Classification of In-vitro Diagnostic Medical Devices

DATE: 23rd July 2021

Drugs Controller General (India)

Directorate General of Health Services
FDA Bhawan, Kotla Road, New Delhi

NOTICE

File No. IVD/Misc/196/2020

Subject: Classification of In-vitro Diagnostic Medical Devices under the provisions of Medical Devices Rules, 2017 – Regarding.

Safety, quality and performance of Medical Devices and In-vitro Diagnostic Medical Devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules, made there under. For the regulation of Medical Devices and In-vitro Diagnostic Medical Devices with respect to the import, manufacture, clinical investigation, clinical performance evaluation, sale and distribution, 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.