Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
NMPA published twelve review reports in January 2024 for innovation devices. Among them are two imported devices. These published review reports serve as important references
Twenty newly-established or revised industry standards were released by NMPA on February 19, 2024, to guide manufacturers for type testing, pre-clinical, clinical studies, and regulatory
NMPA published the “Draft Guideline on Clinical Trial of Peripheral Drug-Coated Balloon Catheters” on February 5, 2024 for feedback. Feedback needs to be submitted by
NMPA granted innovation approvals to seven devices in December 2023, for indications ranging from cardiovascular, orthopedic, immunology and urology. Among them are two imported devices.
Eighteen newly-established or revised industry standards were released by NMPA on November 24, 2023, to guide manufacturers for type testing, pre-clinical, clinical studies, and regulatory
The NMPA issued the innovation approval review report for Varian’s Proton Therapy System. It is the seven imported innovative device approved by the NMPA so
NMPA published 54 draft guidelines on October 25, 2023, for feedback. Feedback needs to be submitted by November 23, 2023. Significance of Device Guidelines The
NMPA issued the notice “Soliciting Feedback of Guideline on Medical Device Human Factors Design for the Second Time” on October 11, 2023, after the first
The NMPA published 45 standards on September 7, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. It includes 6
The NMPA published the “Review Key Points for Artificial Intelligence Software for AI Magnetic Resonance Imaging Systems” on September 15, 2023. The guideline applies to
The NMPA issued four data management guidelines on August 15, 2023. These documents are formulated to facilitate the information technology infrastructure for medical device registration
The NMPA granted innovation approval to Ischemic stroke CT image assisted assessment software and released the review report in July 2023. This software is designed