Indian medical device manufacturers have announced an indigenous quality assurance certification system for Make-in-India products.

The Indian Certification of Medical Devices Scheme (ICMED) is expected to bring down the substantial time and cost that is currently required to obtain globally accepted quality certifications for Indian companies. It is also meant to ensure substantial savings, enhanced credibility and increased competitiveness.

The Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB) have joined hands with Association of Indian Medical Device Industry (AIMED) to roll out the scheme.

Launching the scheme in Delhi today, 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".

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.

 "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.

The Certification Scheme being launched has currently two options for certification, one being 'ICMED 9000 Certification (an ISO 9001 plus additional requirements)' and the other being 'ICMED 13485 (An ISO 13485 Plus additional requirements). A third level, which would additionally prescribe medical device specifications developed by NHSRC of the Ministry of Health and Family Welfare, is still under development and would be launched later.

"QCI is happy to lend a helping hand to the medical device industry in India to showcase its strength in terms of meeting the highest international standards. We have already devised such schemes for ayurvedic products, ready-mix concrete plants and yoga professionals, and this would be a valuable addition to our portfolio. It would go a long way in contributing to the success of the government's flagship 'Make in India' programme," said Adil Zainulbhai, Chairman, QCI.

Dr M.K. Bhan, former secretary, Department of Biotechnology, said that "for a country like India, the twin challenge is to ensure availability of quality healthcare products at reasonable cost so that overall healthcare cost remains reasonable. In this direction, the launch of ICMED is a significant collaborative initiative and will go a long way to ensure realisation of these objectives".

In fact, NABCB has already secured international equivalence for most of its accreditation programmes to facilitate international acceptance of Indian medical devices.

"NABCB is accrediting certification and inspection bodies and its accreditation programmes are internationally equivalent placing it on par with European and American accreditation bodies. This equivalence would help facilitate acceptance of ICMED certification in overseas market," says Anil Jauhri, CEO, NABCB.