04 Jun, 2023

About Indian Medical device

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In India, at present only notified medical devices are regulated as Drugs under the Drugs and Cosmetics Act 1940 and Rules made thereunder in 1945.
  1. (i) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i);
  2. (ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and
  3. devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940;
List Of Devices