LEGAL AND REGULATORY REGIME OF MEDICAL DEVICES IN INDIA
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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 Authority whereas the licensing to manufacture a Class C or Class D device is issued by the Central Licensing Authority. Importing a Notified Medical Device into India requires additional legal formalities, including under the provisions of the Export and Import Policy of India.
1.4 The MDR regulates only certain categories of medical devices specifically notified for regulation by the Ministry of Health and Family Welfare. At the time of enactment of the MDR, only 15 categories of medical devices were regulated under those rules. 14 additional medical devices were notified and included within the regulatory framework in 2018 and 2019 with effect from different points of time in 2019, 2020 and 2021.
1.5 On 11th February, 2020, the Government of India gazetted two Notifications, whereby (a) vide S.O. 648(E), in pursuance of Section 3(b)(iv) of DCA, a new definition of medical devices was incorporated and (b) vide G.S.R. 102 (E), the Medical Devices (Amendment) Rules, 2020 were issued.
1.6 By virtue of the above S.O. 648(E) issued by the Ministry of Health and Family Welfare, which came into force on 1st April 2020, all medical devices were effectively brought within the scope of the MDR (“Definition Notification”).
Rather than notifying each individual medical device, the Definition Notification includes an expansive and catch-all definition of medical devices.