Quality Council of India (QCI), an autonomous body under the Ministry of Commerce & Industry virtually launched the ‘Indian Certification of Medical Devices 13485 PLUS scheme (ICMED 13485 PLUS)’ for undertaking verification of the quality, safety and effectiveness of medical devices in India. It is an upgraded version of the ICMED Scheme launched in 2016 for certification of medical devices.
- QCI & the Association of Indian Manufacturers of Medical Devices (AiMeD) have added new features to the ICMED scheme.
- ICMED Plus is the 1st scheme in the world in which Quality Management Systems along with Product Certification Standards are integrated with regulatory requirements.
- The scheme will be an end to end quality assurance scheme for the medical devices sector in India.
Key Points
i.ICMED 13485 Plus provides the institutional mechanism needed for assuring product quality and safety.
ii.It integrates Quality Management System components and product related quality validation processes through witness testing of products with reference to defined product standards and specifications.
iii.It will help in tackling challenges like counterfeit products, fake certification, and help in eliminating the circulation and use of sub-standard medical products or devices.
iv.The ICMED scheme was launched in 2016 by AiMeD, QCI & the National Accreditation Board for Certification Bodies (NABCB).
Recent Related News:
April 21, 2021, Central Drugs Standard Control Organisation (CDSCO) has extended the License Validity of 8 Medical Devices (listed under Drugs & Cosmetics Act, 1940) by additional 6 Months for manufacturers/importers who have already submitted their applications to Central/State Licencing authorities.
About Quality Council of India (QCI)
It is an autonomous body set up by the Ministry of Commerce and Industry
Chairperson – Adil Zainulbhai
Secretary General – Dr. Ravi P. Singh
Head Office – New Delhi
About Association of Indian Manufacturers of Medical Devices (AiMeD)
Forum Coordinator – Rajiv Nath
Head Office – New Delhi
