Classification of Medical Device pertaining to Physical support

DATE: 26th July 2021

Drugs Controller General (India)
Directorate General of Health Services
FDA Bhawan, Kotla Road, New Delhi

Notice

File No. 29/Misc./03/2020-DC (202)

Subject: Classification of Medical Device pertaining to Physical support 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