Date: 9th September, 2022
Drugs Controller General (India)
Directorate General of Health Services
FDA Bhawan, Kotla Road, New Delhi
File No. 29/Misc./03/2022-DC (228)
Subject: Classification of non-sterile, non-powered, hand-held or hand-manipulated Surgical Instruments for general use intended to be used in various general surgical procedures under the provisions of Medical Devices Rules, 20’17-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 (E) dated 31.01.2017 which is already implemented from 01.01.2018
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