	VERB
ajlm-123	14	16	as	as	ADP
ajlm-123	14	17	a	a	DET
ajlm-123	14	18	barrier	barrier	NOUN
ajlm-123	14	19	to	to	ADP
ajlm-123	14	20	innovation	innovation	NOUN
ajlm-123	14	21	and	and	CCONJ
ajlm-123	14	22	market	market	NOUN
ajlm-123	14	23	entry	entry	NOUN
ajlm-123	14	24	.	.	PUNCT
ajlm-123	15	1	setting	set	VERB
ajlm-123	15	2	international	international	ADJ
ajlm-123	15	3	standards	standard	NOUN
ajlm-123	15	4	and	and	CCONJ
ajlm-123	15	5	streamlining	streamline	VERB
ajlm-123	15	6	the	the	DET
ajlm-123	15	7	regulatory	regulatory	ADJ
ajlm-123	15	8	process	process	NOUN
ajlm-123	15	9	could	could	AUX
ajlm-123	15	10	reduce	reduce	VERB
ajlm-123	15	11	these	these	DET
ajlm-123	15	12	barriers	barrier	NOUN
ajlm-123	15	13	.	.	PUNCT
ajlm-123	16	1	four	four	NUM
ajlm-123	16	2	priority	priority	NOUN
ajlm-123	16	3	activities	activity	NOUN
ajlm-123	16	4	have	have	AUX
ajlm-123	16	5	been	be	AUX
ajlm-123	16	6	identified	identify	VERB
ajlm-123	16	7	where	where	SCONJ
ajlm-123	16	8	convergence	convergence	NOUN
ajlm-123	16	9	of	of	ADP
ajlm-123	16	10	standards	standard	NOUN
ajlm-123	16	11	and	and	CCONJ
ajlm-123	16	12	protocols	protocol	NOUN
ajlm-123	16	13	or	or	CCONJ
ajlm-123	16	14	joint	joint	ADJ
ajlm-123	16	15	review	review	NOUN
ajlm-123	16	16	of	of	ADP
ajlm-123	16	17	data	datum	NOUN
ajlm-123	16	18	would	would	AUX
ajlm-123	16	19	be	be	AUX
ajlm-123	16	20	advantageous	advantageous	ADJ
ajlm-123	16	21	:	:	PUNCT
ajlm-123	16	22	(	(	PUNCT
ajlm-123	16	23	1	1	X
ajlm-123	16	24	)	)	PUNCT
ajlm-123	16	25	adoption	adoption	NOUN
ajlm-123	16	26	of	of	ADP
ajlm-123	16	27	a	a	DET
ajlm-123	16	28	common	common	ADJ
ajlm-123	16	29	registration	registration	NOUN
ajlm-123	16	30	file	file	NOUN
ajlm-123	16	31	for	for	ADP
ajlm-123	16	32	pre	pre	ADJ
ajlm-123	16	33	-	-	ADJ
ajlm-123	16	34	market	market	ADJ
ajlm-123	16	35	approval	approval	NOUN
ajlm-123	16	36	;	;	PUNCT
ajlm-123	16	37	(	(	PUNCT
ajlm-123	16	38	2	2	X
ajlm-123	16	39	)	)	PUNCT
ajlm-123	16	40	convergence	convergence	NOUN
ajlm-123	16	41	of	of	ADP
ajlm-123	16	42	quality	quality	NOUN
ajlm-123	16	43	standards	standard	NOUN
ajlm-123	16	44	for	for	ADP
ajlm-123	16	45	manufacturing	manufacturing	NOUN
ajlm-123	16	46	site	site	NOUN
ajlm-123	16	47	inspections	inspection	NOUN
ajlm-123	16	48	;	;	PUNCT
ajlm-123	16	49	(	(	PUNCT
ajlm-123	16	50	3	3	X
ajlm-123	16	51	)	)	PUNCT
ajlm-123	16	52	use	use	NOUN
ajlm-123	16	53	of	of	ADP
ajlm-123	16	54	common	common	ADJ
ajlm-123	16	55	evaluation	evaluation	NOUN
ajlm-123	16	56	protocols	protocol	NOUN
ajlm-123	16	57	,	,	PUNCT
ajlm-123	16	58	as	as	ADV
ajlm-123	16	59	well	well	ADV
ajlm-123	16	60	as	as	ADP
ajlm-123	16	61	joint	joint	ADJ
ajlm-123	16	62	review	review	NOUN
ajlm-123	16	63	of	of	ADP
ajlm-123	16	64	data	datum	NOUN
ajlm-123	16	65	,	,	PUNCT
ajlm-123	16	66	to	to	PART
ajlm-123	16	67	reduce	reduce	VERB
ajlm-123	16	68	unnecessary	unnecessary	ADJ
ajlm-123	16	69	duplication	duplication	NOUN
ajlm-123	16	70	of	of	ADP
ajlm-123	16	71	lengthy	lengthy	ADJ
ajlm-123	16	72	and	and	CCONJ
ajlm-123	16	73	costly	costly	ADJ
ajlm-123	16	74	clinical	clinical	ADJ
ajlm-123	16	75	performance	performance	NOUN
ajlm-123	16	76	studies	study	NOUN
ajlm-123	16	77	;	;	PUNCT
ajlm-123	16	78	and	and	CCONJ
ajlm-123	16	79	(	(	PUNCT
ajlm-123	16	80	4	4	X
ajlm-123	16	81	)	)	PUNCT
ajlm-123	16	82	use	use	NOUN
ajlm-123	16	83	of	of	ADP
ajlm-123	16	84	networks	network	NOUN
ajlm-123	16	85	of	of	ADP
ajlm-123	16	86	laboratories	laboratory	NOUN
ajlm-123	16	87	for	for	ADP
ajlm-123	16	88	post	post	ADJ
ajlm-123	16	89	-	-	ADJ
ajlm-123	16	90	market	market	ADJ
ajlm-123	16	91	surveillance	surveillance	NOUN
ajlm-123	16	92	in	in	ADP
ajlm-123	16	93	order	order	NOUN
ajlm-123	16	94	to	to	PART
ajlm-123	16	95	monitor	monitor	VERB
ajlm-123	16	96	ongoing	ongoing	ADJ
ajlm-123	16	97	quality	quality	NOUN
ajlm-123	16	98	of	of	ADP
ajlm-123	16	99	diagnostic	diagnostic	ADJ
ajlm-123	16	100	devices	device	NOUN
ajlm-123	16	101	.	.	PUNCT
ajlm-123	17	1	the	the	DET
ajlm-123	17	2	adoption	adoption	NOUN
ajlm-123	17	3	and	and	CCONJ
ajlm-123	17	4	implementation	implementation	NOUN
ajlm-123	17	5	of	of	ADP
ajlm-123	17	6	such	such	ADJ
ajlm-123	17	7	measures	measure	NOUN
ajlm-123	17	8	in	in	ADP
ajlm-123	17	9	developing	develop	VERB
ajlm-123	17	10	countries	country	NOUN
ajlm-123	17	11	could	could	AUX
ajlm-123	17	12	accelerate	accelerate	VERB
ajlm-123	17	13	access	access	NOUN
ajlm-123	17	14	to	to	ADP
ajlm-123	17	15	new	new	ADJ
ajlm-123	17	16	diagnostic	diagnostic	ADJ
ajlm-123	17	17	tests	test	NOUN
ajlm-123	17	18	that	that	PRON
ajlm-123	17	19	are	be	AUX
ajlm-123	17	20	safe	safe	ADJ
ajlm-123	17	21	and	and	CCONJ
ajlm-123	17	22	affordable	affordable	ADJ
ajlm-123	17	23	.	.	PUNCT
ajlm-123	18	1	introduction	introduction	NOUN
ajlm-123	18	2	top	top	PROPN
ajlm-123	18	3	↑	↑	PROPN
ajlm-123	18	4	diagnostic	diagnostic	ADJ
ajlm-123	18	5	tests	test	NOUN
ajlm-123	18	6	make	make	VERB
ajlm-123	18	7	a	a	DET
ajlm-123	18	8	major	major	ADJ
ajlm-123	18	9	contribution	contribution	NOUN
ajlm-123	18	10	to	to	ADP
ajlm-123	18	11	global	global	ADJ
ajlm-123	18	12	health	health	NOUN
ajlm-123	18	13	.	.	PUNCT
ajlm-123	19	1	they	they	PRON
ajlm-123	19	2	are	be	AUX
ajlm-123	19	3	needed	need	VERB
ajlm-123	19	4	in	in	ADP
ajlm-123	19	5	order	order	NOUN
ajlm-123	19	6	to	to	PART
ajlm-123	19	7	guide	guide	VERB
ajlm-123	19	8	treatment	treatment	NOUN
ajlm-123	19	9	decisions	decision	NOUN
ajlm-123	19	10	and	and	CCONJ
ajlm-123	19	11	ensure	ensure	VERB
ajlm-123	19	12	the	the	DET
ajlm-123	19	13	appropriate	appropriate	ADJ
ajlm-123	19	14	use	use	NOUN
ajlm-123	19	15	of	of	ADP
ajlm-123	19	16	medicines	medicine	NOUN
ajlm-123	19	17	.	.	PUNCT
ajlm-123	20	1	they	they	PRON
ajlm-123	20	2	are	be	AUX
ajlm-123	20	3	also	also	ADV
ajlm-123	20	4	vital	vital	ADJ
ajlm-123	20	5	for	for	ADP
ajlm-123	20	6	screening	screen	VERB
ajlm-123	20	7	for	for	ADP
ajlm-123	20	8	infections	infection	NOUN
ajlm-123	20	9	,	,	PUNCT
ajlm-123	20	10	such	such	ADJ
ajlm-123	20	11	as	as	ADP
ajlm-123	20	12	hiv	hiv	PROPN
ajlm-123	20	13	infection	infection	NOUN
ajlm-123	20	14	or	or	CCONJ
ajlm-123	20	15	syphilis	syphili	NOUN
ajlm-123	20	16	,	,	PUNCT
ajlm-123	20	17	in	in	ADP
ajlm-123	20	18	asymptomatic	asymptomatic	ADJ
ajlm-123	20	19	individuals.1	individuals.1	NOUN
ajlm-123	20	20	such	such	ADJ
ajlm-123	20	21	tests	test	NOUN
ajlm-123	20	22	are	be	AUX
ajlm-123	20	23	often	often	ADV
ajlm-123	20	24	lifesaving	lifesave	VERB
ajlm-123	20	25	,	,	PUNCT
ajlm-123	20	26	where	where	SCONJ
ajlm-123	20	27	delay	delay	NOUN
ajlm-123	20	28	or	or	CCONJ
ajlm-123	20	29	lack	lack	NOUN
ajlm-123	20	30	of	of	ADP
ajlm-123	20	31	access	access	NOUN
ajlm-123	20	32	can	can	AUX
ajlm-123	20	33	result	result	VERB
ajlm-123	20	34	in	in	ADP
ajlm-123	20	35	deterioration	deterioration	NOUN
ajlm-123	20	36	of	of	ADP
ajlm-123	20	37	the	the	DET
ajlm-123	20	38	patient	patient	NOUN
ajlm-123	20	39	’s	’s	PART
ajlm-123	20	40	health	health	NOUN
ajlm-123	20	41	and	and	CCONJ
ajlm-123	20	42	lead	lead	VERB
ajlm-123	20	43	to	to	ADP
ajlm-123	20	44	further	further	ADJ
ajlm-123	20	45	complications	complication	NOUN
ajlm-123	20	46	.	.	PUNCT
ajlm-123	21	1	diagnostics	diagnostic	NOUN
ajlm-123	21	2	are	be	AUX
ajlm-123	21	3	particularly	particularly	ADV
ajlm-123	21	4	important	important	ADJ
ajlm-123	21	5	for	for	ADP
ajlm-123	21	6	the	the	DET
ajlm-123	21	7	control	control	NOUN
ajlm-123	21	8	of	of	ADP
ajlm-123	21	9	infectious	infectious	ADJ
ajlm-123	21	10	diseases	disease	NOUN
ajlm-123	21	11	,	,	PUNCT
ajlm-123	21	12	where	where	SCONJ
ajlm-123	21	13	early	early	ADJ
ajlm-123	21	14	detection	detection	NOUN
ajlm-123	21	15	allows	allow	VERB
ajlm-123	21	16	intervention	intervention	NOUN
ajlm-123	21	17	in	in	ADP
ajlm-123	21	18	order	order	NOUN
ajlm-123	21	19	to	to	PART
ajlm-123	21	20	prevent	prevent	VERB
ajlm-123	21	21	onward	onward	NOUN
ajlm-123	21	22	transmission.2	transmission.2	PROPN
ajlm-123	21	23	they	they	PRON
ajlm-123	21	24	may	may	AUX
ajlm-123	21	25	also	also	ADV
ajlm-123	21	26	be	be	AUX
ajlm-123	21	27	used	use	VERB
ajlm-123	21	28	to	to	PART
ajlm-123	21	29	monitor	monitor	VERB
ajlm-123	21	30	the	the	DET
ajlm-123	21	31	outcome	outcome	NOUN
ajlm-123	21	32	of	of	ADP
ajlm-123	21	33	treatment	treatment	NOUN
ajlm-123	21	34	.	.	PUNCT
ajlm-123	22	1	most	most	ADJ
ajlm-123	22	2	diagnostic	diagnostic	ADJ
ajlm-123	22	3	interventions	intervention	NOUN
ajlm-123	22	4	utilise	utilise	VERB
ajlm-123	22	5	in	in	ADP
ajlm-123	22	6	vitro	vitro	X
ajlm-123	22	7	diagnostic	diagnostic	ADJ
ajlm-123	22	8	medical	medical	ADJ
ajlm-123	22	9	devices	device	NOUN
ajlm-123	22	10	(	(	PUNCT
ajlm-123	22	11	ivds	ivds	NOUN
ajlm-123	22	12	)	)	PUNCT
ajlm-123	22	13	which	which	PRON
ajlm-123	22	14	test	test	NOUN
ajlm-123	22	15	specimens	specimen	NOUN
ajlm-123	22	16	obtained	obtain	VERB
ajlm-123	22	17	from	from	ADP
ajlm-123	22	18	a	a	DET
ajlm-123	22	19	patient	patient	NOUN
ajlm-123	22	20	,	,	PUNCT
ajlm-123	22	21	such	such	ADJ
ajlm-123	22	22	as	as	ADP
ajlm-123	22	23	blood	blood	NOUN
ajlm-123	22	24	or	or	CCONJ
ajlm-123	22	25	urine	urine	NOUN
ajlm-123	22	26	.	.	PUNCT
ajlm-123	23	1	ivds	ivds	NOUN
ajlm-123	23	2	include	include	VERB
ajlm-123	23	3	a	a	DET
ajlm-123	23	4	wide	wide	ADJ
ajlm-123	23	5	range	range	NOUN
ajlm-123	23	6	of	of	ADP
ajlm-123	23	7	technologies	technology	NOUN
ajlm-123	23	8	,	,	PUNCT
ajlm-123	23	9	from	from	ADP
ajlm-123	23	10	rapid	rapid	ADJ
ajlm-123	23	11	dip	dip	ADJ
ajlm-123	23	12	-	-	PUNCT
ajlm-123	23	13	stick	stick	NOUN
ajlm-123	23	14	strips	strip	NOUN
ajlm-123	23	15	for	for	ADP
ajlm-123	23	16	use	use	NOUN
ajlm-123	23	17	at	at	ADP
ajlm-123	23	18	the	the	DET
ajlm-123	23	19	point	point	NOUN
ajlm-123	23	20	of	of	ADP
ajlm-123	23	21	care	care	NOUN
ajlm-123	23	22	(	(	PUNCT
ajlm-123	23	23	poc	poc	NOUN
ajlm-123	23	24	)	)	PUNCT
ajlm-123	23	25	to	to	ADP
ajlm-123	23	26	sophisticated	sophisticated	ADJ
ajlm-123	23	27	instrumentation	instrumentation	NOUN
ajlm-123	23	28	for	for	ADP
ajlm-123	23	29	use	use	NOUN
ajlm-123	23	30	in	in	ADP
ajlm-123	23	31	referral	referral	ADJ
ajlm-123	23	32	laboratories	laboratory	NOUN
ajlm-123	23	33	.	.	PUNCT
ajlm-123	24	1	access	access	NOUN
ajlm-123	24	2	to	to	ADP
ajlm-123	24	3	diagnostic	diagnostic	ADJ
ajlm-123	24	4	tests	test	NOUN
ajlm-123	24	5	in	in	ADP
ajlm-123	24	6	developing	develop	VERB
ajlm-123	24	7	countries	country	NOUN
ajlm-123	24	8	is	be	AUX
ajlm-123	24	9	often	often	ADV
ajlm-123	24	10	limited	limit	VERB
ajlm-123	24	11	by	by	ADP
ajlm-123	24	12	their	their	PRON
ajlm-123	24	13	availability	availability	NOUN
ajlm-123	24	14	,	,	PUNCT
ajlm-123	24	15	as	as	SCONJ
ajlm-123	24	16	patients	patient	NOUN
ajlm-123	24	17	frequently	frequently	ADV
ajlm-123	24	18	do	do	AUX
ajlm-123	24	19	not	not	PART
ajlm-123	24	20	live	live	VERB
ajlm-123	24	21	within	within	ADP
ajlm-123	24	22	easy	easy	ADJ
ajlm-123	24	23	travelling	travel	VERB
ajlm-123	24	24	distance	distance	NOUN
ajlm-123	24	25	of	of	ADP
ajlm-123	24	26	a	a	DET
ajlm-123	24	27	well	well	ADV
ajlm-123	24	28	-	-	PUNCT
ajlm-123	24	29	equipped	equip	VERB
ajlm-123	24	30	and	and	CCONJ
ajlm-123	24	31	functional	functional	ADJ
ajlm-123	24	32	laboratory.2,3	laboratory.2,3	PROPN
ajlm-123	24	33	a	a	DET
ajlm-123	24	34	new	new	ADJ
ajlm-123	24	35	generation	generation	NOUN
ajlm-123	24	36	of	of	ADP
ajlm-123	24	37	diagnostic	diagnostic	ADJ
ajlm-123	24	38	tests	test	NOUN
ajlm-123	24	39	is	be	AUX
ajlm-123	24	40	being	be	AUX
ajlm-123	24	41	developed	develop	VERB
ajlm-123	24	42	for	for	ADP
ajlm-123	24	43	use	use	NOUN
ajlm-123	24	44	at	at	ADP
ajlm-123	24	45	the	the	DET
ajlm-123	24	46	point	point	NOUN
ajlm-123	24	47	of	of	ADP
ajlm-123	24	48	care	care	NOUN
ajlm-123	24	49	that	that	PRON
ajlm-123	24	50	will	will	AUX
ajlm-123	24	51	not	not	PART
ajlm-123	24	52	need	need	VERB
ajlm-123	24	53	a	a	DET
ajlm-123	24	54	laboratory.4,5	laboratory.4,5	NOUN
ajlm-123	24	55	prompt	prompt	ADJ
ajlm-123	24	56	access	access	NOUN
ajlm-123	24	57	to	to	ADP
ajlm-123	24	58	the	the	DET
ajlm-123	24	59	new	new	ADJ
ajlm-123	24	60	tests	test	NOUN
ajlm-123	24	61	should	should	AUX
ajlm-123	24	62	be	be	AUX
ajlm-123	24	63	encouraged	encourage	VERB
ajlm-123	24	64	;	;	PUNCT
ajlm-123	24	65	if	if	SCONJ
ajlm-123	24	66	they	they	PRON
ajlm-123	24	67	are	be	AUX
ajlm-123	24	68	made	make	VERB
ajlm-123	24	69	available	available	ADJ
ajlm-123	24	70	in	in	ADP
ajlm-123	24	71	developing	develop	VERB
ajlm-123	24	72	countries	country	NOUN
ajlm-123	24	73	at	at	ADP
ajlm-123	24	74	affordable	affordable	ADJ
ajlm-123	24	75	prices	price	NOUN
ajlm-123	24	76	,	,	PUNCT
ajlm-123	24	77	such	such	ADJ
ajlm-123	24	78	tests	test	NOUN
ajlm-123	24	79	could	could	AUX
ajlm-123	24	80	increase	increase	VERB
ajlm-123	24	81	access	access	NOUN
ajlm-123	24	82	to	to	ADP
ajlm-123	24	83	appropriate	appropriate	ADJ
ajlm-123	24	84	healthcare	healthcare	NOUN
ajlm-123	24	85	,	,	PUNCT
ajlm-123	24	86	thereby	thereby	ADV
ajlm-123	24	87	saving	save	VERB
ajlm-123	24	88	lives	life	NOUN
ajlm-123	24	89	and	and	CCONJ
ajlm-123	24	90	reducing	reduce	VERB
ajlm-123	24	91	the	the	DET
ajlm-123	24	92	spread	spread	NOUN
ajlm-123	24	93	of	of	ADP
ajlm-123	24	94	infectious	infectious	ADJ
ajlm-123	24	95	diseases.4,5,6	diseases.4,5,6	NOUN
ajlm-123	24	96	regulating	regulate	VERB
ajlm-123	24	97	diagnostic	diagnostic	ADJ
ajlm-123	24	98	devices	device	NOUN
ajlm-123	24	99	regulation	regulation	NOUN
ajlm-123	24	100	of	of	ADP
ajlm-123	24	101	medical	medical	ADJ
ajlm-123	24	102	products	product	NOUN
ajlm-123	24	103	is	be	AUX
ajlm-123	24	104	intended	intend	VERB
ajlm-123	24	105	to	to	PART
ajlm-123	24	106	ensure	ensure	VERB
ajlm-123	24	107	safety	safety	NOUN
ajlm-123	24	108	and	and	CCONJ
ajlm-123	24	109	quality	quality	NOUN
ajlm-123	24	110	whilst	whilst	SCONJ
ajlm-123	24	111	ensuring	ensure	VERB
ajlm-123	24	112	that	that	SCONJ
ajlm-123	24	113	the	the	DET
ajlm-123	24	114	public	public	NOUN
ajlm-123	24	115	has	have	VERB
ajlm-123	24	116	timely	timely	ADJ
ajlm-123	24	117	access	access	NOUN
ajlm-123	24	118	to	to	ADP
ajlm-123	24	119	beneficial	beneficial	ADJ
ajlm-123	24	120	new	new	ADJ
ajlm-123	24	121	products	product	NOUN
ajlm-123	24	122	.	.	PUNCT
ajlm-123	25	1	national	national	ADJ
ajlm-123	25	2	regulatory	regulatory	ADJ
ajlm-123	25	3	authorities	authority	NOUN
ajlm-123	25	4	(	(	PUNCT
ajlm-123	25	5	nras	nras	PROPN
ajlm-123	25	6	)	)	PUNCT
ajlm-123	25	7	are	be	AUX
ajlm-123	25	8	usually	usually	ADV
ajlm-123	25	9	mandated	mandate	VERB
ajlm-123	25	10	by	by	ADP
ajlm-123	25	11	law	law	NOUN
ajlm-123	25	12	and	and	CCONJ
ajlm-123	25	13	,	,	PUNCT
ajlm-123	25	14	for	for	SCONJ
ajlm-123	25	15	a	a	DET
ajlm-123	25	16	regulatory	regulatory	ADJ
ajlm-123	25	17	system	system	NOUN
ajlm-123	25	18	to	to	PART
ajlm-123	25	19	be	be	AUX
ajlm-123	25	20	effective	effective	ADJ
ajlm-123	25	21	,	,	PUNCT
ajlm-123	25	22	it	it	PRON
ajlm-123	25	23	should	should	AUX
ajlm-123	25	24	be	be	AUX
ajlm-123	25	25	enforceable	enforceable	ADJ
ajlm-123	25	26	in	in	ADP
ajlm-123	25	27	both	both	CCONJ
ajlm-123	25	28	the	the	DET
ajlm-123	25	29	public	public	ADJ
ajlm-123	25	30	and	and	CCONJ
ajlm-123	25	31	private	private	ADJ
ajlm-123	25	32	healthcare	healthcare	NOUN
ajlm-123	25	33	sector	sector	NOUN
ajlm-123	25	34	.	.	PUNCT
ajlm-123	26	1	following	follow	VERB
ajlm-123	26	2	impartial	impartial	ADJ
ajlm-123	26	3	review	review	NOUN
ajlm-123	26	4	,	,	PUNCT
ajlm-123	26	5	new	new	ADJ
ajlm-123	26	6	tests	test	NOUN
ajlm-123	26	7	that	that	PRON
ajlm-123	26	8	are	be	AUX
ajlm-123	26	9	considered	consider	VERB
ajlm-123	26	10	substandard	substandard	ADJ
ajlm-123	26	11	or	or	CCONJ
ajlm-123	26	12	unsafe	unsafe	ADJ
ajlm-123	26	13	are	be	AUX
ajlm-123	26	14	refused	refuse	VERB
ajlm-123	26	15	entry	entry	NOUN
ajlm-123	26	16	to	to	ADP
ajlm-123	26	17	the	the	DET
ajlm-123	26	18	market	market	NOUN
ajlm-123	26	19	,	,	PUNCT
ajlm-123	26	20	whereas	whereas	SCONJ
ajlm-123	26	21	satisfactory	satisfactory	ADJ
ajlm-123	26	22	products	product	NOUN
ajlm-123	26	23	are	be	AUX
ajlm-123	26	24	approved	approve	VERB
ajlm-123	26	25	and	and	CCONJ
ajlm-123	26	26	registered	register	VERB
ajlm-123	26	27	.	.	PUNCT
ajlm-123	27	1	for	for	ADP
ajlm-123	27	2	regulatory	regulatory	ADJ
ajlm-123	27	3	purposes	purpose	NOUN
ajlm-123	27	4	,	,	PUNCT
ajlm-123	27	5	ivds	ivds	PROPN
ajlm-123	27	6	are	be	AUX
ajlm-123	27	7	classified	classify	VERB
ajlm-123	27	8	as	as	ADP
ajlm-123	27	9	medical	medical	ADJ
ajlm-123	27	10	devices	device	NOUN
ajlm-123	27	11	.	.	PUNCT
ajlm-123	28	1	in	in	ADP
ajlm-123	28	2	this	this	DET
ajlm-123	28	3	context	context	NOUN
ajlm-123	28	4	,	,	PUNCT
ajlm-123	28	5	‘	'	PUNCT
ajlm-123	28	6	medical	medical	ADJ
ajlm-123	28	7	device	device	NOUN
ajlm-123	28	8	’	'	PUNCT
ajlm-123	28	9	means	mean	VERB
ajlm-123	28	10	any	any	DET
ajlm-123	28	11	instrument	instrument	NOUN
ajlm-123	28	12	,	,	PUNCT
ajlm-123	28	13	apparatus	apparatus	NOUN
ajlm-123	28	14	,	,	PUNCT
ajlm-123	28	15	implement	implement	NOUN
ajlm-123	28	16	,	,	PUNCT
ajlm-123	28	17	machine	machine	NOUN
ajlm-123	28	18	,	,	PUNCT
ajlm-123	28	19	appliance	appliance	NOUN
ajlm-123	28	20	,	,	PUNCT
ajlm-123	28	21	implant	implant	ADJ
ajlm-123	28	22	,	,	PUNCT
ajlm-123	28	23	reagent	reagent	NOUN
ajlm-123	28	24	for	for	ADP
ajlm-123	28	25	in	in	ADP
ajlm-123	28	26	vitro	vitro	X
ajlm-123	28	27	use	use	NOUN
ajlm-123	28	28	,	,	PUNCT
ajlm-123	28	29	software	software	NOUN
ajlm-123	28	30	,	,	PUNCT
ajlm-123	28	31	material	material	NOUN
ajlm-123	28	32	,	,	PUNCT
ajlm-123	28	33	or	or	CCONJ
ajlm-123	28	34	any	any	DET
ajlm-123	28	35	other	other	ADJ
ajlm-123	28	36	similar	similar	ADJ
ajlm-123	28	37	or	or	CCONJ
ajlm-123	28	38	related	related	ADJ
ajlm-123	28	39	article	article	NOUN
ajlm-123	28	40	intended	intend	VERB
ajlm-123	28	41	by	by	ADP
ajlm-123	28	42	the	the	DET
ajlm-123	28	43	manufacturer	manufacturer	NOUN
ajlm-123	28	44	to	to	PART
ajlm-123	28	45	be	be	AUX
ajlm-123	28	46	used	use	VERB
ajlm-123	28	47	alone	alone	ADJ
ajlm-123	28	48	or	or	CCONJ
ajlm-123	28	49	in	in	ADP
ajlm-123	28	50	combination	combination	NOUN
ajlm-123	28	51	,	,	PUNCT
ajlm-123	28	52	for	for	ADP
ajlm-123	28	53	human	human	ADJ
ajlm-123	28	54	beings	being	NOUN
ajlm-123	28	55	for	for	ADP
ajlm-123	28	56	one	one	NUM
ajlm-123	28	57	or	or	CCONJ
ajlm-123	28	58	more	more	ADJ
ajlm-123	28	59	of	of	ADP
ajlm-123	28	60	the	the	DET
ajlm-123	28	61	specific	specific	ADJ
ajlm-123	28	62	medical	medical	ADJ
ajlm-123	28	63	purpose(s	purpose(s	NOUN
ajlm-123	28	64	):	):	PUNCT
ajlm-123	28	65	diagnosis	diagnosis	NOUN
ajlm-123	28	66	,	,	PUNCT
ajlm-123	28	67	prevention	prevention	NOUN
ajlm-123	28	68	,	,	PUNCT
ajlm-123	28	69	monitoring	monitoring	NOUN
ajlm-123	28	70	,	,	PUNCT
ajlm-123	28	71	treatment	treatment	NOUN
ajlm-123	28	72	or	or	CCONJ
ajlm-123	28	73	alleviation	alleviation	NOUN
ajlm-123	28	74	of	of	ADP
ajlm-123	28	75	disease	disease	NOUN
ajlm-123	28	76	;	;	PUNCT
ajlm-123	28	77	diagnosis	diagnosis	NOUN
ajlm-123	28	78	,	,	PUNCT
ajlm-123	28	79	monitoring	monitoring	NOUN
ajlm-123	28	80	,	,	PUNCT
ajlm-123	28	81	treatment	treatment	NOUN
ajlm-123	28	82	,	,	PUNCT
ajlm-123	28	83	alleviation	alleviation	NOUN
ajlm-123	28	84	of	of	ADP
ajlm-123	28	85	or	or	CCONJ
ajlm-123	28	86	compensation	compensation	NOUN
ajlm-123	28	87	for	for	ADP
ajlm-123	28	88	an	an	DET
ajlm-123	28	89	injury	injury	NOUN
ajlm-123	28	90	;	;	PUNCT
ajlm-123	28	91	investigation	investigation	NOUN
ajlm-123	28	92	,	,	PUNCT
ajlm-123	28	93	replacement	replacement	NOUN
ajlm-123	28	94	,	,	PUNCT
ajlm-123	28	95	modification	modification	NOUN
ajlm-123	28	96	or	or	CCONJ
ajlm-123	28	97	support	support	NOUN
ajlm-123	28	98	of	of	ADP
ajlm-123	28	99	the	the	DET
ajlm-123	28	100	anatomy	anatomy	NOUN
ajlm-123	28	101	or	or	CCONJ
ajlm-123	28	102	of	of	ADP
ajlm-123	28	103	a	a	DET
ajlm-123	28	104	physiological	physiological	ADJ
ajlm-123	28	105	process	process	NOUN
ajlm-123	28	106	;	;	PUNCT
ajlm-123	28	107	support	support	NOUN
ajlm-123	28	108	or	or	CCONJ
ajlm-123	28	109	sustenance	sustenance	NOUN
ajlm-123	28	110	of	of	ADP
ajlm-123	28	111	life	life	NOUN
ajlm-123	28	112	;	;	PUNCT
ajlm-123	28	113	control	control	NOUN
ajlm-123	28	114	of	of	ADP
ajlm-123	28	115	conception	conception	NOUN
ajlm-123	28	116	;	;	PUNCT
ajlm-123	28	117	disinfection	disinfection	NOUN
ajlm-123	28	118	of	of	ADP
ajlm-123	28	119	medical	medical	ADJ
ajlm-123	28	120	devices	device	NOUN
ajlm-123	28	121	;	;	PUNCT
ajlm-123	28	122	provision	provision	NOUN
ajlm-123	28	123	of	of	ADP
ajlm-123	28	124	information	information	NOUN
ajlm-123	28	125	by	by	ADP
ajlm-123	28	126	means	mean	NOUN
ajlm-123	28	127	of	of	ADP
ajlm-123	28	128	in	in	ADP
ajlm-123	28	129	vitro	vitro	X
ajlm-123	28	130	examination	examination	NOUN
ajlm-123	28	131	of	of	ADP
ajlm-123	28	132	specimens	specimen	NOUN
ajlm-123	28	133	derived	derive	VERB
ajlm-123	28	134	from	from	ADP
ajlm-123	28	135	the	the	DET
ajlm-123	28	136	human	human	ADJ
ajlm-123	28	137	body.7	body.7	PROPN
ajlm-123	28	138	an	an	DET
ajlm-123	28	139	ivd	ivd	NOUN
ajlm-123	28	140	is	be	AUX
ajlm-123	28	141	defined	define	VERB
ajlm-123	28	142	as	as	ADP
ajlm-123	28	143	:	:	PUNCT
ajlm-123	28	144	medical	medical	ADJ
ajlm-123	28	145	device	device	NOUN
ajlm-123	28	146	,	,	PUNCT
ajlm-123	28	147	whether	whether	SCONJ
ajlm-123	28	148	used	use	VERB
ajlm-123	28	149	alone	alone	ADV
ajlm-123	28	150	or	or	CCONJ
ajlm-123	28	151	in	in	ADP
ajlm-123	28	152	combination	combination	NOUN
ajlm-123	28	153	,	,	PUNCT
ajlm-123	28	154	intended	intend	VERB
ajlm-123	28	155	by	by	ADP
ajlm-123	28	156	the	the	DET
ajlm-123	28	157	manufacturer	manufacturer	NOUN
ajlm-123	28	158	for	for	ADP
ajlm-123	28	159	the	the	DET
ajlm-123	28	160	in	in	X
ajlm-123	28	161	vitro	vitro	X
ajlm-123	28	162	examination	examination	NOUN
ajlm-123	28	163	of	of	ADP
ajlm-123	28	164	specimens	specimen	NOUN
ajlm-123	28	165	derived	derive	VERB
ajlm-123	28	166	from	from	ADP
ajlm-123	28	167	the	the	DET
ajlm-123	28	168	human	human	ADJ
ajlm-123	28	169	body	body	NOUN
ajlm-123	28	170	solely	solely	ADV
ajlm-123	28	171	or	or	CCONJ
ajlm-123	28	172	principally	principally	ADV
ajlm-123	28	173	to	to	PART
ajlm-123	28	174	provide	provide	VERB
ajlm-123	28	175	information	information	NOUN
ajlm-123	28	176	for	for	ADP
ajlm-123	28	177	diagnostic	diagnostic	ADJ
ajlm-123	28	178	,	,	PUNCT
ajlm-123	28	179	monitoring	monitoring	NOUN
ajlm-123	28	180	or	or	CCONJ
ajlm-123	28	181	compatibility	compatibility	NOUN
ajlm-123	28	182	purposes.7	purposes.7	NOUN
ajlm-123	28	183	most	most	ADJ
ajlm-123	28	184	countries	country	NOUN
ajlm-123	28	185	have	have	VERB
ajlm-123	28	186	a	a	DET
ajlm-123	28	187	legal	legal	ADJ
ajlm-123	28	188	framework	framework	NOUN
ajlm-123	28	189	and	and	CCONJ
ajlm-123	28	190	a	a	DET
ajlm-123	28	191	nominated	nominate	VERB
ajlm-123	28	192	body	body	NOUN
ajlm-123	28	193	to	to	PART
ajlm-123	28	194	regulate	regulate	VERB
ajlm-123	28	195	medicines	medicine	NOUN
ajlm-123	28	196	,	,	PUNCT
ajlm-123	28	197	but	but	CCONJ
ajlm-123	28	198	regulation	regulation	NOUN
ajlm-123	28	199	of	of	ADP
ajlm-123	28	200	medical	medical	ADJ
ajlm-123	28	201	devices	device	NOUN
ajlm-123	28	202	in	in	ADP
ajlm-123	28	203	developing	develop	VERB
ajlm-123	28	204	countries	country	NOUN
ajlm-123	28	205	is	be	AUX
ajlm-123	28	206	less	less	ADJ
ajlm-123	28	207	common.8	common.8	PUNCT
ajlm-123	28	208	the	the	DET
ajlm-123	28	209	demands	demand	NOUN
ajlm-123	28	210	on	on	ADP
ajlm-123	28	211	regulatory	regulatory	ADJ
ajlm-123	28	212	authorities	authority	NOUN
ajlm-123	28	213	for	for	ADP
ajlm-123	28	214	ivds	ivds	NOUN
ajlm-123	28	215	differ	differ	VERB
ajlm-123	28	216	from	from	ADP
ajlm-123	28	217	that	that	PRON
ajlm-123	28	218	of	of	ADP
ajlm-123	28	219	other	other	ADJ
ajlm-123	28	220	medical	medical	ADJ
ajlm-123	28	221	products	product	NOUN
ajlm-123	28	222	in	in	ADP
ajlm-123	28	223	that	that	SCONJ
ajlm-123	28	224	there	there	PRON
ajlm-123	28	225	are	be	VERB
ajlm-123	28	226	a	a	DET
ajlm-123	28	227	very	very	ADV
ajlm-123	28	228	large	large	ADJ
ajlm-123	28	229	number	number	NOUN
ajlm-123	28	230	of	of	ADP
ajlm-123	28	231	ivds	ivds	NOUN
ajlm-123	28	232	and	and	CCONJ
ajlm-123	28	233	,	,	PUNCT
ajlm-123	28	234	compared	compare	VERB
ajlm-123	28	235	with	with	ADP
ajlm-123	28	236	drugs	drug	NOUN
ajlm-123	28	237	or	or	CCONJ
ajlm-123	28	238	vaccines	vaccine	NOUN
ajlm-123	28	239	,	,	PUNCT
ajlm-123	28	240	their	their	PRON
ajlm-123	28	241	market	market	NOUN
ajlm-123	28	242	life	life	NOUN
ajlm-123	28	243	is	be	AUX
ajlm-123	28	244	often	often	ADV
ajlm-123	28	245	short	short	ADJ
ajlm-123	28	246	given	give	VERB
ajlm-123	28	247	the	the	DET
ajlm-123	28	248	rapid	rapid	ADJ
ajlm-123	28	249	pace	pace	NOUN
ajlm-123	28	250	of	of	ADP
ajlm-123	28	251	technology	technology	NOUN
ajlm-123	28	252	development.9	development.9	VERB
ajlm-123	28	253	current	current	ADJ
ajlm-123	28	254	regulatory	regulatory	ADJ
ajlm-123	28	255	oversight	oversight	NOUN
ajlm-123	28	256	of	of	ADP
ajlm-123	28	257	ivds	ivds	NOUN
ajlm-123	28	258	is	be	AUX
ajlm-123	28	259	variable8	variable8	NOUN
ajlm-123	28	260	and	and	CCONJ
ajlm-123	28	261	,	,	PUNCT
ajlm-123	28	262	in	in	ADP
ajlm-123	28	263	countries	country	NOUN
ajlm-123	28	264	where	where	SCONJ
ajlm-123	28	265	there	there	PRON
ajlm-123	28	266	is	be	VERB
ajlm-123	28	267	no	no	DET
ajlm-123	28	268	regulation	regulation	NOUN
ajlm-123	28	269	,	,	PUNCT
ajlm-123	28	270	substandard	substandard	ADJ
ajlm-123	28	271	and	and	CCONJ
ajlm-123	28	272	counterfeit	counterfeit	ADJ
ajlm-123	28	273	tests	test	NOUN
ajlm-123	28	274	may	may	AUX
ajlm-123	28	275	be	be	AUX
ajlm-123	28	276	sold	sell	VERB
ajlm-123	28	277	openly.10	openly.10	ADJ
ajlm-123	28	278	in	in	ADP
ajlm-123	28	279	countries	country	NOUN
ajlm-123	28	280	that	that	PRON
ajlm-123	28	281	do	do	AUX
ajlm-123	28	282	regulate	regulate	VERB
ajlm-123	28	283	,	,	PUNCT
ajlm-123	28	284	approval	approval	NOUN
ajlm-123	28	285	for	for	ADP
ajlm-123	28	286	ivds	ivds	NOUN
ajlm-123	28	287	is	be	AUX
ajlm-123	28	288	often	often	ADV
ajlm-123	28	289	costly	costly	ADJ
ajlm-123	28	290	,	,	PUNCT
ajlm-123	28	291	lengthy	lengthy	ADJ
ajlm-123	28	292	and	and	CCONJ
ajlm-123	28	293	,	,	PUNCT
ajlm-123	28	294	on	on	ADP
ajlm-123	28	295	occasion	occasion	NOUN
ajlm-123	28	296	,	,	PUNCT
ajlm-123	28	297	lacking	lack	VERB
ajlm-123	28	298	in	in	ADP
ajlm-123	28	299	transparency	transparency	NOUN
ajlm-123	28	300	,	,	PUNCT
ajlm-123	28	301	thus	thus	ADV
ajlm-123	28	302	regulation	regulation	NOUN
ajlm-123	28	303	of	of	ADP
ajlm-123	28	304	diagnostics	diagnostic	NOUN
ajlm-123	28	305	is	be	AUX
ajlm-123	28	306	currently	currently	ADV
ajlm-123	28	307	seen	see	VERB
ajlm-123	28	308	as	as	ADP
ajlm-123	28	309	a	a	DET
ajlm-123	28	310	barrier	barrier	NOUN
ajlm-123	28	311	to	to	ADP
ajlm-123	28	312	innovation	innovation	NOUN
ajlm-123	28	313	and	and	CCONJ
ajlm-123	28	314	access.9,11,12	access.9,11,12	NOUN
ajlm-123	28	315	in	in	ADP
ajlm-123	28	316	2001	2001	NUM
ajlm-123	28	317	,	,	PUNCT
ajlm-123	28	318	the	the	DET
ajlm-123	28	319	pan	pan	PROPN
ajlm-123	28	320	american	american	PROPN
ajlm-123	28	321	health	health	PROPN
ajlm-123	28	322	organisation	organisation	NOUN
ajlm-123	28	323	(	(	PUNCT
ajlm-123	28	324	paho	paho	NOUN
ajlm-123	28	325	)	)	PUNCT
ajlm-123	28	326	,	,	PUNCT
ajlm-123	28	327	the	the	DET
ajlm-123	28	328	regional	regional	ADJ
ajlm-123	28	329	office	office	NOUN
ajlm-123	28	330	for	for	ADP
ajlm-123	28	331	the	the	DET
ajlm-123	28	332	americas	america	NOUN
ajlm-123	28	333	of	of	ADP
ajlm-123	28	334	the	the	DET
ajlm-123	28	335	world	world	PROPN
ajlm-123	28	336	health	health	NOUN
ajlm-123	28	337	organization	organization	NOUN
ajlm-123	28	338	(	(	PUNCT
ajlm-123	28	339	who	who	PRON
ajlm-123	28	340	)	)	PUNCT
ajlm-123	28	341	and	and	CCONJ
ajlm-123	28	342	the	the	DET
ajlm-123	28	343	united	united	PROPN
ajlm-123	28	344	states	states	PROPN
ajlm-123	28	345	food	food	PROPN
ajlm-123	28	346	and	and	CCONJ
ajlm-123	28	347	drug	drug	PROPN
ajlm-123	28	348	administration	administration	PROPN
ajlm-123	28	349	(	(	PUNCT
ajlm-123	28	350	usfda	usfda	PROPN
ajlm-123	28	351	)	)	PUNCT
ajlm-123	28	352	published	publish	VERB
ajlm-123	28	353	a	a	DET
ajlm-123	28	354	model	model	ADJ
ajlm-123	28	355	regulatory	regulatory	ADJ
ajlm-123	28	356	programme	programme	NOUN
ajlm-123	28	357	for	for	ADP
ajlm-123	28	358	medical	medical	ADJ
ajlm-123	28	359	devices	device	NOUN
ajlm-123	28	360	,	,	PUNCT
ajlm-123	28	361	with	with	ADP
ajlm-123	28	362	a	a	DET
ajlm-123	28	363	set	set	NOUN
ajlm-123	28	364	of	of	ADP
ajlm-123	28	365	guiding	guide	VERB
ajlm-123	28	366	principles.13	principles.13	NOUN
ajlm-123	28	367	these	these	DET
ajlm-123	28	368	principles	principle	NOUN
ajlm-123	28	369	include	include	VERB
ajlm-123	28	370	the	the	DET
ajlm-123	28	371	statement	statement	NOUN
ajlm-123	28	372	that	that	SCONJ
ajlm-123	28	373	:	:	PUNCT
ajlm-123	28	374	regulatory	regulatory	ADJ
ajlm-123	28	375	system	system	NOUN
ajlm-123	28	376	should	should	AUX
ajlm-123	28	377	ensure	ensure	VERB
ajlm-123	28	378	that	that	SCONJ
ajlm-123	28	379	valuable	valuable	ADJ
ajlm-123	28	380	new	new	ADJ
ajlm-123	28	381	technologies	technology	NOUN
ajlm-123	28	382	are	be	AUX
ajlm-123	28	383	made	make	VERB
ajlm-123	28	384	available	available	ADJ
ajlm-123	28	385	to	to	ADP
ajlm-123	28	386	the	the	DET
ajlm-123	28	387	clinical	clinical	ADJ
ajlm-123	28	388	community	community	NOUN
ajlm-123	28	389	and	and	CCONJ
ajlm-123	28	390	to	to	ADP
ajlm-123	28	391	patients	patient	NOUN
ajlm-123	28	392	and	and	CCONJ
ajlm-123	28	393	consumers	consumer	NOUN
ajlm-123	28	394	expeditiously	expeditiously	ADV
ajlm-123	28	395	while	while	SCONJ
ajlm-123	28	396	preventing	prevent	VERB
ajlm-123	28	397	unsafe	unsafe	ADJ
ajlm-123	28	398	or	or	CCONJ
ajlm-123	28	399	ineffective	ineffective	ADJ
ajlm-123	28	400	devices	device	NOUN
ajlm-123	28	401	from	from	ADP
ajlm-123	28	402	reaching	reach	VERB
ajlm-123	28	403	the	the	DET
ajlm-123	28	404	market.13	market.13	NOUN
ajlm-123	28	405	they	they	PRON
ajlm-123	28	406	also	also	ADV
ajlm-123	28	407	state	state	VERB
ajlm-123	28	408	that	that	SCONJ
ajlm-123	28	409	regulatory	regulatory	ADJ
ajlm-123	28	410	decisions	decision	NOUN
ajlm-123	28	411	must	must	AUX
ajlm-123	28	412	be	be	AUX
ajlm-123	28	413	based	base	VERB
ajlm-123	28	414	on	on	ADP
ajlm-123	28	415	strong	strong	ADJ
ajlm-123	28	416	and	and	CCONJ
ajlm-123	28	417	clear	clear	ADJ
ajlm-123	28	418	science	science	NOUN
ajlm-123	28	419	,	,	PUNCT
ajlm-123	28	420	free	free	ADJ
ajlm-123	28	421	of	of	ADP
ajlm-123	28	422	external	external	ADJ
ajlm-123	28	423	influences	influence	NOUN
ajlm-123	28	424	and	and	CCONJ
ajlm-123	28	425	,	,	PUNCT
ajlm-123	28	426	in	in	ADP
ajlm-123	28	427	addition	addition	NOUN
ajlm-123	28	428	,	,	PUNCT
ajlm-123	28	429	that	that	SCONJ
ajlm-123	28	430	countries	country	NOUN
ajlm-123	28	431	instituting	institute	VERB
ajlm-123	28	432	regulatory	regulatory	ADJ
ajlm-123	28	433	programmes	programme	NOUN
ajlm-123	28	434	should	should	AUX
ajlm-123	28	435	be	be	AUX
ajlm-123	28	436	cognisant	cognisant	ADJ
ajlm-123	28	437	of	of	ADP
ajlm-123	28	438	ongoing	ongoing	ADJ
ajlm-123	28	439	international	international	ADJ
ajlm-123	28	440	efforts	effort	NOUN
ajlm-123	28	441	to	to	PART
ajlm-123	28	442	harmonise	harmonise	VERB
ajlm-123	28	443	activities	activity	NOUN
ajlm-123	28	444	.	.	PUNCT
ajlm-123	29	1	regulatory	regulatory	ADJ
ajlm-123	29	2	control	control	NOUN
ajlm-123	29	3	of	of	ADP
ajlm-123	29	4	ivd	ivd	PROPN
ajlm-123	29	5	has	have	VERB
ajlm-123	29	6	three	three	NUM
ajlm-123	29	7	components	component	NOUN
ajlm-123	29	8	:	:	PUNCT
ajlm-123	29	9	•	•	NUM
ajlm-123	29	10	pre	pre	ADJ
ajlm-123	29	11	-	-	ADJ
ajlm-123	29	12	market	market	ADJ
ajlm-123	29	13	evaluation	evaluation	NOUN
ajlm-123	29	14	:	:	PUNCT
ajlm-123	29	15	to	to	PART
ajlm-123	29	16	assess	assess	VERB
ajlm-123	29	17	safety	safety	NOUN
ajlm-123	29	18	,	,	PUNCT
ajlm-123	29	19	performance	performance	NOUN
ajlm-123	29	20	,	,	PUNCT
ajlm-123	29	21	benefits	benefit	NOUN
ajlm-123	29	22	and	and	CCONJ
ajlm-123	29	23	risks	risk	NOUN
ajlm-123	29	24	prior	prior	ADV
ajlm-123	29	25	to	to	ADP
ajlm-123	29	26	approval	approval	NOUN
ajlm-123	29	27	to	to	PART
ajlm-123	29	28	market	market	VERB
ajlm-123	29	29	the	the	DET
ajlm-123	29	30	device	device	NOUN
ajlm-123	29	31	.	.	PUNCT
ajlm-123	30	1	•	•	NUM
ajlm-123	30	2	marketing	marketing	NOUN
ajlm-123	30	3	controls	control	NOUN
ajlm-123	30	4	:	:	PUNCT
ajlm-123	30	5	to	to	PART
ajlm-123	30	6	stipulate	stipulate	VERB
ajlm-123	30	7	conditions	condition	NOUN
ajlm-123	30	8	under	under	ADP
ajlm-123	30	9	which	which	PRON
ajlm-123	30	10	devices	device	NOUN
ajlm-123	30	11	can	can	AUX
ajlm-123	30	12	be	be	AUX
ajlm-123	30	13	offered	offer	VERB
ajlm-123	30	14	for	for	ADP
ajlm-123	30	15	sale	sale	NOUN
ajlm-123	30	16	;	;	PUNCT
ajlm-123	30	17	identify	identify	VERB
ajlm-123	30	18	who	who	PRON
ajlm-123	30	19	may	may	AUX
ajlm-123	30	20	use	use	VERB
ajlm-123	30	21	the	the	DET
ajlm-123	30	22	device	device	NOUN
ajlm-123	30	23	and	and	CCONJ
ajlm-123	30	24	under	under	ADP
ajlm-123	30	25	what	what	DET
ajlm-123	30	26	conditions	condition	NOUN
ajlm-123	30	27	;	;	PUNCT
ajlm-123	30	28	and	and	CCONJ
ajlm-123	30	29	to	to	PART
ajlm-123	30	30	avoid	avoid	VERB
ajlm-123	30	31	inappropriate	inappropriate	ADJ
ajlm-123	30	32	marketing	marketing	NOUN
ajlm-123	30	33	or	or	CCONJ
ajlm-123	30	34	misleading	mislead	VERB
ajlm-123	30	35	claims	claim	NOUN
ajlm-123	30	36	regarding	regard	VERB
ajlm-123	30	37	test	test	NOUN
ajlm-123	30	38	effectiveness	effectiveness	NOUN
ajlm-123	30	39	.	.	PUNCT
ajlm-123	31	1	•	•	NUM
ajlm-123	31	2	post	post	ADJ
ajlm-123	31	3	-	-	ADJ
ajlm-123	31	4	marketing	marketing	ADJ
ajlm-123	31	5	controls	control	NOUN
ajlm-123	31	6	:	:	PUNCT
ajlm-123	31	7	to	to	PART
ajlm-123	31	8	maintain	maintain	VERB
ajlm-123	31	9	vigilance	vigilance	NOUN
ajlm-123	31	10	and	and	CCONJ
ajlm-123	31	11	continued	continued	ADJ
ajlm-123	31	12	safety	safety	NOUN
ajlm-123	31	13	and	and	CCONJ
ajlm-123	31	14	quality	quality	NOUN
ajlm-123	31	15	of	of	ADP
ajlm-123	31	16	approved	approve	VERB
ajlm-123	31	17	products	product	NOUN
ajlm-123	31	18	that	that	PRON
ajlm-123	31	19	entails	entail	VERB
ajlm-123	31	20	a	a	DET
ajlm-123	31	21	method	method	NOUN
ajlm-123	31	22	for	for	ADP
ajlm-123	31	23	information	information	NOUN
ajlm-123	31	24	-	-	PUNCT
ajlm-123	31	25	sharing	sharing	NOUN
ajlm-123	31	26	amongst	amongst	ADP
ajlm-123	31	27	users	user	NOUN
ajlm-123	31	28	within	within	ADP
ajlm-123	31	29	the	the	DET
ajlm-123	31	30	country	country	NOUN
ajlm-123	31	31	and	and	CCONJ
ajlm-123	31	32	across	across	ADP
ajlm-123	31	33	national	national	ADJ
ajlm-123	31	34	health	health	NOUN
ajlm-123	31	35	authorities	authority	NOUN
ajlm-123	31	36	.	.	PUNCT
ajlm-123	32	1	there	there	PRON
ajlm-123	32	2	should	should	AUX
ajlm-123	32	3	be	be	AUX
ajlm-123	32	4	a	a	DET
ajlm-123	32	5	means	means	NOUN
ajlm-123	32	6	by	by	ADP
ajlm-123	32	7	which	which	PRON
ajlm-123	32	8	corrections	correction	NOUN
ajlm-123	32	9	can	can	AUX
ajlm-123	32	10	be	be	AUX
ajlm-123	32	11	made	make	VERB
ajlm-123	32	12	as	as	ADV
ajlm-123	32	13	well	well	ADV
ajlm-123	32	14	as	as	ADP
ajlm-123	32	15	a	a	DET
ajlm-123	32	16	mechanism	mechanism	NOUN
ajlm-123	32	17	for	for	ADP
ajlm-123	32	18	removing	remove	VERB
ajlm-123	32	19	substandard	substandard	ADJ
ajlm-123	32	20	products	product	NOUN
ajlm-123	32	21	that	that	PRON
ajlm-123	32	22	pose	pose	VERB
ajlm-123	32	23	a	a	DET
ajlm-123	32	24	risk	risk	NOUN
ajlm-123	32	25	to	to	ADP
ajlm-123	32	26	public	public	ADJ
ajlm-123	32	27	health	health	NOUN
ajlm-123	32	28	.	.	PUNCT
ajlm-123	33	1	risk	risk	NOUN
ajlm-123	33	2	classification	classification	NOUN
ajlm-123	33	3	of	of	ADP
ajlm-123	33	4	in	in	ADP
ajlm-123	33	5	vitro	vitro	X
ajlm-123	33	6	diagnostic	diagnostic	ADJ
ajlm-123	33	7	medical	medical	ADJ
ajlm-123	33	8	devices	device	NOUN
ajlm-123	33	9	the	the	DET
ajlm-123	33	10	degree	degree	NOUN
ajlm-123	33	11	of	of	ADP
ajlm-123	33	12	regulatory	regulatory	ADJ
ajlm-123	33	13	control	control	NOUN
ajlm-123	33	14	for	for	ADP
ajlm-123	33	15	a	a	DET
ajlm-123	33	16	medical	medical	ADJ
ajlm-123	33	17	device	device	NOUN
ajlm-123	33	18	should	should	AUX
ajlm-123	33	19	be	be	AUX
ajlm-123	33	20	proportionate	proportionate	ADJ
ajlm-123	33	21	to	to	ADP
ajlm-123	33	22	the	the	DET
ajlm-123	33	23	risk	risk	NOUN
ajlm-123	33	24	posed	pose	VERB
ajlm-123	33	25	by	by	ADP
ajlm-123	33	26	the	the	DET
ajlm-123	33	27	product	product	NOUN
ajlm-123	33	28	.	.	PUNCT
ajlm-123	34	1	unlike	unlike	ADP
ajlm-123	34	2	medicines	medicine	NOUN
ajlm-123	34	3	or	or	CCONJ
ajlm-123	34	4	vaccines	vaccine	NOUN
ajlm-123	34	5	,	,	PUNCT
ajlm-123	34	6	ivds	ivds	PROPN
ajlm-123	34	7	are	be	AUX
ajlm-123	34	8	not	not	PART
ajlm-123	34	9	ingested	ingest	VERB
ajlm-123	34	10	by	by	ADP
ajlm-123	34	11	the	the	DET
ajlm-123	34	12	patient	patient	NOUN
ajlm-123	34	13	,	,	PUNCT
ajlm-123	34	14	greatly	greatly	ADV
ajlm-123	34	15	reducing	reduce	VERB
ajlm-123	34	16	the	the	DET
ajlm-123	34	17	potential	potential	NOUN
ajlm-123	34	18	for	for	ADP
ajlm-123	34	19	harm	harm	NOUN
ajlm-123	34	20	.	.	PUNCT
ajlm-123	35	1	thus	thus	ADV
ajlm-123	35	2	the	the	DET
ajlm-123	35	3	stringency	stringency	NOUN
ajlm-123	35	4	of	of	ADP
ajlm-123	35	5	regulatory	regulatory	ADJ
ajlm-123	35	6	oversight	oversight	NOUN
ajlm-123	35	7	required	require	VERB
ajlm-123	35	8	is	be	AUX
ajlm-123	35	9	related	relate	VERB
ajlm-123	35	10	to	to	ADP
ajlm-123	35	11	the	the	DET
ajlm-123	35	12	harm	harm	NOUN
ajlm-123	35	13	that	that	SCONJ
ajlm-123	35	14	a	a	DET
ajlm-123	35	15	false	false	ADJ
ajlm-123	35	16	positive	positive	ADJ
ajlm-123	35	17	or	or	CCONJ
ajlm-123	35	18	false	false	ADJ
ajlm-123	35	19	negative	negative	ADJ
ajlm-123	35	20	test	test	NOUN
ajlm-123	35	21	result	result	NOUN
ajlm-123	35	22	may	may	AUX
ajlm-123	35	23	cause	cause	VERB
ajlm-123	35	24	to	to	ADP
ajlm-123	35	25	either	either	CCONJ
ajlm-123	35	26	individual	individual	ADJ
ajlm-123	35	27	or	or	CCONJ
ajlm-123	35	28	public	public	ADJ
ajlm-123	35	29	health	health	NOUN
ajlm-123	35	30	.	.	PUNCT
ajlm-123	36	1	reagents	reagent	NOUN
ajlm-123	36	2	used	use	VERB
ajlm-123	36	3	in	in	ADP
ajlm-123	36	4	diagnostics	diagnostic	NOUN
ajlm-123	36	5	tests	test	NOUN
ajlm-123	36	6	,	,	PUNCT
ajlm-123	36	7	such	such	ADJ
ajlm-123	36	8	as	as	ADP
ajlm-123	36	9	microbiological	microbiological	ADJ
ajlm-123	36	10	stains	stain	NOUN
ajlm-123	36	11	or	or	CCONJ
ajlm-123	36	12	culture	culture	NOUN
ajlm-123	36	13	media	medium	NOUN
ajlm-123	36	14	,	,	PUNCT
ajlm-123	36	15	by	by	ADP
ajlm-123	36	16	themselves	themselves	PRON
ajlm-123	36	17	pose	pose	VERB
ajlm-123	36	18	little	little	ADJ
ajlm-123	36	19	risk	risk	NOUN
ajlm-123	36	20	to	to	ADP
ajlm-123	36	21	human	human	ADJ
ajlm-123	36	22	or	or	CCONJ
ajlm-123	36	23	public	public	ADJ
ajlm-123	36	24	health	health	NOUN
ajlm-123	36	25	and	and	CCONJ
ajlm-123	36	26	are	be	AUX
ajlm-123	36	27	classed	class	VERB
ajlm-123	36	28	as	as	ADP
ajlm-123	36	29	low	low	ADJ
ajlm-123	36	30	risk	risk	NOUN
ajlm-123	36	31	.	.	PUNCT
ajlm-123	37	1	high	high	ADJ
ajlm-123	37	2	risk	risk	NOUN
ajlm-123	37	3	tests	test	NOUN
ajlm-123	37	4	include	include	VERB
ajlm-123	37	5	those	those	PRON
ajlm-123	37	6	used	use	VERB
ajlm-123	37	7	to	to	PART
ajlm-123	37	8	screen	screen	VERB
ajlm-123	37	9	for	for	ADP
ajlm-123	37	10	infections	infection	NOUN
ajlm-123	37	11	such	such	ADJ
ajlm-123	37	12	as	as	ADP
ajlm-123	37	13	hiv	hiv	PROPN
ajlm-123	37	14	,	,	PUNCT
ajlm-123	37	15	where	where	SCONJ
ajlm-123	37	16	a	a	DET
ajlm-123	37	17	false	false	ADJ
ajlm-123	37	18	negative	negative	ADJ
ajlm-123	37	19	test	test	NOUN
ajlm-123	37	20	result	result	NOUN
ajlm-123	37	21	could	could	AUX
ajlm-123	37	22	lead	lead	VERB
ajlm-123	37	23	to	to	ADP
ajlm-123	37	24	the	the	DET
ajlm-123	37	25	individual	individual	NOUN
ajlm-123	37	26	not	not	PART
ajlm-123	37	27	being	be	AUX
ajlm-123	37	28	given	give	VERB
ajlm-123	37	29	life	life	NOUN
ajlm-123	37	30	-	-	PUNCT
ajlm-123	37	31	saving	save	VERB
ajlm-123	37	32	drugs	drug	NOUN
ajlm-123	37	33	and	and	CCONJ
ajlm-123	37	34	continuing	continue	VERB
ajlm-123	37	35	to	to	PART
ajlm-123	37	36	transmit	transmit	VERB
ajlm-123	37	37	the	the	DET
ajlm-123	37	38	infection	infection	NOUN
ajlm-123	37	39	within	within	ADP
ajlm-123	37	40	the	the	DET
ajlm-123	37	41	community	community	NOUN
ajlm-123	37	42	.	.	PUNCT
ajlm-123	38	1	should	should	AUX
ajlm-123	38	2	the	the	DET
ajlm-123	38	3	test	test	NOUN
ajlm-123	38	4	be	be	AUX
ajlm-123	38	5	used	use	VERB
ajlm-123	38	6	to	to	PART
ajlm-123	38	7	screen	screen	VERB
ajlm-123	38	8	blood	blood	NOUN
ajlm-123	38	9	products	product	NOUN
ajlm-123	38	10	,	,	PUNCT
ajlm-123	38	11	then	then	ADV
ajlm-123	38	12	recipients	recipient	NOUN
ajlm-123	38	13	of	of	ADP
ajlm-123	38	14	that	that	DET
ajlm-123	38	15	donation	donation	NOUN
ajlm-123	38	16	would	would	AUX
ajlm-123	38	17	be	be	AUX
ajlm-123	38	18	at	at	ADP
ajlm-123	38	19	risk	risk	NOUN
ajlm-123	38	20	of	of	ADP
ajlm-123	38	21	acquiring	acquire	VERB
ajlm-123	38	22	a	a	DET
ajlm-123	38	23	life	life	NOUN
ajlm-123	38	24	-	-	PUNCT
ajlm-123	38	25	threatening	threaten	VERB
ajlm-123	38	26	disease	disease	NOUN
ajlm-123	38	27	.	.	PUNCT
ajlm-123	39	1	such	such	ADJ
ajlm-123	39	2	tests	test	NOUN
ajlm-123	39	3	require	require	VERB
ajlm-123	39	4	more	more	ADV
ajlm-123	39	5	stringent	stringent	ADJ
ajlm-123	39	6	control	control	NOUN
ajlm-123	39	7	,	,	PUNCT
ajlm-123	39	8	including	include	VERB
ajlm-123	39	9	evidence	evidence	NOUN
ajlm-123	39	10	of	of	ADP
ajlm-123	39	11	their	their	PRON
ajlm-123	39	12	performance	performance	NOUN
ajlm-123	39	13	as	as	SCONJ
ajlm-123	39	14	obtained	obtain	VERB
ajlm-123	39	15	through	through	ADP
ajlm-123	39	16	clinical	clinical	ADJ
ajlm-123	39	17	studies	study	NOUN
ajlm-123	39	18	.	.	PUNCT
ajlm-123	40	1	to	to	PART
ajlm-123	40	2	guide	guide	VERB
ajlm-123	40	3	the	the	DET
ajlm-123	40	4	regulatory	regulatory	ADJ
ajlm-123	40	5	process	process	NOUN
ajlm-123	40	6	,	,	PUNCT
ajlm-123	40	7	products	product	NOUN
ajlm-123	40	8	are	be	AUX
ajlm-123	40	9	grouped	group	VERB
ajlm-123	40	10	or	or	CCONJ
ajlm-123	40	11	classified	classify	VERB
ajlm-123	40	12	according	accord	VERB
ajlm-123	40	13	to	to	ADP
ajlm-123	40	14	their	their	PRON
ajlm-123	40	15	risk	risk	NOUN
ajlm-123	40	16	of	of	ADP
ajlm-123	40	17	causing	cause	VERB
ajlm-123	40	18	harm	harm	NOUN
ajlm-123	40	19	.	.	PUNCT
ajlm-123	41	1	in	in	ADP
ajlm-123	41	2	2006	2006	NUM
ajlm-123	41	3	,	,	PUNCT
ajlm-123	41	4	the	the	DET
ajlm-123	41	5	global	global	ADJ
ajlm-123	41	6	harmonization	harmonization	PROPN
ajlm-123	41	7	task	task	PROPN
ajlm-123	41	8	force	force	NOUN
ajlm-123	41	9	(	(	PUNCT
ajlm-123	41	10	ghtf	ghtf	PROPN
ajlm-123	41	11	)	)	PUNCT
ajlm-123	41	12	,	,	PUNCT
ajlm-123	41	13	a	a	DET
ajlm-123	41	14	voluntary	voluntary	ADJ
ajlm-123	41	15	partnership	partnership	NOUN
ajlm-123	41	16	of	of	ADP
ajlm-123	41	17	stringent	stringent	ADJ
ajlm-123	41	18	regulatory	regulatory	ADJ
ajlm-123	41	19	authorities	authority	NOUN
ajlm-123	41	20	and	and	CCONJ
ajlm-123	41	21	diagnostic	diagnostic	ADJ
ajlm-123	41	22	companies	company	NOUN
ajlm-123	41	23	,	,	PUNCT
ajlm-123	41	24	published	publish	VERB
ajlm-123	41	25	recommendations	recommendation	NOUN
ajlm-123	41	26	regarding	regard	VERB
ajlm-123	41	27	classification	classification	NOUN
ajlm-123	41	28	of	of	ADP
ajlm-123	41	29	medical	medical	ADJ
ajlm-123	41	30	devices	device	NOUN
ajlm-123	41	31	.	.	PUNCT
ajlm-123	42	1	they	they	PRON
ajlm-123	42	2	suggested	suggest	VERB
ajlm-123	42	3	that	that	SCONJ
ajlm-123	42	4	each	each	DET
ajlm-123	42	5	medical	medical	ADJ
ajlm-123	42	6	device	device	NOUN
ajlm-123	42	7	be	be	AUX
ajlm-123	42	8	assigned	assign	VERB
ajlm-123	42	9	to	to	ADP
ajlm-123	42	10	one	one	NUM
ajlm-123	42	11	of	of	ADP
ajlm-123	42	12	four	four	NUM
ajlm-123	42	13	classes	class	NOUN
ajlm-123	42	14	based	base	VERB
ajlm-123	42	15	upon	upon	SCONJ
ajlm-123	42	16	its	its	PRON
ajlm-123	42	17	intended	intend	VERB
ajlm-123	42	18	use	use	NOUN
ajlm-123	42	19	(	(	PUNCT
ajlm-123	42	20	table	table	NOUN
ajlm-123	42	21	1).14	1).14	NUM
ajlm-123	42	22	classification	classification	NOUN
ajlm-123	42	23	provides	provide	VERB
ajlm-123	42	24	a	a	DET
ajlm-123	42	25	mechanism	mechanism	NOUN
ajlm-123	42	26	by	by	ADP
ajlm-123	42	27	which	which	PRON
ajlm-123	42	28	the	the	DET
ajlm-123	42	29	cost	cost	NOUN
ajlm-123	42	30	and	and	CCONJ
ajlm-123	42	31	delay	delay	NOUN
ajlm-123	42	32	of	of	ADP
ajlm-123	42	33	registration	registration	NOUN
ajlm-123	42	34	are	be	AUX
ajlm-123	42	35	moderated	moderate	VERB
ajlm-123	42	36	according	accord	VERB
ajlm-123	42	37	to	to	ADP
ajlm-123	42	38	the	the	DET
ajlm-123	42	39	potential	potential	NOUN
ajlm-123	42	40	of	of	ADP
ajlm-123	42	41	a	a	DET
ajlm-123	42	42	product	product	NOUN
ajlm-123	42	43	to	to	PART
ajlm-123	42	44	cause	cause	VERB
ajlm-123	42	45	harm	harm	NOUN
ajlm-123	42	46	.	.	PUNCT
ajlm-123	43	1	manufacturers	manufacturer	NOUN
ajlm-123	43	2	are	be	AUX
ajlm-123	43	3	required	require	VERB
ajlm-123	43	4	to	to	PART
ajlm-123	43	5	provide	provide	VERB
ajlm-123	43	6	less	less	ADJ
ajlm-123	43	7	-	-	PUNCT
ajlm-123	43	8	substantial	substantial	ADJ
ajlm-123	43	9	submission	submission	NOUN
ajlm-123	43	10	dossiers	dossier	NOUN
ajlm-123	43	11	for	for	ADP
ajlm-123	43	12	products	product	NOUN
ajlm-123	43	13	in	in	ADP
ajlm-123	43	14	risk	risk	NOUN
ajlm-123	43	15	group	group	NOUN
ajlm-123	43	16	class	class	NOUN
ajlm-123	43	17	a	a	NOUN
ajlm-123	43	18	;	;	PUNCT
ajlm-123	43	19	whereas	whereas	SCONJ
ajlm-123	43	20	class	class	NOUN
ajlm-123	43	21	d	d	PROPN
ajlm-123	43	22	products	product	NOUN
ajlm-123	43	23	require	require	VERB
ajlm-123	43	24	stringent	stringent	ADJ
ajlm-123	43	25	conformity	conformity	NOUN
ajlm-123	43	26	assessment	assessment	NOUN
ajlm-123	43	27	,	,	PUNCT
ajlm-123	43	28	including	include	VERB
ajlm-123	43	29	evidence	evidence	NOUN
ajlm-123	43	30	of	of	ADP
ajlm-123	43	31	performance	performance	NOUN
ajlm-123	43	32	in	in	ADP
ajlm-123	43	33	a	a	DET
ajlm-123	43	34	clinical	clinical	ADJ
ajlm-123	43	35	setting	setting	NOUN
ajlm-123	43	36	that	that	PRON
ajlm-123	43	37	is	be	AUX
ajlm-123	43	38	representative	representative	NOUN
ajlm-123	43	39	of	of	ADP
ajlm-123	43	40	the	the	DET
ajlm-123	43	41	intended	intend	VERB
ajlm-123	43	42	use	use	NOUN
ajlm-123	43	43	.	.	PUNCT
ajlm-123	44	1	for	for	SCONJ
ajlm-123	44	2	devices	device	NOUN
ajlm-123	44	3	to	to	PART
ajlm-123	44	4	be	be	AUX
ajlm-123	44	5	used	use	VERB
ajlm-123	44	6	at	at	ADP
ajlm-123	44	7	the	the	DET
ajlm-123	44	8	poc	poc	NOUN
ajlm-123	44	9	,	,	PUNCT
ajlm-123	44	10	studies	study	NOUN
ajlm-123	44	11	should	should	AUX
ajlm-123	44	12	be	be	AUX
ajlm-123	44	13	conducted	conduct	VERB
ajlm-123	44	14	in	in	ADP
ajlm-123	44	15	the	the	DET
ajlm-123	44	16	settings	setting	NOUN
ajlm-123	44	17	of	of	ADP
ajlm-123	44	18	intended	intended	ADJ
ajlm-123	44	19	use	use	NOUN
ajlm-123	44	20	(	(	PUNCT
ajlm-123	44	21	clinic	clinic	NOUN
ajlm-123	44	22	or	or	CCONJ
ajlm-123	44	23	outreach	outreach	NOUN
ajlm-123	44	24	settings	setting	NOUN
ajlm-123	44	25	)	)	PUNCT
ajlm-123	44	26	with	with	ADP
ajlm-123	44	27	testing	testing	NOUN
ajlm-123	44	28	performed	perform	VERB
ajlm-123	44	29	by	by	ADP
ajlm-123	44	30	local	local	ADJ
ajlm-123	44	31	health	health	NOUN
ajlm-123	44	32	providers	provider	NOUN
ajlm-123	44	33	.	.	PUNCT
ajlm-123	45	1	such	such	ADJ
ajlm-123	45	2	studies	study	NOUN
ajlm-123	45	3	are	be	AUX
ajlm-123	45	4	costly	costly	ADJ
ajlm-123	45	5	and	and	CCONJ
ajlm-123	45	6	,	,	PUNCT
ajlm-123	45	7	for	for	ADP
ajlm-123	45	8	some	some	DET
ajlm-123	45	9	diseases	disease	NOUN
ajlm-123	45	10	,	,	PUNCT
ajlm-123	45	11	may	may	AUX
ajlm-123	45	12	require	require	VERB
ajlm-123	45	13	years	year	NOUN
ajlm-123	45	14	to	to	PART
ajlm-123	45	15	plan	plan	VERB
ajlm-123	45	16	and	and	CCONJ
ajlm-123	45	17	execute	execute	VERB
ajlm-123	45	18	.	.	PUNCT
ajlm-123	46	1	the	the	DET
ajlm-123	46	2	classification	classification	NOUN
ajlm-123	46	3	system	system	NOUN
ajlm-123	46	4	requires	require	VERB
ajlm-123	46	5	a	a	DET
ajlm-123	46	6	shorter	short	ADJ
ajlm-123	46	7	and	and	CCONJ
ajlm-123	46	8	less	less	ADV
ajlm-123	46	9	-	-	PUNCT
ajlm-123	46	10	costly	costly	ADJ
ajlm-123	46	11	route	route	NOUN
ajlm-123	46	12	to	to	ADP
ajlm-123	46	13	pre	pre	ADJ
ajlm-123	46	14	-	-	ADJ
ajlm-123	46	15	market	market	ADJ
ajlm-123	46	16	approval	approval	NOUN
ajlm-123	46	17	for	for	ADP
ajlm-123	46	18	low	low	ADJ
ajlm-123	46	19	-	-	PUNCT
ajlm-123	46	20	risk	risk	NOUN
ajlm-123	46	21	products	product	NOUN
ajlm-123	46	22	.	.	PUNCT
ajlm-123	47	1	table	table	NOUN
ajlm-123	47	2	1	1	NUM
ajlm-123	47	3	:	:	PUNCT
ajlm-123	47	4	classification	classification	NOUN
ajlm-123	47	5	of	of	ADP
ajlm-123	47	6	medical	medical	ADJ
ajlm-123	47	7	devices	device	NOUN
ajlm-123	47	8	with	with	ADP
ajlm-123	47	9	examples	example	NOUN
ajlm-123	47	10	of	of	ADP
ajlm-123	47	11	diagnostic	diagnostic	ADJ
ajlm-123	47	12	products	product	NOUN
ajlm-123	47	13	.	.	PUNCT
ajlm-123	48	1	harmonising	harmonise	VERB
ajlm-123	48	2	regulation	regulation	NOUN
ajlm-123	48	3	of	of	ADP
ajlm-123	48	4	diagnostic	diagnostic	ADJ
ajlm-123	48	5	devices	device	NOUN
ajlm-123	48	6	whilst	whilst	SCONJ
ajlm-123	48	7	regulation	regulation	NOUN
ajlm-123	48	8	of	of	ADP
ajlm-123	48	9	medical	medical	ADJ
ajlm-123	48	10	products	product	NOUN
ajlm-123	48	11	is	be	AUX
ajlm-123	48	12	required	require	VERB
ajlm-123	48	13	in	in	ADP
ajlm-123	48	14	order	order	NOUN
ajlm-123	48	15	to	to	PART
ajlm-123	48	16	ensure	ensure	VERB
ajlm-123	48	17	their	their	PRON
ajlm-123	48	18	safety	safety	NOUN
ajlm-123	48	19	,	,	PUNCT
ajlm-123	48	20	it	it	PRON
ajlm-123	48	21	is	be	AUX
ajlm-123	48	22	essential	essential	ADJ
ajlm-123	48	23	that	that	SCONJ
ajlm-123	48	24	regulatory	regulatory	ADJ
ajlm-123	48	25	review	review	NOUN
ajlm-123	48	26	processes	process	NOUN
ajlm-123	48	27	do	do	AUX
ajlm-123	48	28	not	not	PART
ajlm-123	48	29	obstruct	obstruct	VERB
ajlm-123	48	30	or	or	CCONJ
ajlm-123	48	31	unnecessarily	unnecessarily	ADV
ajlm-123	48	32	delay	delay	VERB
ajlm-123	48	33	access	access	NOUN
ajlm-123	48	34	to	to	ADP
ajlm-123	48	35	beneficial	beneficial	ADJ
ajlm-123	48	36	new	new	ADJ
ajlm-123	48	37	products	product	NOUN
ajlm-123	48	38	.	.	PUNCT
ajlm-123	49	1	it	it	PRON
ajlm-123	49	2	is	be	AUX
ajlm-123	49	3	recognised	recognise	VERB
ajlm-123	49	4	that	that	SCONJ
ajlm-123	49	5	the	the	DET
ajlm-123	49	6	current	current	ADJ
ajlm-123	49	7	lack	lack	NOUN
ajlm-123	49	8	of	of	ADP
ajlm-123	49	9	standardisation	standardisation	NOUN
ajlm-123	49	10	across	across	ADP
ajlm-123	49	11	national	national	ADJ
ajlm-123	49	12	regulatory	regulatory	ADJ
ajlm-123	49	13	authorities	authority	NOUN
ajlm-123	49	14	and	and	CCONJ
ajlm-123	49	15	the	the	DET
ajlm-123	49	16	lack	lack	NOUN
ajlm-123	49	17	of	of	ADP
ajlm-123	49	18	clarity	clarity	NOUN
ajlm-123	49	19	surrounding	surround	VERB
ajlm-123	49	20	the	the	DET
ajlm-123	49	21	regulatory	regulatory	ADJ
ajlm-123	49	22	pathways	pathway	NOUN
ajlm-123	49	23	presents	present	VERB
ajlm-123	49	24	an	an	DET
ajlm-123	49	25	unnecessary	unnecessary	ADJ
ajlm-123	49	26	burden	burden	NOUN
ajlm-123	49	27	on	on	ADP
ajlm-123	49	28	manufacturers	manufacturer	NOUN
ajlm-123	49	29	and	and	CCONJ
ajlm-123	49	30	acts	act	NOUN
ajlm-123	49	31	as	as	ADP
ajlm-123	49	32	a	a	DET
ajlm-123	49	33	deterrent	deterrent	NOUN
ajlm-123	49	34	to	to	AUX
ajlm-123	49	35	marketing	market	VERB
ajlm-123	49	36	in	in	ADP
ajlm-123	49	37	countries	country	NOUN
ajlm-123	49	38	where	where	SCONJ
ajlm-123	49	39	the	the	DET
ajlm-123	49	40	financial	financial	ADJ
ajlm-123	49	41	returns	return	NOUN
ajlm-123	49	42	may	may	AUX
ajlm-123	49	43	be	be	AUX
ajlm-123	49	44	modest.9	modest.9	ADJ
ajlm-123	49	45	with	with	ADP
ajlm-123	49	46	the	the	DET
ajlm-123	49	47	exception	exception	NOUN
ajlm-123	49	48	of	of	ADP
ajlm-123	49	49	the	the	DET
ajlm-123	49	50	countries	country	NOUN
ajlm-123	49	51	of	of	ADP
ajlm-123	49	52	the	the	DET
ajlm-123	49	53	european	european	PROPN
ajlm-123	49	54	union	union	PROPN
ajlm-123	49	55	,	,	PUNCT
ajlm-123	49	56	where	where	SCONJ
ajlm-123	49	57	a	a	DET
ajlm-123	49	58	harmonised	harmonise	VERB
ajlm-123	49	59	system	system	NOUN
ajlm-123	49	60	has	have	AUX
ajlm-123	49	61	been	be	AUX
ajlm-123	49	62	adopted	adopt	VERB
ajlm-123	49	63	,	,	PUNCT
ajlm-123	49	64	countries	country	NOUN
ajlm-123	49	65	each	each	PRON
ajlm-123	49	66	have	have	VERB
ajlm-123	49	67	their	their	PRON
ajlm-123	49	68	own	own	ADJ
ajlm-123	49	69	set	set	NOUN
ajlm-123	49	70	of	of	ADP
ajlm-123	49	71	requirements	requirement	NOUN
ajlm-123	49	72	.	.	PUNCT
ajlm-123	50	1	in	in	ADP
ajlm-123	50	2	some	some	DET
ajlm-123	50	3	countries	country	NOUN
ajlm-123	50	4	,	,	PUNCT
ajlm-123	50	5	transparency	transparency	NOUN
ajlm-123	50	6	is	be	AUX
ajlm-123	50	7	lacking	lack	VERB
ajlm-123	50	8	,	,	PUNCT
ajlm-123	50	9	with	with	ADP
ajlm-123	50	10	little	little	ADJ
ajlm-123	50	11	information	information	NOUN
ajlm-123	50	12	available	available	ADJ
ajlm-123	50	13	about	about	ADP
ajlm-123	50	14	the	the	DET
ajlm-123	50	15	regulatory	regulatory	ADJ
ajlm-123	50	16	process	process	NOUN
ajlm-123	50	17	or	or	CCONJ
ajlm-123	50	18	the	the	DET
ajlm-123	50	19	fees	fee	NOUN
ajlm-123	50	20	charged	charge	VERB
ajlm-123	50	21	.	.	PUNCT
ajlm-123	51	1	several	several	ADJ
ajlm-123	51	2	transnational	transnational	ADJ
ajlm-123	51	3	initiatives	initiative	NOUN
ajlm-123	51	4	are	be	AUX
ajlm-123	51	5	striving	strive	VERB
ajlm-123	51	6	toward	toward	ADP
ajlm-123	51	7	improved	improved	ADJ
ajlm-123	51	8	harmonisation	harmonisation	NOUN
ajlm-123	51	9	of	of	ADP
ajlm-123	51	10	regulation	regulation	NOUN
ajlm-123	51	11	of	of	ADP
ajlm-123	51	12	medical	medical	ADJ
ajlm-123	51	13	devices	device	NOUN
ajlm-123	51	14	,	,	PUNCT
ajlm-123	51	15	including	include	VERB
ajlm-123	51	16	ivds	ivds	NOUN
ajlm-123	51	17	(	(	PUNCT
ajlm-123	51	18	table	table	NOUN
ajlm-123	51	19	2	2	NUM
ajlm-123	51	20	)	)	PUNCT
ajlm-123	51	21	.	.	PUNCT
ajlm-123	52	1	harmonisation	harmonisation	NOUN
ajlm-123	52	2	requires	require	VERB
ajlm-123	52	3	the	the	DET
ajlm-123	52	4	use	use	NOUN
ajlm-123	52	5	of	of	ADP
ajlm-123	52	6	standardised	standardised	ADJ
ajlm-123	52	7	terminology	terminology	NOUN
ajlm-123	52	8	and	and	CCONJ
ajlm-123	52	9	definitions	definition	NOUN
ajlm-123	52	10	which	which	PRON
ajlm-123	52	11	are	be	AUX
ajlm-123	52	12	employed	employ	VERB
ajlm-123	52	13	to	to	PART
ajlm-123	52	14	classify	classify	VERB
ajlm-123	52	15	the	the	DET
ajlm-123	52	16	products	product	NOUN
ajlm-123	52	17	under	under	ADP
ajlm-123	52	18	regulation	regulation	NOUN
ajlm-123	52	19	.	.	PUNCT
ajlm-123	53	1	guidance	guidance	NOUN
ajlm-123	53	2	on	on	ADP
ajlm-123	53	3	this	this	DET
ajlm-123	53	4	topic	topic	NOUN
ajlm-123	53	5	was	be	AUX
ajlm-123	53	6	issued	issue	VERB
ajlm-123	53	7	by	by	ADP
ajlm-123	53	8	the	the	DET
ajlm-123	53	9	ghtf	ghtf	PROPN
ajlm-123	53	10	,	,	PUNCT
ajlm-123	53	11	which	which	PRON
ajlm-123	53	12	transitioned	transition	VERB
ajlm-123	53	13	to	to	ADP
ajlm-123	53	14	the	the	DET
ajlm-123	53	15	international	international	ADJ
ajlm-123	53	16	medical	medical	ADJ
ajlm-123	53	17	device	device	NOUN
ajlm-123	53	18	regulators	regulator	NOUN
ajlm-123	53	19	forum	forum	NOUN
ajlm-123	53	20	(	(	PUNCT
ajlm-123	53	21	imdrf	imdrf	PROPN
ajlm-123	53	22	)	)	PUNCT
ajlm-123	53	23	in	in	ADP
ajlm-123	53	24	2012	2012	NUM
ajlm-123	53	25	.	.	PUNCT
ajlm-123	54	1	for	for	ADP
ajlm-123	54	2	ivds	ivds	NOUN
ajlm-123	54	3	used	use	VERB
ajlm-123	54	4	in	in	ADP
ajlm-123	54	5	developing	develop	VERB
ajlm-123	54	6	countries	country	NOUN
ajlm-123	54	7	there	there	PRON
ajlm-123	54	8	are	be	VERB
ajlm-123	54	9	opportunities	opportunity	NOUN
ajlm-123	54	10	to	to	PART
ajlm-123	54	11	streamline	streamline	VERB
ajlm-123	54	12	and	and	CCONJ
ajlm-123	54	13	harmonise	harmonise	VERB
ajlm-123	54	14	activities	activity	NOUN
ajlm-123	54	15	where	where	SCONJ
ajlm-123	54	16	convergence	convergence	NOUN
ajlm-123	54	17	of	of	ADP
ajlm-123	54	18	protocols	protocol	NOUN
ajlm-123	54	19	and	and	CCONJ
ajlm-123	54	20	mutual	mutual	ADJ
ajlm-123	54	21	recognition	recognition	NOUN
ajlm-123	54	22	of	of	ADP
ajlm-123	54	23	other	other	ADJ
ajlm-123	54	24	regulatory	regulatory	ADJ
ajlm-123	54	25	bodies	body	NOUN
ajlm-123	54	26	could	could	AUX
ajlm-123	54	27	improve	improve	VERB
ajlm-123	54	28	their	their	PRON
ajlm-123	54	29	safety	safety	NOUN
ajlm-123	54	30	and	and	CCONJ
ajlm-123	54	31	quality	quality	NOUN
ajlm-123	54	32	,	,	PUNCT
ajlm-123	54	33	accelerating	accelerate	VERB
ajlm-123	54	34	access	access	NOUN
ajlm-123	54	35	to	to	ADP
ajlm-123	54	36	new	new	ADJ
ajlm-123	54	37	tests	test	NOUN
ajlm-123	54	38	while	while	SCONJ
ajlm-123	54	39	simultaneously	simultaneously	ADV
ajlm-123	54	40	minimising	minimise	VERB
ajlm-123	54	41	the	the	DET
ajlm-123	54	42	costs	cost	NOUN
ajlm-123	54	43	incurred	incur	VERB
ajlm-123	54	44	.	.	PUNCT
ajlm-123	55	1	setting	set	VERB
ajlm-123	55	2	international	international	ADJ
ajlm-123	55	3	standards	standard	NOUN
ajlm-123	55	4	and	and	CCONJ
ajlm-123	55	5	streamlining	streamline	VERB
ajlm-123	55	6	the	the	DET
ajlm-123	55	7	regulatory	regulatory	ADJ
ajlm-123	55	8	process	process	NOUN
ajlm-123	55	9	could	could	AUX
ajlm-123	55	10	reduce	reduce	VERB
ajlm-123	55	11	the	the	DET
ajlm-123	55	12	regulatory	regulatory	ADJ
ajlm-123	55	13	burden	burden	NOUN
ajlm-123	55	14	and	and	CCONJ
ajlm-123	55	15	lower	low	ADJ
ajlm-123	55	16	costs	cost	NOUN
ajlm-123	55	17	of	of	ADP
ajlm-123	55	18	new	new	ADJ
ajlm-123	55	19	products	product	NOUN
ajlm-123	55	20	.	.	PUNCT
ajlm-123	56	1	four	four	NUM
ajlm-123	56	2	priority	priority	NOUN
ajlm-123	56	3	areas	area	NOUN
ajlm-123	56	4	for	for	ADP
ajlm-123	56	5	harmonisation	harmonisation	NOUN
ajlm-123	56	6	have	have	AUX
ajlm-123	56	7	been	be	AUX
ajlm-123	56	8	recognised	recognise	VERB
ajlm-123	56	9	:	:	PUNCT
ajlm-123	56	10	(	(	PUNCT
ajlm-123	56	11	1	1	X
ajlm-123	56	12	)	)	PUNCT
ajlm-123	56	13	adoption	adoption	NOUN
ajlm-123	56	14	of	of	ADP
ajlm-123	56	15	common	common	ADJ
ajlm-123	56	16	registration	registration	NOUN
ajlm-123	56	17	requirements	requirement	NOUN
ajlm-123	56	18	and	and	CCONJ
ajlm-123	56	19	submission	submission	NOUN
ajlm-123	56	20	dossiers	dossier	NOUN
ajlm-123	56	21	for	for	ADP
ajlm-123	56	22	pre	pre	ADJ
ajlm-123	56	23	-	-	ADJ
ajlm-123	56	24	market	market	ADJ
ajlm-123	56	25	approval	approval	NOUN
ajlm-123	56	26	;	;	PUNCT
ajlm-123	56	27	(	(	PUNCT
ajlm-123	56	28	2	2	X
ajlm-123	56	29	)	)	PUNCT
ajlm-123	56	30	convergence	convergence	NOUN
ajlm-123	56	31	of	of	ADP
ajlm-123	56	32	quality	quality	NOUN
ajlm-123	56	33	standards	standard	NOUN
ajlm-123	56	34	and	and	CCONJ
ajlm-123	56	35	mutual	mutual	ADJ
ajlm-123	56	36	,	,	PUNCT
ajlm-123	56	37	or	or	CCONJ
ajlm-123	56	38	third	third	ADJ
ajlm-123	56	39	party	party	NOUN
ajlm-123	56	40	,	,	PUNCT
ajlm-123	56	41	recognition	recognition	NOUN
ajlm-123	56	42	of	of	ADP
ajlm-123	56	43	audit	audit	NOUN
ajlm-123	56	44	activities	activity	NOUN
ajlm-123	56	45	;	;	PUNCT
ajlm-123	56	46	(	(	PUNCT
ajlm-123	56	47	3	3	X
ajlm-123	56	48	)	)	PUNCT
ajlm-123	56	49	rationalisation	rationalisation	NOUN
ajlm-123	56	50	of	of	ADP
ajlm-123	56	51	clinical	clinical	ADJ
ajlm-123	56	52	performance	performance	NOUN
ajlm-123	56	53	studies	study	NOUN
ajlm-123	56	54	in	in	ADP
ajlm-123	56	55	order	order	NOUN
ajlm-123	56	56	to	to	PART
ajlm-123	56	57	avoid	avoid	VERB
ajlm-123	56	58	unnecessary	unnecessary	ADJ
ajlm-123	56	59	duplication	duplication	NOUN
ajlm-123	56	60	;	;	PUNCT
ajlm-123	56	61	and	and	CCONJ
ajlm-123	56	62	(	(	PUNCT
ajlm-123	56	63	4	4	X
ajlm-123	56	64	)	)	PUNCT
ajlm-123	56	65	building	building	NOUN
ajlm-123	56	66	of	of	ADP
ajlm-123	56	67	transnational	transnational	ADJ
ajlm-123	56	68	networks	network	NOUN
ajlm-123	56	69	for	for	ADP
ajlm-123	56	70	post	post	ADJ
ajlm-123	56	71	-	-	ADJ
ajlm-123	56	72	market	market	ADJ
ajlm-123	56	73	surveillance	surveillance	NOUN
ajlm-123	56	74	.	.	PUNCT
ajlm-123	57	1	each	each	PRON
ajlm-123	57	2	of	of	ADP
ajlm-123	57	3	the	the	DET
ajlm-123	57	4	aforementioned	aforementioned	ADJ
ajlm-123	57	5	areas	area	NOUN
ajlm-123	57	6	of	of	ADP
ajlm-123	57	7	harmonisation	harmonisation	NOUN
ajlm-123	57	8	is	be	AUX
ajlm-123	57	9	discussed	discuss	VERB
ajlm-123	57	10	in	in	ADP
ajlm-123	57	11	the	the	DET
ajlm-123	57	12	following	follow	VERB
ajlm-123	57	13	sections	section	NOUN
ajlm-123	57	14	.	.	PUNCT
ajlm-123	58	1	the	the	DET
ajlm-123	58	2	status	status	NOUN
ajlm-123	58	3	quo	quo	NOUN
ajlm-123	58	4	and	and	CCONJ
ajlm-123	58	5	need	need	VERB
ajlm-123	58	6	for	for	ADP
ajlm-123	58	7	change	change	NOUN
ajlm-123	58	8	are	be	AUX
ajlm-123	58	9	described	describe	VERB
ajlm-123	58	10	,	,	PUNCT
ajlm-123	58	11	along	along	ADP
ajlm-123	58	12	with	with	ADP
ajlm-123	58	13	recommendations	recommendation	NOUN
ajlm-123	58	14	made	make	VERB
ajlm-123	58	15	for	for	ADP
ajlm-123	58	16	the	the	DET
ajlm-123	58	17	way	way	NOUN
ajlm-123	58	18	forward	forward	ADV
ajlm-123	58	19	.	.	PUNCT
ajlm-123	59	1	the	the	DET
ajlm-123	59	2	impact	impact	NOUN
ajlm-123	59	3	of	of	ADP
ajlm-123	59	4	the	the	DET
ajlm-123	59	5	proposed	propose	VERB
ajlm-123	59	6	harmonisation	harmonisation	NOUN
ajlm-123	59	7	activities	activity	NOUN
ajlm-123	59	8	are	be	AUX
ajlm-123	59	9	summarised	summarise	VERB
ajlm-123	59	10	in	in	ADP
ajlm-123	59	11	table	table	NOUN
ajlm-123	59	12	3	3	NUM
ajlm-123	59	13	.	.	PUNCT
ajlm-123	59	14	table	table	NOUN
ajlm-123	59	15	2	2	NUM
ajlm-123	59	16	:	:	PUNCT
ajlm-123	59	17	organisations	organisation	NOUN
ajlm-123	59	18	promoting	promote	VERB
ajlm-123	59	19	regulatory	regulatory	ADJ
ajlm-123	59	20	harmonisation	harmonisation	NOUN
ajlm-123	59	21	of	of	ADP
ajlm-123	59	22	medical	medical	ADJ
ajlm-123	59	23	devices	device	NOUN
ajlm-123	59	24	or	or	CCONJ
ajlm-123	59	25	in	in	ADP
ajlm-123	59	26	vitro	vitro	X
ajlm-123	59	27	diagnostics	diagnostic	NOUN
ajlm-123	59	28	.	.	PUNCT
ajlm-123	60	1	table	table	NOUN
ajlm-123	60	2	3	3	NUM
ajlm-123	60	3	:	:	PUNCT
ajlm-123	61	1	expected	expect	VERB
ajlm-123	61	2	impact	impact	NOUN
ajlm-123	61	3	of	of	ADP
ajlm-123	61	4	harmonisation	harmonisation	NOUN
ajlm-123	61	5	activities	activity	NOUN
ajlm-123	61	6	.	.	PUNCT
ajlm-123	62	1	a	a	DET
ajlm-123	62	2	common	common	ADJ
ajlm-123	62	3	submission	submission	NOUN
ajlm-123	62	4	dossier	dossier	NOUN
ajlm-123	62	5	top	top	PROPN
ajlm-123	62	6	↑	↑	PROPN
ajlm-123	62	7	companies	company	NOUN
ajlm-123	62	8	seeking	seek	VERB
ajlm-123	62	9	approval	approval	NOUN
ajlm-123	62	10	to	to	PART
ajlm-123	62	11	market	market	VERB
ajlm-123	62	12	an	an	DET
ajlm-123	62	13	ivd	ivd	NOUN
ajlm-123	62	14	are	be	AUX
ajlm-123	62	15	required	require	VERB
ajlm-123	62	16	to	to	PART
ajlm-123	62	17	supply	supply	VERB
ajlm-123	62	18	a	a	DET
ajlm-123	62	19	dossier	dossier	NOUN
ajlm-123	62	20	to	to	ADP
ajlm-123	62	21	the	the	DET
ajlm-123	62	22	appropriate	appropriate	ADJ
ajlm-123	62	23	nra	nra	NOUN
ajlm-123	62	24	describing	describe	VERB
ajlm-123	62	25	the	the	DET
ajlm-123	62	26	device	device	NOUN
ajlm-123	62	27	and	and	CCONJ
ajlm-123	62	28	documenting	document	VERB
ajlm-123	62	29	evidence	evidence	NOUN
ajlm-123	62	30	relating	relate	VERB
ajlm-123	62	31	to	to	ADP
ajlm-123	62	32	the	the	DET
ajlm-123	62	33	quality	quality	NOUN
ajlm-123	62	34	of	of	ADP
ajlm-123	62	35	manufacture	manufacture	NOUN
ajlm-123	62	36	,	,	PUNCT
ajlm-123	62	37	as	as	ADV
ajlm-123	62	38	well	well	ADV
ajlm-123	62	39	as	as	ADP
ajlm-123	62	40	the	the	DET
ajlm-123	62	41	safety	safety	NOUN
ajlm-123	62	42	and	and	CCONJ
ajlm-123	62	43	stability	stability	NOUN
ajlm-123	62	44	of	of	ADP
ajlm-123	62	45	the	the	DET
ajlm-123	62	46	components	component	NOUN
ajlm-123	62	47	.	.	PUNCT
ajlm-123	63	1	in	in	ADP
ajlm-123	63	2	addition	addition	NOUN
ajlm-123	63	3	,	,	PUNCT
ajlm-123	63	4	those	those	DET
ajlm-123	63	5	devices	device	NOUN
ajlm-123	63	6	considered	consider	VERB
ajlm-123	63	7	to	to	PART
ajlm-123	63	8	be	be	AUX
ajlm-123	63	9	at	at	ADP
ajlm-123	63	10	risk	risk	NOUN
ajlm-123	63	11	of	of	ADP
ajlm-123	63	12	causing	cause	VERB
ajlm-123	63	13	harm	harm	NOUN
ajlm-123	63	14	to	to	ADP
ajlm-123	63	15	either	either	CCONJ
ajlm-123	63	16	individual	individual	ADJ
ajlm-123	63	17	or	or	CCONJ
ajlm-123	63	18	public	public	ADJ
ajlm-123	63	19	health	health	NOUN
ajlm-123	63	20	also	also	ADV
ajlm-123	63	21	require	require	VERB
ajlm-123	63	22	evidence	evidence	NOUN
ajlm-123	63	23	regarding	regard	VERB
ajlm-123	63	24	the	the	DET
ajlm-123	63	25	clinical	clinical	ADJ
ajlm-123	63	26	performance	performance	NOUN
ajlm-123	63	27	of	of	ADP
ajlm-123	63	28	the	the	DET
ajlm-123	63	29	device	device	NOUN
ajlm-123	63	30	.	.	PUNCT
ajlm-123	64	1	the	the	DET
ajlm-123	64	2	adoption	adoption	NOUN
ajlm-123	64	3	of	of	ADP
ajlm-123	64	4	a	a	DET
ajlm-123	64	5	standardised	standardised	ADJ
ajlm-123	64	6	submission	submission	NOUN
ajlm-123	64	7	dossier	dossier	NOUN
ajlm-123	64	8	template	template	NOUN
ajlm-123	64	9	would	would	AUX
ajlm-123	64	10	promote	promote	VERB
ajlm-123	64	11	efficiency	efficiency	NOUN
ajlm-123	64	12	within	within	ADP
ajlm-123	64	13	the	the	DET
ajlm-123	64	14	regulatory	regulatory	ADJ
ajlm-123	64	15	review	review	NOUN
ajlm-123	64	16	process	process	NOUN
ajlm-123	64	17	and	and	CCONJ
ajlm-123	64	18	facilitate	facilitate	VERB
ajlm-123	64	19	standardised	standardised	ADJ
ajlm-123	64	20	training	training	NOUN
ajlm-123	64	21	on	on	ADP
ajlm-123	64	22	good	good	ADJ
ajlm-123	64	23	review	review	NOUN
ajlm-123	64	24	practice	practice	NOUN
ajlm-123	64	25	using	use	VERB
ajlm-123	64	26	a	a	DET
ajlm-123	64	27	common	common	ADJ
ajlm-123	64	28	set	set	NOUN
ajlm-123	64	29	of	of	ADP
ajlm-123	64	30	teaching	teach	VERB
ajlm-123	64	31	materials	material	NOUN
ajlm-123	64	32	.	.	PUNCT
ajlm-123	65	1	nras	nras	PROPN
ajlm-123	65	2	would	would	AUX
ajlm-123	65	3	retain	retain	VERB
ajlm-123	65	4	independent	independent	ADJ
ajlm-123	65	5	review	review	NOUN
ajlm-123	65	6	of	of	ADP
ajlm-123	65	7	the	the	DET
ajlm-123	65	8	data	datum	NOUN
ajlm-123	65	9	,	,	PUNCT
ajlm-123	65	10	along	along	ADP
ajlm-123	65	11	with	with	ADP
ajlm-123	65	12	any	any	DET
ajlm-123	65	13	decisions	decision	NOUN
ajlm-123	65	14	for	for	ADP
ajlm-123	65	15	approval	approval	NOUN
ajlm-123	65	16	based	base	VERB
ajlm-123	65	17	on	on	ADP
ajlm-123	65	18	national	national	ADJ
ajlm-123	65	19	requirements	requirement	NOUN
ajlm-123	65	20	as	as	SCONJ
ajlm-123	65	21	they	they	PRON
ajlm-123	65	22	pertain	pertain	VERB
ajlm-123	65	23	to	to	ADP
ajlm-123	65	24	their	their	PRON
ajlm-123	65	25	local	local	ADJ
ajlm-123	65	26	population	population	NOUN
ajlm-123	65	27	needs	need	NOUN
ajlm-123	65	28	.	.	PUNCT
ajlm-123	66	1	the	the	DET
ajlm-123	66	2	need	need	NOUN
ajlm-123	66	3	for	for	ADP
ajlm-123	66	4	a	a	DET
ajlm-123	66	5	common	common	ADJ
ajlm-123	66	6	submission	submission	NOUN
ajlm-123	66	7	dossier	dossier	NOUN
ajlm-123	66	8	was	be	AUX
ajlm-123	66	9	one	one	NUM
ajlm-123	66	10	of	of	ADP
ajlm-123	66	11	the	the	DET
ajlm-123	66	12	top	top	ADJ
ajlm-123	66	13	priorities	priority	NOUN
ajlm-123	66	14	recognised	recognise	VERB
ajlm-123	66	15	by	by	ADP
ajlm-123	66	16	the	the	DET
ajlm-123	66	17	ghtf	ghtf	PROPN
ajlm-123	66	18	and	and	CCONJ
ajlm-123	66	19	was	be	AUX
ajlm-123	66	20	an	an	DET
ajlm-123	66	21	activity	activity	NOUN
ajlm-123	66	22	already	already	ADV
ajlm-123	66	23	adopted	adopt	VERB
ajlm-123	66	24	by	by	ADP
ajlm-123	66	25	the	the	DET
ajlm-123	66	26	asian	asian	ADJ
ajlm-123	66	27	harmonisation	harmonisation	PROPN
ajlm-123	66	28	working	working	PROPN
ajlm-123	66	29	party	party	NOUN
ajlm-123	66	30	(	(	PUNCT
ajlm-123	66	31	ahwp).15	ahwp).15	PROPN
ajlm-123	66	32	status	status	NOUN
ajlm-123	66	33	quo	quo	NOUN
ajlm-123	66	34	with	with	ADP
ajlm-123	66	35	the	the	DET
ajlm-123	66	36	exception	exception	NOUN
ajlm-123	66	37	of	of	ADP
ajlm-123	66	38	the	the	DET
ajlm-123	66	39	european	european	PROPN
ajlm-123	66	40	union	union	PROPN
ajlm-123	66	41	,	,	PUNCT
ajlm-123	66	42	submission	submission	NOUN
ajlm-123	66	43	dossiers	dossier	NOUN
ajlm-123	66	44	are	be	AUX
ajlm-123	66	45	unique	unique	ADJ
ajlm-123	66	46	to	to	ADP
ajlm-123	66	47	the	the	DET
ajlm-123	66	48	country	country	NOUN
ajlm-123	66	49	,	,	PUNCT
ajlm-123	66	50	with	with	ADP
ajlm-123	66	51	each	each	DET
ajlm-123	66	52	nra	nra	NOUN
ajlm-123	66	53	utilising	utilise	VERB
ajlm-123	66	54	its	its	PRON
ajlm-123	66	55	own	own	ADJ
ajlm-123	66	56	indicators	indicator	NOUN
ajlm-123	66	57	,	,	PUNCT
ajlm-123	66	58	nomenclature	nomenclature	NOUN
ajlm-123	66	59	and	and	CCONJ
ajlm-123	66	60	format	format	NOUN
ajlm-123	66	61	in	in	ADP
ajlm-123	66	62	its	its	PRON
ajlm-123	66	63	own	own	ADJ
ajlm-123	66	64	language.9,16	language.9,16	ADJ
ajlm-123	66	65	preparation	preparation	NOUN
ajlm-123	66	66	of	of	ADP
ajlm-123	66	67	a	a	DET
ajlm-123	66	68	submission	submission	NOUN
ajlm-123	66	69	dossier	dossier	NOUN
ajlm-123	66	70	for	for	ADP
ajlm-123	66	71	regulatory	regulatory	ADJ
ajlm-123	66	72	approval	approval	NOUN
ajlm-123	66	73	is	be	AUX
ajlm-123	66	74	a	a	DET
ajlm-123	66	75	substantial	substantial	ADJ
ajlm-123	66	76	undertaking	undertaking	NOUN
ajlm-123	66	77	and	and	CCONJ
ajlm-123	66	78	the	the	DET
ajlm-123	66	79	necessity	necessity	NOUN
ajlm-123	66	80	of	of	ADP
ajlm-123	66	81	preparing	prepare	VERB
ajlm-123	66	82	individual	individual	ADJ
ajlm-123	66	83	dossiers	dossier	NOUN
ajlm-123	66	84	and	and	CCONJ
ajlm-123	66	85	reformulating	reformulate	VERB
ajlm-123	66	86	data	datum	NOUN
ajlm-123	66	87	for	for	ADP
ajlm-123	66	88	each	each	DET
ajlm-123	66	89	nra	nra	NOUN
ajlm-123	66	90	is	be	AUX
ajlm-123	66	91	an	an	DET
ajlm-123	66	92	unnecessary	unnecessary	ADJ
ajlm-123	66	93	burden	burden	NOUN
ajlm-123	66	94	on	on	ADP
ajlm-123	66	95	diagnostic	diagnostic	ADJ
ajlm-123	66	96	companies	company	NOUN
ajlm-123	66	97	,	,	PUNCT
ajlm-123	66	98	causing	cause	VERB
ajlm-123	66	99	overall	overall	ADJ
ajlm-123	66	100	increase	increase	NOUN
ajlm-123	66	101	to	to	ADP
ajlm-123	66	102	the	the	DET
ajlm-123	66	103	cost	cost	NOUN
ajlm-123	66	104	of	of	ADP
ajlm-123	66	105	marketing	market	VERB
ajlm-123	66	106	a	a	DET
ajlm-123	66	107	new	new	ADJ
ajlm-123	66	108	product	product	NOUN
ajlm-123	66	109	.	.	PUNCT
ajlm-123	67	1	in	in	ADP
ajlm-123	67	2	countries	country	NOUN
ajlm-123	67	3	with	with	ADP
ajlm-123	67	4	weak	weak	ADJ
ajlm-123	67	5	economies	economy	NOUN
ajlm-123	67	6	,	,	PUNCT
ajlm-123	67	7	small	small	ADJ
ajlm-123	67	8	populations	population	NOUN
ajlm-123	67	9	or	or	CCONJ
ajlm-123	67	10	low	low	ADJ
ajlm-123	67	11	prevalence	prevalence	NOUN
ajlm-123	67	12	of	of	ADP
ajlm-123	67	13	the	the	DET
ajlm-123	67	14	condition	condition	NOUN
ajlm-123	67	15	or	or	CCONJ
ajlm-123	67	16	disease	disease	NOUN
ajlm-123	67	17	to	to	PART
ajlm-123	67	18	be	be	AUX
ajlm-123	67	19	tested	test	VERB
ajlm-123	67	20	,	,	PUNCT
ajlm-123	67	21	the	the	DET
ajlm-123	67	22	anticipated	anticipated	ADJ
ajlm-123	67	23	market	market	NOUN
ajlm-123	67	24	may	may	AUX
ajlm-123	67	25	be	be	AUX
ajlm-123	67	26	insufficient	insufficient	ADJ
ajlm-123	67	27	to	to	PART
ajlm-123	67	28	warrant	warrant	VERB
ajlm-123	67	29	the	the	DET
ajlm-123	67	30	cost	cost	NOUN
ajlm-123	67	31	of	of	ADP
ajlm-123	67	32	registering	register	VERB
ajlm-123	67	33	the	the	DET
ajlm-123	67	34	product	product	NOUN
ajlm-123	67	35	.	.	PUNCT
ajlm-123	68	1	the	the	DET
ajlm-123	68	2	problem	problem	NOUN
ajlm-123	68	3	is	be	AUX
ajlm-123	68	4	particularly	particularly	ADV
ajlm-123	68	5	acute	acute	ADJ
ajlm-123	68	6	for	for	ADP
ajlm-123	68	7	small	small	ADJ
ajlm-123	68	8	companies	company	NOUN
ajlm-123	68	9	with	with	ADP
ajlm-123	68	10	limited	limited	ADJ
ajlm-123	68	11	regulatory	regulatory	ADJ
ajlm-123	68	12	expertise	expertise	NOUN
ajlm-123	68	13	or	or	CCONJ
ajlm-123	68	14	capacity	capacity	NOUN
ajlm-123	68	15	.	.	PUNCT
ajlm-123	69	1	large	large	ADJ
ajlm-123	69	2	companies	company	NOUN
ajlm-123	69	3	are	be	AUX
ajlm-123	69	4	also	also	ADV
ajlm-123	69	5	not	not	PART
ajlm-123	69	6	exempt	exempt	ADJ
ajlm-123	69	7	from	from	ADP
ajlm-123	69	8	the	the	DET
ajlm-123	69	9	burden	burden	NOUN
ajlm-123	69	10	that	that	PRON
ajlm-123	69	11	a	a	DET
ajlm-123	69	12	submission	submission	NOUN
ajlm-123	69	13	dossier	dossier	NOUN
ajlm-123	69	14	carries	carry	VERB
ajlm-123	69	15	,	,	PUNCT
ajlm-123	69	16	as	as	SCONJ
ajlm-123	69	17	it	it	PRON
ajlm-123	69	18	represents	represent	VERB
ajlm-123	69	19	a	a	DET
ajlm-123	69	20	significant	significant	ADJ
ajlm-123	69	21	commitment	commitment	NOUN
ajlm-123	69	22	of	of	ADP
ajlm-123	69	23	resources	resource	NOUN
ajlm-123	69	24	and	and	CCONJ
ajlm-123	69	25	time	time	NOUN
ajlm-123	69	26	.	.	PUNCT
ajlm-123	70	1	a	a	DET
ajlm-123	70	2	standardised	standardised	ADJ
ajlm-123	70	3	template	template	NOUN
ajlm-123	70	4	for	for	ADP
ajlm-123	70	5	submission	submission	NOUN
ajlm-123	70	6	dossiers	dossier	NOUN
ajlm-123	70	7	would	would	AUX
ajlm-123	70	8	decrease	decrease	VERB
ajlm-123	70	9	the	the	DET
ajlm-123	70	10	time	time	NOUN
ajlm-123	70	11	and	and	CCONJ
ajlm-123	70	12	effort	effort	NOUN
ajlm-123	70	13	required	require	VERB
ajlm-123	70	14	of	of	ADP
ajlm-123	70	15	companies	company	NOUN
ajlm-123	70	16	,	,	PUNCT
ajlm-123	70	17	improve	improve	VERB
ajlm-123	70	18	the	the	DET
ajlm-123	70	19	efficiency	efficiency	NOUN
ajlm-123	70	20	of	of	ADP
ajlm-123	70	21	regulatory	regulatory	ADJ
ajlm-123	70	22	reviews	review	NOUN
ajlm-123	70	23	and	and	CCONJ
ajlm-123	70	24	reduce	reduce	VERB
ajlm-123	70	25	the	the	DET
ajlm-123	70	26	cost	cost	NOUN
ajlm-123	70	27	of	of	ADP
ajlm-123	70	28	goods	good	NOUN
ajlm-123	70	29	for	for	ADP
ajlm-123	70	30	diagnostic	diagnostic	ADJ
ajlm-123	70	31	companies	company	NOUN
ajlm-123	70	32	,	,	PUNCT
ajlm-123	70	33	resulting	result	VERB
ajlm-123	70	34	in	in	ADP
ajlm-123	70	35	a	a	DET
ajlm-123	70	36	more	more	ADV
ajlm-123	70	37	affordable	affordable	ADJ
ajlm-123	70	38	product	product	NOUN
ajlm-123	70	39	and	and	CCONJ
ajlm-123	70	40	overall	overall	ADJ
ajlm-123	70	41	reduced	reduce	VERB
ajlm-123	70	42	time	time	NOUN
ajlm-123	70	43	to	to	ADP
ajlm-123	70	44	market	market	NOUN
ajlm-123	70	45	.	.	PUNCT
ajlm-123	71	1	action	action	NOUN
ajlm-123	71	2	going	go	VERB
ajlm-123	71	3	forward	forward	ADV
ajlm-123	71	4	following	follow	VERB
ajlm-123	71	5	principles	principle	NOUN
ajlm-123	71	6	established	establish	VERB
ajlm-123	71	7	by	by	ADP
ajlm-123	71	8	the	the	DET
ajlm-123	71	9	ghtf	ghtf	PROPN
ajlm-123	71	10	,	,	PUNCT
ajlm-123	71	11	the	the	DET
ajlm-123	71	12	ahwp	ahwp	NOUN
ajlm-123	71	13	has	have	AUX
ajlm-123	71	14	developed	develop	VERB
ajlm-123	71	15	a	a	DET
ajlm-123	71	16	common	common	ADJ
ajlm-123	71	17	submission	submission	NOUN
ajlm-123	71	18	dossier	dossier	NOUN
ajlm-123	71	19	template	template	NOUN
ajlm-123	71	20	(	(	PUNCT
ajlm-123	71	21	csdt	csdt	NOUN
ajlm-123	71	22	)	)	PUNCT
ajlm-123	71	23	for	for	ADP
ajlm-123	71	24	premarket	premarket	ADJ
ajlm-123	71	25	submission	submission	NOUN
ajlm-123	71	26	of	of	ADP
ajlm-123	71	27	ivds	ivds	NOUN
ajlm-123	71	28	.	.	PUNCT
ajlm-123	72	1	the	the	DET
ajlm-123	72	2	dossier	dossier	NOUN
ajlm-123	72	3	incorporates	incorporate	VERB
ajlm-123	72	4	:	:	PUNCT
ajlm-123	72	5	(	(	PUNCT
ajlm-123	72	6	1	1	X
ajlm-123	72	7	)	)	PUNCT
ajlm-123	72	8	marketing	marketing	NOUN
ajlm-123	72	9	history	history	NOUN
ajlm-123	72	10	and	and	CCONJ
ajlm-123	72	11	,	,	PUNCT
ajlm-123	72	12	where	where	SCONJ
ajlm-123	72	13	appropriate	appropriate	ADJ
ajlm-123	72	14	,	,	PUNCT
ajlm-123	72	15	a	a	DET
ajlm-123	72	16	risk	risk	NOUN
ajlm-123	72	17	/	/	SYM
ajlm-123	72	18	benefit	benefit	NOUN
ajlm-123	72	19	assessment	assessment	NOUN
ajlm-123	72	20	,	,	PUNCT
ajlm-123	72	21	any	any	DET
ajlm-123	72	22	prior	prior	ADJ
ajlm-123	72	23	approvals	approval	NOUN
ajlm-123	72	24	and	and	CCONJ
ajlm-123	72	25	current	current	ADJ
ajlm-123	72	26	regulatory	regulatory	ADJ
ajlm-123	72	27	status	status	NOUN
ajlm-123	72	28	,	,	PUNCT
ajlm-123	72	29	as	as	ADV
ajlm-123	72	30	well	well	ADV
ajlm-123	72	31	as	as	ADP
ajlm-123	72	32	documentation	documentation	NOUN
ajlm-123	72	33	to	to	PART
ajlm-123	72	34	demonstrate	demonstrate	VERB
ajlm-123	72	35	conformity	conformity	NOUN
ajlm-123	72	36	to	to	ADP
ajlm-123	72	37	the	the	DET
ajlm-123	72	38	essential	essential	ADJ
ajlm-123	72	39	principles	principle	NOUN
ajlm-123	72	40	of	of	ADP
ajlm-123	72	41	the	the	DET
ajlm-123	72	42	ghtf	ghtf	NOUN
ajlm-123	72	43	;	;	PUNCT
ajlm-123	72	44	(	(	PUNCT
ajlm-123	72	45	2	2	X
ajlm-123	72	46	)	)	PUNCT
ajlm-123	72	47	a	a	DET
ajlm-123	72	48	product	product	NOUN
ajlm-123	72	49	description	description	NOUN
ajlm-123	72	50	which	which	PRON
ajlm-123	72	51	includes	include	VERB
ajlm-123	72	52	intended	intend	VERB
ajlm-123	72	53	use	use	NOUN
ajlm-123	72	54	and	and	CCONJ
ajlm-123	72	55	any	any	DET
ajlm-123	72	56	warnings	warning	NOUN
ajlm-123	72	57	or	or	CCONJ
ajlm-123	72	58	precautions	precaution	NOUN
ajlm-123	72	59	;	;	PUNCT
ajlm-123	72	60	(	(	PUNCT
ajlm-123	72	61	3	3	X
ajlm-123	72	62	)	)	PUNCT
ajlm-123	72	63	a	a	DET
ajlm-123	72	64	summary	summary	NOUN
ajlm-123	72	65	of	of	ADP
ajlm-123	72	66	design	design	NOUN
ajlm-123	72	67	verification	verification	NOUN
ajlm-123	72	68	and	and	CCONJ
ajlm-123	72	69	validation	validation	NOUN
ajlm-123	72	70	documents	document	NOUN
ajlm-123	72	71	–	–	PUNCT
ajlm-123	72	72	these	these	PRON
ajlm-123	72	73	may	may	AUX
ajlm-123	72	74	include	include	VERB
ajlm-123	72	75	sensitivity	sensitivity	NOUN
ajlm-123	72	76	,	,	PUNCT
ajlm-123	72	77	specificity	specificity	NOUN
ajlm-123	72	78	,	,	PUNCT
ajlm-123	72	79	precision	precision	NOUN
ajlm-123	72	80	,	,	PUNCT
ajlm-123	72	81	stability	stability	NOUN
ajlm-123	72	82	,	,	PUNCT
ajlm-123	72	83	storage	storage	NOUN
ajlm-123	72	84	and	and	CCONJ
ajlm-123	72	85	controls	control	NOUN
ajlm-123	72	86	–	–	PUNCT
ajlm-123	72	87	and	and	CCONJ
ajlm-123	72	88	,	,	PUNCT
ajlm-123	72	89	depending	depend	VERB
ajlm-123	72	90	on	on	ADP
ajlm-123	72	91	the	the	DET
ajlm-123	72	92	product	product	NOUN
ajlm-123	72	93	classification	classification	NOUN
ajlm-123	72	94	,	,	PUNCT
ajlm-123	72	95	it	it	PRON
ajlm-123	72	96	may	may	AUX
ajlm-123	72	97	also	also	ADV
ajlm-123	72	98	include	include	VERB
ajlm-123	72	99	evidence	evidence	NOUN
ajlm-123	72	100	from	from	ADP
ajlm-123	72	101	clinical	clinical	ADJ
ajlm-123	72	102	performance	performance	NOUN
ajlm-123	72	103	studies	study	NOUN
ajlm-123	72	104	;	;	PUNCT
ajlm-123	72	105	(	(	PUNCT
ajlm-123	72	106	4	4	X
ajlm-123	72	107	)	)	PUNCT
ajlm-123	72	108	device	device	NOUN
ajlm-123	72	109	labelling	labelling	NOUN
ajlm-123	72	110	,	,	PUNCT
ajlm-123	72	111	with	with	ADP
ajlm-123	72	112	instructions	instruction	NOUN
ajlm-123	72	113	for	for	ADP
ajlm-123	72	114	use	use	NOUN
ajlm-123	72	115	(	(	PUNCT
ajlm-123	72	116	including	include	VERB
ajlm-123	72	117	operating	operate	VERB
ajlm-123	72	118	manual	manual	NOUN
ajlm-123	72	119	and	and	CCONJ
ajlm-123	72	120	user	user	NOUN
ajlm-123	72	121	manual	manual	NOUN
ajlm-123	72	122	)	)	PUNCT
ajlm-123	72	123	,	,	PUNCT
ajlm-123	72	124	patient	patient	ADJ
ajlm-123	72	125	information	information	NOUN
ajlm-123	72	126	leaflet	leaflet	NOUN
ajlm-123	72	127	and	and	CCONJ
ajlm-123	72	128	promotional	promotional	ADJ
ajlm-123	72	129	materials	material	NOUN
ajlm-123	72	130	;	;	PUNCT
ajlm-123	72	131	(	(	PUNCT
ajlm-123	72	132	5	5	X
ajlm-123	72	133	)	)	PUNCT
ajlm-123	72	134	a	a	DET
ajlm-123	72	135	summary	summary	NOUN
ajlm-123	72	136	of	of	ADP
ajlm-123	72	137	the	the	DET
ajlm-123	72	138	risks	risk	NOUN
ajlm-123	72	139	identified	identify	VERB
ajlm-123	72	140	and	and	CCONJ
ajlm-123	72	141	a	a	DET
ajlm-123	72	142	description	description	NOUN
ajlm-123	72	143	of	of	ADP
ajlm-123	72	144	how	how	SCONJ
ajlm-123	72	145	these	these	DET
ajlm-123	72	146	risks	risk	NOUN
ajlm-123	72	147	have	have	AUX
ajlm-123	72	148	been	be	AUX
ajlm-123	72	149	controlled	control	VERB
ajlm-123	72	150	to	to	ADP
ajlm-123	72	151	an	an	DET
ajlm-123	72	152	acceptable	acceptable	ADJ
ajlm-123	72	153	level	level	NOUN
ajlm-123	72	154	;	;	PUNCT
ajlm-123	72	155	and	and	CCONJ
ajlm-123	72	156	(	(	PUNCT
ajlm-123	72	157	6	6	NUM
ajlm-123	72	158	)	)	PUNCT
ajlm-123	72	159	manufacturer	manufacturer	NOUN
ajlm-123	72	160	information	information	NOUN
ajlm-123	72	161	in	in	ADP
ajlm-123	72	162	order	order	NOUN
ajlm-123	72	163	to	to	PART
ajlm-123	72	164	identify	identify	VERB
ajlm-123	72	165	manufacturing	manufacturing	NOUN
ajlm-123	72	166	sites	site	NOUN
ajlm-123	72	167	and	and	CCONJ
ajlm-123	72	168	to	to	PART
ajlm-123	72	169	provide	provide	VERB
ajlm-123	72	170	quality	quality	NOUN
ajlm-123	72	171	management	management	NOUN
ajlm-123	72	172	system	system	NOUN
ajlm-123	72	173	certification	certification	NOUN
ajlm-123	72	174	such	such	ADJ
ajlm-123	72	175	as	as	ADP
ajlm-123	72	176	(	(	PUNCT
ajlm-123	72	177	iso	iso	NOUN
ajlm-123	72	178	)	)	PUNCT
ajlm-123	72	179	13485:2003	13485:2003	NUM
ajlm-123	72	180	and	and	CCONJ
ajlm-123	72	181	a	a	DET
ajlm-123	72	182	description	description	NOUN
ajlm-123	72	183	of	of	ADP
ajlm-123	72	184	the	the	DET
ajlm-123	72	185	manufacturing	manufacturing	NOUN
ajlm-123	72	186	process.15	process.15	NOUN
ajlm-123	72	187	a	a	DET
ajlm-123	72	188	common	common	ADJ
ajlm-123	72	189	dossier	dossier	NOUN
ajlm-123	72	190	is	be	AUX
ajlm-123	72	191	to	to	PART
ajlm-123	72	192	be	be	AUX
ajlm-123	72	193	piloted	pilot	VERB
ajlm-123	72	194	in	in	ADP
ajlm-123	72	195	africa	africa	PROPN
ajlm-123	72	196	and	and	CCONJ
ajlm-123	72	197	other	other	ADJ
ajlm-123	72	198	regions	region	NOUN
ajlm-123	72	199	using	use	VERB
ajlm-123	72	200	a	a	DET
ajlm-123	72	201	poc	poc	NOUN
ajlm-123	72	202	test	test	NOUN
ajlm-123	72	203	as	as	ADP
ajlm-123	72	204	an	an	DET
ajlm-123	72	205	example	example	NOUN
ajlm-123	72	206	.	.	PUNCT
ajlm-123	73	1	transparency	transparency	NOUN
ajlm-123	73	2	of	of	ADP
ajlm-123	73	3	regulatory	regulatory	ADJ
ajlm-123	73	4	requirements	requirement	NOUN
ajlm-123	73	5	and	and	CCONJ
ajlm-123	73	6	processes	process	NOUN
ajlm-123	73	7	shall	shall	AUX
ajlm-123	73	8	be	be	AUX
ajlm-123	73	9	promoted	promote	VERB
ajlm-123	73	10	,	,	PUNCT
ajlm-123	73	11	preferably	preferably	ADV
ajlm-123	73	12	with	with	ADP
ajlm-123	73	13	documents	document	NOUN
ajlm-123	73	14	available	available	ADJ
ajlm-123	73	15	on	on	ADP
ajlm-123	73	16	line	line	NOUN
ajlm-123	73	17	.	.	PUNCT
ajlm-123	74	1	good	good	ADJ
ajlm-123	74	2	review	review	NOUN
ajlm-123	74	3	practice	practice	NOUN
ajlm-123	74	4	will	will	AUX
ajlm-123	74	5	include	include	VERB
ajlm-123	74	6	the	the	DET
ajlm-123	74	7	monitoring	monitoring	NOUN
ajlm-123	74	8	and	and	CCONJ
ajlm-123	74	9	publication	publication	NOUN
ajlm-123	74	10	of	of	ADP
ajlm-123	74	11	the	the	DET
ajlm-123	74	12	time	time	NOUN
ajlm-123	74	13	required	require	VERB
ajlm-123	74	14	for	for	ADP
ajlm-123	74	15	review	review	NOUN
ajlm-123	74	16	.	.	PUNCT
ajlm-123	75	1	fees	fee	NOUN
ajlm-123	75	2	charged	charge	VERB
ajlm-123	75	3	to	to	ADP
ajlm-123	75	4	companies	company	NOUN
ajlm-123	75	5	should	should	AUX
ajlm-123	75	6	reflect	reflect	VERB
ajlm-123	75	7	the	the	DET
ajlm-123	75	8	costs	cost	NOUN
ajlm-123	75	9	of	of	ADP
ajlm-123	75	10	the	the	DET
ajlm-123	75	11	approval	approval	NOUN
ajlm-123	75	12	process	process	NOUN
ajlm-123	75	13	and	and	CCONJ
ajlm-123	75	14	should	should	AUX
ajlm-123	75	15	not	not	PART
ajlm-123	75	16	be	be	AUX
ajlm-123	75	17	seen	see	VERB
ajlm-123	75	18	as	as	ADP
ajlm-123	75	19	an	an	DET
ajlm-123	75	20	opportunity	opportunity	NOUN
ajlm-123	75	21	for	for	ADP
ajlm-123	75	22	profit	profit	NOUN
ajlm-123	75	23	.	.	PUNCT
ajlm-123	76	1	harmonisation	harmonisation	NOUN
ajlm-123	76	2	of	of	ADP
ajlm-123	76	3	submission	submission	NOUN
ajlm-123	76	4	dossier	dossier	NOUN
ajlm-123	76	5	requirements	requirement	NOUN
ajlm-123	76	6	and	and	CCONJ
ajlm-123	76	7	adoption	adoption	NOUN
ajlm-123	76	8	of	of	ADP
ajlm-123	76	9	a	a	DET
ajlm-123	76	10	common	common	ADJ
ajlm-123	76	11	template	template	NOUN
ajlm-123	76	12	will	will	AUX
ajlm-123	76	13	:	:	PUNCT
ajlm-123	76	14	(	(	PUNCT
ajlm-123	76	15	1	1	X
ajlm-123	76	16	)	)	PUNCT
ajlm-123	76	17	reduce	reduce	VERB
ajlm-123	76	18	the	the	DET
ajlm-123	76	19	cost	cost	NOUN
ajlm-123	76	20	to	to	ADP
ajlm-123	76	21	manufacturers	manufacturer	NOUN
ajlm-123	76	22	of	of	ADP
ajlm-123	76	23	registering	register	VERB
ajlm-123	76	24	a	a	DET
ajlm-123	76	25	product	product	NOUN
ajlm-123	76	26	,	,	PUNCT
ajlm-123	76	27	a	a	DET
ajlm-123	76	28	cost	cost	NOUN
ajlm-123	76	29	that	that	PRON
ajlm-123	76	30	would	would	AUX
ajlm-123	76	31	ultimately	ultimately	ADV
ajlm-123	76	32	be	be	AUX
ajlm-123	76	33	passed	pass	VERB
ajlm-123	76	34	to	to	ADP
ajlm-123	76	35	the	the	DET
ajlm-123	76	36	consumers	consumer	NOUN
ajlm-123	76	37	of	of	ADP
ajlm-123	76	38	the	the	DET
ajlm-123	76	39	test	test	NOUN
ajlm-123	76	40	;	;	PUNCT
ajlm-123	76	41	(	(	PUNCT
ajlm-123	76	42	2	2	X
ajlm-123	76	43	)	)	PUNCT
ajlm-123	76	44	reduce	reduce	VERB
ajlm-123	76	45	delays	delay	NOUN
ajlm-123	76	46	in	in	ADP
ajlm-123	76	47	test	test	NOUN
ajlm-123	76	48	registration	registration	NOUN
ajlm-123	76	49	;	;	PUNCT
ajlm-123	76	50	(	(	PUNCT
ajlm-123	76	51	3	3	X
ajlm-123	76	52	)	)	PUNCT
ajlm-123	76	53	reduce	reduce	VERB
ajlm-123	76	54	barriers	barrier	NOUN
ajlm-123	76	55	to	to	ADP
ajlm-123	76	56	marketing	marketing	NOUN
ajlm-123	76	57	in	in	ADP
ajlm-123	76	58	small	small	ADJ
ajlm-123	76	59	economies	economy	NOUN
ajlm-123	76	60	;	;	PUNCT
ajlm-123	76	61	and	and	CCONJ
ajlm-123	76	62	(	(	PUNCT
ajlm-123	76	63	4	4	X
ajlm-123	76	64	)	)	PUNCT
ajlm-123	76	65	facilitate	facilitate	VERB
ajlm-123	76	66	harmonised	harmonise	VERB
ajlm-123	76	67	approval	approval	NOUN
ajlm-123	76	68	of	of	ADP
ajlm-123	76	69	diagnostic	diagnostic	ADJ
ajlm-123	76	70	devices	device	NOUN
ajlm-123	76	71	,	,	PUNCT
ajlm-123	76	72	ultimately	ultimately	ADV
ajlm-123	76	73	reducing	reduce	VERB
ajlm-123	76	74	the	the	DET
ajlm-123	76	75	burden	burden	NOUN
ajlm-123	76	76	on	on	ADP
ajlm-123	76	77	nras	nras	PROPN
ajlm-123	76	78	and	and	CCONJ
ajlm-123	76	79	the	the	DET
ajlm-123	76	80	cost	cost	NOUN
ajlm-123	76	81	of	of	ADP
ajlm-123	76	82	national	national	ADJ
ajlm-123	76	83	regulatory	regulatory	ADJ
ajlm-123	76	84	approval	approval	NOUN
ajlm-123	76	85	.	.	PUNCT
ajlm-123	77	1	harmonisation	harmonisation	NOUN
ajlm-123	77	2	will	will	AUX
ajlm-123	77	3	require	require	VERB
ajlm-123	77	4	consensus	consensus	NOUN
ajlm-123	77	5	on	on	ADP
ajlm-123	77	6	the	the	DET
ajlm-123	77	7	fundamental	fundamental	ADJ
ajlm-123	77	8	principles	principle	NOUN
ajlm-123	77	9	of	of	ADP
ajlm-123	77	10	regulating	regulate	VERB
ajlm-123	77	11	diagnostic	diagnostic	ADJ
ajlm-123	77	12	devices	device	NOUN
ajlm-123	77	13	for	for	ADP
ajlm-123	77	14	health	health	NOUN
ajlm-123	77	15	,	,	PUNCT
ajlm-123	77	16	but	but	CCONJ
ajlm-123	77	17	independent	independent	ADJ
ajlm-123	77	18	decision	decision	NOUN
ajlm-123	77	19	making	make	VERB
ajlm-123	77	20	shall	shall	AUX
ajlm-123	77	21	be	be	AUX
ajlm-123	77	22	retained	retain	VERB
ajlm-123	77	23	by	by	ADP
ajlm-123	77	24	the	the	DET
ajlm-123	77	25	nra	nra	PROPN
ajlm-123	77	26	.	.	PUNCT
ajlm-123	78	1	convergence	convergence	NOUN
ajlm-123	78	2	in	in	ADP
ajlm-123	78	3	the	the	DET
ajlm-123	78	4	auditing	auditing	NOUN
ajlm-123	78	5	of	of	ADP
ajlm-123	78	6	quality	quality	NOUN
ajlm-123	78	7	systems	system	NOUN
ajlm-123	78	8	top	top	PROPN
ajlm-123	78	9	↑	↑	PROPN
ajlm-123	78	10	regulatory	regulatory	ADJ
ajlm-123	78	11	oversight	oversight	NOUN
ajlm-123	78	12	requires	require	VERB
ajlm-123	78	13	assurance	assurance	NOUN
ajlm-123	78	14	that	that	SCONJ
ajlm-123	78	15	the	the	DET
ajlm-123	78	16	manufacturer	manufacturer	NOUN
ajlm-123	78	17	of	of	ADP
ajlm-123	78	18	the	the	DET
ajlm-123	78	19	device	device	NOUN
ajlm-123	78	20	conforms	conform	VERB
ajlm-123	78	21	to	to	ADP
ajlm-123	78	22	a	a	DET
ajlm-123	78	23	satisfactory	satisfactory	ADJ
ajlm-123	78	24	quality	quality	NOUN
ajlm-123	78	25	management	management	NOUN
ajlm-123	78	26	system	system	NOUN
ajlm-123	78	27	.	.	PUNCT
ajlm-123	79	1	these	these	DET
ajlm-123	79	2	quality	quality	NOUN
ajlm-123	79	3	management	management	NOUN
ajlm-123	79	4	standards	standard	NOUN
ajlm-123	79	5	are	be	AUX
ajlm-123	79	6	universal	universal	ADJ
ajlm-123	79	7	and	and	CCONJ
ajlm-123	79	8	should	should	AUX
ajlm-123	79	9	not	not	PART
ajlm-123	79	10	differ	differ	VERB
ajlm-123	79	11	from	from	ADP
ajlm-123	79	12	country	country	NOUN
ajlm-123	79	13	to	to	ADP
ajlm-123	79	14	country	country	NOUN
ajlm-123	79	15	.	.	PUNCT
ajlm-123	80	1	the	the	DET
ajlm-123	80	2	quality	quality	NOUN
ajlm-123	80	3	management	management	NOUN
ajlm-123	80	4	system	system	NOUN
ajlm-123	80	5	used	use	VERB
ajlm-123	80	6	by	by	ADP
ajlm-123	80	7	a	a	DET
ajlm-123	80	8	manufacturer	manufacturer	NOUN
ajlm-123	80	9	to	to	PART
ajlm-123	80	10	control	control	VERB
ajlm-123	80	11	the	the	DET
ajlm-123	80	12	quality	quality	NOUN
ajlm-123	80	13	of	of	ADP
ajlm-123	80	14	their	their	PRON
ajlm-123	80	15	product	product	NOUN
ajlm-123	80	16	should	should	AUX
ajlm-123	80	17	be	be	AUX
ajlm-123	80	18	audited	audit	VERB
ajlm-123	80	19	in	in	ADP
ajlm-123	80	20	order	order	NOUN
ajlm-123	80	21	to	to	PART
ajlm-123	80	22	provide	provide	VERB
ajlm-123	80	23	assurance	assurance	NOUN
ajlm-123	80	24	that	that	SCONJ
ajlm-123	80	25	safe	safe	ADJ
ajlm-123	80	26	and	and	CCONJ
ajlm-123	80	27	effective	effective	ADJ
ajlm-123	80	28	devices	device	NOUN
ajlm-123	80	29	will	will	AUX
ajlm-123	80	30	be	be	AUX
ajlm-123	80	31	manufactured	manufacture	VERB
ajlm-123	80	32	.	.	PUNCT
ajlm-123	81	1	the	the	DET
ajlm-123	81	2	audit	audit	NOUN
ajlm-123	81	3	should	should	AUX
ajlm-123	81	4	make	make	VERB
ajlm-123	81	5	certain	certain	ADJ
ajlm-123	81	6	that	that	PRON
ajlm-123	81	7	specified	specify	VERB
ajlm-123	81	8	minimum	minimum	NOUN
ajlm-123	81	9	standards	standard	NOUN
ajlm-123	81	10	are	be	AUX
ajlm-123	81	11	met	meet	VERB
ajlm-123	81	12	during	during	ADP
ajlm-123	81	13	manufacturing	manufacturing	NOUN
ajlm-123	81	14	and	and	CCONJ
ajlm-123	81	15	provide	provide	VERB
ajlm-123	81	16	impartial	impartial	ADJ
ajlm-123	81	17	,	,	PUNCT
ajlm-123	81	18	reliable	reliable	ADJ
ajlm-123	81	19	and	and	CCONJ
ajlm-123	81	20	objective	objective	ADJ
ajlm-123	81	21	evaluation	evaluation	NOUN
ajlm-123	81	22	of	of	ADP
ajlm-123	81	23	compliance	compliance	NOUN
ajlm-123	81	24	with	with	ADP
ajlm-123	81	25	regulatory	regulatory	ADJ
ajlm-123	81	26	requirements	requirement	NOUN
ajlm-123	81	27	.	.	PUNCT
ajlm-123	82	1	iso	iso	PROPN
ajlm-123	82	2	13485:2003	13485:2003	PROPN
ajlm-123	82	3	is	be	AUX
ajlm-123	82	4	an	an	DET
ajlm-123	82	5	international	international	ADJ
ajlm-123	82	6	standard	standard	NOUN
ajlm-123	82	7	established	establish	VERB
ajlm-123	82	8	for	for	ADP
ajlm-123	82	9	the	the	DET
ajlm-123	82	10	manufacture	manufacture	NOUN
ajlm-123	82	11	of	of	ADP
ajlm-123	82	12	ivds.17	ivds.17	NOUN
ajlm-123	82	13	if	if	SCONJ
ajlm-123	82	14	satisfactory	satisfactory	ADJ
ajlm-123	82	15	quality	quality	NOUN
ajlm-123	82	16	management	management	NOUN
ajlm-123	82	17	is	be	AUX
ajlm-123	82	18	not	not	PART
ajlm-123	82	19	practised	practise	VERB
ajlm-123	82	20	by	by	ADP
ajlm-123	82	21	the	the	DET
ajlm-123	82	22	manufacturers	manufacturer	NOUN
ajlm-123	82	23	,	,	PUNCT
ajlm-123	82	24	corrective	corrective	ADJ
ajlm-123	82	25	measures	measure	NOUN
ajlm-123	82	26	may	may	AUX
ajlm-123	82	27	be	be	AUX
ajlm-123	82	28	recommended	recommend	VERB
ajlm-123	82	29	.	.	PUNCT
ajlm-123	83	1	for	for	ADP
ajlm-123	83	2	ivds	ivds	NOUN
ajlm-123	83	3	considered	consider	VERB
ajlm-123	83	4	to	to	PART
ajlm-123	83	5	have	have	VERB
ajlm-123	83	6	a	a	DET
ajlm-123	83	7	risk	risk	NOUN
ajlm-123	83	8	of	of	ADP
ajlm-123	83	9	causing	cause	VERB
ajlm-123	83	10	harm	harm	NOUN
ajlm-123	83	11	(	(	PUNCT
ajlm-123	83	12	to	to	ADP
ajlm-123	83	13	potential	potential	ADJ
ajlm-123	83	14	patients	patient	NOUN
ajlm-123	83	15	or	or	CCONJ
ajlm-123	83	16	users	user	NOUN
ajlm-123	83	17	)	)	PUNCT
ajlm-123	83	18	,	,	PUNCT
ajlm-123	83	19	assessment	assessment	NOUN
ajlm-123	83	20	of	of	ADP
ajlm-123	83	21	adherence	adherence	NOUN
ajlm-123	83	22	to	to	ADP
ajlm-123	83	23	satisfactory	satisfactory	ADJ
ajlm-123	83	24	quality	quality	NOUN
ajlm-123	83	25	systems	system	NOUN
ajlm-123	83	26	will	will	AUX
ajlm-123	83	27	include	include	VERB
ajlm-123	83	28	visiting	visit	VERB
ajlm-123	83	29	the	the	DET
ajlm-123	83	30	site	site	NOUN
ajlm-123	83	31	of	of	ADP
ajlm-123	83	32	manufacture	manufacture	NOUN
ajlm-123	83	33	.	.	PUNCT
ajlm-123	84	1	audit	audit	NOUN
ajlm-123	84	2	teams	team	NOUN
ajlm-123	84	3	must	must	AUX
ajlm-123	84	4	encompass	encompass	VERB
ajlm-123	84	5	a	a	DET
ajlm-123	84	6	range	range	NOUN
ajlm-123	84	7	of	of	ADP
ajlm-123	84	8	skills	skill	NOUN
ajlm-123	84	9	and	and	CCONJ
ajlm-123	84	10	expertise	expertise	NOUN
ajlm-123	84	11	enabling	enable	VERB
ajlm-123	84	12	them	they	PRON
ajlm-123	84	13	to	to	PART
ajlm-123	84	14	assess	assess	VERB
ajlm-123	84	15	the	the	DET
ajlm-123	84	16	quality	quality	NOUN
ajlm-123	84	17	management	management	NOUN
ajlm-123	84	18	system	system	NOUN
ajlm-123	84	19	and	and	CCONJ
ajlm-123	84	20	to	to	PART
ajlm-123	84	21	determine	determine	VERB
ajlm-123	84	22	the	the	DET
ajlm-123	84	23	effectiveness	effectiveness	NOUN
ajlm-123	84	24	of	of	ADP
ajlm-123	84	25	its	its	PRON
ajlm-123	84	26	implementation	implementation	NOUN
ajlm-123	84	27	.	.	PUNCT
ajlm-123	85	1	the	the	DET
ajlm-123	85	2	range	range	NOUN
ajlm-123	85	3	of	of	ADP
ajlm-123	85	4	skills	skill	NOUN
ajlm-123	85	5	includes	include	VERB
ajlm-123	85	6	understanding	understand	VERB
ajlm-123	85	7	the	the	DET
ajlm-123	85	8	regulations	regulation	NOUN
ajlm-123	85	9	and	and	CCONJ
ajlm-123	85	10	standards	standard	NOUN
ajlm-123	85	11	applicable	applicable	ADJ
ajlm-123	85	12	to	to	ADP
ajlm-123	85	13	the	the	DET
ajlm-123	85	14	specific	specific	ADJ
ajlm-123	85	15	ivd	ivd	NOUN
ajlm-123	85	16	submitted	submit	VERB
ajlm-123	85	17	for	for	ADP
ajlm-123	85	18	approval	approval	NOUN
ajlm-123	85	19	,	,	PUNCT
ajlm-123	85	20	the	the	DET
ajlm-123	85	21	intended	intend	VERB
ajlm-123	85	22	use	use	NOUN
ajlm-123	85	23	and	and	CCONJ
ajlm-123	85	24	associated	associated	ADJ
ajlm-123	85	25	risks	risk	NOUN
ajlm-123	85	26	of	of	ADP
ajlm-123	85	27	the	the	DET
ajlm-123	85	28	device	device	NOUN
ajlm-123	85	29	,	,	PUNCT
ajlm-123	85	30	as	as	ADV
ajlm-123	85	31	well	well	ADV
ajlm-123	85	32	as	as	ADP
ajlm-123	85	33	the	the	DET
ajlm-123	85	34	knowledge	knowledge	NOUN
ajlm-123	85	35	to	to	PART
ajlm-123	85	36	assess	assess	VERB
ajlm-123	85	37	the	the	DET
ajlm-123	85	38	design	design	NOUN
ajlm-123	85	39	,	,	PUNCT
ajlm-123	85	40	manufacturing	manufacturing	NOUN
ajlm-123	85	41	processes	process	NOUN
ajlm-123	85	42	and	and	CCONJ
ajlm-123	85	43	technologies	technology	NOUN
ajlm-123	85	44	involved	involve	VERB
ajlm-123	85	45	.	.	PUNCT
ajlm-123	86	1	convergence	convergence	NOUN
ajlm-123	86	2	of	of	ADP
ajlm-123	86	3	quality	quality	NOUN
ajlm-123	86	4	standards	standard	NOUN
ajlm-123	86	5	and	and	CCONJ
ajlm-123	86	6	mutual	mutual	ADJ
ajlm-123	86	7	or	or	CCONJ
ajlm-123	86	8	third	third	ADJ
ajlm-123	86	9	-	-	PUNCT
ajlm-123	86	10	party	party	NOUN
ajlm-123	86	11	recognition	recognition	NOUN
ajlm-123	86	12	of	of	ADP
ajlm-123	86	13	inspection	inspection	NOUN
ajlm-123	86	14	results	result	NOUN
ajlm-123	86	15	could	could	AUX
ajlm-123	86	16	reduce	reduce	VERB
ajlm-123	86	17	duplication	duplication	NOUN
ajlm-123	86	18	of	of	ADP
ajlm-123	86	19	efforts	effort	NOUN
ajlm-123	86	20	where	where	SCONJ
ajlm-123	86	21	teams	team	NOUN
ajlm-123	86	22	representing	represent	VERB
ajlm-123	86	23	different	different	ADJ
ajlm-123	86	24	nras	nra	NOUN
ajlm-123	86	25	undertake	undertake	VERB
ajlm-123	86	26	independent	independent	ADJ
ajlm-123	86	27	audit	audit	NOUN
ajlm-123	86	28	of	of	ADP
ajlm-123	86	29	the	the	DET
ajlm-123	86	30	same	same	ADJ
ajlm-123	86	31	site	site	NOUN
ajlm-123	86	32	,	,	PUNCT
ajlm-123	86	33	saving	save	VERB
ajlm-123	86	34	expenditure	expenditure	NOUN
ajlm-123	86	35	and	and	CCONJ
ajlm-123	86	36	reducing	reduce	VERB
ajlm-123	86	37	delays	delay	NOUN
ajlm-123	86	38	in	in	ADP
ajlm-123	86	39	regulatory	regulatory	ADJ
ajlm-123	86	40	approval	approval	NOUN
ajlm-123	86	41	.	.	PUNCT
ajlm-123	87	1	status	status	NOUN
ajlm-123	87	2	quo	quo	VERB
ajlm-123	87	3	regulatory	regulatory	ADJ
ajlm-123	87	4	audits	audits	NOUN
ajlm-123	87	5	and	and	CCONJ
ajlm-123	87	6	site	site	NOUN
ajlm-123	87	7	visits	visit	NOUN
ajlm-123	87	8	are	be	AUX
ajlm-123	87	9	costly	costly	ADJ
ajlm-123	87	10	for	for	ADP
ajlm-123	87	11	companies	company	NOUN
ajlm-123	87	12	,	,	PUNCT
ajlm-123	87	13	with	with	ADP
ajlm-123	87	14	each	each	DET
ajlm-123	87	15	audit	audit	NOUN
ajlm-123	87	16	costing	cost	VERB
ajlm-123	87	17	as	as	ADV
ajlm-123	87	18	much	much	ADV
ajlm-123	87	19	as	as	ADP
ajlm-123	87	20	usd	usd	NOUN
ajlm-123	87	21	200	200	NUM
ajlm-123	87	22	 	 	SPACE
ajlm-123	87	23	000	000	NUM
ajlm-123	87	24	(	(	PUNCT
ajlm-123	87	25	personal	personal	ADJ
ajlm-123	87	26	communication	communication	NOUN
ajlm-123	87	27	)	)	PUNCT
ajlm-123	87	28	.	.	PUNCT
ajlm-123	88	1	although	although	SCONJ
ajlm-123	88	2	costs	cost	NOUN
ajlm-123	88	3	are	be	AUX
ajlm-123	88	4	met	meet	VERB
ajlm-123	88	5	in	in	ADP
ajlm-123	88	6	the	the	DET
ajlm-123	88	7	first	first	ADJ
ajlm-123	88	8	instance	instance	NOUN
ajlm-123	88	9	by	by	ADP
ajlm-123	88	10	the	the	DET
ajlm-123	88	11	companies	company	NOUN
ajlm-123	88	12	,	,	PUNCT
ajlm-123	88	13	they	they	PRON
ajlm-123	88	14	will	will	AUX
ajlm-123	88	15	ultimately	ultimately	ADV
ajlm-123	88	16	be	be	AUX
ajlm-123	88	17	reflected	reflect	VERB
ajlm-123	88	18	in	in	ADP
ajlm-123	88	19	the	the	DET
ajlm-123	88	20	price	price	NOUN
ajlm-123	88	21	of	of	ADP
ajlm-123	88	22	the	the	DET
ajlm-123	88	23	product	product	NOUN
ajlm-123	88	24	and	and	CCONJ
ajlm-123	88	25	recouped	recoup	VERB
ajlm-123	88	26	from	from	ADP
ajlm-123	88	27	the	the	DET
ajlm-123	88	28	end	end	NOUN
ajlm-123	88	29	users	user	NOUN
ajlm-123	88	30	.	.	PUNCT
ajlm-123	89	1	duplication	duplication	NOUN
ajlm-123	89	2	of	of	ADP
ajlm-123	89	3	audits	audits	NOUN
ajlm-123	89	4	inflates	inflate	VERB
ajlm-123	89	5	the	the	DET
ajlm-123	89	6	cost	cost	NOUN
ajlm-123	89	7	of	of	ADP
ajlm-123	89	8	bringing	bring	VERB
ajlm-123	89	9	a	a	DET
ajlm-123	89	10	product	product	NOUN
ajlm-123	89	11	to	to	ADP
ajlm-123	89	12	market	market	NOUN
ajlm-123	89	13	and	and	CCONJ
ajlm-123	89	14	results	result	NOUN
ajlm-123	89	15	in	in	ADP
ajlm-123	89	16	unnecessary	unnecessary	ADJ
ajlm-123	89	17	delays	delay	NOUN
ajlm-123	89	18	.	.	PUNCT
ajlm-123	90	1	nras	nras	PROPN
ajlm-123	90	2	that	that	PRON
ajlm-123	90	3	require	require	VERB
ajlm-123	90	4	manufacturing	manufacturing	NOUN
ajlm-123	90	5	site	site	NOUN
ajlm-123	90	6	inspections	inspection	NOUN
ajlm-123	90	7	for	for	ADP
ajlm-123	90	8	every	every	DET
ajlm-123	90	9	medical	medical	ADJ
ajlm-123	90	10	device	device	NOUN
ajlm-123	90	11	sold	sell	VERB
ajlm-123	90	12	often	often	ADV
ajlm-123	90	13	have	have	VERB
ajlm-123	90	14	long	long	ADJ
ajlm-123	90	15	delays	delay	NOUN
ajlm-123	90	16	in	in	ADP
ajlm-123	90	17	approving	approve	VERB
ajlm-123	90	18	products	product	NOUN
ajlm-123	90	19	for	for	ADP
ajlm-123	90	20	the	the	DET
ajlm-123	90	21	market	market	NOUN
ajlm-123	90	22	.	.	PUNCT
ajlm-123	91	1	in	in	ADP
ajlm-123	91	2	their	their	PRON
ajlm-123	91	3	2012	2012	NUM
ajlm-123	91	4	annual	annual	ADJ
ajlm-123	91	5	report	report	NOUN
ajlm-123	91	6	,	,	PUNCT
ajlm-123	91	7	the	the	DET
ajlm-123	91	8	brazilian	brazilian	ADJ
ajlm-123	91	9	national	national	PROPN
ajlm-123	91	10	health	health	PROPN
ajlm-123	91	11	surveillance	surveillance	NOUN
ajlm-123	91	12	agency	agency	PROPN
ajlm-123	91	13	(	(	PUNCT
ajlm-123	91	14	anvisa	anvisa	PROPN
ajlm-123	91	15	)	)	PUNCT
ajlm-123	91	16	,	,	PUNCT
ajlm-123	91	17	reported	report	VERB
ajlm-123	91	18	a	a	DET
ajlm-123	91	19	backlog	backlog	NOUN
ajlm-123	91	20	of	of	ADP
ajlm-123	91	21	over	over	ADP
ajlm-123	91	22	1000	1000	NUM
ajlm-123	91	23	products	product	NOUN
ajlm-123	91	24	awaiting	await	VERB
ajlm-123	91	25	evaluation.18	evaluation.18	PROPN
ajlm-123	91	26	nras	nras	PROPN
ajlm-123	91	27	in	in	ADP
ajlm-123	91	28	the	the	DET
ajlm-123	91	29	developing	develop	VERB
ajlm-123	91	30	world	world	NOUN
ajlm-123	91	31	lack	lack	VERB
ajlm-123	91	32	the	the	DET
ajlm-123	91	33	expertise	expertise	NOUN
ajlm-123	91	34	and	and	CCONJ
ajlm-123	91	35	capacity	capacity	NOUN
ajlm-123	91	36	required	require	VERB
ajlm-123	91	37	in	in	ADP
ajlm-123	91	38	order	order	NOUN
ajlm-123	91	39	to	to	PART
ajlm-123	91	40	undertake	undertake	VERB
ajlm-123	91	41	audits	audits	NOUN
ajlm-123	91	42	,	,	PUNCT
ajlm-123	91	43	which	which	PRON
ajlm-123	91	44	ultimately	ultimately	ADV
ajlm-123	91	45	results	result	VERB
ajlm-123	91	46	in	in	ADP
ajlm-123	91	47	delayed	delay	VERB
ajlm-123	91	48	approval	approval	NOUN
ajlm-123	91	49	.	.	PUNCT
ajlm-123	92	1	action	action	NOUN
ajlm-123	92	2	going	go	VERB
ajlm-123	92	3	forward	forward	ADV
ajlm-123	92	4	minimum	minimum	NOUN
ajlm-123	92	5	standards	standard	NOUN
ajlm-123	92	6	should	should	AUX
ajlm-123	92	7	be	be	AUX
ajlm-123	92	8	identified	identify	VERB
ajlm-123	92	9	for	for	ADP
ajlm-123	92	10	quality	quality	NOUN
ajlm-123	92	11	management	management	NOUN
ajlm-123	92	12	in	in	ADP
ajlm-123	92	13	the	the	DET
ajlm-123	92	14	manufacture	manufacture	NOUN
ajlm-123	92	15	of	of	ADP
ajlm-123	92	16	poc	poc	NOUN
ajlm-123	92	17	diagnostics	diagnostic	NOUN
ajlm-123	92	18	in	in	ADP
ajlm-123	92	19	addition	addition	NOUN
ajlm-123	92	20	to	to	ADP
ajlm-123	92	21	iso	iso	PROPN
ajlm-123	92	22	13485:2003.17	13485:2003.17	PROPN
ajlm-123	92	23	to	to	PART
ajlm-123	92	24	reduce	reduce	VERB
ajlm-123	92	25	duplication	duplication	NOUN
ajlm-123	92	26	,	,	PUNCT
ajlm-123	92	27	competent	competent	ADJ
ajlm-123	92	28	authorities	authority	NOUN
ajlm-123	92	29	or	or	CCONJ
ajlm-123	92	30	organisations	organisation	NOUN
ajlm-123	92	31	capable	capable	ADJ
ajlm-123	92	32	of	of	ADP
ajlm-123	92	33	undertaking	undertake	VERB
ajlm-123	92	34	inspections	inspection	NOUN
ajlm-123	92	35	should	should	AUX
ajlm-123	92	36	be	be	AUX
ajlm-123	92	37	identified	identify	VERB
ajlm-123	92	38	and	and	CCONJ
ajlm-123	92	39	mutual	mutual	ADJ
ajlm-123	92	40	recognition	recognition	NOUN
ajlm-123	92	41	or	or	CCONJ
ajlm-123	92	42	recognition	recognition	NOUN
ajlm-123	92	43	of	of	ADP
ajlm-123	92	44	competent	competent	ADJ
ajlm-123	92	45	third	third	ADJ
ajlm-123	92	46	-	-	PUNCT
ajlm-123	92	47	party	party	NOUN
ajlm-123	92	48	quality	quality	NOUN
ajlm-123	92	49	management	management	NOUN
ajlm-123	92	50	audits	audits	NOUN
ajlm-123	92	51	adopted	adopt	VERB
ajlm-123	92	52	.	.	PUNCT
ajlm-123	93	1	in	in	ADP
ajlm-123	93	2	addition	addition	NOUN
ajlm-123	93	3	,	,	PUNCT
ajlm-123	93	4	mechanisms	mechanism	NOUN
ajlm-123	93	5	for	for	ADP
ajlm-123	93	6	sharing	share	VERB
ajlm-123	93	7	information	information	NOUN
ajlm-123	93	8	should	should	AUX
ajlm-123	93	9	be	be	AUX
ajlm-123	93	10	established	establish	VERB
ajlm-123	93	11	.	.	PUNCT
ajlm-123	94	1	harmonisation	harmonisation	NOUN
ajlm-123	94	2	of	of	ADP
ajlm-123	94	3	quality	quality	NOUN
ajlm-123	94	4	systems	system	NOUN
ajlm-123	94	5	audits	audits	NOUN
ajlm-123	94	6	through	through	ADP
ajlm-123	94	7	convergence	convergence	NOUN
ajlm-123	94	8	of	of	ADP
ajlm-123	94	9	standards	standard	NOUN
ajlm-123	94	10	and/or	and/or	CCONJ
ajlm-123	94	11	mutual	mutual	ADJ
ajlm-123	94	12	recognition	recognition	NOUN
ajlm-123	94	13	will	will	AUX
ajlm-123	94	14	make	make	VERB
ajlm-123	94	15	more	more	ADV
ajlm-123	94	16	efficient	efficient	ADJ
ajlm-123	94	17	use	use	NOUN
ajlm-123	94	18	of	of	ADP
ajlm-123	94	19	auditing	auditing	NOUN
ajlm-123	94	20	resources	resource	NOUN
ajlm-123	94	21	and	and	CCONJ
ajlm-123	94	22	reduce	reduce	VERB
ajlm-123	94	23	the	the	DET
ajlm-123	94	24	number	number	NOUN
ajlm-123	94	25	of	of	ADP
ajlm-123	94	26	audits	audits	NOUN
ajlm-123	94	27	by	by	ADP
ajlm-123	94	28	different	different	ADJ
ajlm-123	94	29	regulatory	regulatory	ADJ
ajlm-123	94	30	bodies	body	NOUN
ajlm-123	94	31	for	for	ADP
ajlm-123	94	32	the	the	DET
ajlm-123	94	33	same	same	ADJ
ajlm-123	94	34	product	product	NOUN
ajlm-123	94	35	,	,	PUNCT
ajlm-123	94	36	saving	save	VERB
ajlm-123	94	37	costs	cost	NOUN
ajlm-123	94	38	and	and	CCONJ
ajlm-123	94	39	reducing	reduce	VERB
ajlm-123	94	40	delays	delay	NOUN
ajlm-123	94	41	in	in	ADP
ajlm-123	94	42	new	new	ADJ
ajlm-123	94	43	products	product	NOUN
ajlm-123	94	44	reaching	reach	VERB
ajlm-123	94	45	the	the	DET
ajlm-123	94	46	market	market	NOUN
ajlm-123	94	47	.	.	PUNCT
ajlm-123	95	1	use	use	NOUN
ajlm-123	95	2	of	of	ADP
ajlm-123	95	3	standardised	standardised	ADJ
ajlm-123	95	4	audit	audit	NOUN
ajlm-123	95	5	protocols	protocol	NOUN
ajlm-123	95	6	and	and	CCONJ
ajlm-123	95	7	expert	expert	NOUN
ajlm-123	95	8	bodies	body	NOUN
ajlm-123	95	9	will	will	AUX
ajlm-123	95	10	streamline	streamline	VERB
ajlm-123	95	11	auditing	auditing	NOUN
ajlm-123	95	12	,	,	PUNCT
ajlm-123	95	13	leading	lead	VERB
ajlm-123	95	14	to	to	ADP
ajlm-123	95	15	improved	improve	VERB
ajlm-123	95	16	quality	quality	NOUN
ajlm-123	95	17	management	management	NOUN
ajlm-123	95	18	and	and	CCONJ
ajlm-123	95	19	product	product	NOUN
ajlm-123	95	20	quality	quality	NOUN
ajlm-123	95	21	.	.	PUNCT
ajlm-123	96	1	this	this	PRON
ajlm-123	96	2	will	will	AUX
ajlm-123	96	3	provide	provide	VERB
ajlm-123	96	4	greater	great	ADJ
ajlm-123	96	5	consistency	consistency	NOUN
ajlm-123	96	6	and	and	CCONJ
ajlm-123	96	7	increased	increase	VERB
ajlm-123	96	8	confidence	confidence	NOUN
ajlm-123	96	9	in	in	ADP
ajlm-123	96	10	audits	audits	NOUN
ajlm-123	96	11	.	.	PUNCT
ajlm-123	97	1	enhanced	enhance	VERB
ajlm-123	97	2	consistency	consistency	NOUN
ajlm-123	97	3	in	in	ADP
ajlm-123	97	4	audit	audit	NOUN
ajlm-123	97	5	practices	practice	NOUN
ajlm-123	97	6	and	and	CCONJ
ajlm-123	97	7	feedback	feedback	NOUN
ajlm-123	97	8	provided	provide	VERB
ajlm-123	97	9	to	to	ADP
ajlm-123	97	10	manufacturers	manufacturer	NOUN
ajlm-123	97	11	regarding	regard	VERB
ajlm-123	97	12	quality	quality	NOUN
ajlm-123	97	13	management	management	NOUN
ajlm-123	97	14	will	will	AUX
ajlm-123	97	15	facilitate	facilitate	VERB
ajlm-123	97	16	improvements	improvement	NOUN
ajlm-123	97	17	in	in	ADP
ajlm-123	97	18	manufacturing	manufacturing	NOUN
ajlm-123	97	19	practice	practice	NOUN
ajlm-123	97	20	.	.	PUNCT
ajlm-123	98	1	the	the	DET
ajlm-123	98	2	ultimate	ultimate	ADJ
ajlm-123	98	3	beneficiaries	beneficiary	NOUN
ajlm-123	98	4	will	will	AUX
ajlm-123	98	5	be	be	AUX
ajlm-123	98	6	patients	patient	NOUN
ajlm-123	98	7	and	and	CCONJ
ajlm-123	98	8	users	user	NOUN
ajlm-123	98	9	of	of	ADP
ajlm-123	98	10	diagnostic	diagnostic	ADJ
ajlm-123	98	11	devices	device	NOUN
ajlm-123	98	12	,	,	PUNCT
ajlm-123	98	13	who	who	PRON
ajlm-123	98	14	will	will	AUX
ajlm-123	98	15	gain	gain	VERB
ajlm-123	98	16	an	an	DET
ajlm-123	98	17	increased	increase	VERB
ajlm-123	98	18	assurance	assurance	NOUN
ajlm-123	98	19	that	that	PRON
ajlm-123	98	20	medical	medical	ADJ
ajlm-123	98	21	devices	device	NOUN
ajlm-123	98	22	placed	place	VERB
ajlm-123	98	23	on	on	ADP
ajlm-123	98	24	the	the	DET
ajlm-123	98	25	market	market	NOUN
ajlm-123	98	26	are	be	AUX
ajlm-123	98	27	safe	safe	ADJ
ajlm-123	98	28	and	and	CCONJ
ajlm-123	98	29	effective	effective	ADJ
ajlm-123	98	30	whilst	whilst	SCONJ
ajlm-123	98	31	simultaneously	simultaneously	ADV
ajlm-123	98	32	ensuring	ensure	VERB
ajlm-123	98	33	that	that	SCONJ
ajlm-123	98	34	the	the	DET
ajlm-123	98	35	costs	cost	NOUN
ajlm-123	98	36	of	of	ADP
ajlm-123	98	37	implementing	implement	VERB
ajlm-123	98	38	an	an	DET
ajlm-123	98	39	effective	effective	ADJ
ajlm-123	98	40	system	system	NOUN
ajlm-123	98	41	do	do	AUX
ajlm-123	98	42	not	not	PART
ajlm-123	98	43	unnecessarily	unnecessarily	ADV
ajlm-123	98	44	inflate	inflate	VERB
ajlm-123	98	45	the	the	DET
ajlm-123	98	46	price	price	NOUN
ajlm-123	98	47	.	.	PUNCT
ajlm-123	99	1	reducing	reduce	VERB
ajlm-123	99	2	duplication	duplication	NOUN
ajlm-123	99	3	in	in	ADP
ajlm-123	99	4	studies	study	NOUN
ajlm-123	99	5	of	of	ADP
ajlm-123	99	6	clinical	clinical	ADJ
ajlm-123	99	7	performance	performance	NOUN
ajlm-123	99	8	top	top	NOUN
ajlm-123	99	9	↑	↑	ADJ
ajlm-123	99	10	pre	pre	ADJ
ajlm-123	99	11	-	-	ADJ
ajlm-123	99	12	market	market	ADJ
ajlm-123	99	13	approval	approval	NOUN
ajlm-123	99	14	of	of	ADP
ajlm-123	99	15	those	those	DET
ajlm-123	99	16	ivds	ivds	NOUN
ajlm-123	99	17	considered	consider	VERB
ajlm-123	99	18	to	to	PART
ajlm-123	99	19	be	be	AUX
ajlm-123	99	20	high	high	ADJ
ajlm-123	99	21	risk	risk	NOUN
ajlm-123	99	22	to	to	ADP
ajlm-123	99	23	individual	individual	ADJ
ajlm-123	99	24	or	or	CCONJ
ajlm-123	99	25	public	public	ADJ
ajlm-123	99	26	health	health	NOUN
ajlm-123	99	27	requires	require	VERB
ajlm-123	99	28	supporting	support	VERB
ajlm-123	99	29	evidence	evidence	NOUN
ajlm-123	99	30	of	of	ADP
ajlm-123	99	31	the	the	DET
ajlm-123	99	32	performance	performance	NOUN
ajlm-123	99	33	and	and	CCONJ
ajlm-123	99	34	operational	operational	ADJ
ajlm-123	99	35	characteristics	characteristic	NOUN
ajlm-123	99	36	of	of	ADP
ajlm-123	99	37	the	the	DET
ajlm-123	99	38	device	device	NOUN
ajlm-123	99	39	.	.	PUNCT
ajlm-123	100	1	for	for	ADP
ajlm-123	100	2	laboratory	laboratory	NOUN
ajlm-123	100	3	-	-	PUNCT
ajlm-123	100	4	based	base	VERB
ajlm-123	100	5	diagnostic	diagnostic	ADJ
ajlm-123	100	6	tests	test	NOUN
ajlm-123	100	7	,	,	PUNCT
ajlm-123	100	8	such	such	ADJ
ajlm-123	100	9	evaluations	evaluation	NOUN
ajlm-123	100	10	are	be	AUX
ajlm-123	100	11	often	often	ADV
ajlm-123	100	12	conducted	conduct	VERB
ajlm-123	100	13	using	use	VERB
ajlm-123	100	14	well	well	ADV
ajlm-123	100	15	-	-	PUNCT
ajlm-123	100	16	characterised	characterise	VERB
ajlm-123	100	17	archived	archive	VERB
ajlm-123	100	18	samples	sample	NOUN
ajlm-123	100	19	.	.	PUNCT
ajlm-123	101	1	if	if	SCONJ
ajlm-123	101	2	the	the	DET
ajlm-123	101	3	new	new	ADJ
ajlm-123	101	4	product	product	NOUN
ajlm-123	101	5	is	be	AUX
ajlm-123	101	6	a	a	DET
ajlm-123	101	7	poc	poc	NOUN
ajlm-123	101	8	test	test	NOUN
ajlm-123	101	9	intended	intend	VERB
ajlm-123	101	10	for	for	ADP
ajlm-123	101	11	use	use	NOUN
ajlm-123	101	12	in	in	ADP
ajlm-123	101	13	decentralised	decentralise	VERB
ajlm-123	101	14	health	health	NOUN
ajlm-123	101	15	centres	centre	NOUN
ajlm-123	101	16	or	or	CCONJ
ajlm-123	101	17	dispensaries	dispensary	NOUN
ajlm-123	101	18	,	,	PUNCT
ajlm-123	101	19	evaluations	evaluation	NOUN
ajlm-123	101	20	of	of	ADP
ajlm-123	101	21	sensitivity	sensitivity	NOUN
ajlm-123	101	22	,	,	PUNCT
ajlm-123	101	23	specificity	specificity	NOUN
ajlm-123	101	24	,	,	PUNCT
ajlm-123	101	25	precision	precision	NOUN
ajlm-123	101	26	and	and	CCONJ
ajlm-123	101	27	ease	ease	NOUN
ajlm-123	101	28	of	of	ADP
ajlm-123	101	29	use	use	NOUN
ajlm-123	101	30	should	should	AUX
ajlm-123	101	31	be	be	AUX
ajlm-123	101	32	conducted	conduct	VERB
ajlm-123	101	33	in	in	ADP
ajlm-123	101	34	the	the	DET
ajlm-123	101	35	settings	setting	NOUN
ajlm-123	101	36	of	of	ADP
ajlm-123	101	37	intended	intended	ADJ
ajlm-123	101	38	use	use	NOUN
ajlm-123	101	39	,	,	PUNCT
ajlm-123	101	40	with	with	ADP
ajlm-123	101	41	the	the	DET
ajlm-123	101	42	test	test	NOUN
ajlm-123	101	43	performed	perform	VERB
ajlm-123	101	44	by	by	ADP
ajlm-123	101	45	the	the	DET
ajlm-123	101	46	proposed	propose	VERB
ajlm-123	101	47	end	end	NOUN
ajlm-123	101	48	users.19	users.19	PRON
ajlm-123	101	49	such	such	ADJ
ajlm-123	101	50	studies	study	NOUN
ajlm-123	101	51	need	need	VERB
ajlm-123	101	52	to	to	PART
ajlm-123	101	53	be	be	AUX
ajlm-123	101	54	based	base	VERB
ajlm-123	101	55	on	on	ADP
ajlm-123	101	56	sufficient	sufficient	ADJ
ajlm-123	101	57	sample	sample	NOUN
ajlm-123	101	58	size	size	NOUN
ajlm-123	101	59	with	with	ADP
ajlm-123	101	60	assurance	assurance	NOUN
ajlm-123	101	61	of	of	ADP
ajlm-123	101	62	quality	quality	NOUN
ajlm-123	101	63	so	so	SCONJ
ajlm-123	101	64	as	as	SCONJ
ajlm-123	101	65	to	to	PART
ajlm-123	101	66	allow	allow	VERB
ajlm-123	101	67	informed	informed	ADJ
ajlm-123	101	68	decisions	decision	NOUN
ajlm-123	101	69	on	on	ADP
ajlm-123	101	70	the	the	DET
ajlm-123	101	71	performance	performance	NOUN
ajlm-123	101	72	and	and	CCONJ
ajlm-123	101	73	utility	utility	NOUN
ajlm-123	101	74	of	of	ADP
ajlm-123	101	75	the	the	DET
ajlm-123	101	76	device	device	NOUN
ajlm-123	101	77	as	as	ADP
ajlm-123	101	78	to	to	ADP
ajlm-123	101	79	whether	whether	SCONJ
ajlm-123	101	80	the	the	DET
ajlm-123	101	81	probable	probable	ADJ
ajlm-123	101	82	benefits	benefit	NOUN
ajlm-123	101	83	of	of	ADP
ajlm-123	101	84	the	the	DET
ajlm-123	101	85	device	device	NOUN
ajlm-123	101	86	outweigh	outweigh	VERB
ajlm-123	101	87	the	the	DET
ajlm-123	101	88	risks	risk	NOUN
ajlm-123	101	89	.	.	PUNCT
ajlm-123	102	1	data	datum	NOUN
ajlm-123	102	2	generated	generate	VERB
ajlm-123	102	3	in	in	ADP
ajlm-123	102	4	clinical	clinical	ADJ
ajlm-123	102	5	studies	study	NOUN
ajlm-123	102	6	are	be	AUX
ajlm-123	102	7	presented	present	VERB
ajlm-123	102	8	to	to	ADP
ajlm-123	102	9	nras	nras	PROPN
ajlm-123	102	10	as	as	ADP
ajlm-123	102	11	part	part	NOUN
ajlm-123	102	12	of	of	ADP
ajlm-123	102	13	the	the	DET
ajlm-123	102	14	submission	submission	NOUN
ajlm-123	102	15	dossier	dossier	NOUN
ajlm-123	102	16	for	for	ADP
ajlm-123	102	17	pre	pre	ADJ
ajlm-123	102	18	-	-	ADJ
ajlm-123	102	19	market	market	ADJ
ajlm-123	102	20	approval	approval	NOUN
ajlm-123	102	21	.	.	PUNCT
ajlm-123	103	1	the	the	DET
ajlm-123	103	2	high	high	ADJ
ajlm-123	103	3	cost	cost	NOUN
ajlm-123	103	4	of	of	ADP
ajlm-123	103	5	clinical	clinical	ADJ
ajlm-123	103	6	trials	trial	NOUN
ajlm-123	103	7	and	and	CCONJ
ajlm-123	103	8	the	the	DET
ajlm-123	103	9	length	length	NOUN
ajlm-123	103	10	of	of	ADP
ajlm-123	103	11	time	time	NOUN
ajlm-123	103	12	they	they	PRON
ajlm-123	103	13	require	require	VERB
ajlm-123	103	14	may	may	AUX
ajlm-123	103	15	result	result	VERB
ajlm-123	103	16	in	in	ADP
ajlm-123	103	17	higher	high	ADJ
ajlm-123	103	18	cost	cost	NOUN
ajlm-123	103	19	of	of	ADP
ajlm-123	103	20	goods	good	NOUN
ajlm-123	103	21	and	and	CCONJ
ajlm-123	103	22	significant	significant	ADJ
ajlm-123	103	23	delay	delay	NOUN
ajlm-123	103	24	in	in	ADP
ajlm-123	103	25	gaining	gain	VERB
ajlm-123	103	26	access	access	NOUN
ajlm-123	103	27	to	to	ADP
ajlm-123	103	28	new	new	ADJ
ajlm-123	103	29	products	product	NOUN
ajlm-123	103	30	that	that	PRON
ajlm-123	103	31	could	could	AUX
ajlm-123	103	32	potentially	potentially	ADV
ajlm-123	103	33	save	save	VERB
ajlm-123	103	34	lives.20	lives.20	PROPN
ajlm-123	103	35	status	status	X
ajlm-123	103	36	quo	quo	VERB
ajlm-123	103	37	the	the	DET
ajlm-123	103	38	requirement	requirement	NOUN
ajlm-123	103	39	of	of	ADP
ajlm-123	103	40	nras	nras	PROPN
ajlm-123	103	41	to	to	PART
ajlm-123	103	42	have	have	VERB
ajlm-123	103	43	national	national	ADJ
ajlm-123	103	44	trial	trial	NOUN
ajlm-123	103	45	data	datum	NOUN
ajlm-123	103	46	for	for	ADP
ajlm-123	103	47	approval	approval	NOUN
ajlm-123	103	48	has	have	AUX
ajlm-123	103	49	resulted	result	VERB
ajlm-123	103	50	in	in	ADP
ajlm-123	103	51	unnecessary	unnecessary	ADJ
ajlm-123	103	52	duplication	duplication	NOUN
ajlm-123	103	53	,	,	PUNCT
ajlm-123	103	54	where	where	SCONJ
ajlm-123	103	55	further	further	ADJ
ajlm-123	103	56	studies	study	NOUN
ajlm-123	103	57	provide	provide	VERB
ajlm-123	103	58	little	little	ADJ
ajlm-123	103	59	or	or	CCONJ
ajlm-123	103	60	no	no	PRON
ajlm-123	103	61	added	add	VERB
ajlm-123	103	62	scientific	scientific	ADJ
ajlm-123	103	63	benefit.21,22	benefit.21,22	NOUN
ajlm-123	103	64	high	high	ADJ
ajlm-123	103	65	costs	cost	NOUN
ajlm-123	103	66	and	and	CCONJ
ajlm-123	103	67	delays	delay	NOUN
ajlm-123	103	68	incurred	incur	VERB
ajlm-123	103	69	during	during	ADP
ajlm-123	103	70	clinical	clinical	ADJ
ajlm-123	103	71	studies	study	NOUN
ajlm-123	103	72	are	be	AUX
ajlm-123	103	73	a	a	DET
ajlm-123	103	74	deterrent	deterrent	NOUN
ajlm-123	103	75	for	for	ADP
ajlm-123	103	76	companies	company	NOUN
ajlm-123	103	77	entering	enter	VERB
ajlm-123	103	78	the	the	DET
ajlm-123	103	79	market	market	NOUN
ajlm-123	103	80	,	,	PUNCT
ajlm-123	103	81	particularly	particularly	ADV
ajlm-123	103	82	in	in	ADP
ajlm-123	103	83	smaller	small	ADJ
ajlm-123	103	84	countries	country	NOUN
ajlm-123	103	85	where	where	SCONJ
ajlm-123	103	86	financial	financial	ADJ
ajlm-123	103	87	returns	return	NOUN
ajlm-123	103	88	may	may	AUX
ajlm-123	103	89	be	be	AUX
ajlm-123	103	90	modest.9,12	modest.9,12	PROPN
ajlm-123	103	91	costs	cost	NOUN
ajlm-123	103	92	borne	bear	VERB
ajlm-123	103	93	by	by	ADP
ajlm-123	103	94	the	the	DET
ajlm-123	103	95	manufacturer	manufacturer	NOUN
ajlm-123	103	96	are	be	AUX
ajlm-123	103	97	ultimately	ultimately	ADV
ajlm-123	103	98	passed	pass	VERB
ajlm-123	103	99	on	on	ADP
ajlm-123	103	100	to	to	ADP
ajlm-123	103	101	the	the	DET
ajlm-123	103	102	consumer	consumer	NOUN
ajlm-123	103	103	,	,	PUNCT
ajlm-123	103	104	making	make	VERB
ajlm-123	103	105	devices	device	NOUN
ajlm-123	103	106	less	less	ADV
ajlm-123	103	107	affordable	affordable	ADJ
ajlm-123	103	108	.	.	PUNCT
ajlm-123	104	1	since	since	SCONJ
ajlm-123	104	2	not	not	PART
ajlm-123	104	3	every	every	DET
ajlm-123	104	4	country	country	NOUN
ajlm-123	104	5	has	have	VERB
ajlm-123	104	6	the	the	DET
ajlm-123	104	7	capacity	capacity	NOUN
ajlm-123	104	8	to	to	PART
ajlm-123	104	9	conduct	conduct	VERB
ajlm-123	104	10	high	high	ADJ
ajlm-123	104	11	quality	quality	NOUN
ajlm-123	104	12	studies	study	NOUN
ajlm-123	104	13	in	in	ADP
ajlm-123	104	14	a	a	DET
ajlm-123	104	15	timely	timely	ADJ
ajlm-123	104	16	manner	manner	NOUN
ajlm-123	104	17	,	,	PUNCT
ajlm-123	104	18	resulting	result	VERB
ajlm-123	104	19	from	from	ADP
ajlm-123	104	20	a	a	DET
ajlm-123	104	21	lack	lack	NOUN
ajlm-123	104	22	of	of	ADP
ajlm-123	104	23	specialist	specialist	ADJ
ajlm-123	104	24	facilities	facility	NOUN
ajlm-123	104	25	or	or	CCONJ
ajlm-123	104	26	limited	limited	ADJ
ajlm-123	104	27	access	access	NOUN
ajlm-123	104	28	to	to	ADP
ajlm-123	104	29	appropriate	appropriate	ADJ
ajlm-123	104	30	patient	patient	ADJ
ajlm-123	104	31	groups	group	NOUN
ajlm-123	104	32	,	,	PUNCT
ajlm-123	104	33	multi	multi	ADJ
ajlm-123	104	34	-	-	ADJ
ajlm-123	104	35	country	country	ADJ
ajlm-123	104	36	evaluations	evaluation	NOUN
ajlm-123	104	37	and	and	CCONJ
ajlm-123	104	38	nras	nras	PROPN
ajlm-123	104	39	coming	come	VERB
ajlm-123	104	40	together	together	ADV
ajlm-123	104	41	to	to	PART
ajlm-123	104	42	review	review	VERB
ajlm-123	104	43	trial	trial	NOUN
ajlm-123	104	44	data	datum	NOUN
ajlm-123	104	45	and	and	CCONJ
ajlm-123	104	46	then	then	ADV
ajlm-123	104	47	making	make	VERB
ajlm-123	104	48	their	their	PRON
ajlm-123	104	49	own	own	ADJ
ajlm-123	104	50	decisions	decision	NOUN
ajlm-123	104	51	for	for	ADP
ajlm-123	104	52	approval	approval	NOUN
ajlm-123	104	53	would	would	AUX
ajlm-123	104	54	be	be	AUX
ajlm-123	104	55	a	a	DET
ajlm-123	104	56	more	more	ADV
ajlm-123	104	57	efficient	efficient	ADJ
ajlm-123	104	58	approach	approach	NOUN
ajlm-123	104	59	.	.	PUNCT
ajlm-123	105	1	action	action	NOUN
ajlm-123	105	2	going	go	VERB
ajlm-123	105	3	forward	forward	ADV
ajlm-123	105	4	multi	multi	ADJ
ajlm-123	105	5	-	-	ADJ
ajlm-123	105	6	country	country	ADJ
ajlm-123	105	7	studies	study	NOUN
ajlm-123	105	8	using	use	VERB
ajlm-123	105	9	a	a	DET
ajlm-123	105	10	standardised	standardised	ADJ
ajlm-123	105	11	protocol	protocol	NOUN
ajlm-123	105	12	and	and	CCONJ
ajlm-123	105	13	joint	joint	ADJ
ajlm-123	105	14	review	review	NOUN
ajlm-123	105	15	of	of	ADP
ajlm-123	105	16	trial	trial	NOUN
ajlm-123	105	17	data	datum	NOUN
ajlm-123	105	18	should	should	AUX
ajlm-123	105	19	be	be	AUX
ajlm-123	105	20	encouraged	encourage	VERB
ajlm-123	105	21	in	in	ADP
ajlm-123	105	22	order	order	NOUN
ajlm-123	105	23	to	to	PART
ajlm-123	105	24	shorten	shorten	VERB
ajlm-123	105	25	trial	trial	NOUN
ajlm-123	105	26	duration	duration	NOUN
ajlm-123	105	27	and	and	CCONJ
ajlm-123	105	28	reduce	reduce	VERB
ajlm-123	105	29	duplication	duplication	NOUN
ajlm-123	105	30	.	.	PUNCT
ajlm-123	106	1	a	a	DET
ajlm-123	106	2	clinical	clinical	ADJ
ajlm-123	106	3	trials	trial	NOUN
ajlm-123	106	4	registry	registry	NOUN
ajlm-123	106	5	should	should	AUX
ajlm-123	106	6	be	be	AUX
ajlm-123	106	7	established	establish	VERB
ajlm-123	106	8	to	to	PART
ajlm-123	106	9	reduce	reduce	VERB
ajlm-123	106	10	unintentional	unintentional	ADJ
ajlm-123	106	11	duplication	duplication	NOUN
ajlm-123	106	12	and	and	CCONJ
ajlm-123	106	13	promote	promote	VERB
ajlm-123	106	14	maximal	maximal	ADJ
ajlm-123	106	15	use	use	NOUN
ajlm-123	106	16	of	of	ADP
ajlm-123	106	17	resources	resource	NOUN
ajlm-123	106	18	.	.	PUNCT
ajlm-123	107	1	clinical	clinical	ADJ
ajlm-123	107	2	performance	performance	NOUN
ajlm-123	107	3	studies	study	NOUN
ajlm-123	107	4	should	should	AUX
ajlm-123	107	5	be	be	AUX
ajlm-123	107	6	conducted	conduct	VERB
ajlm-123	107	7	by	by	ADP
ajlm-123	107	8	accredited	accredit	VERB
ajlm-123	107	9	laboratories	laboratory	NOUN
ajlm-123	107	10	and	and	CCONJ
ajlm-123	107	11	clinics	clinic	NOUN
ajlm-123	107	12	with	with	ADP
ajlm-123	107	13	external	external	ADJ
ajlm-123	107	14	oversight	oversight	NOUN
ajlm-123	107	15	,	,	PUNCT
ajlm-123	107	16	so	so	SCONJ
ajlm-123	107	17	as	as	SCONJ
ajlm-123	107	18	to	to	PART
ajlm-123	107	19	ensure	ensure	VERB
ajlm-123	107	20	conformity	conformity	NOUN
ajlm-123	107	21	with	with	ADP
ajlm-123	107	22	international	international	ADJ
ajlm-123	107	23	standards	standard	NOUN
ajlm-123	107	24	,	,	PUNCT
ajlm-123	107	25	including	include	VERB
ajlm-123	107	26	good	good	ADJ
ajlm-123	107	27	laboratory	laboratory	NOUN
ajlm-123	107	28	and	and	CCONJ
ajlm-123	107	29	clinical	clinical	ADJ
ajlm-123	107	30	practice.23,24,25	practice.23,24,25	NOUN
ajlm-123	107	31	prior	prior	ADJ
ajlm-123	107	32	joint	joint	ADJ
ajlm-123	107	33	approval	approval	NOUN
ajlm-123	107	34	of	of	ADP
ajlm-123	107	35	clinical	clinical	ADJ
ajlm-123	107	36	and	and	CCONJ
ajlm-123	107	37	laboratory	laboratory	NOUN
ajlm-123	107	38	protocols	protocol	NOUN
ajlm-123	107	39	by	by	ADP
ajlm-123	107	40	institutional	institutional	ADJ
ajlm-123	107	41	review	review	NOUN
ajlm-123	107	42	boards	board	NOUN
ajlm-123	107	43	will	will	AUX
ajlm-123	107	44	ensure	ensure	VERB
ajlm-123	107	45	quality	quality	NOUN
ajlm-123	107	46	and	and	CCONJ
ajlm-123	107	47	acceptance	acceptance	NOUN
ajlm-123	107	48	by	by	ADP
ajlm-123	107	49	representatives	representative	NOUN
ajlm-123	107	50	of	of	ADP
ajlm-123	107	51	regulatory	regulatory	ADJ
ajlm-123	107	52	authorities	authority	NOUN
ajlm-123	107	53	.	.	PUNCT
ajlm-123	108	1	reducing	reduce	VERB
ajlm-123	108	2	duplication	duplication	NOUN
ajlm-123	108	3	of	of	ADP
ajlm-123	108	4	clinical	clinical	ADJ
ajlm-123	108	5	trials	trial	NOUN
ajlm-123	108	6	will	will	AUX
ajlm-123	108	7	:	:	PUNCT
ajlm-123	108	8	(	(	PUNCT
ajlm-123	108	9	1	1	X
ajlm-123	108	10	)	)	PUNCT
ajlm-123	108	11	reduce	reduce	VERB
ajlm-123	108	12	the	the	DET
ajlm-123	108	13	cost	cost	NOUN
ajlm-123	108	14	of	of	ADP
ajlm-123	108	15	accessing	access	VERB
ajlm-123	108	16	the	the	DET
ajlm-123	108	17	market	market	NOUN
ajlm-123	108	18	,	,	PUNCT
ajlm-123	108	19	making	make	VERB
ajlm-123	108	20	tests	test	NOUN
ajlm-123	108	21	more	more	ADV
ajlm-123	108	22	affordable	affordable	ADJ
ajlm-123	108	23	;	;	PUNCT
ajlm-123	108	24	(	(	PUNCT
ajlm-123	108	25	2	2	X
ajlm-123	108	26	)	)	PUNCT
ajlm-123	108	27	reduce	reduce	VERB
ajlm-123	108	28	delays	delay	NOUN
ajlm-123	108	29	in	in	ADP
ajlm-123	108	30	regulatory	regulatory	ADJ
ajlm-123	108	31	approval	approval	NOUN
ajlm-123	108	32	,	,	PUNCT
ajlm-123	108	33	accelerating	accelerate	VERB
ajlm-123	108	34	access	access	NOUN
ajlm-123	108	35	to	to	ADP
ajlm-123	108	36	new	new	ADJ
ajlm-123	108	37	products	product	NOUN
ajlm-123	108	38	;	;	PUNCT
ajlm-123	108	39	(	(	PUNCT
ajlm-123	108	40	3	3	X
ajlm-123	108	41	)	)	PUNCT
ajlm-123	108	42	reduce	reduce	VERB
ajlm-123	108	43	barriers	barrier	NOUN
ajlm-123	108	44	to	to	ADP
ajlm-123	108	45	marketing	marketing	NOUN
ajlm-123	108	46	in	in	ADP
ajlm-123	108	47	small	small	ADJ
ajlm-123	108	48	economies	economy	NOUN
ajlm-123	108	49	;	;	PUNCT
ajlm-123	108	50	and	and	CCONJ
ajlm-123	108	51	(	(	PUNCT
ajlm-123	108	52	4	4	X
ajlm-123	108	53	)	)	PUNCT
ajlm-123	108	54	allow	allow	VERB
ajlm-123	108	55	nras	nras	PROPN
ajlm-123	108	56	to	to	PART
ajlm-123	108	57	maintain	maintain	VERB
ajlm-123	108	58	independent	independent	ADJ
ajlm-123	108	59	decision	decision	NOUN
ajlm-123	108	60	making	making	NOUN
ajlm-123	108	61	for	for	ADP
ajlm-123	108	62	new	new	ADJ
ajlm-123	108	63	products	product	NOUN
ajlm-123	108	64	without	without	ADP
ajlm-123	108	65	requiring	require	VERB
ajlm-123	108	66	local	local	ADJ
ajlm-123	108	67	trials	trial	NOUN
ajlm-123	108	68	.	.	PUNCT
ajlm-123	109	1	convergence	convergence	NOUN
ajlm-123	109	2	in	in	ADP
ajlm-123	109	3	post	post	ADJ
ajlm-123	109	4	-	-	ADJ
ajlm-123	109	5	market	market	ADJ
ajlm-123	109	6	surveillance	surveillance	NOUN
ajlm-123	109	7	top	top	ADJ
ajlm-123	109	8	↑	↑	ADJ
ajlm-123	109	9	post	post	ADJ
ajlm-123	109	10	-	-	ADJ
ajlm-123	109	11	market	market	ADJ
ajlm-123	109	12	surveillance	surveillance	NOUN
ajlm-123	109	13	ensures	ensure	VERB
ajlm-123	109	14	that	that	SCONJ
ajlm-123	109	15	products	product	NOUN
ajlm-123	109	16	continue	continue	VERB
ajlm-123	109	17	to	to	PART
ajlm-123	109	18	meet	meet	VERB
ajlm-123	109	19	expected	expect	VERB
ajlm-123	109	20	safety	safety	NOUN
ajlm-123	109	21	and	and	CCONJ
ajlm-123	109	22	quality	quality	NOUN
ajlm-123	109	23	standards	standard	NOUN
ajlm-123	109	24	following	follow	VERB
ajlm-123	109	25	approval	approval	NOUN
ajlm-123	109	26	by	by	ADP
ajlm-123	109	27	nras	nras	PROPN
ajlm-123	109	28	and	and	CCONJ
ajlm-123	109	29	an	an	DET
ajlm-123	109	30	important	important	ADJ
ajlm-123	109	31	component	component	NOUN
ajlm-123	109	32	of	of	ADP
ajlm-123	109	33	regulatory	regulatory	ADJ
ajlm-123	109	34	oversight	oversight	NOUN
ajlm-123	109	35	of	of	ADP
ajlm-123	109	36	diagnostic	diagnostic	ADJ
ajlm-123	109	37	products	product	NOUN
ajlm-123	109	38	for	for	ADP
ajlm-123	109	39	health.26	health.26	NOUN
ajlm-123	109	40	proactive	proactive	ADJ
ajlm-123	109	41	post	post	ADJ
ajlm-123	109	42	-	-	ADJ
ajlm-123	109	43	market	market	ADJ
ajlm-123	109	44	surveillance	surveillance	NOUN
ajlm-123	109	45	requires	require	VERB
ajlm-123	109	46	the	the	DET
ajlm-123	109	47	systematic	systematic	ADJ
ajlm-123	109	48	collection	collection	NOUN
ajlm-123	109	49	of	of	ADP
ajlm-123	109	50	data	datum	NOUN
ajlm-123	109	51	from	from	ADP
ajlm-123	109	52	laboratory	laboratory	NOUN
ajlm-123	109	53	studies	study	NOUN
ajlm-123	109	54	in	in	ADP
ajlm-123	109	55	order	order	NOUN
ajlm-123	109	56	to	to	PART
ajlm-123	109	57	monitor	monitor	VERB
ajlm-123	109	58	test	test	NOUN
ajlm-123	109	59	performance	performance	NOUN
ajlm-123	109	60	using	use	VERB
ajlm-123	109	61	a	a	DET
ajlm-123	109	62	panel	panel	NOUN
ajlm-123	109	63	of	of	ADP
ajlm-123	109	64	appropriate	appropriate	ADJ
ajlm-123	109	65	reagents	reagent	NOUN
ajlm-123	109	66	or	or	CCONJ
ajlm-123	109	67	,	,	PUNCT
ajlm-123	109	68	alternatively	alternatively	ADV
ajlm-123	109	69	,	,	PUNCT
ajlm-123	109	70	through	through	ADP
ajlm-123	109	71	field	field	NOUN
ajlm-123	109	72	testing	testing	NOUN
ajlm-123	109	73	using	use	VERB
ajlm-123	109	74	a	a	DET
ajlm-123	109	75	panel	panel	NOUN
ajlm-123	109	76	of	of	ADP
ajlm-123	109	77	well	well	ADV
ajlm-123	109	78	-	-	PUNCT
ajlm-123	109	79	characterised	characterise	VERB
ajlm-123	109	80	samples	sample	NOUN
ajlm-123	109	81	.	.	PUNCT
ajlm-123	110	1	reactive	reactive	ADJ
ajlm-123	110	2	surveillance	surveillance	NOUN
ajlm-123	110	3	requires	require	VERB
ajlm-123	110	4	manufacturers	manufacturer	NOUN
ajlm-123	110	5	,	,	PUNCT
ajlm-123	110	6	or	or	CCONJ
ajlm-123	110	7	testers	tester	NOUN
ajlm-123	110	8	,	,	PUNCT
ajlm-123	110	9	to	to	PART
ajlm-123	110	10	report	report	VERB
ajlm-123	110	11	problems	problem	NOUN
ajlm-123	110	12	voluntarily	voluntarily	ADV
ajlm-123	110	13	through	through	ADP
ajlm-123	110	14	an	an	DET
ajlm-123	110	15	established	establish	VERB
ajlm-123	110	16	reporting	reporting	NOUN
ajlm-123	110	17	system	system	NOUN
ajlm-123	110	18	.	.	PUNCT
ajlm-123	111	1	such	such	ADJ
ajlm-123	111	2	activities	activity	NOUN
ajlm-123	111	3	are	be	AUX
ajlm-123	111	4	applicable	applicable	ADJ
ajlm-123	111	5	to	to	ADP
ajlm-123	111	6	manufacturers	manufacturer	NOUN
ajlm-123	111	7	,	,	PUNCT
ajlm-123	111	8	importers	importer	NOUN
ajlm-123	111	9	and	and	CCONJ
ajlm-123	111	10	distributors	distributor	NOUN
ajlm-123	111	11	.	.	PUNCT
ajlm-123	112	1	there	there	PRON
ajlm-123	112	2	is	be	VERB
ajlm-123	112	3	a	a	DET
ajlm-123	112	4	need	need	NOUN
ajlm-123	112	5	for	for	ADP
ajlm-123	112	6	cross	cross	ADJ
ajlm-123	112	7	-	-	ADJ
ajlm-123	112	8	border	border	ADJ
ajlm-123	112	9	,	,	PUNCT
ajlm-123	112	10	regional	regional	ADJ
ajlm-123	112	11	and	and	CCONJ
ajlm-123	112	12	global	global	ADJ
ajlm-123	112	13	sharing	sharing	NOUN
ajlm-123	112	14	of	of	ADP
ajlm-123	112	15	adverse	adverse	ADJ
ajlm-123	112	16	events	event	NOUN
ajlm-123	112	17	that	that	PRON
ajlm-123	112	18	threaten	threaten	VERB
ajlm-123	112	19	safety	safety	NOUN
ajlm-123	112	20	of	of	ADP
ajlm-123	112	21	individuals	individual	NOUN
ajlm-123	112	22	or	or	CCONJ
ajlm-123	112	23	public	public	ADJ
ajlm-123	112	24	health	health	NOUN
ajlm-123	112	25	so	so	SCONJ
ajlm-123	112	26	as	as	SCONJ
ajlm-123	112	27	to	to	PART
ajlm-123	112	28	accelerate	accelerate	VERB
ajlm-123	112	29	information	information	NOUN
ajlm-123	112	30	gathering	gathering	NOUN
ajlm-123	112	31	and	and	CCONJ
ajlm-123	112	32	enable	enable	VERB
ajlm-123	112	33	substandard	substandard	ADJ
ajlm-123	112	34	products	product	NOUN
ajlm-123	112	35	to	to	PART
ajlm-123	112	36	be	be	AUX
ajlm-123	112	37	withdrawn	withdraw	VERB
ajlm-123	112	38	more	more	ADV
ajlm-123	112	39	quickly	quickly	ADV
ajlm-123	112	40	.	.	PUNCT
ajlm-123	113	1	the	the	DET
ajlm-123	113	2	national	national	ADJ
ajlm-123	113	3	competent	competent	ADJ
ajlm-123	113	4	authorities	authority	NOUN
ajlm-123	113	5	report	report	VERB
ajlm-123	113	6	(	(	PUNCT
ajlm-123	113	7	ncar	ncar	NOUN
ajlm-123	113	8	)	)	PUNCT
ajlm-123	113	9	is	be	AUX
ajlm-123	113	10	a	a	DET
ajlm-123	113	11	membership	membership	NOUN
ajlm-123	113	12	-	-	PUNCT
ajlm-123	113	13	based	base	VERB
ajlm-123	113	14	system	system	NOUN
ajlm-123	113	15	open	open	ADJ
ajlm-123	113	16	to	to	ADP
ajlm-123	113	17	those	those	DET
ajlm-123	113	18	countries	country	NOUN
ajlm-123	113	19	with	with	ADP
ajlm-123	113	20	stringent	stringent	ADJ
ajlm-123	113	21	regulatory	regulatory	ADJ
ajlm-123	113	22	authorities.27	authorities.27	NOUN
ajlm-123	113	23	the	the	DET
ajlm-123	113	24	system	system	NOUN
ajlm-123	113	25	incorporates	incorporate	VERB
ajlm-123	113	26	post	post	ADJ
ajlm-123	113	27	-	-	ADJ
ajlm-123	113	28	market	market	ADJ
ajlm-123	113	29	surveillance	surveillance	NOUN
ajlm-123	113	30	,	,	PUNCT
ajlm-123	113	31	vigilance	vigilance	NOUN
ajlm-123	113	32	and	and	CCONJ
ajlm-123	113	33	reporting	reporting	NOUN
ajlm-123	113	34	of	of	ADP
ajlm-123	113	35	adverse	adverse	ADJ
ajlm-123	113	36	events	event	NOUN
ajlm-123	113	37	and	and	CCONJ
ajlm-123	113	38	is	be	AUX
ajlm-123	113	39	aimed	aim	VERB
ajlm-123	113	40	at	at	ADP
ajlm-123	113	41	improving	improve	VERB
ajlm-123	113	42	safety	safety	NOUN
ajlm-123	113	43	by	by	ADP
ajlm-123	113	44	reducing	reduce	VERB
ajlm-123	113	45	the	the	DET
ajlm-123	113	46	likelihood	likelihood	NOUN
ajlm-123	113	47	of	of	ADP
ajlm-123	113	48	repeated	repeat	VERB
ajlm-123	113	49	adverse	adverse	ADJ
ajlm-123	113	50	events	event	NOUN
ajlm-123	113	51	.	.	PUNCT
ajlm-123	114	1	there	there	PRON
ajlm-123	114	2	are	be	VERB
ajlm-123	114	3	two	two	NUM
ajlm-123	114	4	levels	level	NOUN
ajlm-123	114	5	of	of	ADP
ajlm-123	114	6	ncar	ncar	ADJ
ajlm-123	114	7	participation	participation	NOUN
ajlm-123	114	8	.	.	PUNCT
ajlm-123	115	1	full	full	ADJ
ajlm-123	115	2	participation	participation	NOUN
ajlm-123	115	3	involves	involve	VERB
ajlm-123	115	4	national	national	ADJ
ajlm-123	115	5	competent	competent	ADJ
ajlm-123	115	6	authorities	authority	NOUN
ajlm-123	115	7	with	with	ADP
ajlm-123	115	8	established	establish	VERB
ajlm-123	115	9	national	national	ADJ
ajlm-123	115	10	adverse	adverse	ADJ
ajlm-123	115	11	event	event	NOUN
ajlm-123	115	12	reporting	report	VERB
ajlm-123	115	13	programmes	programme	NOUN
ajlm-123	115	14	.	.	PUNCT
ajlm-123	116	1	being	be	AUX
ajlm-123	116	2	a	a	DET
ajlm-123	116	3	full	full	ADJ
ajlm-123	116	4	participant	participant	NOUN
ajlm-123	116	5	,	,	PUNCT
ajlm-123	116	6	a	a	DET
ajlm-123	116	7	national	national	ADJ
ajlm-123	116	8	authority	authority	NOUN
ajlm-123	116	9	receives	receive	VERB
ajlm-123	116	10	both	both	CCONJ
ajlm-123	116	11	public	public	ADJ
ajlm-123	116	12	and	and	CCONJ
ajlm-123	116	13	confidential	confidential	ADJ
ajlm-123	116	14	or	or	CCONJ
ajlm-123	116	15	highly	highly	ADV
ajlm-123	116	16	-	-	PUNCT
ajlm-123	116	17	sensitive	sensitive	ADJ
ajlm-123	116	18	information	information	NOUN
ajlm-123	116	19	from	from	ADP
ajlm-123	116	20	other	other	ADJ
ajlm-123	116	21	ncar	ncar	NOUN
ajlm-123	116	22	participants	participant	NOUN
ajlm-123	116	23	.	.	PUNCT
ajlm-123	117	1	associate	associate	ADJ
ajlm-123	117	2	participants	participant	NOUN
ajlm-123	117	3	are	be	AUX
ajlm-123	117	4	a	a	DET
ajlm-123	117	5	second	second	ADJ
ajlm-123	117	6	tier	tier	NOUN
ajlm-123	117	7	of	of	ADP
ajlm-123	117	8	membership	membership	NOUN
ajlm-123	117	9	that	that	PRON
ajlm-123	117	10	receive	receive	VERB
ajlm-123	117	11	public	public	ADJ
ajlm-123	117	12	information	information	NOUN
ajlm-123	117	13	,	,	PUNCT
ajlm-123	117	14	such	such	ADJ
ajlm-123	117	15	as	as	ADP
ajlm-123	117	16	recall	recall	NOUN
ajlm-123	117	17	notices	notice	NOUN
ajlm-123	117	18	,	,	PUNCT
ajlm-123	117	19	safety	safety	NOUN
ajlm-123	117	20	and	and	CCONJ
ajlm-123	117	21	hazard	hazard	NOUN
ajlm-123	117	22	alerts	alert	NOUN
ajlm-123	117	23	.	.	PUNCT
ajlm-123	118	1	status	status	PROPN
ajlm-123	118	2	quo	quo	PROPN
ajlm-123	118	3	currently	currently	ADV
ajlm-123	118	4	,	,	PUNCT
ajlm-123	118	5	there	there	PRON
ajlm-123	118	6	is	be	VERB
ajlm-123	118	7	limited	limited	ADJ
ajlm-123	118	8	capacity	capacity	NOUN
ajlm-123	118	9	for	for	ADP
ajlm-123	118	10	post	post	ADJ
ajlm-123	118	11	-	-	ADJ
ajlm-123	118	12	market	market	ADJ
ajlm-123	118	13	surveillance	surveillance	NOUN
ajlm-123	118	14	in	in	ADP
ajlm-123	118	15	much	much	ADJ
ajlm-123	118	16	of	of	ADP
ajlm-123	118	17	the	the	DET
ajlm-123	118	18	developing	develop	VERB
ajlm-123	118	19	world	world	NOUN
ajlm-123	118	20	.	.	PUNCT
ajlm-123	119	1	systems	system	NOUN
ajlm-123	119	2	for	for	ADP
ajlm-123	119	3	post	post	ADJ
ajlm-123	119	4	-	-	ADJ
ajlm-123	119	5	market	market	ADJ
ajlm-123	119	6	surveillance	surveillance	NOUN
ajlm-123	119	7	for	for	ADP
ajlm-123	119	8	diagnostic	diagnostic	ADJ
ajlm-123	119	9	devices	device	NOUN
ajlm-123	119	10	are	be	AUX
ajlm-123	119	11	not	not	PART
ajlm-123	119	12	implemented	implement	VERB
ajlm-123	119	13	globally26	globally26	NOUN
ajlm-123	119	14	and	and	CCONJ
ajlm-123	119	15	,	,	PUNCT
ajlm-123	119	16	in	in	ADP
ajlm-123	119	17	most	most	ADJ
ajlm-123	119	18	developing	develop	VERB
ajlm-123	119	19	countries	country	NOUN
ajlm-123	119	20	,	,	PUNCT
ajlm-123	119	21	reporting	reporting	NOUN
ajlm-123	119	22	and	and	CCONJ
ajlm-123	119	23	information	information	NOUN
ajlm-123	119	24	sharing	sharing	NOUN
ajlm-123	119	25	occurs	occur	VERB
ajlm-123	119	26	on	on	ADP
ajlm-123	119	27	an	an	DET
ajlm-123	119	28	ad	ad	NOUN
ajlm-123	119	29	hoc	hoc	X
ajlm-123	119	30	basis	basis	NOUN
ajlm-123	119	31	.	.	PUNCT
ajlm-123	120	1	in	in	ADP
ajlm-123	120	2	many	many	ADJ
ajlm-123	120	3	countries	country	NOUN
ajlm-123	120	4	,	,	PUNCT
ajlm-123	120	5	random	random	ADJ
ajlm-123	120	6	quality	quality	NOUN
ajlm-123	120	7	checks	check	NOUN
ajlm-123	120	8	,	,	PUNCT
ajlm-123	120	9	such	such	ADJ
ajlm-123	120	10	as	as	ADP
ajlm-123	120	11	lot	lot	NOUN
ajlm-123	120	12	testing	testing	NOUN
ajlm-123	120	13	,	,	PUNCT
ajlm-123	120	14	are	be	AUX
ajlm-123	120	15	not	not	PART
ajlm-123	120	16	performed	perform	VERB
ajlm-123	120	17	and	and	CCONJ
ajlm-123	120	18	tests	test	NOUN
ajlm-123	120	19	can	can	AUX
ajlm-123	120	20	enter	enter	VERB
ajlm-123	120	21	the	the	DET
ajlm-123	120	22	market	market	NOUN
ajlm-123	120	23	without	without	ADP
ajlm-123	120	24	checks	check	NOUN
ajlm-123	120	25	on	on	ADP
ajlm-123	120	26	their	their	PRON
ajlm-123	120	27	quality.21,28	quality.21,28	NOUN
ajlm-123	120	28	most	most	ADJ
ajlm-123	120	29	developing	develop	VERB
ajlm-123	120	30	countries	country	NOUN
ajlm-123	120	31	lack	lack	VERB
ajlm-123	120	32	a	a	DET
ajlm-123	120	33	feedback	feedback	NOUN
ajlm-123	120	34	mechanism	mechanism	NOUN
ajlm-123	120	35	to	to	PART
ajlm-123	120	36	provide	provide	VERB
ajlm-123	120	37	manufacturers	manufacturer	NOUN
ajlm-123	120	38	with	with	ADP
ajlm-123	120	39	information	information	NOUN
ajlm-123	120	40	regarding	regard	VERB
ajlm-123	120	41	the	the	DET
ajlm-123	120	42	need	need	NOUN
ajlm-123	120	43	for	for	ADP
ajlm-123	120	44	corrective	corrective	ADJ
ajlm-123	120	45	action	action	NOUN
ajlm-123	120	46	as	as	ADV
ajlm-123	120	47	well	well	ADV
ajlm-123	120	48	as	as	ADP
ajlm-123	120	49	a	a	DET
ajlm-123	120	50	mechanism	mechanism	NOUN
ajlm-123	120	51	for	for	ADP
ajlm-123	120	52	removal	removal	NOUN
ajlm-123	120	53	of	of	ADP
ajlm-123	120	54	substandard	substandard	ADJ
ajlm-123	120	55	tests	test	NOUN
ajlm-123	120	56	that	that	PRON
ajlm-123	120	57	present	present	VERB
ajlm-123	120	58	a	a	DET
ajlm-123	120	59	risk	risk	NOUN
ajlm-123	120	60	to	to	ADP
ajlm-123	120	61	public	public	ADJ
ajlm-123	120	62	health	health	NOUN
ajlm-123	120	63	.	.	PUNCT
ajlm-123	121	1	disruption	disruption	NOUN
ajlm-123	121	2	of	of	ADP
ajlm-123	121	3	services	service	NOUN
ajlm-123	121	4	for	for	ADP
ajlm-123	121	5	some	some	DET
ajlm-123	121	6	priority	priority	NOUN
ajlm-123	121	7	diseases	disease	NOUN
ajlm-123	121	8	,	,	PUNCT
ajlm-123	121	9	such	such	ADJ
ajlm-123	121	10	as	as	ADP
ajlm-123	121	11	hiv	hiv	PROPN
ajlm-123	121	12	,	,	PUNCT
ajlm-123	121	13	has	have	AUX
ajlm-123	121	14	occurred	occur	VERB
ajlm-123	121	15	where	where	SCONJ
ajlm-123	121	16	publicity	publicity	NOUN
ajlm-123	121	17	regarding	regard	VERB
ajlm-123	121	18	quality	quality	NOUN
ajlm-123	121	19	problems	problem	NOUN
ajlm-123	121	20	has	have	AUX
ajlm-123	121	21	led	lead	VERB
ajlm-123	121	22	,	,	PUNCT
ajlm-123	121	23	in	in	ADP
ajlm-123	121	24	some	some	DET
ajlm-123	121	25	countries	country	NOUN
ajlm-123	121	26	,	,	PUNCT
ajlm-123	121	27	to	to	ADP
ajlm-123	121	28	discontinuation	discontinuation	NOUN
ajlm-123	121	29	of	of	ADP
ajlm-123	121	30	use	use	NOUN
ajlm-123	121	31	without	without	ADP
ajlm-123	121	32	replacement	replacement	NOUN
ajlm-123	121	33	devices	device	NOUN
ajlm-123	121	34	being	be	AUX
ajlm-123	121	35	available.29	available.29	NOUN
ajlm-123	121	36	action	action	NOUN
ajlm-123	121	37	going	go	VERB
ajlm-123	121	38	forward	forward	ADV
ajlm-123	121	39	a	a	DET
ajlm-123	121	40	mix	mix	NOUN
ajlm-123	121	41	of	of	ADP
ajlm-123	121	42	proactive	proactive	ADJ
ajlm-123	121	43	and	and	CCONJ
ajlm-123	121	44	reactive	reactive	ADJ
ajlm-123	121	45	post	post	ADJ
ajlm-123	121	46	-	-	ADJ
ajlm-123	121	47	market	market	ADJ
ajlm-123	121	48	surveillance	surveillance	NOUN
ajlm-123	121	49	activities	activity	NOUN
ajlm-123	121	50	should	should	AUX
ajlm-123	121	51	be	be	AUX
ajlm-123	121	52	encouraged	encourage	VERB
ajlm-123	121	53	.	.	PUNCT
ajlm-123	122	1	reporting	reporting	NOUN
ajlm-123	122	2	should	should	AUX
ajlm-123	122	3	be	be	AUX
ajlm-123	122	4	mandatory	mandatory	ADJ
ajlm-123	122	5	in	in	ADP
ajlm-123	122	6	the	the	DET
ajlm-123	122	7	case	case	NOUN
ajlm-123	122	8	of	of	ADP
ajlm-123	122	9	a	a	DET
ajlm-123	122	10	death	death	NOUN
ajlm-123	122	11	,	,	PUNCT
ajlm-123	122	12	a	a	DET
ajlm-123	122	13	serious	serious	ADJ
ajlm-123	122	14	injury	injury	NOUN
ajlm-123	122	15	that	that	PRON
ajlm-123	122	16	is	be	AUX
ajlm-123	122	17	life	life	NOUN
ajlm-123	122	18	threatening	threaten	VERB
ajlm-123	122	19	or	or	CCONJ
ajlm-123	122	20	results	result	NOUN
ajlm-123	122	21	in	in	ADP
ajlm-123	122	22	permanent	permanent	ADJ
ajlm-123	122	23	damage	damage	NOUN
ajlm-123	122	24	or	or	CCONJ
ajlm-123	122	25	impairment	impairment	NOUN
ajlm-123	122	26	of	of	ADP
ajlm-123	122	27	a	a	DET
ajlm-123	122	28	body	body	NOUN
ajlm-123	122	29	function	function	NOUN
ajlm-123	122	30	,	,	PUNCT
ajlm-123	122	31	or	or	CCONJ
ajlm-123	122	32	a	a	DET
ajlm-123	122	33	malfunction	malfunction	NOUN
ajlm-123	122	34	.	.	PUNCT
ajlm-123	123	1	to	to	PART
ajlm-123	123	2	implement	implement	VERB
ajlm-123	123	3	post	post	ADJ
ajlm-123	123	4	-	-	ADJ
ajlm-123	123	5	market	market	ADJ
ajlm-123	123	6	surveillance	surveillance	NOUN
ajlm-123	123	7	for	for	ADP
ajlm-123	123	8	ivd	ivd	PROPN
ajlm-123	123	9	medical	medical	ADJ
ajlm-123	123	10	devices	device	NOUN
ajlm-123	123	11	in	in	ADP
ajlm-123	123	12	developing	develop	VERB
ajlm-123	123	13	countries	country	NOUN
ajlm-123	123	14	,	,	PUNCT
ajlm-123	123	15	regional	regional	ADJ
ajlm-123	123	16	networks	network	NOUN
ajlm-123	123	17	of	of	ADP
ajlm-123	123	18	accredited	accredit	VERB
ajlm-123	123	19	laboratories	laboratory	NOUN
ajlm-123	123	20	should	should	AUX
ajlm-123	123	21	be	be	AUX
ajlm-123	123	22	established	establish	VERB
ajlm-123	123	23	in	in	ADP
ajlm-123	123	24	order	order	NOUN
ajlm-123	123	25	to	to	PART
ajlm-123	123	26	undertake	undertake	VERB
ajlm-123	123	27	batch	batch	NOUN
ajlm-123	123	28	testing	testing	NOUN
ajlm-123	123	29	and	and	CCONJ
ajlm-123	123	30	monitor	monitor	VERB
ajlm-123	123	31	performance	performance	NOUN
ajlm-123	123	32	and	and	CCONJ
ajlm-123	123	33	safety	safety	NOUN
ajlm-123	123	34	.	.	PUNCT
ajlm-123	124	1	standardised	standardised	ADJ
ajlm-123	124	2	protocols	protocol	NOUN
ajlm-123	124	3	should	should	AUX
ajlm-123	124	4	be	be	AUX
ajlm-123	124	5	established	establish	VERB
ajlm-123	124	6	and	and	CCONJ
ajlm-123	124	7	reference	reference	VERB
ajlm-123	124	8	quality	quality	NOUN
ajlm-123	124	9	assurance	assurance	NOUN
ajlm-123	124	10	materials	material	NOUN
ajlm-123	124	11	shared	share	VERB
ajlm-123	124	12	.	.	PUNCT
ajlm-123	125	1	these	these	DET
ajlm-123	125	2	practices	practice	NOUN
ajlm-123	125	3	would	would	AUX
ajlm-123	125	4	promote	promote	VERB
ajlm-123	125	5	good	good	ADJ
ajlm-123	125	6	practice	practice	NOUN
ajlm-123	125	7	and	and	CCONJ
ajlm-123	125	8	instil	instil	NOUN
ajlm-123	125	9	confidence	confidence	NOUN
ajlm-123	125	10	in	in	ADP
ajlm-123	125	11	the	the	DET
ajlm-123	125	12	system	system	NOUN
ajlm-123	125	13	,	,	PUNCT
ajlm-123	125	14	in	in	ADP
ajlm-123	125	15	addition	addition	NOUN
ajlm-123	125	16	to	to	ADP
ajlm-123	125	17	facilitating	facilitate	VERB
ajlm-123	125	18	the	the	DET
ajlm-123	125	19	exchange	exchange	NOUN
ajlm-123	125	20	of	of	ADP
ajlm-123	125	21	data	datum	NOUN
ajlm-123	125	22	.	.	PUNCT
ajlm-123	126	1	global	global	ADJ
ajlm-123	126	2	and	and	CCONJ
ajlm-123	126	3	regional	regional	ADJ
ajlm-123	126	4	mechanisms	mechanism	NOUN
ajlm-123	126	5	should	should	AUX
ajlm-123	126	6	be	be	AUX
ajlm-123	126	7	established	establish	VERB
ajlm-123	126	8	so	so	SCONJ
ajlm-123	126	9	as	as	SCONJ
ajlm-123	126	10	to	to	PART
ajlm-123	126	11	facilitate	facilitate	VERB
ajlm-123	126	12	investigation	investigation	NOUN
ajlm-123	126	13	and	and	CCONJ
ajlm-123	126	14	procedural	procedural	ADJ
ajlm-123	126	15	corrective	corrective	ADJ
ajlm-123	126	16	actions	action	NOUN
ajlm-123	126	17	or	or	CCONJ
ajlm-123	126	18	recalls	recall	VERB
ajlm-123	126	19	for	for	ADP
ajlm-123	126	20	products	product	NOUN
ajlm-123	126	21	found	find	VERB
ajlm-123	126	22	to	to	PART
ajlm-123	126	23	be	be	AUX
ajlm-123	126	24	unsatisfactory	unsatisfactory	ADJ
ajlm-123	126	25	.	.	PUNCT
ajlm-123	127	1	harmonisation	harmonisation	NOUN
ajlm-123	127	2	of	of	ADP
ajlm-123	127	3	proactive	proactive	ADJ
ajlm-123	127	4	activities	activity	NOUN
ajlm-123	127	5	,	,	PUNCT
ajlm-123	127	6	such	such	ADJ
ajlm-123	127	7	as	as	ADP
ajlm-123	127	8	batch	batch	NOUN
ajlm-123	127	9	monitoring	monitoring	NOUN
ajlm-123	127	10	,	,	PUNCT
ajlm-123	127	11	would	would	AUX
ajlm-123	127	12	enhance	enhance	VERB
ajlm-123	127	13	safety	safety	NOUN
ajlm-123	127	14	by	by	ADP
ajlm-123	127	15	reducing	reduce	VERB
ajlm-123	127	16	reporting	reporting	NOUN
ajlm-123	127	17	delays	delay	NOUN
ajlm-123	127	18	,	,	PUNCT
ajlm-123	127	19	allowing	allow	VERB
ajlm-123	127	20	prompt	prompt	ADJ
ajlm-123	127	21	action	action	NOUN
ajlm-123	127	22	to	to	PART
ajlm-123	127	23	be	be	AUX
ajlm-123	127	24	taken	take	VERB
ajlm-123	127	25	should	should	AUX
ajlm-123	127	26	unsafe	unsafe	ADJ
ajlm-123	127	27	products	product	NOUN
ajlm-123	127	28	be	be	AUX
ajlm-123	127	29	reported	report	VERB
ajlm-123	127	30	.	.	PUNCT
ajlm-123	128	1	standardisation	standardisation	NOUN
ajlm-123	128	2	of	of	ADP
ajlm-123	128	3	protocols	protocol	NOUN
ajlm-123	128	4	,	,	PUNCT
ajlm-123	128	5	test	test	NOUN
ajlm-123	128	6	reagents	reagent	NOUN
ajlm-123	128	7	and	and	CCONJ
ajlm-123	128	8	sample	sample	NOUN
ajlm-123	128	9	panels	panel	NOUN
ajlm-123	128	10	across	across	ADP
ajlm-123	128	11	geographic	geographic	ADJ
ajlm-123	128	12	regions	region	NOUN
ajlm-123	128	13	would	would	AUX
ajlm-123	128	14	assist	assist	VERB
ajlm-123	128	15	surveillance	surveillance	NOUN
ajlm-123	128	16	whilst	whilst	SCONJ
ajlm-123	128	17	simultaneously	simultaneously	ADV
ajlm-123	128	18	minimising	minimise	VERB
ajlm-123	128	19	costs	cost	NOUN
ajlm-123	128	20	.	.	PUNCT
ajlm-123	129	1	national	national	ADJ
ajlm-123	129	2	and	and	CCONJ
ajlm-123	129	3	transnational	transnational	ADJ
ajlm-123	129	4	communication	communication	NOUN
ajlm-123	129	5	platforms	platform	NOUN
ajlm-123	129	6	are	be	AUX
ajlm-123	129	7	needed	need	VERB
ajlm-123	129	8	to	to	PART
ajlm-123	129	9	simplify	simplify	VERB
ajlm-123	129	10	current	current	ADJ
ajlm-123	129	11	procedures	procedure	NOUN
ajlm-123	129	12	.	.	PUNCT
ajlm-123	130	1	networks	network	NOUN
ajlm-123	130	2	of	of	ADP
ajlm-123	130	3	accredited	accredit	VERB
ajlm-123	130	4	laboratories	laboratory	NOUN
ajlm-123	130	5	should	should	AUX
ajlm-123	130	6	be	be	AUX
ajlm-123	130	7	established	establish	VERB
ajlm-123	130	8	to	to	PART
ajlm-123	130	9	facilitate	facilitate	VERB
ajlm-123	130	10	mutual	mutual	ADJ
ajlm-123	130	11	recognition	recognition	NOUN
ajlm-123	130	12	of	of	ADP
ajlm-123	130	13	surveillance	surveillance	NOUN
ajlm-123	130	14	data	datum	NOUN
ajlm-123	130	15	.	.	PUNCT
ajlm-123	131	1	convergence	convergence	NOUN
ajlm-123	131	2	of	of	ADP
ajlm-123	131	3	post	post	ADJ
ajlm-123	131	4	-	-	ADJ
ajlm-123	131	5	market	market	ADJ
ajlm-123	131	6	surveillance	surveillance	NOUN
ajlm-123	131	7	activities	activity	NOUN
ajlm-123	131	8	will	will	AUX
ajlm-123	131	9	:	:	PUNCT
ajlm-123	131	10	(	(	PUNCT
ajlm-123	131	11	1	1	X
ajlm-123	131	12	)	)	PUNCT
ajlm-123	131	13	ensure	ensure	VERB
ajlm-123	131	14	that	that	SCONJ
ajlm-123	131	15	products	product	NOUN
ajlm-123	131	16	continue	continue	VERB
ajlm-123	131	17	to	to	PART
ajlm-123	131	18	meet	meet	VERB
ajlm-123	131	19	expected	expect	VERB
ajlm-123	131	20	safety	safety	NOUN
ajlm-123	131	21	,	,	PUNCT
ajlm-123	131	22	performance	performance	NOUN
ajlm-123	131	23	and	and	CCONJ
ajlm-123	131	24	efficacy	efficacy	NOUN
ajlm-123	131	25	requirements	requirement	NOUN
ajlm-123	131	26	following	follow	VERB
ajlm-123	131	27	pre	pre	ADJ
ajlm-123	131	28	-	-	ADJ
ajlm-123	131	29	market	market	ADJ
ajlm-123	131	30	approval	approval	NOUN
ajlm-123	131	31	;	;	PUNCT
ajlm-123	131	32	(	(	PUNCT
ajlm-123	131	33	2	2	X
ajlm-123	131	34	)	)	PUNCT
ajlm-123	131	35	prevent	prevent	VERB
ajlm-123	131	36	substandard	substandard	ADJ
ajlm-123	131	37	tests	test	NOUN
ajlm-123	131	38	,	,	PUNCT
ajlm-123	131	39	or	or	CCONJ
ajlm-123	131	40	batches	batch	NOUN
ajlm-123	131	41	of	of	ADP
ajlm-123	131	42	tests	test	NOUN
ajlm-123	131	43	,	,	PUNCT
ajlm-123	131	44	from	from	ADP
ajlm-123	131	45	entering	enter	VERB
ajlm-123	131	46	the	the	DET
ajlm-123	131	47	market	market	NOUN
ajlm-123	131	48	;	;	PUNCT
ajlm-123	131	49	(	(	PUNCT
ajlm-123	131	50	3	3	X
ajlm-123	131	51	)	)	PUNCT
ajlm-123	131	52	enable	enable	VERB
ajlm-123	131	53	corrective	corrective	ADJ
ajlm-123	131	54	actions	action	NOUN
ajlm-123	131	55	to	to	PART
ajlm-123	131	56	be	be	AUX
ajlm-123	131	57	taken	take	VERB
ajlm-123	131	58	by	by	ADP
ajlm-123	131	59	manufacturers	manufacturer	NOUN
ajlm-123	131	60	;	;	PUNCT
ajlm-123	131	61	and	and	CCONJ
ajlm-123	131	62	(	(	PUNCT
ajlm-123	131	63	4	4	X
ajlm-123	131	64	)	)	PUNCT
ajlm-123	131	65	facilitate	facilitate	NOUN
ajlm-123	131	66	removal	removal	NOUN
ajlm-123	131	67	of	of	ADP
ajlm-123	131	68	substandard	substandard	ADJ
ajlm-123	131	69	tests	test	NOUN
ajlm-123	131	70	from	from	ADP
ajlm-123	131	71	the	the	DET
ajlm-123	131	72	market	market	NOUN
ajlm-123	131	73	,	,	PUNCT
ajlm-123	131	74	ultimately	ultimately	ADV
ajlm-123	131	75	reducing	reduce	VERB
ajlm-123	131	76	costs	cost	NOUN
ajlm-123	131	77	and	and	CCONJ
ajlm-123	131	78	maximising	maximise	VERB
ajlm-123	131	79	efficient	efficient	ADJ
ajlm-123	131	80	use	use	NOUN
ajlm-123	131	81	of	of	ADP
ajlm-123	131	82	resources	resource	NOUN
ajlm-123	131	83	by	by	ADP
ajlm-123	131	84	nras	nras	PROPN
ajlm-123	131	85	.	.	PUNCT
ajlm-123	132	1	conclusion	conclusion	NOUN
ajlm-123	132	2	top	top	ADJ
ajlm-123	132	3	↑	↑	PROPN
ajlm-123	132	4	diagnostic	diagnostic	ADJ
ajlm-123	132	5	tests	test	NOUN
ajlm-123	132	6	can	can	AUX
ajlm-123	132	7	play	play	VERB
ajlm-123	132	8	a	a	DET
ajlm-123	132	9	vital	vital	ADJ
ajlm-123	132	10	role	role	NOUN
ajlm-123	132	11	in	in	ADP
ajlm-123	132	12	improving	improve	VERB
ajlm-123	132	13	access	access	NOUN
ajlm-123	132	14	to	to	ADP
ajlm-123	132	15	effective	effective	ADJ
ajlm-123	132	16	healthcare	healthcare	NOUN
ajlm-123	132	17	,	,	PUNCT
ajlm-123	132	18	but	but	CCONJ
ajlm-123	132	19	the	the	DET
ajlm-123	132	20	current	current	ADJ
ajlm-123	132	21	regulatory	regulatory	ADJ
ajlm-123	132	22	landscape	landscape	NOUN
ajlm-123	132	23	in	in	ADP
ajlm-123	132	24	developing	develop	VERB
ajlm-123	132	25	countries	country	NOUN
ajlm-123	132	26	creates	create	VERB
ajlm-123	132	27	significant	significant	ADJ
ajlm-123	132	28	barriers	barrier	NOUN
ajlm-123	132	29	to	to	ADP
ajlm-123	132	30	market	market	NOUN
ajlm-123	132	31	entry	entry	NOUN
ajlm-123	132	32	and	and	CCONJ
ajlm-123	132	33	has	have	AUX
ajlm-123	132	34	become	become	VERB
ajlm-123	132	35	a	a	DET
ajlm-123	132	36	deterrent	deterrent	NOUN
ajlm-123	132	37	to	to	ADP
ajlm-123	132	38	innovation	innovation	NOUN
ajlm-123	132	39	.	.	PUNCT
ajlm-123	133	1	setting	set	VERB
ajlm-123	133	2	international	international	ADJ
ajlm-123	133	3	standards	standard	NOUN
ajlm-123	133	4	and	and	CCONJ
ajlm-123	133	5	streamlining	streamline	VERB
ajlm-123	133	6	the	the	DET
ajlm-123	133	7	regulatory	regulatory	ADJ
ajlm-123	133	8	process	process	NOUN
ajlm-123	133	9	for	for	ADP
ajlm-123	133	10	in	in	X
ajlm-123	133	11	vitro	vitro	X
ajlm-123	133	12	diagnostic	diagnostic	ADJ
ajlm-123	133	13	devices	device	NOUN
ajlm-123	133	14	could	could	AUX
ajlm-123	133	15	diminish	diminish	VERB
ajlm-123	133	16	the	the	DET
ajlm-123	133	17	regulatory	regulatory	ADJ
ajlm-123	133	18	burden	burden	NOUN
ajlm-123	133	19	.	.	PUNCT
ajlm-123	134	1	four	four	NUM
ajlm-123	134	2	areas	area	NOUN
ajlm-123	134	3	where	where	SCONJ
ajlm-123	134	4	action	action	NOUN
ajlm-123	134	5	could	could	AUX
ajlm-123	134	6	lower	lower	VERB
ajlm-123	134	7	costs	cost	NOUN
ajlm-123	134	8	,	,	PUNCT
ajlm-123	134	9	reduce	reduce	VERB
ajlm-123	134	10	delays	delay	NOUN
ajlm-123	134	11	,	,	PUNCT
ajlm-123	134	12	and	and	CCONJ
ajlm-123	134	13	accelerate	accelerate	VERB
ajlm-123	134	14	access	access	NOUN
ajlm-123	134	15	to	to	ADP
ajlm-123	134	16	quality	quality	NOUN
ajlm-123	134	17	diagnostic	diagnostic	ADJ
ajlm-123	134	18	products	product	NOUN
ajlm-123	134	19	for	for	ADP
ajlm-123	134	20	health	health	NOUN
ajlm-123	134	21	are	be	AUX
ajlm-123	134	22	:	:	PUNCT
ajlm-123	134	23	(	(	PUNCT
ajlm-123	134	24	1	1	X
ajlm-123	134	25	)	)	PUNCT
ajlm-123	134	26	adoption	adoption	NOUN
ajlm-123	134	27	of	of	ADP
ajlm-123	134	28	common	common	ADJ
ajlm-123	134	29	registration	registration	NOUN
ajlm-123	134	30	requirements	requirement	NOUN
ajlm-123	134	31	and	and	CCONJ
ajlm-123	134	32	submission	submission	NOUN
ajlm-123	134	33	dossier	dossier	NOUN
ajlm-123	134	34	for	for	ADP
ajlm-123	134	35	pre	pre	ADJ
ajlm-123	134	36	-	-	ADJ
ajlm-123	134	37	market	market	ADJ
ajlm-123	134	38	approval	approval	NOUN
ajlm-123	134	39	;	;	PUNCT
ajlm-123	134	40	(	(	PUNCT
ajlm-123	134	41	2	2	X
ajlm-123	134	42	)	)	PUNCT
ajlm-123	134	43	convergence	convergence	NOUN
ajlm-123	134	44	of	of	ADP
ajlm-123	134	45	quality	quality	NOUN
ajlm-123	134	46	standards	standard	NOUN
ajlm-123	134	47	and	and	CCONJ
ajlm-123	134	48	mutual	mutual	ADJ
ajlm-123	134	49	,	,	PUNCT
ajlm-123	134	50	or	or	CCONJ
ajlm-123	134	51	third	third	ADJ
ajlm-123	134	52	-	-	PUNCT
ajlm-123	134	53	party	party	NOUN
ajlm-123	134	54	,	,	PUNCT
ajlm-123	134	55	recognition	recognition	NOUN
ajlm-123	134	56	of	of	ADP
ajlm-123	134	57	audit	audit	NOUN
ajlm-123	134	58	activities	activity	NOUN
ajlm-123	134	59	;	;	PUNCT
ajlm-123	134	60	(	(	PUNCT
ajlm-123	134	61	3	3	X
ajlm-123	134	62	)	)	PUNCT
ajlm-123	134	63	rationalisation	rationalisation	NOUN
ajlm-123	134	64	of	of	ADP
ajlm-123	134	65	clinical	clinical	ADJ
ajlm-123	134	66	performance	performance	NOUN
ajlm-123	134	67	studies	study	NOUN
ajlm-123	134	68	in	in	ADP
ajlm-123	134	69	order	order	NOUN
ajlm-123	134	70	to	to	PART
ajlm-123	134	71	avoid	avoid	VERB
ajlm-123	134	72	unnecessary	unnecessary	ADJ
ajlm-123	134	73	duplication	duplication	NOUN
ajlm-123	134	74	;	;	PUNCT
ajlm-123	134	75	and	and	CCONJ
ajlm-123	134	76	(	(	PUNCT
ajlm-123	134	77	4	4	X
ajlm-123	134	78	)	)	PUNCT
ajlm-123	134	79	building	build	VERB
ajlm-123	134	80	transnational	transnational	ADJ
ajlm-123	134	81	networks	network	NOUN
ajlm-123	134	82	for	for	ADP
ajlm-123	134	83	post	post	ADJ
ajlm-123	134	84	-	-	ADJ
ajlm-123	134	85	market	market	ADJ
ajlm-123	134	86	surveillance	surveillance	NOUN
ajlm-123	134	87	.	.	PUNCT
ajlm-123	135	1	acknowledgements	acknowledgement	NOUN
ajlm-123	135	2	top	top	PROPN
ajlm-123	135	3	↑	↑	PROPN
ajlm-123	135	4	the	the	DET
ajlm-123	135	5	authors	author	NOUN
ajlm-123	135	6	received	receive	VERB
ajlm-123	135	7	financial	financial	ADJ
ajlm-123	135	8	support	support	NOUN
ajlm-123	135	9	from	from	ADP
ajlm-123	135	10	grand	grand	ADJ
ajlm-123	135	11	challenges	challenge	NOUN
ajlm-123	135	12	canada	canada	PROPN
ajlm-123	135	13	.	.	PUNCT
ajlm-123	136	1	competing	compete	VERB
ajlm-123	136	2	interests	interest	NOUN
ajlm-123	136	3	the	the	DET
ajlm-123	136	4	authors	author	NOUN
ajlm-123	136	5	declare	declare	VERB
ajlm-123	136	6	that	that	SCONJ
ajlm-123	136	7	they	they	PRON
ajlm-123	136	8	have	have	VERB
ajlm-123	136	9	no	no	DET
ajlm-123	136	10	financial	financial	ADJ
ajlm-123	136	11	or	or	CCONJ
ajlm-123	136	12	personal	personal	ADJ
ajlm-123	136	13	relationship(s	relationship(s	NOUN
ajlm-123	136	14	)	)	PUNCT
ajlm-123	136	15	that	that	PRON
ajlm-123	136	16	may	may	AUX
ajlm-123	136	17	have	have	AUX
ajlm-123	136	18	inappropriately	inappropriately	ADV
ajlm-123	136	19	influenced	influence	VERB
ajlm-123	136	20	them	they	PRON
ajlm-123	136	21	in	in	ADP
ajlm-123	136	22	writing	write	VERB
ajlm-123	136	23	this	this	DET
ajlm-123	136	24	article	article	NOUN
ajlm-123	136	25	.	.	PUNCT
ajlm-123	137	1	authors	author	NOUN
ajlm-123	137	2	’	’	PART
ajlm-123	137	3	contributions	contribution	NOUN
ajlm-123	137	4	r.w.p	r.w.p	NOUN
ajlm-123	137	5	.	.	PUNCT
ajlm-123	138	1	(	(	PUNCT
ajlm-123	138	2	london	london	PROPN
ajlm-123	138	3	school	school	NOUN
ajlm-123	138	4	of	of	ADP
ajlm-123	138	5	hygiene	hygiene	PROPN
ajlm-123	138	6	&	&	CCONJ
ajlm-123	138	7	tropical	tropical	ADJ
ajlm-123	138	8	medicine	medicine	NOUN
ajlm-123	138	9	)	)	PUNCT
ajlm-123	138	10	conceived	conceive	VERB
ajlm-123	138	11	the	the	DET
ajlm-123	138	12	article	article	NOUN
ajlm-123	138	13	;	;	PUNCT
ajlm-123	138	14	r.m	r.m	PROPN
ajlm-123	138	15	.	.	PROPN
ajlm-123	139	1	(	(	PUNCT
ajlm-123	139	2	london	london	PROPN
ajlm-123	139	3	school	school	NOUN
ajlm-123	139	4	of	of	ADP
ajlm-123	139	5	hygiene	hygiene	PROPN
ajlm-123	139	6	&	&	CCONJ
ajlm-123	139	7	tropical	tropical	ADJ
ajlm-123	139	8	medicine	medicine	NOUN
ajlm-123	139	9	)	)	PUNCT
ajlm-123	139	10	developed	develop	VERB
ajlm-123	139	11	the	the	DET
ajlm-123	139	12	first	first	ADJ
ajlm-123	139	13	draft	draft	NOUN
ajlm-123	139	14	and	and	CCONJ
ajlm-123	139	15	all	all	DET
ajlm-123	139	16	authors	author	NOUN
ajlm-123	139	17	contributed	contribute	VERB
ajlm-123	139	18	to	to	ADP
ajlm-123	139	19	writing	write	VERB
ajlm-123	139	20	the	the	DET
ajlm-123	139	21	article	article	NOUN
ajlm-123	139	22	.	.	PUNCT
ajlm-123	140	1	references	reference	NOUN
ajlm-123	140	2	top	top	VERB
ajlm-123	140	3	↑	↑	PROPN
ajlm-123	140	4	1	1	NUM
ajlm-123	140	5	.	.	PUNCT
ajlm-123	140	6	peeling	peel	VERB
ajlm-123	140	7	rw	rw	NOUN
ajlm-123	140	8	,	,	PUNCT
ajlm-123	140	9	mabey	mabey	PROPN
ajlm-123	140	10	d	d	PROPN
ajlm-123	140	11	,	,	PUNCT
ajlm-123	140	12	herring	herre	VERB
ajlm-123	140	13	a	a	PRON
ajlm-123	140	14	,	,	PUNCT
ajlm-123	140	15	et	et	PROPN
ajlm-123	140	16	al	al	PROPN
ajlm-123	140	17	.	.	PUNCT
ajlm-123	141	1	why	why	SCONJ
ajlm-123	141	2	do	do	AUX
ajlm-123	141	3	we	we	PRON
ajlm-123	141	4	need	need	VERB
ajlm-123	141	5	quality	quality	NOUN
ajlm-123	141	6	-	-	PUNCT
ajlm-123	141	7	assured	assure	VERB
ajlm-123	141	8	diagnostic	diagnostic	ADJ
ajlm-123	141	9	tests	test	NOUN
ajlm-123	141	10	for	for	ADP
ajlm-123	141	11	sexually	sexually	ADV
ajlm-123	141	12	transmitted	transmit	VERB
ajlm-123	141	13	infections	infection	NOUN
ajlm-123	141	14	?	?	PUNCT
ajlm-123	142	1	nat	nat	PROPN
ajlm-123	142	2	rev	rev	VERB
ajlm-123	142	3	microbiol	microbiol	PROPN
ajlm-123	142	4	.	.	PUNCT
ajlm-123	143	1	2006;4(12):909–921	2006;4(12):909–921	NOUN
ajlm-123	143	2	.	.	PUNCT
ajlm-123	144	1	http://dx.doi.org/10.1038/nrmicro1555	http://dx.doi.org/10.1038/nrmicro1555	PROPN
ajlm-123	144	2	,	,	PUNCT
ajlm-123	144	3	pubmed	pubmed	PROPN
ajlm-123	144	4	pmid	pmid	PROPN
ajlm-123	144	5	:	:	PUNCT
ajlm-123	144	6	171090302	171090302	NUM
ajlm-123	144	7	.	.	PUNCT
ajlm-123	145	1	mabey	mabey	PROPN
ajlm-123	145	2	d	d	PROPN
ajlm-123	145	3	,	,	PUNCT
ajlm-123	145	4	peeling	peel	VERB
ajlm-123	145	5	rw	rw	NOUN
ajlm-123	145	6	,	,	PUNCT
ajlm-123	145	7	ustianowski	ustianowski	VERB
ajlm-123	145	8	a	a	PRON
ajlm-123	145	9	,	,	PUNCT
ajlm-123	145	10	et	et	PROPN
ajlm-123	145	11	al	al	PROPN
ajlm-123	145	12	.	.	PUNCT
ajlm-123	146	1	diagnostics	diagnostic	NOUN
ajlm-123	146	2	for	for	ADP
ajlm-123	146	3	the	the	DET
ajlm-123	146	4	developing	develop	VERB
ajlm-123	146	5	world	world	NOUN
ajlm-123	146	6	.	.	PUNCT
ajlm-123	147	1	nat	nat	PROPN
ajlm-123	147	2	rev	rev	PROPN
ajlm-123	147	3	microbiol	microbiol	PROPN
ajlm-123	147	4	.	.	PUNCT
ajlm-123	148	1	2004;2(3):231–240	2004;2(3):231–240	X
ajlm-123	148	2	.	.	PUNCT
ajlm-123	148	3	http://dx.doi.org/10.1038/nrmicro841	http://dx.doi.org/10.1038/nrmicro841	PROPN
ajlm-123	148	4	,	,	PUNCT
ajlm-123	148	5	pubmed	pubmed	PROPN
ajlm-123	148	6	pmid	pmid	PROPN
ajlm-123	148	7	:	:	PUNCT
ajlm-123	148	8	15083158	15083158	NUM
ajlm-123	148	9	3	3	NUM
ajlm-123	148	10	.	.	PUNCT
ajlm-123	148	11	storla	storla	NOUN
ajlm-123	148	12	dg	dg	PROPN
ajlm-123	148	13	,	,	PUNCT
ajlm-123	148	14	yimer	yimer	NOUN
ajlm-123	148	15	s	s	PROPN
ajlm-123	148	16	,	,	PUNCT
ajlm-123	148	17	bjune	bjune	PROPN
ajlm-123	148	18	ga	ga	PROPN
ajlm-123	148	19	.	.	PROPN
ajlm-123	149	1	a	a	DET
ajlm-123	149	2	systematic	systematic	ADJ
ajlm-123	149	3	review	review	NOUN
ajlm-123	149	4	of	of	ADP
ajlm-123	149	5	delay	delay	NOUN
ajlm-123	149	6	in	in	ADP
ajlm-123	149	7	the	the	DET
ajlm-123	149	8	diagnosis	diagnosis	NOUN
ajlm-123	149	9	and	and	CCONJ
ajlm-123	149	10	treatment	treatment	NOUN
ajlm-123	149	11	of	of	ADP
ajlm-123	149	12	tuberculosis	tuberculosis	NOUN
ajlm-123	149	13	.	.	PUNCT
ajlm-123	150	1	bmc	bmc	ADJ
ajlm-123	150	2	public	public	ADJ
ajlm-123	150	3	health	health	NOUN
ajlm-123	150	4	.	.	PUNCT
ajlm-123	151	1	2008;8:15	2008;8:15	NOUN
ajlm-123	151	2	.	.	PUNCT
ajlm-123	152	1	http://dx.doi.org/10.1186/1471-2458-8-15	http://dx.doi.org/10.1186/1471-2458-8-15	NOUN
ajlm-123	152	2	,	,	PUNCT
ajlm-123	152	3	pubmed	pubmed	PROPN
ajlm-123	152	4	pmid	pmid	PROPN
ajlm-123	152	5	:	:	PUNCT
ajlm-123	152	6	18194573	18194573	NUM
ajlm-123	152	7	,	,	PUNCT
ajlm-123	152	8	pubmed	pubmed	PROPN
ajlm-123	152	9	central	central	ADJ
ajlm-123	152	10	pmcid	pmcid	NOUN
ajlm-123	152	11	:	:	PUNCT
ajlm-123	152	12	2265684	2265684	NUM
ajlm-123	152	13	4	4	NUM
ajlm-123	152	14	.	.	X
ajlm-123	152	15	peeling	peel	VERB
ajlm-123	152	16	rw	rw	NOUN
ajlm-123	152	17	,	,	PUNCT
ajlm-123	152	18	mabey	mabey	PROPN
ajlm-123	152	19	d.	d.	PROPN
ajlm-123	152	20	point	point	PROPN
ajlm-123	152	21	-	-	PUNCT
ajlm-123	152	22	of	of	ADP
ajlm-123	152	23	-	-	PUNCT
ajlm-123	152	24	care	care	NOUN
ajlm-123	152	25	tests	test	NOUN
ajlm-123	152	26	for	for	ADP
ajlm-123	152	27	diagnosing	diagnose	VERB
ajlm-123	152	28	infections	infection	NOUN
ajlm-123	152	29	in	in	ADP
ajlm-123	152	30	the	the	DET
ajlm-123	152	31	developing	develop	VERB
ajlm-123	152	32	world	world	NOUN
ajlm-123	152	33	.	.	PUNCT
ajlm-123	153	1	clin	clin	PROPN
ajlm-123	153	2	microbiol	microbiol	PROPN
ajlm-123	153	3	infect	infect	PROPN
ajlm-123	153	4	.	.	PUNCT
ajlm-123	154	1	2010;16(8):1062–1069	2010;16(8):1062–1069	NOUN
ajlm-123	154	2	.	.	PUNCT
ajlm-123	155	1	http://dx.doi.org/10.1111/j.1469-0691.2010.03279.x	http://dx.doi.org/10.1111/j.1469-0691.2010.03279.x	ADJ
ajlm-123	155	2	,	,	PUNCT
ajlm-123	155	3	pubmed	pubmed	PROPN
ajlm-123	155	4	pmid	pmid	PROPN
ajlm-123	155	5	:	:	PUNCT
ajlm-123	155	6	20670288	20670288	NUM
ajlm-123	155	7	,	,	PUNCT
ajlm-123	155	8	5	5	NUM
ajlm-123	155	9	.	.	NOUN
ajlm-123	155	10	mcnerney	mcnerney	PROPN
ajlm-123	155	11	r	r	PROPN
ajlm-123	155	12	,	,	PUNCT
ajlm-123	155	13	daley	daley	PROPN
ajlm-123	155	14	p.	p.	PROPN
ajlm-123	155	15	towards	towards	ADP
ajlm-123	155	16	a	a	DET
ajlm-123	155	17	point	point	NOUN
ajlm-123	155	18	-	-	PUNCT
ajlm-123	155	19	of	of	ADP
ajlm-123	155	20	-	-	PUNCT
ajlm-123	155	21	care	care	NOUN
ajlm-123	155	22	test	test	NOUN
ajlm-123	155	23	for	for	ADP
ajlm-123	155	24	active	active	ADJ
ajlm-123	155	25	tuberculosis	tuberculosis	NOUN
ajlm-123	155	26	:	:	PUNCT
ajlm-123	155	27	obstacles	obstacle	NOUN
ajlm-123	155	28	and	and	CCONJ
ajlm-123	155	29	opportunities	opportunity	NOUN
ajlm-123	155	30	.	.	PUNCT
ajlm-123	156	1	nat	nat	PROPN
ajlm-123	156	2	rev	rev	VERB
ajlm-123	156	3	microbiol	microbiol	PROPN
ajlm-123	156	4	.	.	PUNCT
ajlm-123	157	1	2011;9(3):204–213	2011;9(3):204–213	NUM
ajlm-123	157	2	.	.	X
ajlm-123	158	1	http://dx.doi.org/10.1038/nrmicro2521	http://dx.doi.org/10.1038/nrmicro2521	PROPN
ajlm-123	158	2	,	,	PUNCT
ajlm-123	158	3	pubmed	pubmed	PROPN
ajlm-123	158	4	pmid	pmid	PROPN
ajlm-123	158	5	:	:	PUNCT
ajlm-123	158	6	21326275	21326275	NUM
ajlm-123	158	7	6	6	NUM
ajlm-123	158	8	.	.	PUNCT
ajlm-123	159	1	mabey	mabey	PROPN
ajlm-123	159	2	d	d	PROPN
ajlm-123	159	3	,	,	PUNCT
ajlm-123	159	4	peeling	peel	VERB
ajlm-123	159	5	r	r	NOUN
ajlm-123	159	6	,	,	PUNCT
ajlm-123	159	7	perkins	perkins	PROPN
ajlm-123	159	8	m.	m.	NOUN
ajlm-123	159	9	rapid	rapid	ADJ
ajlm-123	159	10	and	and	CCONJ
ajlm-123	159	11	simple	simple	ADJ
ajlm-123	159	12	point	point	NOUN
ajlm-123	159	13	of	of	ADP
ajlm-123	159	14	care	care	NOUN
ajlm-123	159	15	diagnostics	diagnostic	NOUN
ajlm-123	159	16	for	for	ADP
ajlm-123	159	17	stis	stis	NOUN
ajlm-123	159	18	.	.	PUNCT
ajlm-123	160	1	sex	sex	NOUN
ajlm-123	160	2	transm	transm	PROPN
ajlm-123	160	3	infect	infect	VERB
ajlm-123	160	4	.	.	PUNCT
ajlm-123	161	1	2001;77(6):397–398	2001;77(6):397–398	X
ajlm-123	161	2	.	.	PUNCT
ajlm-123	162	1	http://dx.doi.org/10.1136/sti.77.6.397	http://dx.doi.org/10.1136/sti.77.6.397	PROPN
ajlm-123	162	2	,	,	PUNCT
ajlm-123	162	3	pubmed	pubmed	PROPN
ajlm-123	162	4	pmid	pmid	PROPN
ajlm-123	162	5	:	:	PUNCT
ajlm-123	162	6	11714933	11714933	NUM
ajlm-123	162	7	,	,	PUNCT
ajlm-123	162	8	pubmed	pubmed	PROPN
ajlm-123	162	9	central	central	ADJ
ajlm-123	162	10	pmcid	pmcid	NOUN
ajlm-123	162	11	:	:	PUNCT
ajlm-123	163	1	1744415	1744415	NUM
ajlm-123	163	2	7	7	NUM
ajlm-123	163	3	.	.	PUNCT
ajlm-123	163	4	global	global	ADJ
ajlm-123	163	5	harmonization	harmonization	PROPN
ajlm-123	163	6	task	task	PROPN
ajlm-123	163	7	force	force	NOUN
ajlm-123	163	8	.	.	PUNCT
ajlm-123	164	1	definition	definition	NOUN
ajlm-123	164	2	of	of	ADP
ajlm-123	164	3	the	the	DET
ajlm-123	164	4	terms	term	NOUN
ajlm-123	164	5	‘	'	PUNCT
ajlm-123	164	6	medical	medical	ADJ
ajlm-123	164	7	device	device	NOUN
ajlm-123	164	8	’	'	PUNCT
ajlm-123	164	9	and	and	CCONJ
ajlm-123	164	10	‘	'	PUNCT
ajlm-123	164	11	in	in	X
ajlm-123	164	12	vitro	vitro	X
ajlm-123	164	13	diagnostic	diagnostic	ADJ
ajlm-123	164	14	(	(	PUNCT
ajlm-123	164	15	ivd	ivd	NOUN
ajlm-123	164	16	)	)	PUNCT
ajlm-123	164	17	medical	medical	ADJ
ajlm-123	164	18	device	device	NOUN
ajlm-123	164	19	’	'	PUNCT
ajlm-123	164	20	.	.	PUNCT
ajlm-123	165	1	ghtf	ghtf	PROPN
ajlm-123	165	2	/	/	SYM
ajlm-123	165	3	sg1	sg1	PROPN
ajlm-123	165	4	/	/	SYM
ajlm-123	165	5	n071:2012	n071:2012	PROPN
ajlm-123	165	6	;	;	PUNCT
ajlm-123	165	7	2012	2012	NUM
ajlm-123	165	8	.	.	PUNCT
ajlm-123	166	1	8	8	X
ajlm-123	166	2	.	.	PUNCT
ajlm-123	166	3	special	special	ADJ
ajlm-123	166	4	programme	programme	NOUN
ajlm-123	166	5	for	for	ADP
ajlm-123	166	6	research	research	NOUN
ajlm-123	166	7	&	&	CCONJ
ajlm-123	166	8	training	training	NOUN
ajlm-123	166	9	in	in	ADP
ajlm-123	166	10	tropical	tropical	ADJ
ajlm-123	166	11	diseases	disease	NOUN
ajlm-123	166	12	(	(	PUNCT
ajlm-123	166	13	tdr	tdr	PROPN
ajlm-123	166	14	)	)	PUNCT
ajlm-123	166	15	.	.	PUNCT
ajlm-123	167	1	regulation	regulation	NOUN
ajlm-123	167	2	of	of	ADP
ajlm-123	167	3	vitro	vitro	X
ajlm-123	167	4	diagnostics	diagnostic	NOUN
ajlm-123	167	5	:	:	PUNCT
ajlm-123	167	6	a	a	DET
ajlm-123	167	7	global	global	ADJ
ajlm-123	167	8	perspective	perspective	NOUN
ajlm-123	167	9	.	.	PUNCT
ajlm-123	168	1	find	find	VERB
ajlm-123	168	2	sa	sa	PROPN
ajlm-123	168	3	/	/	SYM
ajlm-123	168	4	tdr	tdr	PROPN
ajlm-123	168	5	:	:	PUNCT
ajlm-123	168	6	geneva	geneva	PROPN
ajlm-123	168	7	;	;	PUNCT
ajlm-123	168	8	2002	2002	NUM
ajlm-123	168	9	[	[	X
ajlm-123	168	10	reproduced	reproduce	VERB
ajlm-123	168	11	as	as	ADP
ajlm-123	168	12	annex	annex	NOUN
ajlm-123	168	13	to	to	ADP
ajlm-123	168	14	diagnostics	diagnostic	NOUN
ajlm-123	168	15	for	for	ADP
ajlm-123	168	16	tuberculosis	tuberculosis	NOUN
ajlm-123	168	17	:	:	PUNCT
ajlm-123	168	18	global	global	ADJ
ajlm-123	168	19	demand	demand	NOUN
ajlm-123	168	20	and	and	CCONJ
ajlm-123	168	21	market	market	NOUN
ajlm-123	168	22	potential	potential	NOUN
ajlm-123	168	23	.	.	PUNCT
ajlm-123	169	1	geneva	geneva	NOUN
ajlm-123	169	2	:	:	PUNCT
ajlm-123	169	3	world	world	PROPN
ajlm-123	169	4	health	health	NOUN
ajlm-123	169	5	organization	organization	NOUN
ajlm-123	169	6	;	;	PUNCT
ajlm-123	169	7	2006	2006	NUM
ajlm-123	169	8	]	]	PUNCT
ajlm-123	169	9	.	.	PUNCT
ajlm-123	170	1	9	9	X
ajlm-123	170	2	.	.	X
ajlm-123	170	3	peeling	peel	VERB
ajlm-123	170	4	r	r	NOUN
ajlm-123	170	5	,	,	PUNCT
ajlm-123	170	6	mcnerney	mcnerney	PROPN
ajlm-123	170	7	r.	r.	NOUN
ajlm-123	170	8	increasing	increase	VERB
ajlm-123	170	9	access	access	NOUN
ajlm-123	170	10	to	to	ADP
ajlm-123	170	11	diagnostics	diagnostic	NOUN
ajlm-123	170	12	through	through	ADP
ajlm-123	170	13	technology	technology	NOUN
ajlm-123	170	14	transfer	transfer	NOUN
ajlm-123	170	15	and	and	CCONJ
ajlm-123	170	16	local	local	ADJ
ajlm-123	170	17	production	production	NOUN
ajlm-123	170	18	.	.	PUNCT
ajlm-123	171	1	geneva	geneva	PROPN
ajlm-123	171	2	:	:	PUNCT
ajlm-123	172	1	who	who	PRON
ajlm-123	172	2	;	;	PUNCT
ajlm-123	172	3	2011	2011	NUM
ajlm-123	172	4	.	.	PUNCT
ajlm-123	173	1	10	10	NUM
ajlm-123	173	2	.	.	PUNCT
ajlm-123	174	1	dowdy	dowdy	ADJ
ajlm-123	174	2	dw	dw	PROPN
ajlm-123	174	3	,	,	PUNCT
ajlm-123	174	4	steingart	steingart	PROPN
ajlm-123	174	5	kr	kr	PROPN
ajlm-123	174	6	,	,	PUNCT
ajlm-123	174	7	pai	pai	PROPN
ajlm-123	174	8	m.	m.	NOUN
ajlm-123	174	9	serological	serological	ADJ
ajlm-123	174	10	testing	testing	NOUN
ajlm-123	174	11	versus	versus	ADP
ajlm-123	174	12	other	other	ADJ
ajlm-123	174	13	strategies	strategy	NOUN
ajlm-123	174	14	for	for	ADP
ajlm-123	174	15	diagnosis	diagnosis	NOUN
ajlm-123	174	16	of	of	ADP
ajlm-123	174	17	active	active	ADJ
ajlm-123	174	18	tuberculosis	tuberculosis	NOUN
ajlm-123	174	19	in	in	ADP
ajlm-123	174	20	india	india	PROPN
ajlm-123	174	21	:	:	PUNCT
ajlm-123	174	22	a	a	DET
ajlm-123	174	23	cost	cost	NOUN
ajlm-123	174	24	-	-	PUNCT
ajlm-123	174	25	effectiveness	effectiveness	NOUN
ajlm-123	174	26	analysis	analysis	NOUN
ajlm-123	174	27	.	.	PUNCT
ajlm-123	175	1	plos	plos	PROPN
ajlm-123	175	2	med	med	PROPN
ajlm-123	175	3	.	.	PUNCT
ajlm-123	176	1	2011;8(8):e1001074	2011;8(8):e1001074	PRON
ajlm-123	176	2	.	.	PUNCT
ajlm-123	177	1	http://dx.doi.org/10.1371/journal.pmed.1001074	http://dx.doi.org/10.1371/journal.pmed.1001074	PROPN
ajlm-123	177	2	,	,	PUNCT
ajlm-123	177	3	pubmed	pubmed	PROPN
ajlm-123	177	4	pmid	pmid	PROPN
ajlm-123	177	5	:	:	PUNCT
ajlm-123	177	6	21857810	21857810	NUM
ajlm-123	177	7	,	,	PUNCT
ajlm-123	177	8	pubmed	pubmed	PROPN
ajlm-123	177	9	central	central	ADJ
ajlm-123	177	10	pmcid	pmcid	NOUN
ajlm-123	177	11	:	:	PUNCT
ajlm-123	177	12	3153451	3153451	NUM
ajlm-123	177	13	11	11	NUM
ajlm-123	177	14	.	.	PUNCT
ajlm-123	178	1	macarthur	macarthur	PROPN
ajlm-123	178	2	g.	g.	PROPN
ajlm-123	178	3	global	global	PROPN
ajlm-123	178	4	health	health	PROPN
ajlm-123	178	5	diagnostics	diagnostic	NOUN
ajlm-123	178	6	:	:	PUNCT
ajlm-123	178	7	research	research	NOUN
ajlm-123	178	8	,	,	PUNCT
ajlm-123	178	9	development	development	NOUN
ajlm-123	178	10	and	and	CCONJ
ajlm-123	178	11	regulation	regulation	NOUN
ajlm-123	178	12	.	.	PUNCT
ajlm-123	179	1	london	london	PROPN
ajlm-123	179	2	:	:	PUNCT
ajlm-123	179	3	the	the	DET
ajlm-123	179	4	academy	academy	NOUN
ajlm-123	179	5	of	of	ADP
ajlm-123	179	6	medical	medical	ADJ
ajlm-123	179	7	sciences	science	NOUN
ajlm-123	179	8	;	;	PUNCT
ajlm-123	179	9	2009	2009	NUM
ajlm-123	179	10	.	.	PUNCT
ajlm-123	180	1	isbn	isbn	PROPN
ajlm-123	180	2	no	no	PRON
ajlm-123	180	3	:	:	PUNCT
ajlm-123	180	4	1	1	NUM
ajlm-123	180	5	-	-	SYM
ajlm-123	180	6	903401	903401	NUM
ajlm-123	180	7	-	-	PUNCT
ajlm-123	180	8	20	20	NUM
ajlm-123	180	9	-	-	SYM
ajlm-123	180	10	8	8	NUM
ajlm-123	180	11	12	12	NUM
ajlm-123	180	12	.	.	PUNCT
ajlm-123	181	1	hoerr	hoerr	PROPN
ajlm-123	181	2	ra	ra	PROPN
ajlm-123	181	3	.	.	PUNCT
ajlm-123	182	1	regulatory	regulatory	ADJ
ajlm-123	182	2	uncertainty	uncertainty	NOUN
ajlm-123	182	3	and	and	CCONJ
ajlm-123	182	4	the	the	DET
ajlm-123	182	5	associated	associated	ADJ
ajlm-123	182	6	business	business	NOUN
ajlm-123	182	7	risk	risk	NOUN
ajlm-123	182	8	for	for	ADP
ajlm-123	182	9	emerging	emerge	VERB
ajlm-123	182	10	technologies	technology	NOUN
ajlm-123	182	11	.	.	PUNCT
ajlm-123	183	1	j	j	PROPN
ajlm-123	183	2	nanopart	nanopart	PROPN
ajlm-123	183	3	res	re	NOUN
ajlm-123	183	4	.	.	PUNCT
ajlm-123	184	1	2011;13(4):1513–1520	2011;13(4):1513–1520	NUM
ajlm-123	184	2	.	.	PUNCT
ajlm-123	185	1	http://dx.doi.org/10.1007/s11051-011-0260-z	http://dx.doi.org/10.1007/s11051-011-0260-z	ADJ
ajlm-123	185	2	13	13	NUM
ajlm-123	185	3	.	.	PUNCT
ajlm-123	186	1	eccleston	eccleston	PROPN
ajlm-123	186	2	rc	rc	PROPN
ajlm-123	186	3	.	.	PUNCT
ajlm-123	187	1	a	a	DET
ajlm-123	187	2	model	model	ADJ
ajlm-123	187	3	regulatory	regulatory	ADJ
ajlm-123	187	4	program	program	NOUN
ajlm-123	187	5	for	for	ADP
ajlm-123	187	6	medical	medical	ADJ
ajlm-123	187	7	devices	device	NOUN
ajlm-123	187	8	:	:	PUNCT
ajlm-123	187	9	an	an	DET
ajlm-123	187	10	international	international	ADJ
ajlm-123	187	11	guide	guide	NOUN
ajlm-123	187	12	.	.	PUNCT
ajlm-123	188	1	washington	washington	PROPN
ajlm-123	188	2	,	,	PUNCT
ajlm-123	188	3	dc	dc	PROPN
ajlm-123	188	4	:	:	PUNCT
ajlm-123	188	5	world	world	PROPN
ajlm-123	188	6	health	health	PROPN
ajlm-123	188	7	organization	organization	PROPN
ajlm-123	188	8	and	and	CCONJ
ajlm-123	188	9	united	united	PROPN
ajlm-123	188	10	states	states	PROPN
ajlm-123	188	11	food	food	PROPN
ajlm-123	188	12	and	and	CCONJ
ajlm-123	188	13	drug	drug	NOUN
ajlm-123	188	14	administration	administration	NOUN
ajlm-123	188	15	;	;	PUNCT
ajlm-123	188	16	2001	2001	NUM
ajlm-123	188	17	.	.	PUNCT
ajlm-123	189	1	14	14	NUM
ajlm-123	189	2	.	.	PUNCT
ajlm-123	190	1	global	global	ADJ
ajlm-123	190	2	harmonization	harmonization	PROPN
ajlm-123	190	3	task	task	NOUN
ajlm-123	190	4	force	force	NOUN
ajlm-123	190	5	.	.	PUNCT
ajlm-123	191	1	principles	principle	NOUN
ajlm-123	191	2	of	of	ADP
ajlm-123	191	3	in	in	ADP
ajlm-123	191	4	vitro	vitro	X
ajlm-123	191	5	diagnostic	diagnostic	ADJ
ajlm-123	191	6	medical	medical	ADJ
ajlm-123	191	7	devices	device	NOUN
ajlm-123	191	8	classification	classification	NOUN
ajlm-123	191	9	.	.	PUNCT
ajlm-123	192	1	ghtf	ghtf	PROPN
ajlm-123	192	2	/	/	SYM
ajlm-123	192	3	sg1	sg1	PROPN
ajlm-123	192	4	/	/	SYM
ajlm-123	192	5	n452008	n452008	NOUN
ajlm-123	192	6	.	.	PUNCT
ajlm-123	193	1	[	[	X
ajlm-123	193	2	document	document	NOUN
ajlm-123	193	3	on	on	ADP
ajlm-123	193	4	the	the	DET
ajlm-123	193	5	internet	internet	NOUN
ajlm-123	193	6	]	]	PUNCT
ajlm-123	193	7	.	.	PUNCT
ajlm-123	194	1	[	[	X
ajlm-123	194	2	c2012	c2012	X
ajlm-123	194	3	]	]	X
ajlm-123	194	4	[	[	X
ajlm-123	194	5	cited	cite	VERB
ajlm-123	194	6	22	22	NUM
ajlm-123	194	7	january	january	NOUN
ajlm-123	194	8	2014	2014	NUM
ajlm-123	194	9	]	]	PUNCT
ajlm-123	194	10	.	.	PUNCT
ajlm-123	195	1	available	available	ADJ
ajlm-123	195	2	from	from	ADP
ajlm-123	195	3	:	:	PUNCT
ajlm-123	195	4	http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n77-2012-principles-medical-devices-classification-121102.pdf	http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n77-2012-principles-medical-devices-classification-121102.pdf	PROPN
ajlm-123	195	5	15	15	NUM
ajlm-123	195	6	.	.	PUNCT
ajlm-123	196	1	global	global	ADJ
ajlm-123	196	2	harmonization	harmonization	PROPN
ajlm-123	196	3	task	task	NOUN
ajlm-123	196	4	force	force	NOUN
ajlm-123	196	5	.	.	PUNCT
ajlm-123	197	1	summary	summary	NOUN
ajlm-123	197	2	technical	technical	ADJ
ajlm-123	197	3	documentation	documentation	NOUN
ajlm-123	197	4	(	(	PUNCT
ajlm-123	197	5	sted	ste	VERB
ajlm-123	197	6	)	)	PUNCT
ajlm-123	197	7	for	for	ADP
ajlm-123	197	8	demonstrating	demonstrate	VERB
ajlm-123	197	9	conformity	conformity	NOUN
ajlm-123	197	10	to	to	ADP
ajlm-123	197	11	the	the	DET
ajlm-123	197	12	essential	essential	ADJ
ajlm-123	197	13	principles	principle	NOUN
ajlm-123	197	14	of	of	ADP
ajlm-123	197	15	safety	safety	NOUN
ajlm-123	197	16	and	and	CCONJ
ajlm-123	197	17	performance	performance	NOUN
ajlm-123	197	18	of	of	ADP
ajlm-123	197	19	in	in	ADP
ajlm-123	197	20	vitro	vitro	X
ajlm-123	197	21	diagnostic	diagnostic	ADJ
ajlm-123	197	22	medical	medical	ADJ
ajlm-123	197	23	devices	device	NOUN
ajlm-123	197	24	.	.	PUNCT
ajlm-123	198	1	ghtf	ghtf	PROPN
ajlm-123	198	2	/	/	SYM
ajlm-123	198	3	sg1	sg1	PROPN
ajlm-123	198	4	/	/	SYM
ajlm-123	198	5	n063:2011	n063:2011	PROPN
ajlm-123	198	6	;	;	PUNCT
ajlm-123	198	7	2011	2011	NUM
ajlm-123	198	8	.	.	PUNCT
ajlm-123	199	1	16	16	NUM
ajlm-123	199	2	.	.	PUNCT
ajlm-123	200	1	kramer	kramer	PROPN
ajlm-123	200	2	db	db	PROPN
ajlm-123	200	3	,	,	PUNCT
ajlm-123	200	4	xu	xu	PROPN
ajlm-123	200	5	s	s	PROPN
ajlm-123	200	6	,	,	PUNCT
ajlm-123	200	7	kesselheim	kesselheim	PROPN
ajlm-123	200	8	as	as	ADP
ajlm-123	200	9	.	.	PUNCT
ajlm-123	201	1	how	how	SCONJ
ajlm-123	201	2	does	do	AUX
ajlm-123	201	3	medical	medical	ADJ
ajlm-123	201	4	device	device	NOUN
ajlm-123	201	5	regulation	regulation	NOUN
ajlm-123	201	6	perform	perform	VERB
ajlm-123	201	7	in	in	ADP
ajlm-123	201	8	the	the	DET
ajlm-123	201	9	united	united	PROPN
ajlm-123	201	10	states	states	PROPN
ajlm-123	201	11	and	and	CCONJ
ajlm-123	201	12	the	the	DET
ajlm-123	201	13	european	european	PROPN
ajlm-123	201	14	union	union	PROPN
ajlm-123	201	15	?	?	PUNCT
ajlm-123	202	1	a	a	DET
ajlm-123	202	2	systematic	systematic	ADJ
ajlm-123	202	3	review	review	NOUN
ajlm-123	202	4	.	.	PUNCT
ajlm-123	203	1	plos	plos	PROPN
ajlm-123	203	2	med	med	PROPN
ajlm-123	203	3	.	.	PUNCT
ajlm-123	204	1	2012;9(7):e1001276	2012;9(7):e1001276	PROPN
ajlm-123	204	2	.	.	PUNCT
ajlm-123	205	1	http://dx.doi.org/10.1371/journal.pmed.1001276	http://dx.doi.org/10.1371/journal.pmed.1001276	PROPN
ajlm-123	205	2	,	,	PUNCT
ajlm-123	205	3	pubmed	pubmed	PROPN
ajlm-123	205	4	pmid	pmid	PROPN
ajlm-123	205	5	:	:	PUNCT
ajlm-123	205	6	22912563	22912563	NUM
ajlm-123	205	7	17	17	NUM
ajlm-123	205	8	.	.	PUNCT
ajlm-123	206	1	praxiom	praxiom	PROPN
ajlm-123	206	2	research	research	PROPN
ajlm-123	206	3	group	group	PROPN
ajlm-123	206	4	limited	limit	VERB
ajlm-123	206	5	.	.	PUNCT
ajlm-123	207	1	iso	iso	NOUN
ajlm-123	207	2	13485	13485	NUM
ajlm-123	207	3	medical	medical	ADJ
ajlm-123	207	4	device	device	NOUN
ajlm-123	207	5	standard	standard	NOUN
ajlm-123	207	6	translated	translate	VERB
ajlm-123	207	7	into	into	ADP
ajlm-123	207	8	plain	plain	ADJ
ajlm-123	207	9	english	english	PROPN
ajlm-123	207	10	.	.	PUNCT
ajlm-123	208	1	[	[	X
ajlm-123	208	2	page	page	NOUN
ajlm-123	208	3	on	on	ADP
ajlm-123	208	4	the	the	DET
ajlm-123	208	5	internet	internet	NOUN
ajlm-123	208	6	]	]	PUNCT
ajlm-123	208	7	.	.	PUNCT
ajlm-123	209	1	[	[	X
ajlm-123	209	2	c2004	c2004	X
ajlm-123	209	3	]	]	X
ajlm-123	210	1	[	[	X
ajlm-123	210	2	updated	update	VERB
ajlm-123	210	3	2013	2013	NUM
ajlm-123	210	4	may	may	PROPN
ajlm-123	210	5	15	15	NUM
ajlm-123	210	6	;	;	PUNCT
ajlm-123	210	7	cited	cite	VERB
ajlm-123	210	8	2013	2013	NUM
ajlm-123	210	9	sep	sep	NOUN
ajlm-123	210	10	03	03	NUM
ajlm-123	210	11	]	]	PUNCT
ajlm-123	210	12	.	.	PUNCT
ajlm-123	211	1	available	available	ADJ
ajlm-123	211	2	from	from	ADP
ajlm-123	211	3	:	:	PUNCT
ajlm-123	211	4	http://www.praxiom.com/iso-13485.htm	http://www.praxiom.com/iso-13485.htm	PROPN
ajlm-123	211	5	18	18	NUM
ajlm-123	211	6	.	.	PUNCT
ajlm-123	212	1	agência	agência	PROPN
ajlm-123	212	2	nacional	nacional	PROPN
ajlm-123	212	3	de	de	X
ajlm-123	212	4	vigilância	vigilância	PROPN
ajlm-123	212	5	sanitária	sanitária	PROPN
ajlm-123	212	6	.	.	PUNCT
ajlm-123	213	1	anvisa	anvisa	PROPN
ajlm-123	213	2	.	.	PUNCT
ajlm-123	214	1	anvisa	anvisa	PROPN
ajlm-123	214	2	annual	annual	ADJ
ajlm-123	214	3	report	report	NOUN
ajlm-123	214	4	brazil	brazil	PROPN
ajlm-123	214	5	;	;	PUNCT
ajlm-123	214	6	2012	2012	NUM
ajlm-123	214	7	.	.	PUNCT
ajlm-123	215	1	19	19	NUM
ajlm-123	215	2	.	.	PUNCT
ajlm-123	215	3	banoo	banoo	PROPN
ajlm-123	215	4	s	s	PROPN
ajlm-123	215	5	,	,	PUNCT
ajlm-123	215	6	bell	bell	PROPN
ajlm-123	215	7	d	d	PROPN
ajlm-123	215	8	,	,	PUNCT
ajlm-123	215	9	bossuyt	bossuyt	NOUN
ajlm-123	215	10	p	p	NOUN
ajlm-123	215	11	,	,	PUNCT
ajlm-123	215	12	et	et	PROPN
ajlm-123	215	13	al	al	PROPN
ajlm-123	215	14	.	.	PUNCT
ajlm-123	215	15	evaluation	evaluation	NOUN
ajlm-123	215	16	of	of	ADP
ajlm-123	215	17	diagnostic	diagnostic	ADJ
ajlm-123	215	18	tests	test	NOUN
ajlm-123	215	19	for	for	ADP
ajlm-123	215	20	infectious	infectious	ADJ
ajlm-123	215	21	diseases	disease	NOUN
ajlm-123	215	22	:	:	PUNCT
ajlm-123	215	23	general	general	ADJ
ajlm-123	215	24	principles	principle	NOUN
ajlm-123	215	25	.	.	PUNCT
ajlm-123	216	1	nat	nat	PROPN
ajlm-123	216	2	rev	rev	PROPN
ajlm-123	216	3	microbiol	microbiol	PROPN
ajlm-123	216	4	.	.	PUNCT
ajlm-123	217	1	2010;8(12	2010;8(12	NUM
ajlm-123	217	2	suppl):s17–29	suppl):s17–29	X
ajlm-123	217	3	.	.	PUNCT
ajlm-123	218	1	pubmed	pubmed	PROPN
ajlm-123	218	2	pmid	pmid	PROPN
ajlm-123	218	3	:	:	PUNCT
ajlm-123	218	4	21548184	21548184	NUM
ajlm-123	218	5	20	20	NUM
ajlm-123	218	6	.	.	PUNCT
ajlm-123	219	1	cohen	cohen	PROPN
ajlm-123	219	2	p.	p.	NOUN
ajlm-123	220	1	the	the	DET
ajlm-123	220	2	changing	change	VERB
ajlm-123	220	3	regulatory	regulatory	ADJ
ajlm-123	220	4	environment	environment	NOUN
ajlm-123	220	5	of	of	ADP
ajlm-123	220	6	in	in	ADP
ajlm-123	220	7	vitro	vitro	X
ajlm-123	220	8	diagnostics	diagnostic	NOUN
ajlm-123	220	9	:	:	PUNCT
ajlm-123	220	10	implications	implication	NOUN
ajlm-123	220	11	for	for	ADP
ajlm-123	220	12	sponsors	sponsor	NOUN
ajlm-123	220	13	,	,	PUNCT
ajlm-123	220	14	manufacturers	manufacturer	NOUN
ajlm-123	220	15	and	and	CCONJ
ajlm-123	220	16	laboratory	laboratory	NOUN
ajlm-123	220	17	users	user	NOUN
ajlm-123	220	18	.	.	PUNCT
ajlm-123	221	1	aus	aus	PROPN
ajlm-123	221	2	j	j	PROPN
ajlm-123	221	3	med	med	PROPN
ajlm-123	221	4	sci	sci	PROPN
ajlm-123	221	5	2010;31(1):9–15	2010;31(1):9–15	PROPN
ajlm-123	221	6	.	.	PUNCT
ajlm-123	222	1	21	21	NUM
ajlm-123	222	2	.	.	PUNCT
ajlm-123	223	1	peeling	peel	VERB
ajlm-123	223	2	rw	rw	NOUN
ajlm-123	223	3	,	,	PUNCT
ajlm-123	223	4	smith	smith	PROPN
ajlm-123	223	5	pg	pg	PROPN
ajlm-123	223	6	,	,	PUNCT
ajlm-123	223	7	bossuyt	bossuyt	NOUN
ajlm-123	223	8	pm	pm	VERB
ajlm-123	223	9	.	.	PUNCT
ajlm-123	224	1	a	a	DET
ajlm-123	224	2	guide	guide	NOUN
ajlm-123	224	3	for	for	ADP
ajlm-123	224	4	diagnostic	diagnostic	ADJ
ajlm-123	224	5	evaluations	evaluation	NOUN
ajlm-123	224	6	.	.	PUNCT
ajlm-123	225	1	nat	nat	PROPN
ajlm-123	225	2	rev	rev	PROPN
ajlm-123	225	3	microbiol	microbiol	PROPN
ajlm-123	225	4	.	.	PUNCT
ajlm-123	226	1	2006;4(9	2006;4(9	NUM
ajlm-123	226	2	suppl):s2–6	suppl):s2–6	NOUN
ajlm-123	226	3	.	.	PUNCT
ajlm-123	226	4	http://dx.doi.org/10.1038/nrmicro1568	http://dx.doi.org/10.1038/nrmicro1568	PROPN
ajlm-123	226	5	,	,	PUNCT
ajlm-123	226	6	pubmed	pubmed	PROPN
ajlm-123	226	7	pmid	pmid	PROPN
ajlm-123	226	8	:	:	PUNCT
ajlm-123	226	9	17003769	17003769	NUM
ajlm-123	226	10	22	22	NUM
ajlm-123	226	11	.	.	PUNCT
ajlm-123	227	1	small	small	ADJ
ajlm-123	227	2	pm	pm	PROPN
ajlm-123	227	3	,	,	PUNCT
ajlm-123	227	4	perkins	perkins	PROPN
ajlm-123	227	5	md	md	PROPN
ajlm-123	227	6	.	.	PROPN
ajlm-123	228	1	more	more	ADJ
ajlm-123	228	2	rigour	rigour	NOUN
ajlm-123	228	3	needed	need	VERB
ajlm-123	228	4	in	in	ADP
ajlm-123	228	5	trials	trial	NOUN
ajlm-123	228	6	of	of	ADP
ajlm-123	228	7	new	new	ADJ
ajlm-123	228	8	diagnostic	diagnostic	ADJ
ajlm-123	228	9	agents	agent	NOUN
ajlm-123	228	10	for	for	ADP
ajlm-123	228	11	tuberculosis	tuberculosis	NOUN
ajlm-123	228	12	.	.	PUNCT
ajlm-123	229	1	lancet	lancet	NOUN
ajlm-123	229	2	.	.	PUNCT
ajlm-123	230	1	2000;356(9235):1048–1049	2000;356(9235):1048–1049	NOUN
ajlm-123	230	2	.	.	PUNCT
ajlm-123	231	1	http://dx.doi.org/10.1016/s0140-6736(00)02724-0	http://dx.doi.org/10.1016/s0140-6736(00)02724-0	NOUN
ajlm-123	231	2	,	,	PUNCT
ajlm-123	231	3	pubmed	pubmed	PROPN
ajlm-123	231	4	pmid	pmid	PROPN
ajlm-123	231	5	:	:	PUNCT
ajlm-123	231	6	11009137	11009137	NUM
ajlm-123	231	7	23	23	NUM
ajlm-123	231	8	.	.	PUNCT
ajlm-123	232	1	world	world	PROPN
ajlm-123	232	2	health	health	PROPN
ajlm-123	232	3	organization	organization	PROPN
ajlm-123	232	4	.	.	PUNCT
ajlm-123	233	1	handbook	handbook	NOUN
ajlm-123	233	2	:	:	PUNCT
ajlm-123	233	3	good	good	ADJ
ajlm-123	233	4	laboratory	laboratory	NOUN
ajlm-123	233	5	practice	practice	NOUN
ajlm-123	233	6	(	(	PUNCT
ajlm-123	233	7	glp	glp	NOUN
ajlm-123	233	8	):	):	PUNCT
ajlm-123	233	9	quality	quality	NOUN
ajlm-123	233	10	practices	practice	NOUN
ajlm-123	233	11	for	for	ADP
ajlm-123	233	12	regulated	regulated	ADJ
ajlm-123	233	13	non	non	ADJ
ajlm-123	233	14	-	-	ADJ
ajlm-123	233	15	clinical	clinical	ADJ
ajlm-123	233	16	research	research	NOUN
ajlm-123	233	17	and	and	CCONJ
ajlm-123	233	18	development	development	NOUN
ajlm-123	233	19	.	.	PUNCT
ajlm-123	234	1	geneva	geneva	PROPN
ajlm-123	234	2	:	:	PUNCT
ajlm-123	234	3	world	world	PROPN
ajlm-123	234	4	health	health	NOUN
ajlm-123	234	5	organization	organization	NOUN
ajlm-123	234	6	;	;	PUNCT
ajlm-123	234	7	2009	2009	NUM
ajlm-123	234	8	.	.	PUNCT
ajlm-123	235	1	24	24	NUM
ajlm-123	235	2	.	.	PUNCT
ajlm-123	235	3	world	world	PROPN
ajlm-123	235	4	health	health	PROPN
ajlm-123	235	5	organization	organization	PROPN
ajlm-123	235	6	.	.	PUNCT
ajlm-123	236	1	guidelines	guideline	NOUN
ajlm-123	236	2	for	for	ADP
ajlm-123	236	3	good	good	ADJ
ajlm-123	236	4	clinical	clinical	ADJ
ajlm-123	236	5	practice	practice	NOUN
ajlm-123	236	6	(	(	PUNCT
ajlm-123	236	7	gcp	gcp	NOUN
ajlm-123	236	8	)	)	PUNCT
ajlm-123	236	9	for	for	ADP
ajlm-123	236	10	trials	trial	NOUN
ajlm-123	236	11	on	on	ADP
ajlm-123	236	12	pharmaceutical	pharmaceutical	ADJ
ajlm-123	236	13	products	product	NOUN
ajlm-123	236	14	.	.	PUNCT
ajlm-123	237	1	geneva	geneva	PROPN
ajlm-123	237	2	:	:	PUNCT
ajlm-123	237	3	world	world	PROPN
ajlm-123	237	4	health	health	NOUN
ajlm-123	237	5	organization	organization	NOUN
ajlm-123	237	6	;	;	PUNCT
ajlm-123	237	7	1995	1995	NUM
ajlm-123	237	8	.	.	PUNCT
ajlm-123	238	1	25	25	NUM
ajlm-123	238	2	.	.	X
ajlm-123	238	3	bossuyt	bossuyt	PROPN
ajlm-123	238	4	pm	pm	PROPN
ajlm-123	238	5	,	,	PUNCT
ajlm-123	238	6	reitsma	reitsma	VERB
ajlm-123	238	7	jb	jb	PROPN
ajlm-123	238	8	,	,	PUNCT
ajlm-123	238	9	bruns	bruns	PROPN
ajlm-123	238	10	de	de	PROPN
ajlm-123	238	11	,	,	PUNCT
ajlm-123	238	12	et	et	PROPN
ajlm-123	238	13	al	al	PROPN
ajlm-123	238	14	.	.	PROPN
ajlm-123	239	1	towards	towards	ADP
ajlm-123	239	2	complete	complete	ADJ
ajlm-123	239	3	and	and	CCONJ
ajlm-123	239	4	accurate	accurate	ADJ
ajlm-123	239	5	reporting	reporting	NOUN
ajlm-123	239	6	of	of	ADP
ajlm-123	239	7	studies	study	NOUN
ajlm-123	239	8	of	of	ADP
ajlm-123	239	9	diagnostic	diagnostic	ADJ
ajlm-123	239	10	accuracy	accuracy	NOUN
ajlm-123	239	11	:	:	PUNCT
ajlm-123	239	12	the	the	DET
ajlm-123	239	13	stard	stard	PROPN
ajlm-123	239	14	initiative	initiative	NOUN
ajlm-123	239	15	.	.	PUNCT
ajlm-123	240	1	clin	clin	PROPN
ajlm-123	240	2	radiol	radiol	PROPN
ajlm-123	240	3	.	.	PUNCT
ajlm-123	241	1	2003;58(8):575–580	2003;58(8):575–580	X
ajlm-123	241	2	.	.	PUNCT
ajlm-123	241	3	http://dx.doi.org/10.1016/s0009-9260(03)00258-7	http://dx.doi.org/10.1016/s0009-9260(03)00258-7	PROPN
ajlm-123	241	4	,	,	PUNCT
ajlm-123	241	5	pubmed	pubmed	PROPN
ajlm-123	241	6	pmid	pmid	PROPN
ajlm-123	241	7	:	:	PUNCT
ajlm-123	241	8	12887949	12887949	NUM
ajlm-123	241	9	26	26	NUM
ajlm-123	241	10	.	.	PUNCT
ajlm-123	242	1	kramer	kramer	PROPN
ajlm-123	242	2	db	db	PROPN
ajlm-123	242	3	,	,	PUNCT
ajlm-123	242	4	tan	tan	PROPN
ajlm-123	242	5	yt	yt	PROPN
ajlm-123	242	6	,	,	PUNCT
ajlm-123	242	7	sato	sato	PROPN
ajlm-123	242	8	c	c	AUX
ajlm-123	242	9	,	,	PUNCT
ajlm-123	242	10	et	et	PROPN
ajlm-123	242	11	al	al	PROPN
ajlm-123	242	12	.	.	PUNCT
ajlm-123	243	1	postmarket	postmarket	ADJ
ajlm-123	243	2	surveillance	surveillance	NOUN
ajlm-123	243	3	of	of	ADP
ajlm-123	243	4	medical	medical	ADJ
ajlm-123	243	5	devices	device	NOUN
ajlm-123	243	6	:	:	PUNCT
ajlm-123	243	7	a	a	DET
ajlm-123	243	8	comparison	comparison	NOUN
ajlm-123	243	9	of	of	ADP
ajlm-123	243	10	strategies	strategy	NOUN
ajlm-123	243	11	in	in	ADP
ajlm-123	243	12	the	the	DET
ajlm-123	243	13	us	us	PROPN
ajlm-123	243	14	,	,	PUNCT
ajlm-123	243	15	eu	eu	PROPN
ajlm-123	243	16	,	,	PUNCT
ajlm-123	243	17	japan	japan	PROPN
ajlm-123	243	18	,	,	PUNCT
ajlm-123	243	19	and	and	CCONJ
ajlm-123	243	20	china	china	PROPN
ajlm-123	243	21	.	.	PUNCT
ajlm-123	244	1	plos	plos	PROPN
ajlm-123	244	2	med	med	PROPN
ajlm-123	244	3	.	.	PUNCT
ajlm-123	245	1	2013;10(9):e1001519	2013;10(9):e1001519	X
ajlm-123	245	2	.	.	PUNCT
ajlm-123	246	1	http://dx.doi.org/10.1371/journal.pmed.1001519	http://dx.doi.org/10.1371/journal.pmed.1001519	VERB
ajlm-123	246	2	27	27	NUM
ajlm-123	246	3	.	.	PUNCT
ajlm-123	247	1	global	global	ADJ
ajlm-123	247	2	harmonization	harmonization	PROPN
ajlm-123	247	3	task	task	PROPN
ajlm-123	247	4	force	force	NOUN
ajlm-123	247	5	.	.	PUNCT
ajlm-123	248	1	application	application	NOUN
ajlm-123	248	2	requirements	requirement	NOUN
ajlm-123	248	3	for	for	ADP
ajlm-123	248	4	participation	participation	NOUN
ajlm-123	248	5	in	in	ADP
ajlm-123	248	6	the	the	DET
ajlm-123	248	7	ghtf	ghtf	PROPN
ajlm-123	248	8	national	national	PROPN
ajlm-123	248	9	competent	competent	PROPN
ajlm-123	248	10	authority	authority	PROPN
ajlm-123	248	11	report	report	PROPN
ajlm-123	248	12	exchange	exchange	NOUN
ajlm-123	248	13	program	program	NOUN
ajlm-123	248	14	.	.	PUNCT
ajlm-123	249	1	ghtf	ghtf	PROPN
ajlm-123	249	2	/	/	SYM
ajlm-123	249	3	sg2/	sg2/	PROPN
ajlm-123	249	4	n38r19:2009	n38r19:2009	NOUN
ajlm-123	249	5	;	;	PUNCT
ajlm-123	249	6	2009	2009	NUM
ajlm-123	249	7	.	.	PUNCT
ajlm-123	250	1	28	28	NUM
ajlm-123	250	2	.	.	PUNCT
ajlm-123	251	1	bell	bell	PROPN
ajlm-123	251	2	d	d	PROPN
ajlm-123	251	3	,	,	PUNCT
ajlm-123	251	4	wongsrichanalai	wongsrichanalai	PROPN
ajlm-123	251	5	c	c	PROPN
ajlm-123	251	6	,	,	PUNCT
ajlm-123	251	7	barnwell	barnwell	PROPN
ajlm-123	251	8	jw	jw	PROPN
ajlm-123	251	9	.	.	PROPN
ajlm-123	251	10	ensuring	ensure	VERB
ajlm-123	251	11	quality	quality	NOUN
ajlm-123	251	12	and	and	CCONJ
ajlm-123	251	13	access	access	NOUN
ajlm-123	251	14	for	for	ADP
ajlm-123	251	15	malaria	malaria	ADJ
ajlm-123	251	16	diagnosis	diagnosis	NOUN
ajlm-123	251	17	:	:	PUNCT
ajlm-123	251	18	how	how	SCONJ
ajlm-123	251	19	can	can	AUX
ajlm-123	251	20	it	it	PRON
ajlm-123	251	21	be	be	AUX
ajlm-123	251	22	achieved	achieve	VERB
ajlm-123	251	23	?	?	PUNCT
ajlm-123	252	1	nat	nat	PROPN
ajlm-123	252	2	rev	rev	VERB
ajlm-123	252	3	microbiol	microbiol	PROPN
ajlm-123	252	4	.	.	PUNCT
ajlm-123	253	1	2006;4(9	2006;4(9	NUM
ajlm-123	253	2	suppl):s7–20	suppl):s7–20	NOUN
ajlm-123	253	3	.	.	PUNCT
ajlm-123	254	1	http://dx.doi.org/10.1038/nrmicro1525	http://dx.doi.org/10.1038/nrmicro1525	PROPN
ajlm-123	254	2	,	,	PUNCT
ajlm-123	254	3	pubmed	pubmed	PROPN
ajlm-123	254	4	pmid	pmid	PROPN
ajlm-123	254	5	:	:	PUNCT
ajlm-123	254	6	17003770	17003770	NUM
ajlm-123	254	7	29	29	NUM
ajlm-123	254	8	.	.	PUNCT
ajlm-123	255	1	africomnet	africomnet	PROPN
ajlm-123	255	2	.	.	PUNCT
ajlm-123	256	1	tanzania	tanzania	PROPN
ajlm-123	256	2	:	:	PUNCT
ajlm-123	256	3	search	search	VERB
ajlm-123	256	4	on	on	ADP
ajlm-123	256	5	for	for	ADP
ajlm-123	256	6	new	new	ADJ
ajlm-123	256	7	supplier	supplier	NOUN
ajlm-123	256	8	of	of	ADP
ajlm-123	256	9	hiv	hiv	PROPN
ajlm-123	256	10	test	test	NOUN
ajlm-123	256	11	kits	kit	NOUN
ajlm-123	256	12	.	.	PUNCT
ajlm-123	257	1	[	[	X
ajlm-123	257	2	page	page	NOUN
ajlm-123	257	3	on	on	ADP
ajlm-123	257	4	the	the	DET
ajlm-123	257	5	internet	internet	NOUN
ajlm-123	257	6	]	]	PUNCT
ajlm-123	257	7	.	.	PUNCT
ajlm-123	258	1	[	[	X
ajlm-123	258	2	c2012	c2012	X
ajlm-123	258	3	]	]	X
ajlm-123	258	4	[	[	X
ajlm-123	258	5	cited	cite	VERB
ajlm-123	258	6	2013	2013	NUM
ajlm-123	258	7	oct	oct	NOUN
ajlm-123	258	8	28	28	NUM
ajlm-123	258	9	]	]	PUNCT
ajlm-123	258	10	.	.	PUNCT
ajlm-123	259	1	available	available	ADJ
ajlm-123	259	2	from	from	ADP
ajlm-123	259	3	:	:	PUNCT
ajlm-123	259	4	http://www.africomnet.org/communication-resources/highlights/1904-tanzania-search-on-for-new-supplier-of-hiv-test-kits.html	http://www.africomnet.org/communication-resources/highlights/1904-tanzania-search-on-for-new-supplier-of-hiv-test-kits.html	NOUN