The Quality Council of India (QCI), and the Association of Indian Manufacturers of Medical Devices (AiMeD) have added further features to the ICMED the Scheme that had been launched for Certification of Medical Devices in 2016.
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The ICMED 13485 PLUS, as the new scheme has been christened, will undertake verification of the quality, safety and efficacy of medical devices. The ICMED 13485 PLUS Scheme was launched digitally.
Quality Council of India (QCI) was set up in 1997 jointly by the Government of India and the Indian Industry represented by the three premier industry associations i.e. ASSOCHAM, CII and FICCI, to establish and operate national accreditation structure.
The Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, is the nodal ministry for QCI.
The Council is independent and works under the directions of its Governing Body (GB) having equal representation of government, industry and industry associations. It does not get funded by the government and is a self-sustaining non-profit organization with its own Memorandum of Association (MOA) and Rules.