Licence validity for regulated medical devices extended by additional 6 months

In a bid to ensure continued access and easy import of CT Scan, X-Ray, MRI machines etc the Drugs Controller General on Sunday ordered extension of the validity of licence for additional six months, for those manufacturers who have already submitted their applications.

The union health ministry had earlier notified eight medical items– all Implantable Medical Devices, CT scan equipment, MRI equipment, Defibrillators, PET Equipment, Dialysis Machine, X-Ray Machine and Bone marrow cell separator–to be regulated under the Drugs and Cosmetics Act which was to come into effect from 1st April, 2021 under Medical Devices Rules 2017.

Accordingly, the importers/manufacturers are required to take import/manufacturing licence from Central Licencing Authority or State Licencing Authority, as the case may be, for import/manufacture of above devices, w.e.f. 1st April, 2021.

In order to ensure supply chain continuity and access to these Medical Devices, while implementing smooth transition into the new regulatory regime, Union Ministry of Health and Family Welfare has now decided that in case an existing importer/manufacturer who is already importing /manufacturing any of these devices, has submitted application to Central Licencing Authority or State Licencing Authority, for grant of import /manufacturing licence in respect of the said device under the provisions of MDR, 2017, the said application shall be deemed valid and the importer/manufacturer can continue to import /manufacture the said device up to 6 months from issue of this order or till the time, the Central Licencing Authority or State Licencing Authority, as the case may be, takes a decision on the said application, whichever is earlier, the Central Drugs Standard Control Organisation said in the order. Live Mint