New Regulatory Regime for 8 Medical Items under Drugs and Cosmetics Act

Adopting a proactive and sensitive approach to address the needs of the Indian Industry, the Union Ministry of Health & Family Welfare has taken a significant decision for ensuring continued access of eight regulated medical devices today.

The Ministry had earlier notified the following medical items to be regulated under the Drugs and Cosmetics Act which was to come into effect from 1^st April, 2021 (as per S.O. 775(E) dated 08^th February, 2019 under Medical Devices Rules 2017):

1. All Implantable Medical Devices;
2. CT scan equipment;
3. MRI equipment;
4. Defibrillators;
5. PET Equipment;
6. Dialysis Machine;
7. X-Ray Machine; and
8. 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. 1^st 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 hasnow 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, as the case may be, 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 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. Order in this regard has been issued by Drugs Controller General (India) on 18^th April 2021 through CDSCO website.