Regulation of Medical Devices/ Equipments

Only 14 categories of the medical devices notified under the Drugs and Cosmetics Act, 1940 and Rules made thereunder are regulated as drugs. The National Pharmaceutical Pricing Authority (NPPA) under the Department of Pharmaceuticals regulates the pricing of medical devices. The Authority has informed that the pricing of two devices, namely, 'condom' and, 'Intrauterine Device (IUD)' containing copper is regulated under the provisions of the Drugs Price Control Order, 2013.