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, 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 31.01.2017 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 hereby classifies the medical devices 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 subjected to the followings:
1. General intended use given against each of the devices is for guidance to the
applicants who intend 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.
Clarity on Classification of Pediatrics and Neonatology devices
Reference link –https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzU5Mw==
