6 mths' transition time allowed for access to 8 medical devices while implementing regulatory order

·2-min read

New Delhi, Apr 18 (PTI) The health ministry has decided that an application for a licence to import or manufacture eight listed medical devices by anyone already importing or manufacturing those be deemed valid for six months to ensure continued access to these equipment while the new regulatory order under the Medical Device Rules (MDR), 2017 gets implemented.

The ministry had earlier notified the medical items -- all implantable medical devices, CT scan equipment, MRI equipment, defibrillators, PET equipment, dialysis machines, X-ray machines and bone marrow cell separators -- to be regulated under the Drugs and Cosmetics Act, which was to come into effect from April 1 under the Medical Devices Rules (MDR) 2017.

The ministry has approved a transition time of six months to implement the provisions of the MDR, 2017, according to which the importers and manufacturers are required to take an import or manufacturing licence from the Central Licensing Authority or a State Licensing Authority for the import or manufacture of the eight medical devices with effect from April.

'In order to ensure supply chain continuity and access to these medical devices, while implementing a smooth transition into the new regulatory regime, the health ministry has now decided that in case an existing importer or manufacturer, who is already importing or manufacturing any of these devices, has submitted an application to the Central Licensing Authority or State Licensing Authority for the grant of an import or manufacturing licence..., the said application shall be deemed valid and the importer or manufacturer can continue to import or manufacture the said device(s) up to six months from the issue of this order or till the time the Central Licensing Authority or State Licensing Authority takes a decision on the said application...,' the ministry said. PTI PLB RC