The Indian Certification of Medical Devices (ICMED) Plus Scheme was launched by the Quality Council of India (QCI).
About ICMED Plus Scheme:
The QCI and the Association of Indian Manufacturers of Medical Devices (AiMeD) have enhanced the ICMED Scheme, which was launched in 2016.
The new scheme is known as ICMED 13485 PLUS.
The scheme will verify 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 via witness testing of products against defined product standards and specifications.
This is the world’s first scheme 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 India’s medical device sector.