Indian Certification of Medical Devices (ICMED) Plus Scheme
Source : Indian Express
GS II : Government policies and interventions for development in various sectors and issues arising out of their design and implementation
Approach for Indian Certification of Medical Devices (ICMED) Plus Scheme : Prelims and Mains Perspective
- About The Scheme
- How it Helps ?
- Quality Council of India (QCI)
Why in News ?
Quality Council of India (QCI) and the Association of Indian Manufacturers of Medical Devices (AiMeD) have added further features to the Indian Certification of Medical Devices (ICMED) the Scheme that had been launched for Certification of Medical Devices in 2016.
- Access to affordable and quality medical devices can be realised through ICMED Plus certification.
Key Facts
- The ICMED 13485 PLUS as the new scheme will undertake verification of the quality, safety and efficacy of medical devices.
- The ICMED 13485 PLUS Scheme was launched digitally.
- About ICMED 13485 Plus
Photo by Piron Guillaume on Unsplash - ICMED 13485 Plus 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.
- How it helps ?
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- This scheme provides the much-needed institutional mechanism for assuring the product quality and safety.
- Helps assisting the procurement agencies to tackle the challenges relating to the menace of counterfeit products and fake certification.
- Eliminating the circulation and use of sub-standard medical products or devices of doubtful origin that could prove to be serious health hazards.
- To reduce the load on regulators ICMED Plus certification should be considered as deemed compliance for one year under MDR-2017.
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Quality Council of India (QCI)
- Quality Council of India is an autonomous body set up by the Ministry of Commerce and Industry, Government of India jointly with the
- Associated Chambers of Commerce and Industry of India (ASSOCHAM)
- Confederation of Indian Industry (CII)
- Federation of Indian Chambers of Commerce and Industry (FICCI)
- It aims to establish and operate national accreditation structure and promote quality through National Quality Campaign.
- Quality Council of India (QCI) is registered as a non-profit society with its own Memorandum of Association and is governed by a Council with equal representations of government, industry and consumers.
- Council plays a pivotal role at the national level in propagating, adoption and adherence to quality standards in all important spheres of activities
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