PROCEDURE FOR TEST LICENCE TO MANUFACTURE MEDICAL DEVICES FOR TEST, EVALUATION, CLINICAL INVESTIGATIONS, DEMONSTRATION OR TRAINING

Aryan Panwar

Aryan Panwar

Published on: Apr 23, 2026

Shatakshi Sharma

Updated on: Apr 23, 2026

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17

Introduction

A Test License is an official authorisation issued by the Central Drugs Standard Control Organisation (CDSCO) that permits manufacturers or importers to produce or import small quantities of medical devices strictly for purposes of testing, evaluation, clinical investigation, demonstration, or training, and not for commercial sale.

APPLICABLE PROVISIONS

Rules 31, 32 and 33 of Medical Devices Rules, 2017.

Documents Required

1. Covering Letter mentioning the objective of the test license
2. Brief description of the applied medical device
3. Undertaking stating that the required facilities, including equipment, instruments, and personnel, have been provided to manufacture such medical devices.
4. List of equipment, instruments for manufacturing and testing of applied medical devices
5. List of qualified personnel for manufacturing and testing of applied medical devices
6. Justification of the quantity proposed to be manufactured, along with its utilisation breakup
7. Test specification and protocol along with applicable standards
8. Brief description of the manufacturing and testing process and flowchart
9. Copy of the manufacturing license of the premises where the development/testing activity is to be carried out, under these rules, if any
10. Approval letter authorizing to undertake research and development activities issued by any government organisation, if any
11. Other documents, if any,
12. Fee Chalan
13. Legal Form

Process for License

1. Applicant shall submit Form MD-12 along with the prescribed fees given below and the required documents to obtain a Test License to manufacture medical devices for test, evaluation, clinical investigations, demonstration or training via SUGAM Portal.
2. CDSCO will review the application and verify the documents by evaluating their authenticity and completeness while additionally checking for eligibility. Once all the criteria are satisfied, the authority shall grant a license under MD-17.

License Validity

The License shall remain valid for a duration of three (3) years starting from the date it is issued by the regulatory authority. Provided that the license can be cancelled, if there is any breach of regulatory rules.