CDSCO – Announcement related to Suspension of License – Medical Device Industry – Med Dev Amendment Rules 2021
NOTIFICATION FROM MINISTRY OF HEALTH AND FAMILY WELFARE
Dt 18th January, 2022
Content of the notification :
G.S.R. 23(E).—The following draft of certain rules further to amend the Medical Device Rules, 2017,
which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and in consultation after publication with the Drugs Technical Advisory Board, is hereby published for information of all persons likely to be affected thereby and notice is hereby given that the said draft rules shall be taken into consideration or after the expiry of a period of forty-five days from the date on which the copies of the Gazette of India these draft rules are made available to public;
Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government;
Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi – 110011 or emailed at drugsdiv-mohfw@gov.in.
DRAFT RULES
- (1) These rules may be called the Medical Devices (……Amendment) Rules, 2021.
(2) These rules shall, unless specified otherwise, come into force on the date of its final publication in the Official Gazette.
- In the Medical Devices Rules, 2017, after rule 43, the following rule shall be inserted, namely:—
“43A. Suspension and cancellation of license.— (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 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 presence of officer authorized by Central Licensing Authority, if in its opinion, the licensee has failed to comply with any of the conditions of the license or with any provisions of the Act or 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, may file 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 for hearing, pass such order as it thinks fit.”.
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