ICMED - country’s first indigenously developed international class quality assurance system for India manufactured medical devices

New Delhi, 18th March, 2016: Indian Certification of Medical Devices Scheme (ICMED)” – country’s first indigenous quality assurance system for India manufactured medical devices was launched today in the presence of top representatives from government, healthcare industry and quality council fraternity.

ICMED - the first home developed international class certification scheme for the medical devices in the country – is an initiative of Association of Indian Medical Device Industry (AIMED) in collaboration with the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB). ICMED is aimed at enhancing patient safety, to provide enhanced consumer protection along with much needed product credentials to manufacturers for instilling confidence among buyers and users. This Scheme is intended to significantly eliminate trading of sub-standard products or devices of doubtful origins, a widespread and injurious phenomenon in the Indian market.

For manufacturers, it aims to bring down the substantial time and cost-run to obtain globally accepted quality certification for Indian companies and eliminate the malpractices of sub-standard or fraudulent certification or quality audits, thereby ensuring substantial savings, enhanced credibility and increased competitiveness.



“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,” said Dr V K Subburaj, Secretary, Dept of Pharmaceuticals, GoI while launching the scheme.

AIMED has termed it a significant milestone due to multiple benefits it would assure to different stakeholders.

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