New regulatory regime for medical devices to be effective after 6 months

The regulatory order under Medical Devices Rules (2017) adopts a proactive and sensitive approach to address the needs of the Indian industry, the union ministry of health and family welfare stated in a release.

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 April 2021 (as per SO 775(E) dated 8 February 2019 under Medical Devices Rules 2017):

·       All implantable medical devices,

·       CT scan equipment,

·       MRI equipment,

·       Defibrillators,

·       PET equipment,

·       Dialysis machine,

·       X-ray machine, and

·       Bone marrow cell separator.

As per the order 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 these devices, with effect from 1 April 2021.

In order to ensure  supply chain continuity and access to these medical devices, while implementing  smooth transition into the new regulatory regime, the ministry 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, 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 licence is granted. 

Drugs Controller General (India) issued an order in this regard on 18 April 2021 through CDSCO website.