Manufacture License for (Class A and B) Medical Devices
Relevant Guideline: Medical Devices Rules, 2017.
Documents requirements:
- Cover letter
- Location ownership/ agreement/ tenancy, details of constitution of the firm
- Test license
- Device Master File
- Site Master File
- Quality Management System Documents
Time line: 3 to 5 months
Fees: 5000 INR
Validity of License: A license obtained by approval as FORM MD-5 is valid permanently, as long as the license retention fee is paid timely, before completion of five years from the date of issuing by the State Licensing Authority as per the Second Schedule. However, a License can be suspended or cancelled by the State Licensing Authority based on competent reasons at any point of time.