DATE: 26th July 2021
Drugs Controller General (India)
Directorate General of Health Services
FDA Bhawan, Kotla Road, New Delhi
Notice
File No. 29/Misc./0312020-DC (147)
Subject: Classification of Medical Device pertaining to Dermatological & Plastic Surgery under the provisions of Medical Devices Rules, 2017- Reg.
Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules made thereunder. For the regulation of medical devices with respect to the import, manufacture, sale and distribution, clinical investigation, the Central Government, after consultation with the Drugs Technical Advisory Board, has notified Medical Devices Rules, 2017 vide G.S.R. 78 (F) dated 31.01.2017 which is already implemented from 01.01.2018
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