In India, medical device registration, as governed by the Medical Devices Rules (MDR), 2017 under the Central Drugs Standard Control Organization (CDSCO), results in the issuance of licenses that are valid for 5 years from the date of issuance. This applies to:
- Manufacturing Licenses:
- Form MD-5: For Class A and B devices (low and low-moderate risk), issued by State Licensing Authorities.
- Form MD-9: For Class C and D devices (moderate-high and high risk), issued by CDSCO.
- Import Licenses:
- Form MD-15: For all classes of imported devices, issued by CDSCO.
Renewal Process
- Licenses must be renewed at least 90 days before expiry through the SUGAM portal (www.cdscoonline.gov.in).
- Renewal requires submission of updated documentation, compliance with ISO 13485 (for Class C/D), and payment of applicable fees.
- Failure to renew on time may result in the need for a new application.
Additional Notes
- Non-Notified Devices: Under the Voluntary Registration Scheme, registration certificates are valid until the device is officially notified or for a specified period (e.g., 3 years), after which mandatory licensing applies.
- Post-Market Compliance: During the validity period, manufacturers and importers must comply with post-market surveillance, adverse event reporting, and CDSCO inspections.
For expert assistance with renewals or registration, contact Satish Mehra in Delhi at +91-8920964801 (WhatsApp or call).