New regulatory regime for 8 medical items under Drugs & Cosmetics Act

The transition time of six months allowed for ensuring supply chain continuity and access while implementing their regulatory order under Medical Devices Rules (2017)

0
54
Image for representational purpose only.
New Delhi: Union Ministry of Health and Family Welfare has issued a fresh order for ensuring continued access to eight regulated medical devices on April 18, 2021.
The Ministry had earlier notified eight medical items to be regulated under the Drugs and Cosmetics Act which was to come into effect from 1st April, 2021 (as per S.O. 775(E) dated 8th February, 2019 under Medical Devices Rules 2017). These include All Implantable Medical Devices; CT scan equipment; MRI equipment; Defibrillators; PET Equipment; Dialysis Machine; X-Ray Machine; and Bone marrow cell separator.
Accordingly, as per the said order 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 case an existing importer/manufacturer is already importing any of these devices with valid approval from Central Licencing Authority or State Licencing Authority, they shall be allowed to carry on for ensuring supply chain continuity and access to these Medical Devices. This is to implement a smooth transition into the new regulatory regime.
“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 device(s) up to 6 months from the 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.” read the order in this regard that has been issued by Drugs Controller General (India) on 18th April 2021 through the CDSCO website.