New Delhi, the 18th May, 2022 G.S.R. 356(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. 23(E), dated the 18th January, 2022, 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 the 19th January, 2022; 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 the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Medical Devices Rules, 2017, namely:—
Paragraph 1
1. (1) These rules may be called the Medical Devices (Third Amendment) Rules, 2022. (2) They shall come into force on the date of their publication in the Official Gazette.
Paragraph 2
2. In the Medical Devices Rules, 2017, after rule 43, the following rule shall be inserted, namely:— “43A. Suspension and cancellation of licence.— (1) If the manufacturer or licensee fails to comply with any of the conditions of an import license, or any provisions of the Act and these rules, the Central Licensing Authority may after giving the manufacturer or licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, cancel a license issued under rules, or suspend it for such period as it may thinks fit either wholly or in respect of any of the part of medical device to which it relates or direct the licensee to stop import, sale or distribution of the said medical device and, thereupon, order the destruction of medical device and the stock thereof in the presence of an officer authorised by the Central Licensing Authority, if in its opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or the rules made thereunder: Provided that a person who is aggrieved by the order passed by the Central Licensing Authority under this rule may, within thirty days of the serving of the order, file an appeal to the Central Government, and the Central Government may, after such enquiry into the matter, as it considers necessary and after giving the said appellant an opportunity of being heard, pass such order as it thinks fit.”.
[F. No. X.11014/4/2019-DR] Dr. MANDEEP K. BHANDARI, Jt. Secy. Note : The Medical Devices Rules, 2017 was published in the Official Gazette vide notification number G.S.R. 78(E), dated the 31st January, 2017 and last amended vide notification number G.S.R. 174(E), dated the 4th March, 2022.