THE MEDICAL DEVICES RULES, 2017
The draft of the Medical Devices Rules, 2016 was published, as required under sub-section (1) of Section 12 and sub-section (1) of Section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), vide notification number G.S.R. 983(E), dated the 17th October, 2016, by the Central Government.
All objections and suggestions received in response to the said draft notification have been duly considered by the Central Government; Now, therefore, in exercise of the powers conferred by Section 12 and Section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the Medical Devices Rules, 2017
These rules shall, unless specified otherwise, come into force with effect from 1st day of January, 2018
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 Page 2 of 248 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).