The Quality Council of India (QCI) and Association of Indian Manufacturers of Medical Devices (AiMeD) added further features to the ICMED Scheme that was launched for Certification of Medical Devices in 2016.
Context
The Quality Council of India (QCI) and Association of Indian Manufacturers of Medical Devices (AiMeD) added further features to the ICMED Scheme that was launched for Certification of Medical Devices in 2016.
About the ICMED 13485 PLUS Scheme
- The new scheme will undertake verification of the quality, safety, and efficacy of the medical devices.
- ICMED 13485 Plus has been designed to integrate the Quality Management System components and the product-related quality validation processes.
- This is the first scheme of the world in which quality management systems and 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 institutional mechanism for assuring product quality and safety.
- It will assist the procurement agencies to tackle the challenges related to the menace of counterfeit products and fake certification.
- This will also help in eliminating the circulation the sub-standard medical products or devices of doubtful origin that could do serious health hazards.
- It will provide medical device products to consumers in India and will compete by adopting global best practices for medical devices.
Quality Council of India (QCI)
- It is an autonomous body set up by the Ministry of Commerce and Industry.
- Under this, the Indian Industry is represented by the three premier industry associations
- Associated Chambers of Commerce and Industry of India (ASSOCHAM)
- Confederation of Indian Industry (CII)
- Federation of Indian Chambers of Commerce and Industry (FICCI)
- Its purpose is to establish and operate a national accreditation structure and to promote quality through National Quality Campaign.
- It was established in 1997
- Quality Council of India (QCI) is registered as a non-profit society.
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