The Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare regulates the safety, efficacy and quality of notified medical devices under the provisions of Drugs and Cosmetics Act, 1940 and Rules made thereunder.
In order to bring all the non-notified Medical Devices under the regulation, Ministry of Health & Family Welfare, Govt. of India has prepared a road map and published draft rule vide G.S.R. 797 (E), dated 18th October, 2019.
Further, a Notice has been issued seeking the comments of the stakeholders on a proposal to notify all the medical devices under sub section (b) of section (3) of the Drugs and Cosmetics Act, 1940 to regulate them as per the provisions of the said Act and Medical Devices Rules, 2017 framed thereunder.
The Minister of State (Health and Family Welfare), ShAshwini Kumar Choubey stated this in a written reply in the Rajya Sabha here today.
