Medical Device Registration Gujarat
Medical Device Registration issued under the Medical Devices Rules, 2017 (MDR 2017) by the Central Drugs Standard Control Organization (CDSCO) and State Licensing Authority (Gujarat Food and Drugs Control Administration - FDCA), Ministry of Health and Family Welfare, Government of India, legally authorizes businesses to manufacture, import, distribute, and sell medical devices across India.
- Mandatory Compliance under Medical Devices Rules, 2017 (MDR 2017)
- Risk-Based Four Tier System: Class A (Low), B (Low-Mod), C (Mod-High), D (High)
- SUGAM Online Portal Application Filing & Indian Authorized Agent (IAA) Setup
- Requires ISO 13485:2016 QMS Implementation & Device Master File (DMF)
- Valid Nationally with 5-Year Registration Validity & Periodic Retention Fees
What is Medical Device Registration in Gujarat?
Under the Drugs and Cosmetics Act, 1940 and Medical Devices Rules, 2017, all notified medical devices, in-vitro diagnostics (IVD), and software as a medical device (SaMD) require mandatory registration and licensing prior to manufacturing, importing, or selling in India. Gujarat is one of India's premier medical device and pharmaceutical manufacturing hubs, housing major medical device parks in Vadodara, Ahmedabad, Rajkot, and Ankleshwar.
Medical devices are classified into four risk categories: Class A (Low Risk, e.g., surgical dressings, thermometers), Class B (Low-Moderate Risk, e.g., hypodermic needles, suction pumps), Class C (Moderate-High Risk, e.g., ventilators, bone plates), and Class D (High Risk, e.g., heart valves, pacemakers).
For manufacturers and importers operating in Gujarat, Class A & B manufacturing licenses are issued by the State Licensing Authority (Gujarat FDCA, Gandhinagar) in Form MD-5, while Class C & D licenses are issued by Central Licensing Authority (CDSCO) in Form MD-9. Importers obtain Form MD-15 via an Indian Authorized Agent (IAA). Shree Meeracorp offers end-to-end consulting for seamless medical device registration in Gujarat.