The Indian devicemakers’ association is pushing for mandatory certification for all devices marketed in the country.
The Indian Certification of Medical Devices Scheme was unveiled in March as the first domestic quality assurance system in the country.
There are two certification options under the scheme — ICMED 9000 (an ISO 9001 plus additional requirements) for low-risk devices and ICMED 13485 (an ISO 13485 plus additional requirements) for medium- and high-risk devices ().
A third level, which would introduce device specifications developed by the Health Ministry’s National Health System Resource Centre, will be launched later this year.
The industry is still mapping out a plan for manufacturers and importers to register medical devices via an online government portal, said Ragiv Nath, forum coordinator for the Association of Indian Medical Device Industry (AiMeD), which represents domestic devicemakers.
He told IDDM that the association was pleased to see India gaining traction to have separate rules governing medical devices. He also stressed the need to register low-risk and moderate-risk devices for third-party manufacturers.
AiMED advocates mandatory ICMED certification to fill in regulatory gaps in quality for medical devices, Nath said. — Joya Patel