Classification of medical devices pertaining to Anesthesiology

DATE: 2nd July 2021

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

NOTICE
File No. 29/Misc.103/2020-DC (177)

Subject: Classification of medical devices pertaining to Anesthesiology 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 for their with respect to the import, manufacture, clinical investigation, 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 31.1.2017 which are to be commence from 01.01.2018.

In this connection, in exercise of the powers conferred under sub-rule (3) of rule 4 of Medical Devices Rules, 2017, the undersigned is hereby classify the medical devices, Appendix A, based on the intended use of the device, risk associated with the device and other parameters specified in the First Schedule.

List of medical devices placed at Appendix A is subjected to the followings:

1. General intended use given against each of the devices is for guidance to the applicants intends to furnish application of import or manufacture of medical devices under the provisions of Medical Devices Rules, 2017. However, a device may have specific intended use as specified by its manufacturer.
2. This list is dynamic and is subject to revision from time to time under the provisions of the Medical Devices Rules, 2017

(Dr. V.G. Somani) Drugs Controller General (I)