Regulatory Framework for Medical Devices

Central Drugs Standard Control Organisaton (CDSCO) regulates the quality, safety and performance of notified medical devices under the provisions of Drugs and Cosmetics Act, 1940 and Medical Devices Rules, 2017 thereunder. Ministry of Health and Family Welfare, Government of India designated five Central Medical Device Testing Laboratories for testing and evaluation of medical devices vide S.O. 2237(E), dated 01/06/2018. Further, CDSCO has registered four laboratories to carry out test and evaluation of medical devices on behalf of manufacturer.

Furthermore, Bureau of Indian Standards (BIS) also undertakes testing of such equipments as per their procedures. The Minister of State (Health and Family Welfare), Sh Ashwini Kumar Choubey stated this in a written reply in the Lok Sabha.