Chapters IV and V of the MDR 2017 provide detailed guidelines for manufacturers and importers seeking to manufacture or import small quantities of medical devices for specific purposes in India. These licenses enable companies to conduct clinical investigations, testing, evaluation, demonstrations, or training without the need for full manufacturing or import licenses. In this article, we provide an in-depth overview of the test license regulatory process, eligibility requirements, steps involved, necessary documentation, validity, cancellation conditions, and the benefits associated with obtaining a test license.

Any importer or manufacturer aiming to import or manufacture small amounts of medical devices for testing, evaluation, demonstration, or training purposes must obtain a test licence approved by the Central Drugs Standard Control Organization (CDSCO). For commercial purposes, a full import or manufacturing licence is required.

Steps to Apply for Test License:

1. Create an account on the NSWS portal and register.
2. Apply for approval using Form MD-16 for import or Form MD-12 for manufacture.
3. Upload all necessary documents.
4. Pay the prescribed fee.
5. CDSCO will review the application form and issue a test license in Form MD-17 for import or Form MD-13 for manufacture if found satisfactory.

Documents Required:

1. Brief description of the medical device, including intended use, material of construction, and design.
2. Justification of the proposed quantity
3. Test protocol/Approved clinical investigation plan
4. Quality certificates such as QMS
5. Labels and Instructions for Use (IFU)
6. Undertaking stating the use of the medical device for non-commercial purpose.
7. Undertaking from the testing laboratory confirming the provision of required facilities.

Applicable Fees:
1. Test license for manufacture: 500 Rs for each distinct medical device
2. Test license for import: 100USD for each distinct medical device

Validity: The test license remains valid for 3 years from the date of issue.

Cancellation of Test License: If a licensee contravenes any provisions of the rules, the Central Licensing Authority may issue a show cause notice for cancellation. The licensee has the right to appeal to the Central Government within forty-five days from the date of the cancellation order.

Benefits:
1. Facilitates innovation while ensuring compliance with regulatory standards
2. Allows companies to do product testing/ clinical investigation prior to market introduction.
3. Provides opportunity for companies to conduct internal trainings prior to full-scale commercial launch.

Obtaining a test license for medical devices in India is essential for companies engaging in testing, evaluation, demonstration, or training activities. By adhering to regulatory standards and obtaining expert guidance, companies can navigate the licensing process effectively and contribute to advancing healthcare innovation in India.

Regulatory Solutions India (RSI) provides comprehensive regulatory consulting services to assist companies in obtaining test license for medical devices in India. With expertise in eligibility criteria, documentation preparation, submission, and compliance with regulatory requirements, RSI can streamline the licensing process, mitigate risks, and accelerate market entry of your medical device in India.

Contact us for all regulatory needs.

Test License For Manufacturing:

Test License For Import: