PRELIMINARY 1. Short title and commencement (1) These rules may be called the Medical Devices Rules, 2017. (2) These rules shall, unless specified otherwise, come into force with effect from 1st day of January, 2018. 2. Application These rules shall be applicable in respect of, — (i) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India and blood component collection bag with or without anticoagulant covered under sub-clause (i); (ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and (iii) 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).