Procedure for Import Licence for Test, Evaluation, Demonstration, or Training

Aryan Panwar

Aryan Panwar

Published on: Apr 23, 2026

Shatakshi Sharma

Updated on: Apr 23, 2026

★★★★★(1 Rating)

11

Introduction

An Import License for Medical Devices is an important regulatory document, as it acts as a formal permission to bring foreign medical products into the country. This license is required to legally bring medical devices, instruments, and in-vitro diagnostics from overseas into the country.

APPLICABLE PROVISIONS

Rules 40 and 41 of Medical Devices Rules, 2017.

Documents Required

1. Covering Letter mentioning the objective of test license
2. Brief description of applied medical device
3. Justification of quantity proposed to be imported along with its utilization break-up
4. Test specification and protocol along with applicable standards
5. Quality certificates like QMS etc., of the manufacturer, if any
6. Labels and IFU, as per Rule 48
7. Other document, if any
8. An undertaking stating that the medical device proposed to be imported to be used exclusively forpurpose specified at serial number 7 of Form-16 and shall not be used for commercial purpose.
9. An undertaking stating that required facilities including equipment, instruments, and personnel will be provided to test or evaluate medical devices.
10. Fee Challan
11. Legal Form

Process for License

1. Applicant shall submit Form MD-16 along with the prescribed fees given below and the required documents to obtain an import licence for test, evaluation, demonstration, or training via the 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 license under MD-13.

Licence 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.