Readable HTML

English — official gazette text

G.S.R. 174(E) — Medical Devices (2nd Amendment) Rules, 2022

Link directly to a passage with its anchor — for example #notification — to open it highlighted. This reference version is generated from the authority’s publication and does not replace it. Language: English.

New Delhi, the 4th March, 2022 G.S.R. 174(E).—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. 850(E), dated the 10 th December, 2021, in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), inviting objections and suggestions from persons likely to be affected thereby before the expiry of a period of forty- five days from the date on which the copies of the Official Gazette containing the said notification were made available to the public; And whereas copies of the said Official Gazette were made available to the public on 10 th December, 2021; And whereas objections and suggestions received from the public on the said draft rules have been considered by the Central Government; Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with Drugs Technical Advisory Board, hereby makes the following rules further to amend the Medical Devices Rules, 2017, namely:―

para-1

Paragraph 1

1. (1) These rules may be called the Medical Devices (2 nd Amendment) Rules, 2022. (2) These rules shall come into force on the date of their publication in the Official Gazette.

para-2

Paragraph 2

2. In the Medical Devices Rules, 2017, in rule 36, in sub-rule (3), for the words “or the United States of America” the words “United Kingdom or the United States of America” shall be substituted.

[F. No. X.11014/7/2021-DR] Dr. MANDEEP K. BHANDARI, Jt. Secy. Note : The Medical Devices Rules, 2017 was published in the Gazette of India, Extraordinary, Part II, section 3, sub-section(i) vide notification number G.S.R. 78 (E), dated the 31 st January, 2017 and last amended vide notification number G.S.R.19(E), dated the 18 th January 2022.