Medical devices which are notified as drugs to be mandatorily registered under The Medical Devices Amendment Rules, 2020

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The Ministry of Health and Family Welfare in its notification dated 11th February 2020 has published the Medical Devices (Amendment) Rules, 2020 which shall be in force from 1st April 2020.

Every medical devices which have been notified as “Drug “under section 3(b) of the Act except the devices specified in the Annexure of Eighth Schedule of these rules shall be registered with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organization.

The registration shall be on voluntary basis for a period of eighteen months from the commencement of this Chapter. there after it shall be mandatory. The manufacturer of a medical device or any person who imports any medical device will have to upload the information related to that medical device for registration on the ‘Online System for Medical Devices’ established by the CDSCO for this purpose.

Central Licensing Authority may verify the documents at any point of time and investigate quality or safety related failure or complaints and it can also cancel the license of a manufacturer if it finds lapses.

Click here to read the Notification.

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