Ministry of Health amends the Medical Devices Rules, 2017; prescribes suspension and cancellation of licence for manufacturer or licensee for failure to comply with conditions of an import license; effective immediately

Ministry of Health and Family Welfare has notified the Medical Devices (Third Amendment) Rules, 2022 in order to amend the Medical Devices Rules, 2017 (“Rules”).

The Medical Devices (Third Amendment) Rules, 2022 introduces a new Section 43A regarding ‘suspension and cancellation of licence’. If the manufacturer or licensee fails to comply with the conditions of an import licence, or with any provisions of the Act or the Rules, the Central Licensing Authority, may, after giving the manufacturer or licensee an opportunity to show cause, may (by written Order) cancel a license issued under the Rules, or suspend it for a period as it may think 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.

Further, any person who is aggrieved by the Order passed by the Central Licensing Authority, may file an appeal to the Central Government within thirty days of the serving of the order.

The Notification will gain effect immediately.

A copy of the Notification is attached herewith for ease of reference.

Source: Ministry of Health and Family Welfare