MED ASSOCIATION SEEKS MORE TIME TO REGULATE DEVICES

The Association of Indian Medical Device Industry wants more time before implantable medical devices, CT scans and MRIs are categorised as drugs and monitored by the Central Drugs Standard Control Organisation (CDSCO). The Centre had set April 2020 as the deadline.

The association was taken by surprise by the notification, and said that it had been agreed that there would be a road map for regulating the sale and manufacturing of medical devices.

The association said it was agreed that the shift would be done in phases over a fiveyear period.

Association coordinator Rajiv Nath explained, “This is too short a time. Manufacturers have to build infrastructure, capability and capacity. Testing facilities have to be set up. Manufacturers are struggling to get licences and have to compete with foreign manufactures.”

The Central Drugs Standard Control Organisation has to build capacity in terms of regulators, auditors and testing facilities.

The medical devices need to be evaluated on electronic safety and biocompatibility in the case of implants. These various categories have to be charted out which will required skilled manpower both in the manufacturing units and the government departments.

A drug controller stated they had only been reading about notifications from the government but there was no clarity on how it would be implemented.