Tag Archive for: clinical trial

Registering Innovative Medical Devices in India

Innovative device (those without a registered “predicate”) registration in India can be complicated with many variations to the requirements, and options to proceed.

CHINA MEDICAL DEVICE AND IVD CLINICAL TRIAL EXEMPTION LIST

As part of the NMPA’s ongoing regulatory evolution, the Chinese competent authority, formerly known as the CFDA, has released a draft list of new product types to be considered exempt from clinical trials as part of the registration process moving forward.