Regulators, Medical Device Industry in India Team Up to Bolster Medical Device Certification System

In the latest move by India to ensure the quality and safety of medical devices produced in the country, government regulators are joining forces with leading medical device manufacturers associations to integrate industry quality management systems with regulatory requirements.

The new framework launched in June by the Quality Council of India, the Association of Indian Manufacturers of Medical Devices and the Ministry of Commerce and Industry is an enhancement to the Indian Certification of Medical Devices (ICMED) process first introduced by government regulators in 2016. Called ICMED 13485 Plus, it is described by the government as an end to end process that integrates product testing with quality validation processes. It is also designed to diminish the circulation of counterfeit products and certifications.