Indian Certification of Medical Devices Scheme (ICMED) launched

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Source: Wikimedia commons

The Association of Indian Medical Device Industry (AIMED) in collaboration with Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB) have launched the Indian Certification of Medical Devices (ICMED) Scheme, which is the first indigenously developed international-class “Quality assurance” certification scheme for medical devices that were manufactured in India.

It aims to enhance patient safety, provide better consumer protection and provide the product credentials to manufacturers that will hopefully boost confidence among the users and buyers. This scheme is expected to help alleviate trading of sub-standard products or devices of dubious origins which is widespread in the Indian market.

This scheme was launched recently in the presence of top representatives from government, healthcare industry and quality council fraternity.

From the manufacturers standpoint, it aims to bring down the time to obtain globally accepted quality certifications for Indian companies, while eliminating the malpractices of sub-standard or fraudulent certification or quality edits. This could lead to lower costs and subsequently increased savings, enhanced credibility and more competitiveness in the global arena.

The ICMED scheme also fills a big regulatory void that was prevalent- as there was no India-specific official quality assurance system till now. This led to the foreign companies being more competitive compared to the Indian medical device manufacturers.

Speaking at the launch of the scheme, Dr V K Subburaj, Secretary, Dept of Pharmaceuticals, GoI said, “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.

The newly launched scheme has presently two options for certification, one being ‘ICMED 9000 Certification (an ISO 9001 plus additional requirements)’ and other being ‘ICMED 13485 (An ISO 13485 Plus additional requirements). A third one is under development and will be launched later, that would additionally prescribe medical device specifications developed by NHSRC of the Ministry of Health and Family Welfare.

“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 govt’s flagship Make in India programme,” said Adil Zainulbhai, Chairman, QCI.

NABCB has been successful in securing international equivalence for most of its accreditation programmes and it would 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,” pointed out Anil Jauhri, CEO, NABCB.

The above article was adapted from the Financial express.

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