Medical Devices (Third Amendment) Rules, 2022


The Department of Health and Family Welfare vide notification dated 18th May, 2022 has issued the Medical Devices (Third Amendment) Rules, 2022. The amendment provides that if the manufacturer or licensee importing medical devices 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 authorized by the Central Licensing Authority, if in its opinion, the licensee has failed to comply with any of the conditions of the license.

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.

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