Medical Device Registration in
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
Medical Device Registration in India:
- 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.
Documents Required:
- Form 40
- TR6 Challan
- Power of Attorney
- Schedule D
- ISO 13485 certificate
- CE Design certificate or Declaration of Conformity
- Free Sales Certificate
- Certificate of Marketability from GHTF countries
- Other Regulatory Approvals
- PMS report
- Plant Master File
- Device Master File
Post-market surveillance:
Unexpected serious adverse event – 15 days
Legalized/Notarised Documents (if any)
Free Sales Certificate
Applicable QMS:
ISO 13485
Registration Timeline:
9 – 12 months
Authorized Representative:
Yes. Indian Authorized Agent
License Validity:
Does not expire, unless the license retention fees is paid
Special Notes:
Renewal processes to be initiated 9 months in advance