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Ramesh Shankar
Wednesday, August 4, 2021, 08:00 Hrs  [IST]

Quality of medical devices has been a major issue in the country for a long time. Till the year 2016, there was a big regulatory void in regulation of medical devices as there was no India-specific official quality assurance system till then. As the quality of medical devices will have a direct impact on the health of the patients, there was a dire need to eliminate trading of sub-standard medical devices of doubtful origins, a widespread and injurious phenomenon in the Indian market, thereby ensuring substantial savings, enhanced credibility and increased competitiveness for Indian manufacturers. In the absence of a quality assurance system, Indian medical device manufacturers encountered loss of competitiveness to foreign companies while the patients ended up paying extra premium with no concomitant benefits. It was under this background, the apex quality facilitation and national accreditation body Quality Council of India launched the country’s first medical devices quality assurance system named the Indian Certification for Medical Devices Scheme (ICMED) on March 15, 2016. This first indigenously developed international class voluntary certification scheme for the medical devices in India was aimed to reduce time and cost-run for obtaining globally accepted quality certification for Indian companies thus eliminating the malpractices of sub-standard or fraudulent certification or quality audits. An initiative of the Association of Indian Medical Device Industry (AIMED) in collaboration with QCI and the National Accreditation Board for Certification Bodies (NABCB), the ICMED scheme was also aimed at enhancing patient safety and providing consumer protection and the much needed product credentials to manufacturers for instilling confidence among buyers and users.

Recently, the QCI and the AIMED jointly came up with the ICMED Plus scheme which added further features to the ICMED. Aimed primarily to eliminate the sub-standard medical devices of doubtful origin, the ICMED Plus scheme is also a competency building exercise to achieve harmonization with global medical device quality certifications. The new scheme will undertake verification of the quality, safety and efficacy of medical devices. ICMED Plus scheme has been designed to integrate the Quality Management System components and product related quality validation processes through witness testing of products with reference to the defined product standards and specifications. This is the first scheme around the world in which quality management systems along with product certification standards are integrated with regulatory requirements. This scheme will be an end to end quality assurance scheme for the medical devices sector in India. This scheme provides the much-needed institutional mechanism for assuring the product quality and safety. It will go a long way in assisting the procurement agencies to tackle the challenges relating to the menace of counterfeit products and fake certification. The need for an Indian quality certification system for medical devices was never felt as strongly as during the current Covid pandemic. So, the launch of ICMED Plus scheme is a significant milestone for both consumers as well as manufacturers as it will bring quality, accountability and competitiveness in the system. For a country like India, the two major challenges are to ensure availability of quality healthcare products at reasonable cost so that overall healthcare cost remains reasonable. Definitely, the launch of ICMED schemes is a significant collaborative initiative which will go a long way to ensure realization of both these objectives.


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Salini .V Aug 5, 2021 8:15 PM
Pharmacist post
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