Announcement from MOHFW on UD1 – Medical Devices Industry – Medical Device (Amendment) Rules 2021 – Notification date 31st Dec 2021
NOTIFICATION FROM MOHFW
Release Date – New Delhi, the 31st December, 2021
Content of the Notification :
G.S.R. 918(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. 877(E), dated the 23rd 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 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 23rd 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), with consideration that consultation with Drugs Technical Advisory Board shall be held as per the provisions, the Central Government hereby makes the following rules further to amend the Medical Devices Rules, 2017, namely:―
- (1) These rules may be called the Medical Devices (Amendment) Rules, 2021.
(2) These rules shall come into force on the date of their publication in the Official Gazette.
- In the Medical Devices Rules, 2017, for rule 46, the following rule shall be substituted, namely:—
“46. Unique device identification of medical device.— With effect from such date as the Central Government may, by order specify, every medical device approved for manufacture for sale or distribution or import, shall bear a unique device identification in the manner as may be specified in such order.”.
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