Indian Certification of Medical Devices (ICMED) Plus Scheme
GS PAPER II: Important aspects of governance, transparency and accountability, e-governance- applications, models, successes, limitations, and potential; citizens charters, transparency & accountability and institutional and other measures.
Context: Quality Council of India (QCI) launches Indian Certification of Medical Devices (ICMED) Plus Scheme.
ICMED 13485 PLUS
- The Quality Council of India (QCI) and the Association of Indian Manufacturers of Medical Devices (AiMeD) have added further features to the ICMED the Scheme that had been launched for Certification of Medical Devices in 2016.
- The ICMED 13485 PLUS, as the new scheme will undertake verification of the quality, safety and efficacy of medical devices.
- 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.
- This scheme provides the much-needed institutional mechanism for assuring the product quality and safety.
- It will assist 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.
About The Quality Council of India
- It is an autonomous body set up by the Ministry of Commerce and Industry, Government of India jointly with the Indian Industry represented by the three premier industry associations i.e. Associated Chambers of Commerce and Industry of India (ASSOCHAM), Confederation of Indian Industry (CII) and Federation of Indian Chambers of Commerce and Industry (FICCI), 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.
- The Council plays a pivotal role at the national level in propagating, adoption and adherence to quality standards in all important spheres of activities including education, healthcare, environment protection, governance, social sectors, infrastructure sector and such other areas of organized activities that have significant bearing in improving the quality of life and wellbeing of the citizens of India.
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