From UPSC perspective, the following things are important :
Prelims level : ICMED 13485 PLUS
Mains level : NA
The Quality Council of India (QCI), and the Association of Indian Manufacturers of Medical Devices (AiMeD) have added further features to the ICMED Scheme for Certification of Medical Devices.
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 was first launched in 2016.
- 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.
Details of the scheme
- This scheme provides the much-needed institutional mechanism for assuring product quality and safety.
- It will go a long way in assisting the procurement agencies to tackle the challenges relating to the menace of counterfeit products and fake certification.
- This will also help in eliminating the circulation and use of sub-standard medical products or devices of doubtful origin that could prove to be serious health hazards.