Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
The NMPA issued the second draft “Regulations on Self-test of Medical Device Registration (Draft)” on July 23, 2021, proposing further guidance to manufacturers on how
NMPA issued the “Artificial Intelligence Medical Software Classification Guideline” on July 8, 2021, to direct manufacturers for the classification and the corresponding clinical data and
China NMPA moves fast to provide more details in support of the State Council “Regulation on the Supervision and Administration of Medical Devices”, to support
NMPA granted nine manufacturers innovation approval and priority review status, including four overseas ones. The List Oncology Mevion Medical Systems: Proton Therapy System Biosense Webster
By the end of 2020, 100 innovative medical devices have been approved by NMPA since the “Green Pathway” for innovative medical devices was created in
The NMPA released the Revised Catalog of Medical Devices and IVD Products Exempted from Clinical Trials on January 19, 2021. It is an effort to
The NMPA Medical Device Standardization Administration released the second batch of results for medical device classification, excluding 86 products as medical devices. It also identifies
The NMPA released the updated Medical Device Classification Catalog on December 31, 2020, providing modification on management category and device classification. Classification Catalog 2020 Complete
China’s current NMPA medical device classification system has been in place since August 1, 2018, which specifies that “classifications should be based on the Device
You may find it complicated and confusing when trying to navigate through China’s medical device classification, registration and clinical trials process. In addition, to make