India

Ministry of Health: 

Ministry of Health and Family Welfare

Regulatory Authority:       

Central Drugs Standard Control Organisation (CDSCO)

Medical Device Regulation:

Medical Device Rule, 2017

Official Language:   

Hindi and English

Classification:        

Class A, B, C and D

Registration Process:       

• There are 2 types – Central Licensing Authority (CLA) and State Licensing Authority (SLA)
• For Indian Manufacturers – They first need to obtain Manufacturer License (Form MD-03 or MD-07), followed by Product Registration as per Form 40 for notified medical devices
• For Foreign Manufacturers – They need to apply for Registration Certificate & Import License
• All applications are filed online via the SUGAM portal
• Determine the device classification.
• Appoint Indian Authorized Agent
• Prepare all company documents and Registration Dossier
• Submit the dossier under Form 40 to the Drugs Controller General of India (DCGI) along with fees.
• DCGI reviews the application and sends back an inquiry letter. They may request for a technical presentation of the product.
• Once Registration Certificate approval is obtained, apply for Import License
• The manufacturer/Importer may start marketing the device once both the Registration Certificate and Import License in obtained.