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Industry specific-Medical Central Ministry of Health & Family Welfare Drugs and Cosmetics Act, 1940

Medical Devices (Third Amendment) Rules, 2022

18-May-2022 | G.S.R. 356(E)

The Ministry of Health and Family Welfare has issued Medical Devices (Third Amendment) Rules, 2022. By the virtue of amendment, Rule 43A has been inserted in the Rules, which specifies Suspension and cancellation of licence of manufacturer or licensee for import of medical device. Under the Rule 43A, 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, after giving an opportunity to show the reason, may 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.

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