Procedure to obtain a medical device manufacturing license

Obtaining a medical device manufacturing license in India typically entails the following steps:

Step 1: Submit the application online at cdscomdonline.gov.in using the form MD-3 (or MD-4 for loan license) for a license to be issued on the form MD-5, or as applicable as per the Medical Device Rules.

Upload necessary documents including covering letter, fees challan receipt, the constitution of the firm, documents of site ownership or tenancy agreement, plant master file, device master file for each product, performance evaluation report (if applicable), copy of test license (if applicable), and undertaking that the manufacturing site is in compliance with the provisions of the Fifth Schedule.

Step 2: Application scrutiny and query raised if any discrepancy is noted. Further action is taken upon receipt of the reply to the query from the applicant.

Step 3: Audit of applicant premises by a notified body.

Step 4: Upon receipt of the audit report, it is examined and if found satisfactory, it will be forwarded for the next step.

Step 5: Scrutiny of the details of the products applied to ensure compliance with norms.

Step 6: If all the prescribed conditions are complied with, the manufacturing license is granted.