On 31st January 2017, the Ministry of Health and Family Welfare (MoHFW) released the Medical Devices Rules, 2017 [G.S.R. 78(E)]. These rules have been effected since the 1st of January 2018.
The Medical Devices Rules, 2017 are applicable to:
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);
Substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii);
Devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940).
The Medical Devices Rules, 2017 can be accessed via the Central Drugs Standard Control Organization website.