NMPA’s UDI Requirements in China for Medical Device Manufacturers
NMPA had issued rules for Medical Device identification under Order 66, released in October 2019, which states that medical devices marketed in China shall comply with UDI regulations and implementation plan.
New Program for the Review of Innovative Medical Devices in China
The Chinese National Medical Products Administration (NMPA) has published revised requirements for its innovative medical device review program that will take effect December 1, 2018. The new NMPA policy, Order 83  includes three major changes: Applications for Innovative Devices must be submitted to NMPA within five years of patent publications; Application review timeframes will […]