Dignitaries present during the launch of Indian Certification of Medical Devices Scheme (ICMED)
Indian Certification of Medical Devices Scheme (ICMED)" - country's first indigenous quality assurance system for India manufactured medical devices was launched 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.
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.