The Indian Certification of Medical Devices (ICMED) scheme is a new system of quality assurance brought by the manufacturers of such devices, with a view to bringing down the cost and time taken to obtain global quality certifications, while at the same time enhancing credibility.

It also aims to bring down trading in sub-standard products or devices of suspect origin, which has been a major and dangerous facet of the market for medical devices in the country.

The scheme was evolved by the Association of Indian Medical Device Industry (AIMED)in conjunction with The Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB).

Launching the scheme in Delhi, V.K. Subburaj, Secretary, Department of Pharmaceuticals, said that the “scheme fills a big regulatory vacuum in quality certification space for medical devices in the country and will enhance the competitiveness and profitability of Indian medical device industry”.

“The Scheme is a significant milestone for both consumers as well as manufacturers as it brings quality, accountability and competitiveness in the system,” said Rajiv Nath, Forum Coordinator, AIMED &Chairman, Technical Committee, QCI-AIMED Voluntary Initiative on Medical Devices.

NABCB is accrediting certification and inspection bodies and its accreditation programmes are on par with European and American accreditation bodies, according to Anil Jauhri, CEO, NABCB.


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