The Quality Council of India (QCI), and Association of Indian Manufacturers of Medical Devices (AiMeD) have added new features to the Indian Certification for Medical Devices (ICMED) Scheme. This had been launched in 2016. The new scheme called, ICMED 13485 Plus, will undertake verification of the quality, safety and efficacy of medical devices.

The scheme 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 will be an end to end quality assurance scheme for the medical devices sector in India.

Source: The Economic Times