The Central Drugs Standard Control Organisation on 18th April 2021 has extended the validity of licence for regulation of CT scan equipment, implant devices and MRI equipment’s for another 6 months.
The Health Ministry had earlier notified eight medical items including 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).
As per the earlier notification 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, w.e.f. 1st April, 2021.
However it has now been decided that in case an existing importer/manufacturer who is already importing /manufacturing any of these devices, has submitted an application to Central Licencing Authority or State Licencing Authority, for grant of import /manufacturing licence in respect of the said device(s) under the provisions of MDR, 2017, the said application shall be deemed valid and the importer/manufacturer can continue to import /manufacture the said devices 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(CDSCO) said in the order.
