Whereas a draft of certain rules further to amend the Medical Devices Rules, 2017 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) vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R 660(E) dated the 19th July, 2018, in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i) by the Central Government, inviting objections and suggestions from all
persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which copies of the said Official Gazette containing the said notification were made available to the public;
And whereas, copies of the Official Gazette containing the said notification were made available to the public on the 21st July 2018;
And whereas, no objections or suggestions were received from the public on the said rules for consideration 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 following rules further to amend the Medical Device Rules, 2017, namely:-
- (a) These rules may be called the Medical Devices (Second Amendment) Rules, 2019.
(b) They shall come into force on the date of their publication in the Official Gazette.
- In the Medical Devices Rules, 2017, in the Fifth Schedule, in Annexure ‘A’, in the Table,-
(a) for the entries relating to the medical device “Condom” and entries relating thereto in column (1), (2) and (3) thereof, the following entries shall be substituted, namely:-
| “Condoms | Compounding | Well ventilated area with neat and clean environment, free from dust and other particulate matter |
| Moulding | Well ventilated area with neat and clean environment, free from dust and other particulate matter | |
| Vulcanising | Normal Air | |
| Primary Packing | Air Conditioned” ; |
(b) for the entries relating to the medical device “Surgical dressings” and entries relating thereto in column (1), (2) and (3) thereof, the following entries shall be substituted, namely:-
| “Sterile surgical dressings | Final Primary Packing | 9”. |
Note: The principal rules were published in the Official Gazette vide notification number 78(E), dated 31st January 2017 and last amended vide notification number G.S.R. 30(E), dated the 15th January 2019.
