The medical device manufacturers of India introduce a new certification system for quality assurance on March 15 . The Certification of Medical Devices Scheme (ICMED) – the first indigenously developed international class certification scheme for the medical devices in India to reduce the valuable time and cost required to obtain quality certifications for Indian companies at the present time. It is also meant to ensure valuable savings, improved credibility and increased competitiveness. The Association of Indian Medical Device Industry (AIMED) has joined hands with The Quality Council of India (QCI) and The National Accreditation Board for Certification Bodies (NABCB) to introduce the service to the market.
V.K. Subburaj, Secretary, Department of Pharmaceuticals has launched the scheme. This program is intended to importantly eliminate trading of sub-standard products or devices of doubtful origins, a widespread and deleterious phenomenon in the Indian market. “The program is a significant milestone for both consumers as well as manufacturers as it brings quality, accountability and competitiveness in the system” said Rajiv Nath, AIMED &Chairman, Government of India while launching the scheme.
This certification Scheme currently has two options,
- CMED 9000 Certification (an ISO 9001 plus additional requirements)
- ICMED 13485 (An ISO 13485 Plus additional requirements).
NHSRC developed another level, is under development process that determines the specifications of medical device.”QCI is happy to contribute the medical device industry in India to exhibit its power in terms of meeting the high quality. Such programmers’ are already formulated for some products like ayurvedic products, yoga professionals plants and ready-mix concrete plants and this would be a valuable addition to our portfolio.
The manufacturers would need to approach any one of the certification bodies approved by QCI under the ICMED scheme for obtaining certification. The certification bodies shall be under the oversight of NABCB, which is the national accreditation body, would accredit these certifying bodies as per applicable international standards.
More than twenty government and non-government organizations including Department of Commerce, National Health System Resource Centre, Bureau of Indian Standards (BIS), Central Drugs Standard Control Organization (CDSCO), Engineering Export Promotion Council (EEPC), prominent industry bodies like AIMED and Confederation of Indian Industry (CII), Center for Bio medical Engineering, IIT Delhi, Indian Medical Association (IMA) participated in various committees.
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