Quality Council of India (QCI) and Association of Indian Manufacturers of Medical Devices (AiMeD) have launched “Indian Certification of Medical Devices Plus (ICMED) Scheme”.
ICMED scheme added further features to the ICMED Scheme that was launched in 2016 for Certification of Medical Devices.
About ICMED 13485 PLUS:
- The ICMED 13485 PLUS, as the new scheme has been christened, will undertake verification of the quality, safety and efficacy of medical devices.
- It 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.
Significance of the scheme:
The scheme will not only assist procurement agencies to tackle challenges related to counterfeit products and fake certification but will also eliminate circulation and use of sub-standard medical products or devices of doubtful origin.
About Quality Council of India (QCI):
- Quality Council of India (QCI) was set up in 1997 jointly by the Government of India (GoI) and the Indian Industry represented by the three premier industry associations i.e. ASSOCHAM, CII and FICCI, to establish and operate national accreditation structure.
- It was established under Societies Registration Act in 1997 to provide accreditation services across different sectors for products, services and persons.
- 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.
- It is headquartered in New Delhi.