Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
NMPA Center for Drug Inspection issued the “Inspection Points for Artificial Intelligence Medical Devices (Draft)” for feedback. Feedbacks need to be submitted by October 28,
The NMPA issued “On-Site Inspection Guideline for Standalone Software of the Medical Device Production Quality Management Specification” on September 30, 2026. It is intended to
On March 17, 2026, the NMPA released 26 medical device industry standards, including the revised YY/T 1406—2026: Guidance on the Application of GB/T 42062 to
The NMPA published four guidelines for AI software on July 10, 2023, propelling China to be the leader in the AI applications. Full List of
The NMPA published the “Key Points of Ultrasound Imaging Artificial Intelligence Software (Process Optimization)” on July 10, 2023, to direct related manufacturers for type testing,