LEGAL AND REGULATORY REGIME OF MEDICAL DEVICES IN INDIA
LEGAL AND REGULATORY REGIME OF MEDICAL DEVICES IN INDIA MnA Chambers 1 | 12 APPENDIX A LEGAL PROVISIONS 1. Legal & Regulatory Regime of Indian Medical Device Sector: 1.1 The Drugs and Cosmetics Act, 1940, (“DCA”), together with Rules framed thereunder, viz. Drugs and Cosmetics Rules, 1945 (“D&C Rules”) and the Medical Devices Rules, 2017 (“MDR”) regulates the Indian medical device sector, by governing their authorization, import, manufacture, distribution and sale in India. 1.2 The MDR classifies medical devices into four classes as Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk) and Class D (high risk). 1.3 Each manufacturing location requires a separate license for each Notified Medical Device. The license for manufacturing a Class A or Class B device is issued by the State Licensing…
