Launched - “Indian Certification of Medical Devices Scheme (ICMED)” - country’s first indigenously developed world class quality assurance system for medical devices
• A joint initiative of AIMED, QCI and NABCB, the scheme ushers news standards for device/patient safety for consumers and the convenience of obtaining international class Quality Certification within the country for manufacturers, thereby ensuring significant savings and enhancing 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 – Dr V K Subburaj, Secretary, Dept of Pharmaceuticals, GoI
• The Scheme is a significant milestone for both consumers as well as manufacturers as it brings quality, accountability and competitiveness in the system,” Mr Rajiv Nath, Jt Coordinator AIMED
New Delhi, 15th March, 2016:
“Indian Certification of Medical Devices Scheme (ICMED)” – country’s first indigenous quality assurance system for 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 a joint initiative of Association of Indian Medical Device Industry (AIMED) and 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.
As currently, there is no India-specific official quality assurance system, due to which Indian medical device manufacturer’s encountered loss of competitiveness to foreign companies while consumers ended up paying extra premium with no concomitant benefits, ICMED also fills a big regulatory void.
“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 systems and in due course will also bring respect to Brand India for those carrying this certificate ,” said Mr Rajiv Nath, Forum Coordinator, AIMED &Chairman, Technical Committee, QCI-AIMED Voluntary Initiative on Medical Devices.
The Certification Scheme being launched has presently two options for certification, one being ‘ICMED 9000 Certification (an ISO 9001 plus additional requirements)’ for low risk medical devices and other being ‘ICMED 13485 (An ISO 13485 Plus additional requirements) for medium and higher risk devices.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 this year.
According to Dr M K Bhan, former Secretary to the Government of India, Department of Biotechnology, Ministry of Science and Technology,“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 realization of these objectives.”
“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 Mr Adil Zainulbhai, Chairman, QCI.
It may be added that NABCB has already secured 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 Mr Anil Jauhri, CEO, NABCB.
The manufacturers would need to approach any one of the certification bodies approved by QCI under the Scheme for obtaining certification. The certification bodies shall be under the oversight of NABCB, which as the national accreditation body, would accredit these certifying bodies as per applicable international standards.The certification scheme is open to both indigenous and foreign manufacturers though Indian manufacturers would be expected to queue up initially. Since it's a voluntary certification scheme its initial success would ride on procurement agencies demanding for this as a qualifying criteria.
Among the dignitaries present during the launch function of ICMED included: Mr Amitabh Kant, CEO, NITI Ayog; Dr V.K. Subburaj,Secretary, Department of Pharmaceutical, Mr C Viswanath, Secretary, Department of Consumer Affairs; Mr Wajahat Habibullah, Chairman, PSAIIF & the Jury; Mr Samir Behl, Regional President, Amway, Europe, Africa and India; Mr Bejon Misra, Founder, Consumer Online Foundation and Mr Adil Zainulbhai, Chairman, QCI.