Class C and D Device Manufacturers: Are You Compliant with the IMDR 2017?
From October 2023 onwards, the mandatory registration of Class C and D medical devices in India will require conformance with the Quality Management System (QMS) requirements, as per the Indian Medical Device Rules (IMDR) 2017. Thus, medical device manufacturers will have to implement a QMS that meets the requirements of Schedule V of the IMDR 2017. It is mandatory for manufacturers to be compliant with these requirements for the successful registration of their Class C and D devices.