Imdrf Adoption

Official source: Bureau of Indian Standards; IMDRF; QCI ICMED

The International Medical Device Regulators Forum (IMDRF) develops consensus documents on medical device regulation, classification, and safety. While India is not an official IMDRF member, CDSCO often references IMDRF guidance documents on topics such as software as a medical device, in vitro diagnostic devices, and clinical evaluation. Manufacturers may reference IMDRF documents to support regulatory submissions and demonstrate alignment with international best practices.