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Received April 23, 2024, accepted June 2, 2025, date of publication September 10, 2025.

Review

Catchment of the Test License for the Regulation of Medical 
Devices in India

Rupak Kumar*, Deepak K. Gupta, Jyoti Batra, Aarti Sahu and Suchita Markan

Indian Council of Medical Research (ICMR), New Delhi, India.

* Corresponding Author Email: rupakraman@gmail.com

ABSTRACT

The medical device industry in India is gaining momentum and is expected to grow rapidly. Given the significant impact of 
medical devices (MD) on patient health, a robust regulatory framework that combines policies, laws, regulations, and approvals 
is necessary to ensure adherence to standards before market entry. To initiate regulatory approval, test license is the preliminary 
step. It is required to manufacture or import materials in small quantities for specified purposes; for example, testing, training, 
examination, evaluation, demonstration, and clinical investigation under India’s Medical Devices Rules (MDR) 2017. In general, 
as the associated risk of the device increases, the testing or evaluation parameters required to establish its safety and efficacy 
also increases. In this regard, test license is introduced so that manufacturers or importers must navigate to ensure compliance 
for the generation of data, particularly in the context of quality aspects of a MD or in vitro diagnostics (IVD), such as its design 
verification and validation, material of construction, testing, functionality, durability, sterility, biocompatibility, electrical safety, 
usability, and many more. Therefore, the present paper deals with the basic requirement and the details of the requisite docu-
ments for the grant of test license for the aforementioned purposes. It also aims to address the challenges so as to reduce the 
time-lapsed, effort, and financial burden to the applicant. 

Keywords—Medical device, In vitro diagnostics, Test license, Medical device rules, Testing, Evaluation.    

Copyright © 2025. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY): Creative Commons - 
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owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduc-
tion is permitted which does not comply with these terms.

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Kumar, Gupta, Batra, Sahu and Markan: Catchment of the Test License for the Regulation of Medical Devices in India

J Global Clinical Engineering Vol.7 Issue 3: 2025 48

INTRODUCTION 

The medical device sector in India is the fourth largest 
medical devices (MD) market in Asia after Japan, China, 
and South Korea, and is among the top twenty globally 
because of its growth potential driven by the country’s 
increasing healthcare demands, technological advance-
ment, innovations, and government support through 
various initiatives or incentive opportunities.1 As MD have 
a significant potential for hazards, it should be ensured 
that they are safe and effective before being marketed. 
Thus, Govt. of India (GOI), Ministry of Health and Family 
Welfare’s Central Drugs Standard Control Organization 
(CDSCO) headed by the Drug Controller General of India 
(DCGI), who is the central licensing authority (CLA), has 
notified Medical Devices Rules (MDR), 2017, vide GSR 
78(E), dated 31st January 2017, effective from 1st January, 
2018, and its amendment came into effect as Medical De-
vices (Amendment) Rules, 2020 vide GSR 777(E) dated 
14th October, 2022, effective from 14th October, 2022, to 
have specific requirements for MD that have been framed 
in conformity with the Global Harmonization Task Force 
(GHTF) framework in order to align with the best inter-
national practices wherein the requirements for import, 
manufacture, clinical investigation/performance, sale 
and distribution of MD including in vitro diagnostics 
(IVD) have been prescribed.2 As India recently joined the 
International Medical Device Regulators Forum (IMDRF) 
on 3rd October, 2024, as an affiliate member to accelerate 
global collaboration, harmonization, and convergence in 
medical device regulations, the importance of test license 
significantly helps to protect public health.3 

At present, 38 categories of MD have been notified and 
regulated; the current regulatory practices in India are 
fully geared to meet the requirements to introduce in the 
country.4 The present study provides a critical explanation 
and significance of the regulatory framework’s initiation, 
that is, commencement of test license governing MD, aim-
ing to annotate how such pivotal approvals have shaped 
the current regulatory landscape and influenced the MD 
industry in India. It is mandatory that, an applicant shall 
apply for test license for manufacturing or importing a 
small quantity of MD/IVD (in case of both availability and 
unavailability of predicate device in India) to manufacture/
import three consecutive test batches accompanied with 

a fee, as specified in the second schedule of MDR-2017 
having a validity of three years. A predicate device is an 
approved MD (manufacture/import) that may be legally 
marketed in the country of origin or globally and used as 
a point of comparison for new IVD/investigational MD 
seeking approval through CDSCO. An applicant can choose 
the right predicate device that is similar/ subsequent 
equivalence to the subject device with regard to indica-
tions for use (disease treatment/screening/diagnosis/
management), material of construction (MoC), design 
and technological characteristics/underlying principle, 
and types of specimen. Any remarkable change in the 
said features that does not come under the predicate 
device are supposed to be investigational MD/new IVD. 
Moreover, if no such predicate device is available in India 
against the proposed device, meaning that it comes under 
the scope of investigational MD or new IVD, the applicant 
must also initiate the regulatory approval by applying for 
test license.

INITIATION OF TEST LICENSE

A test license is required to ensure that MD/IVD is 
safe, effective, and meets quality standards before they 
are sold or used. Test license is a type of approval from 
CLA that allows an applicant (person/firm/organization/
startup/innovator/institute/sole proprietor/limited li-
ability partnership/others) as manufacturer or importer 
for all risk-based classification to make or import a test 
device or IVD in a small quantity (Figures 1a and 1b) on 
the digital platform—a government initiative of National 
Single Window System (NSWS) for any of the following 
conditions in Form MD-12 (for manufacture) or Form 
MD-16 (for import).5

• Proof of concept is validated with working prototype, 
and the design is finalized.

• MD/IVD should be already approved (either manu-
facture/imported) in India.

• Investigational MD/new IVD in case no such approved 
devices are available in India.

• For all risk-based classification of MD/IVD (except 
risk-based class A—non sterile and non measuring).



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Kumar, Gupta, Batra, Sahu and Markan: Catchment of the Test License for the Regulation of Medical Devices in India

• Before conducting any preclinical/clinical studies, 
it is mandatory to obtain the approval for test license. 
All data obtained prior to granting of test license is not 
considered for regulatory approval of MD/IVD. 

The specific process for obtaining a test license for 
the proposed MD/IVD in India involves several steps, as 
outlined in Figure 1c (for manufacture in Form MD-12) 
and Figure 1d (for import in Form MD-16).

PURPOSE OF TEST LICENSE

Test license is granted (Form MD-13) in order to 
manufacture and import small quantities of MD or IVD 
(either earlier approved/investigational medical device/
new IVD) for any of the following purposes at a time: 
testing, evaluation, clinical investigation, examination, 
demonstration, and training. The purpose of applying for 
the test license should be very specific in nature, as only 
one option of purpose is available while filling the Form 
MD-12 on the NSWS portal. In addition, when a particular 
purpose of applying the test license is changed, a fresh 
application must be submitted. A brief illustration of a 
specific purpose for the grant of test license is given below.

Demonstration

The proposed device (either earlier approved/inves-
tigational/new) is manufactured or imported for the 
purpose of showcasing the said device at a national or 
international platform/forum.

Training

The proposed device (either earlier approved/inves-
tigational/new) is manufactured or imported for the 
purpose of training for process/method or learning any 
skills on the said device.

Examination

The proposed device (either earlier approved/inves-
tigational/new) is manufactured or imported for the 
purpose of conducting an examination to understand the 
technology, familiarity, or proficiency on the said device.

FIGURE 1. (A) An overview to apply for a test license for the 
manufacture or import of MD/IVD. (B) A process flow to grant 
a test license. Serial numbers 1 to 4 indicate the prerequisites 
to apply for test license, and serial numbers 5 to 9 mention 
the respective steps to grant approval for test license. (C) The 
process of obtaining manufacture test license (Form MD-12) in 
India. (D) The process of obtaining import test license (Form 
MD-16) in India.



Kumar, Gupta, Batra, Sahu and Markan: Catchment of the Test License for the Regulation of Medical Devices in India

J Global Clinical Engineering Vol.7 Issue 3: 2025 50

the validity of the finding). Analytical performance of an 
IVD is the ability to measure or detect a specific analyte 
accurately and reliably. These studies demonstrate the 
analytical performance of an IVD that includes device 
specification, accuracy, precision, linearity, detection limit, 
quantitation limit, cross reactivity, specificity, sensitivity, 
either qualitative or quantitative, and range. However, clini-
cal performance is the output of a device to yield results 
that are correlated with a particular clinical condition 
based on sample size, diagnostic sensitivity, diagnostic 
accuracy, diagnostic specificity, PPV, NPV, likelihood ratio, 
and expected values in normal and affected populations.8 
Performance Evaluation Reports (PER), which are es-
sential technical documents for the regulatory approval 
of the subject IVD, include clinical performance reports 
as a key component. 

Clinical Investigation/Clinical Performance Evaluation

Clinical trials using MD are referred as clinical in-
vestigations. The purpose of a clinical investigation is 
to answer important scientific questions. It must follow 
strict scientific standards (ISO-International Organization 
for Standardization 14155:2020—clinical investigation 
of MD for human subjects), which can protect patients 
and produce reliable scientific outcomes. One of the 
purposes of a clinical investigation could be to establish 
and verify clinical safety, meaning to understand how 

Testing

In general, medical device testing is the process of 
demonstrating that the device will reliably perform safely 
in use. It is used if the proposed device (either approved/
investigational/new) is manufactured or imported for the 
purpose of assessing various quality aspects of a device, 
such as its design verification and validation, material test-
ing, mechanical test, reliability test, functionality, durabil-
ity, sterility, stability, biocompatibility (ISO-International 
Organization for Standardization 10993 standard for 
evaluating the biocompatibility of MD), electrical safety 
and usability, ex vivo (animal performance study), and 
software verification and validation (for any software 
components). 

Evaluation/Performance Evaluation

Predominantly, it is the theoretical assessment of evalu-
ating the safety, effectiveness, and performance of MD that 
should start even before the product is marketed. If the 
proposed device (whether approved, investigational, or 
new) is manufactured or imported for the said purpose 
that include physical (mechanical, electrical), analytical 
(sensitivity, specificity, toxicity, stability, linearity, limit of 
detection, positive predictive value-PPV, negative predic-
tive value-NPV), biological (biocompatibility) and other 
parameters (sometimes, clinical samples/left over samples 
are also used) assessment to evaluate its functions as 
intended use and doesn’t provide any faulty information. 

Particularly, performance evaluation is carried out 
specifically for IVD, irrespective of either new or earlier 
approved devices at CDSCO designated lab under sub-
rule (1) of rule 19 of MDR-2017/ National Accreditation 
Board for Testing and Calibration Laboratories (NABL) 
accredited lab/Govt. Lab/In-house lab (in case of unavail-
ability of these labs with prior approval from CDSCO).6 It 
mainly covers three major parameters, namely, scientific 
validity, analytical performance, and clinical performance 
(Figure 2).7 Scientific validity covers the degree to which 
a study or test accurately measures what it is intended 
to measure in a broader population. It is achieved by 
defining research objectives (to accomplish), choosing 
appropriate methods (to collect and analyze data), using 
rigorous methods (to apply strict techniques to ensure the 
data are accurate), and evaluating the results (to assess 

FIGURE 2.  Performance evaluation of the IVD with three major 
parameters.



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Kumar, Gupta, Batra, Sahu and Markan: Catchment of the Test License for the Regulation of Medical Devices in India

to prevent and reduce risks, errors, and harm that may 
happen to patients/end users. Furthermore, the purpose 
of a clinical investigation is to establish and verify the 
performance of a device in human subjects. Broadly, it 
focuses on good clinical practice (GCP) for the design, 
conduct, recording, and reporting of the adverse events 
of clinical investigations carried out on human subjects 
to assess the clinical effectiveness and safety of MD as per 
the seventh schedule of MDR-2017. This means check-
ing the ability (or capability) of a device to perform as 
per intended use until the specified period/duration. It 
needs to be verified whether it enables the manufacturer 
to achieve the intended purpose of the device leading to 
clinical benefits for patients.9 

Moreover, evaluation of clinical performance is the 
systematic study that can be used to diagnose and treat 
diseases in vitro. Broadly speaking, it is the assessment of 
an IVD using a specimen taken from humans to evaluate 
its performance when used as intended by the manu-
facturer. IVDs are designed to extract information from 
human samples, such as blood, tissues, and biological 
fluids that can allow for drawing of conclusions, such as 
physiological or pathological changes in the body. Clinical 
performance evaluations may include: 

• Testing for sensitivity, specificity, accuracy, precision, 
and clinical validity.

• Using clinical performance evaluation plan in human 
specimens.

• Analyzing and summarizing clinical data.

• Demonstrating scientific validity.

• Demonstrating analytical performance.

For applying for a test license (manufacturer) for clini-
cal investigation of MD, a copy of the grant of permission 
is to be provided (in Form MD-23, whether it is for pilot/
pivotal/post-marketing clinical study). Conditional approval 
of test license may be granted in absentia of Form MD-23. 
However, for permission to conduct clinical investigation 
for an earlier approved medical device, valid approval 
from the ethics committee is required (Table 1). 

On the other hand, for applying for a test license 
(manufacturer) for the evaluation of the clinical perfor-
mance of a new IVD, a copy of the grant of permission is 
required (in Form MD-25). Conditional approval of test 
license may be granted in absentia of Form MD-25 with 
prior submission of the clinical investigation plan and 
approval from the institutional ethics committee (IEC).

However, for permission to conduct evaluation of clinical 
performance of an earlier approved IVD, valid approval 
from the ethics committee is required (Table 2). In addi-
tion, if a certain medical device/IVD is imported for the 
purpose of clinical investigation/clinical performance 
evaluation from the USA, Britain, the United Kingdom, 
Japan, the European Union, Australia, and Canada (with a 
condition that the product has already been marketed for 
at least 2 years in these territories, and the CLA is satisfied 
with the data of safety, performance, and pharmacovigi-
lance of the said device), the requirement to apply for 
test license to conduct clinical investigation/evaluation 
of clinical performance is waived off. However, if medical 
device/IVD is approved and marketed in places other than 
these territories, proof of grant of permission to conduct 
clinical investigation/evaluation of clinical performance 
(Form MD-23/ Form MD-25) is required in accordance 
with the test license (Table 1). 

CONSEQUENT ATTRIBUTES AFTER TEST LICENSE

Once test license has been granted for any of the 
aforesaid purposes, the applicant may prepare/import at 
least three test batches of the said device in statistically 
significant quantities at the manufacturing site (in-house) 
to generate quality control (QC) data that comply with 
the essential principles of safety and performance of 
the proposed device. In addition, these data should also 
be generated at the testing site that may be comparable 
enough with the in-house data. However, in the case of 
manufacture/import of IVD, PER that would be generated 
at designated labs (specific for a particular IVD) should 
be compared with the in-house data generated. These 
data are further used in the next regulatory application 
in order to get the final approval of the device/IVD for 
sale and distribution in the market.



Kumar, Gupta, Batra, Sahu and Markan: Catchment of the Test License for the Regulation of Medical Devices in India

J Global Clinical Engineering Vol.7 Issue 3: 2025 52

Moreover, it has been noticed that at the time of applying 
for the test license, it is not mandatory that the manufac-
turing site should comply with the quality management 
system (QMS) as per the fifth schedule of MDR-2017 and 
the subject device should adhere with applicable Bureau 
of Indian Standards (BIS)/ISO/International Electrotech-
nical Commission (IEC)/pharmacopeial standards). But, 
while applying for the commercial manufacturing license, 
the manufacturing facility must comply with QMS or have 
ISO 13485, which may be audited later by the concern 
notified body (in the case of risk-based class of A and B 
by the state licensing authority) or by a medical device 
officer (in the case of risk-based class of C and D by the 
CLA), and the proposed device must follow the respec-
tive standards. 

All the data obtained prior to granting of the test license 
is not to be considered for regulatory approval of medical 
device/IVD (Figures 3 and 4). In this regard, it is advisable 
that the innovator may refer to the regulatory pathway 
for MD/IVD given on the CDSCO website.10

DOCUMENT UNDERLYING FOR APPLYING THE 
TEST LICENSE

There are a certain set of documents for applying 
for test license against the proposed device/IVD as per 
Form MDR-2017.2 A brief overview of each document is 
herewith discussed and summarized in Table 2.

1. Covering letter mentioning the objective of the test 
license specifically details the purpose, intended use, 
justification of quantity, and regulatory status (i.e., avail-
ability of predicate device in India and approval status in 
other countries), and detail of manufacturing and testing/
evaluation site.

2. Brief description of applied MD/IVD including in-
tended use, material of construction (MoC, design, label, 
specimen used for testing (human/animal), type of speci-
men (blood, serum, plasma, etc.). If a predicate device is 
available, the applicant needs to submit the substantial 
equivalence evaluation along with relevant published lit-
erature, that is, comparative analysis to prove substantial 
equivalence to the predicate device(s) as claimed with 
respect to intended use, MoC, design characteristics, 
mechanism, principal of operation, etc.

TABLE 1. Requirement for the application of test license with the purpose of clinical investigation/evaluation of clinical 
performance. 

Objective Test License for MD/IVD

Manufacture
Investigational MD/new IVD Proof of grant of permission to conduct clinical investigation/evaluation of 

clinical performance (Form MD-23 for MD), (Form MD-25 for IVD).

Earlier approved in India Ethics committee (EC) approval

Import

Investigational MD/new IVD in 
the country of origin

• Waive off if:
• Medical device imported from the United States, Britain, the United Kingdom, 
Japan, the European Union, Australia, and Canada.
• Already marketed for at least 2 years in these territories.
• CLA is satisfied with the data of safety, performance, and pharmacovigilance of 
the said device*,2

However, if medical device/IVD is approved and marketed in places other than 
these countries, proof of grant of permission to conduct clinical investigation/
evaluation of clinical performance (Form MD-23 for MD), (Form MD-25 for 
IVD) is required.

Earlier approved in the country 
of origin

MD: Medical device, IVD: In vitro diagnostics. *Subject to approval from the CLA. 



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FIGURE 3.  Road map to apply test license (Form MD-12) for MD with the purpose of testing.

FIGURE 4.  Road map to apply test license (Form MD-12) for IVD with the purpose of evaluation/performance evaluation.



Kumar, Gupta, Batra, Sahu and Markan: Catchment of the Test License for the Regulation of Medical Devices in India

J Global Clinical Engineering Vol.7 Issue 3: 2025 54

3. Undertaking stating that the required facilities 
including equipment, instruments, and personnel have 
been provided to manufacture such MD/IVD on the let-
terhead with a stamp and signed. However, in the case 
of import of MD/IVD in small quantities, 2 undertakings 
are required, namely:

• An undertaking stating that the MD/IVD proposed 
to be imported is to be used exclusively for the specified 
purpose and not for commercial purpose.

• An undertaking stating that required facilities including 
equipment, instrument, and personnel will be provided 
to test or evaluate the medical device. 

4. List of equipment, instruments for manufacturing 
and testing/evaluation of applied MD/IVD (not applicable 
for the import of MD/IVD).

5. List of qualified personnel for manufacturing and 
testing of applied MD/IVD in tabular form under whose 
direction and supervision the test batches’ manufacturing 
activity, testing, and evaluation of a medical device shall 
be undertaken (not applicable for the import of MD/IVD)

6. Justification of quantity proposed to be manufactured 
along with its utilization breakup mentioning testing pa-
rameters with quantity required for the applied quantity, 
mentioning both internal and external evaluations (if ap-
plicable). Moreover, the same implies for IVD with quan-
tity required for evaluating at both internal and external 
evaluation sites (if applicable). However, in the case of 
import of MD/IVD in small quantities, the applicant can 
give the proper justification of the quantity proposed to 
be imported with its utilization breakup.

7. Test specification and protocol along with applicable 
standards that provide the testing protocol or any other 
protocol specific to the device/IVD. Approved clinical 
study protocol or approval copy of Form MD-23 or Form 
MD-25 will be required if the selected purpose of applying 
for the test license is for clinical investigation or evalua-
tion of clinical performance. It is also applicable for the 
import of MD/IVD in small quantities.

8. Brief description of the manufacturing and testing 
process and flowchart that includes each process step of 
manufacturing of the subject device/IVD.

9. Copy of the manufacturing license of the premises 
where the development/testing activity is to be carried 
out, under these rules, if any. It is applicable only to ex-
isting manufacturers who have been previously issued a 
license; otherwise, this does not apply. Please upload a 
declaration confirming this.

10. Approval letter authorizing to undertake research 
and development activities issued by a government or-
ganization, if any. Any approval from agencies funding 
research internally or externally

11. Other documents, if any. It may include publication/
research paper in support of intended claims, design, 
principal of operation, MoC, etc.

12. Fee challan that will be paid online via the Bharat 
Kosh portal (https://bharatkosh.gov.in/) directed through 
the NSWS portal. The fee amount is subjective and is 
calculated automatically by the system based on the 
device applied (as per second schedule of MDR-2017). 
It is advisable not to pay the respective amount directly 
through the Bharat Kosh portal.

13. Legal form. It is a system-generated filled form of 
MD-12 application that should be submitted after being 
digitally signed with the digital signature certificate (DSC) 
of an authorized signatory.

In addition, the following documents are used exclu-
sively for the import of MD/IVD in small quantities:

• Quality certificates like QMS, etc., of the manufacturer, 
if any. Manufacturing site should comply with QMS as per 
the fifth schedule of MDR-2017 or ISO 13485.

• Labels and instructions for use (IFU), as per Rule 
44 of MDR-2017. Labelling of MD needs particulars such 
as name of the medical device; the details necessary for 
the user to identify the device and its use; the name of 
the manufacturer and the address of the manufacturing 
premises; the correct statement about the net quantity 
in terms of weight, measure, volume, number of units, 
as the case may be; and the number of the devices con-
tained in the package expressed in the metric system; 
the month and year of manufacture and expiry (the label 
may indicate the product's shelf life. For sterile devices 
composed of stable materials such as stainless steel or 



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titanium, and supplied non-sterile, the date of steriliza-
tion may be treated as the manufacturing date. In the 
case of medical equipment, instruments, or apparatus, 
it may not be necessary to specify an expiry date) on the 
shelf pack of the MD or on the outer cover of the MD that 
shall be printed in indelible ink on the label, whereas the 
intended use of a medical device is clearly communicated 
in the IFU. The IFU (or electronic IFU) is a set of instruc-
tions that are legally required for MD to be sold and are 
intended to ensure the safe and effective use of the device. 
It should include: 

• Intended use: The specific intended use of the device.

• Precautions: Any precautions or warnings that should 
be considered while using the device.

• Preparation: How to prepare the device for use, such 
as sterilization, assembly, or calibration.

• Disposal: How to dispose of the device.

• Other information: The name of the device, manu-
facturer’s address, shelf-life, storage requirements, and 
technical specifications.

In cases where certain requisite documents are not 
applicable to a particular device or IVD, the applicant 
must provide a proper justification and upload the same 
on the portal.

EXCLUSION OF THE TEST LICENSE

A test license is not required to apply for all MD in 
India, but it depends on the risk-based class of device, 
usability, and the purpose in certain conditions as follows: 

Manufacture/Import of Class A Nonsterile and 
Nonmeasuring device

Consequent to the implementation of the notification 
G.S.R. 102 (E) dated 11th Feb, 2020, all MD are under the 
licensing regime (except for class A—non-sterile and 
non-measuring MD), and license is required for the im-
port/manufacture of MD in the country.11 These devices 
such as scalpels, scissors, walking sticks, eyeglasses, and 
wheelchairs do not require a license, but they do need 
to be registered on “online system for medical devices” 

established by CDSCO for this purpose.12 The registration 
number obtained shall not be considered as a regulatory 
approval for the manufacture/import of devices.

Import of MD/IVD from the Founding Member 
Countries of the GHTF

Clinical investigation will be waived off for the subject 
device if it is imported from the United States, Britain, the 
United Kingdom, Japan, the European Union, Australia, and 
Canada and remains marketed for at least 2 years in these 
territories (Table 1). In addition, the CLA is satisfied with 
the data of safety, performance and pharmacovigilance 
of the said device as per rule 63 of MDR-2017.2 However, 
it is subject to approval from the CDSCO on a case basis.

Imported for Personal Use

Test license is not required for the import of small 
quantities of MD/IVD for personal use (by a person or by 
a government hospital or statutory medical institution for 
the treatment of a patient), which is otherwise prohibited 
under Section 10 of the Act. MD/IVD may be imported for 
personal use subject to prior approval in Form MD-20 as 
per rule 43 of MDR-2017 accompanied by requisite docu-
ments and the fee as specified in the second schedule of 
MDR-2017 on the cited portal.12 On the other hand, small 
quantities of an investigational medical device, the import 
of which is not allowed, but approved in the country of 
origin, may be allowed to be imported by the CLA for the 
treatment of a patient suffering from a life-threatening 
disease, or disease causing serious permanent disability, 
or disease requiring therapy for an unmet medical need, 
on an application made by a medical officer through the 
medical superintendent of a government hospital or a 
statutory medical institution in Form MD-18 as per rule 
42 of MDR-2017 accompanied by requisite documents 
required and the fee as specified in the second schedule 
of MDR-2017 on the cited portal for this purpose.12

Manufacturing of Custom-Made Device

MD that are made specifically in accordance with a 
written prescription of a registered medical practitioner, 
specialized in the relevant area, under his/her responsibility 
in accordance with a specific design, characteristics, and 



Kumar, Gupta, Batra, Sahu and Markan: Catchment of the Test License for the Regulation of Medical Devices in India

J Global Clinical Engineering Vol.7 Issue 3: 2025 56

• Role in regulatory compliance: Obtaining test license 
is an important step which helps in ensuring adherence 
with the existing regulatory framework so that it can be 
of help to protect public health. It also ensures that prod-
ucts that are manufactured/imported in small quantities 
after obtaining test license shall be used only for specified 
purposes and not for commercial purposes. 

• Safety measures: Test license granted against manufac-
turing/importing the MD/IVD for the purpose of testing/
evaluation ensures that testing/evaluation carried out 
with respect to applicable gold standards will establish 
that the products are safe and effective for human use.

• Commercial manufacturing preparedness: The grant 
of a test license is the preliminary step for the prepared-
ness of commercial manufacturing license for sale and 
distribution of MD/IVD in the Indian market, as it helps 
to prevent the marketing of unsafe or ineffective devices. 
Usually, it is applied for once the working prototype is 
ready, and its design is finalized in the case of investiga-
tional MD/new IVD.

• Build trust: The end user can build trust in the com-
pany’s various products of MD/IVD for which the license 
has been granted.

• Adverse event surveillance: Test license encompasses 
the compliance of regulatory approval, identification of 
all quality-related issues, investigation of the root cause, 
and implementation of necessary legal actions in case 
of adverse events reported (if any) of the subject device. 
This ensures that such problems do not arise again and 
develops the confidence of users on device potentially, 
safety, and effectiveness of use in humans.

KEY CHALLENGES AND SUGGESTIONS FOR 
AMELIORATION 

Test license permits the manufacturer/importer to 
make/import a limited quantity of MD/IVD falling within 
class A (except non-sterile and non-measuring)/B/C/D 
for any of the aforesaid purposes before being put into 
commercial use. There are certain challenges with regard 
to applying the test license and possible suggestions, 
which are summarized below.

the same is intended for the sole use of a particular patient, 
and the label mentions “for the sole use of a particular 
patient,” and does not include the mass production of such 
a device. All provisions of chapter IV (manufacture of MD 
for sale or for distribution and chapter V (Import of MD) 
are exempted as per the eighth schedule of MDR-2017.

WITHDRAWAL, REJECTION, AND CANCELLATION 
OF TEST LICENSE

Once the test license application is submitted success-
fully, there is no option to withdraw/amend the submitted 
test license application on the NSWS portal. However, 
an applicant can request the CLA for cancellation with 
a proper justification for the same. In addition, after 
obtaining the test license in Form MD-13, if an applicant 
fails to comply with relevant provisions of the MDR-2017 
against the proposed device/IVD, the CLA may issue a 
show cause notice for cancellation giving an opportunity 
to explain in writing the licensee’s defense against an or-
der for cancellation. The licensee has the right to appeal 
to the central government within 45 days from the date 
of cancellation of the order.2 

The CLA may reject the grant of a test license in Form 
MD-17, and the reasons, such as the requirements of 
these rules are not satisfied by the applicant, are to be 
recorded in writing within a period of thirty days from 
the date of the application under sub-rule (2) of rule 40 
of MDR-2017.2 

SIGNIFICANCE OF TEST LICENSE

The importance of test license significantly implies a 
quality of MD/IVD that should make it worthy of global 
acceptance. Within a functioning healthcare system, 
initiating the regulatory application process—beginning 
with the issuance of a test license—is a crucial first step 
for any subject device intended for widespread use in 
the prevention, diagnosis, treatment, monitoring, and 
rehabilitation of a broad range of diseases and medical 
conditions. In addition, it can also be used to monitor vital 
signs, deliver medications, remove biological waste, and 
support or replace damaged body parts. The important 
aspects of test license are herewith outlined below: 



57 J Global Clinical Engineering Vol.7 Issue 3: 2025

Kumar, Gupta, Batra, Sahu and Markan: Catchment of the Test License for the Regulation of Medical Devices in India

Extended application review period

In general, 30 working days are allocated to review the 
application and grant approval. However, long extended 
time has been utilized to review the application because 
of a large volume of applications or insufficient informa-
tion/incorrect documents submitted by the applicants.

POSSIBLE SUGGESTIONS

Inconsistent Testing Standards 

There may be inconsistencies in how different laborato-
ries apply the standards, leading to variability in testing/
performance outcomes. There is no harmonization of the 
analytical parameter, which is established to conduct the 
performance evaluation of the subject IVD that varies 
across designated labs. Aligning the harmonized results 
with MDR-2017 is critical for approval.

Emergence of New Technologies:

Emergence of new technologies for health solutions 
require new risk-based classification under either software 
integrated medical device (SiMD) or software as medical 
device (SaMD) for addressing efficacy/intended use in 
ways that are not previously covered.

An Awareness-Strengthening Regulation

Since, there is an overall trend to cover all MD/IVD 
under the license regime, it is primarily recommended as 
safety concern grows, to be aware about increased regu-
lation over previously non-notified category of MD/IVD.

CONCLUSION

MedTech industry is not just a component of health-
care but is the catalyst that links patients, payors, service 
providers, and regulators to create a stronger and more 
equitable system in a fast-paced environment globally. 
In this regard, MD/IVD is the unique positioning of the 
MedTech sector that holds the promise of revolutionizing 
healthcare delivery and outcomes, both in India and glob-
ally. The wide spectrum MD/IVD, from simple technologies 
to complex high-throughput systems, presents varying 
degrees of risk that may directly influence patient health 

Challenges Faced

The dynamic and complexity of regulatory compliance: 

With ongoing amendments and regular updates to 
MDR-2017 in India, usually the applicants often face the 
following challenges in fully understanding the nuances 
related to device/IVD:

• Class of MD/IVD: Correct identification of a risk-based 
class of the device.

• Laboratory for conducting performance evaluation: 
Availability and identification of CDSCO designated labs 
under sub-rule (1) of rule 19 of MDR-2017 for IVD.

• Identification of predicate device: It is essential for 
confirmation that it either falls under investigational MD 
or New IVD or subsequent equivalent of the approved 
device/IVD.

• Understanding of different components/accessories/
consumables: It includes a basic overview of the device 
and its parts, whether or not consumable items are in-
cluded—along with their respective risk-based classification 
and intended use, is not clearly explained in the remarks. 
Justification of quantity to be manufactured/imported for 
different purposes and their breakups utilization.

• Clarity on grouping of MD/IVD; either it falls under 
the category of single, system, group, family, or cluster.

• Identification of test batch manufacturing sites/
testing sites. 

Technical Barriers on the NSWS Portal

The NSWS platform, while designed to simplify regu-
latory processes, can present technical barriers, such as 
slow response times, connectivity issues, or errors in 
uploading required documents along with login creden-
tial requirements of mandatory DSC, which is linked to 
the permanent account number (PAN) of the business 
entity or signatory authority for its validation to submit 
the application as well as approval.



Kumar, Gupta, Batra, Sahu and Markan: Catchment of the Test License for the Regulation of Medical Devices in India

J Global Clinical Engineering Vol.7 Issue 3: 2025 58

CONFLICTS OF INTEREST

We have no conflicts of interest to disclose.

ETHICS APPROVAL AND CONSENT TO PARTICIPATE 

Not applicable.

CONSENT FOR PUBLICATION

Not applicable.

FURTHER DISCLOSURE

Not applicable.

  REFERENCES
1. Press releases, Ministry of Health and Family Welfare, 

Government of India. December 19, 2024. Available online: 
https://mohfw.gov.in/press-info/8078.

2. The medical devices rules, 2017. Available online: https://
cdsco.gov.in/opencms/opencms/system/modules/CDSCO.
WEB/elements/download_file_division.jsp?num_id=OTg4NQ.

3. Press releases, Central Drugs Standard Control Organization 
under Ministry of Health & Family Welfare, India becomes 
affiliate member of the International Medical Device Regu-
lators Forum. October 03, 2024. Available online: https://
pib.gov.in/PressReleasePage.aspx?PRID=2061397.

4. India’s CDSCO extends list of notified devices. January 
13, 2021. Available online: https://asiaactual.com/blog/
indias-cdsco-extends-list-of-notified-devices/.

5. CDSCO Launched National Single Window System (NSWS) 
Portal. January 01, 2024. Available online: https://www.
nsws.gov.in/.

6. Guidance on performance evaluation of in-vitro diagnostic 
medical devices. August 7, 2018. Available online: https://
cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-
documents/medical-device/guidanceperformanceivd.pdf.

7. IVDR performance evaluation (2019–2024). Available online: 
https://www.thinqbetter.com/ivdr-performance-evaluation

8. Clinical performance definition IVDR, Celegence. April 
6, 2022. Available online: https://www.celegence.com/
clinical-performance-ivdr/Jj.

and safety. On the other end, the regulatory compliances 
in accordance of risk-based classification of MD/IVD vary. 
However, test license is an important principal require-
ment to get the necessary approval for manufacture/
import of a small quantity of MD/IVD for the purpose of 
clinical investigation, testing, evaluation, examination, 
demonstration, or training. The process of obtaining test 
license under the MDR-2017 in India via the NSWS portal 
involves navigating complex regulations and ensuring 
compliance with testing standards. The objective of the 
current study is to provide a significant overview of the 
regulatory framework that brings test license approval of 
the MD in India. These approvals facilitate ease of doing 
business, remove regulatory bottlenecks to make in India, 
while ensuring availability of better MD for patient care 
and safety. Conversely, there are certain challenges that 
significantly present opportunities for improvement in 
regulatory frameworks and quality standards, potentially 
leading to a more robust medical device market in India. 
These insights may be relevant when considering the 
broader context of MD/IVD testing and licensing under 
MDR-2017.

AUTHOR CONTRIBUTIONS

Conceptualization and Writing– Review & Editing, 
R.K.; Methodology, D.K.G.; Visualization, J.B.; Resources, 
A.S.; Supervision, S.M.

ACKNOWLEDGMENTS

I greatly acknowledge ICMR for providing the neces-
sary infrastructure, computing resources, study materi-
als, circulars, and documents to prepare the manuscript. 

FUNDING

This study received no funding. 

DATA AVAILABILITY STATEMENT

Not applicable.

https://mohfw.gov.in/press-info/8078
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTg4NQ 
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTg4NQ 
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTg4NQ 
 https://pib.gov.in/PressReleasePage.aspx?PRID=2061397
 https://pib.gov.in/PressReleasePage.aspx?PRID=2061397
 https://asiaactual.com/blog/indias-cdsco-extends-list-of-notified-devices/
 https://asiaactual.com/blog/indias-cdsco-extends-list-of-notified-devices/
https://www.nsws.gov.in/
https://www.nsws.gov.in/
https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/guidanceperformanceivd.pdf 
https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/guidanceperformanceivd.pdf 
https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/guidanceperformanceivd.pdf 
https://www.celegence.com/clinical-performance-ivdr/Jj 
https://www.celegence.com/clinical-performance-ivdr/Jj 


59 J Global Clinical Engineering Vol.7 Issue 3: 2025

Kumar, Gupta, Batra, Sahu and Markan: Catchment of the Test License for the Regulation of Medical Devices in India

9. Clinical investigation and clinical evaluation of medical devices. 
May 10, 2022. Available online: https://medicaldevicehq.
com/articles/clinical-investigation-and-clinical-evaluation/.

10. Regulatory pathway to be followed for the medical device 
from its development to commercialization under medical 
devices rules, 2017. Available online: https://cdsco.gov.
in/opencms/export/sites/CDSCO_WEB/Pdf-documents/
md123.pdf.

11. Ministry of Health and Family Welfare (Department of 
Health and Family Welfare). Notification, G.S.R. 102 (E) 
dated 11th February, 2020. Available online: https://cdsco.
gov.in/opencms/resources/UploadCDSCOWeb/2018/Up-
loadGazette_NotificationsFiles/Gsr102eRegistration%20
of%20certain%20medical%20devices.pdf.

12. Online system for medical devices. Available online: https://
cdscomdonline.gov.in/NewMedDev/Homepage.

https://medicaldevicehq.com/articles/clinical-investigation-and-clinical-evaluation/ 
https://medicaldevicehq.com/articles/clinical-investigation-and-clinical-evaluation/ 
 https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/md123.pdf
 https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/md123.pdf
 https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/md123.pdf
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadGazette_NotificationsFiles/Gsr102eRegistration%20of%20certain%20medical%20devices.pdf
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadGazette_NotificationsFiles/Gsr102eRegistration%20of%20certain%20medical%20devices.pdf
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadGazette_NotificationsFiles/Gsr102eRegistration%20of%20certain%20medical%20devices.pdf
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadGazette_NotificationsFiles/Gsr102eRegistration%20of%20certain%20medical%20devices.pdf
https://cdscomdonline.gov.in/NewMedDev/Homepage
https://cdscomdonline.gov.in/NewMedDev/Homepage

