Regulation for Medical Implant Devices

The Bill including separate legislative provisions for medical devices called as the Drugs and Cosmetics (Amendment) Bill was introduced in the Rajya Sabha on 29.08.2013 which was referred to the Standing Committee of Parliament. The Standing Committee made certain recommendations for changing the provisions of the Bill.

Accordingly, a proposal regarding withdrawal of the Drugs and Cosmetics (Amendment) Bill, 2013 and introduction of the Drugs and Cosmetics (Amendment) Bill, 2015 was placed on 11.02.2016 before the Group of Ministers for consideration. The Group of Ministers considered the proposal and decided that the Department of Health and Family Welfare may inter alia frame rules for regulation of Medical Devices keeping in view the fact that framing of such rules is feasible in terms of the existing Drugs and Cosmetics Act,1940.

Therefore, Medical Devices Rules, 2017 were framed and notified on 31.01.2017 which have become effective from 01.01.2018.

Medical devices are regulated as drugs notified under section 3 (b) (iv) of the Drugs & Cosmetics Act 1940 from time to time. Such medical devices are regulated under the said Act and Medical Devices Rules, 2017 made there under. The Minister of State (Health and Family Welfare), ShAshwini Kumar Choubey stated this in a written reply in the Lok Sabha.