ICMED, which was launched recently, is the country’s first indigenous quality assurance system for medical devices
Hindustan Syringes & Medical Devices (HMD), makers of DISPOVAN, has received the Indian Certification of Medical Devices (ICMED) Scheme. ICMED is the country’s first indigenous quality assurance system for medical devices, which was launched recently.
ICMED 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 to enhance patient safety, to provide consumer protection along with much needed product credentials to manufacturers for instilling confidence among buyers and users. The 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 Anil Jauhri, CEO, National Accreditation Board for Certification Bodies. The ICMED Certification 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, Joint Managing Director, HMD. He said, “In due course it will also bring respect to Brand India for those carrying this certificate.”
Currently, the certification scheme has 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 will be launched later this year.
According to Dr MK Bhan, Former Secretary, 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 the 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.”
“QCI is happy to lend a helping hand to the medical devices 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.
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 and respect for Indian manufacturers,” pointed out Jauhri.
“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,” said Nath.