Licence mandatory for eight new medical devices

  21 April, 2021

Licence mandatory
for eight new medical devices

The Union Ministry of Health and Family Welfare in India has notified that with effect from April 1, 2021, eight medical items, namely, all Implantable Medical Devices, CT scan equipment, MRI equipment, Defibrillators, PET Equipment, Dialysis Machine, X-Ray Machine and Bone marrow cell separator, will be regulated as per the Drugs and Cosmetics Act. In simple terms, what this means is that all importers and manufacturers of the aforementioned medical products will now need to issue an import/ manufacturing licence from either Central or State Licencing Authority.

To ensure a smooth transition into the new regulatory phase, the Central Drugs Standard Control Organization (CDSCO) iterated that in case an existing importer/manufacturer who is already importing /manufacturing any of the eight mentioned devices, has already submitted an application to Central or State Licencing Authority for grant of licence 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(s) 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.

To read the original notice issued by the CDSCO, click here.