As per CDSCO Update on Suspension and Cancellation of license. All the medical devices manufacturers and importers will be required to comply with the regulation laid by the CDSCO authorities. In case of any non-compliance with the regulation, the regulator may choose to take the below mentioned action. Below are the excepts from the Gazetted Notification. Also find the link to the notification below.
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,
(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.
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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.
A few days ago CDSCO has also share the notification for the Class A and B devices mandatory requirement of license by 1st Oct 2022. Read more on this update CDSCO licensing regime for Medical devices
Reference Link: http://operonstrategist.com/resource/CDSCO-Suspension-and-cancellation-of-license.pdf
