Quality Council of India (QCI) and Association of Indian Manufacturers of Medical Devices (AiMeD) have launched “Indian Certification of Medical Devices Plus (ICMED) Scheme”.
About ICMED 13485 scheme
- ICMED scheme added further features to the ICMED Scheme that was launched in 2016 for Certification of Medical Devices.
- This scheme will undertake verification of quality, safety and efficacy of medical devices.
- Scheme has been designed to integrate Quality Management System components and product related quality validation processes by witness testing of products with respect to the defined product standards and specifications.
- This is the first such scheme across the world in which quality management systems & product certification standards are integrated with regulatory requirements.
- It will be an end-to-end quality assurance scheme for medical devices sector in India and much-needed institutional mechanism to assure the product quality and safety.
Significance of scheme
Scheme will assist procurement agencies to tackle challenges related to counterfeit products and fake certification. It will also eliminate circulation and use of sub-standard medical products or devices of doubtful origin.
Quality Council of India (QCI)
QCI was set up in 1997 as public private partnership model based on the model existing in Netherlands. QCI was organized as an independent autonomous body which worked for assuring quality standards across all spheres of economic and social activities. It was established under Societies Registration Act in 1997 to provide accreditation services across different sectors for product, services and persons.