Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
The NMPA published twenty industry standards on October 17, 2022, to guide manufacturers for local type testing and regulatory approval. Mandatory NMPA Standards October 2022
The electronic registration certificate for medical devices will be fully implemented, starting on November 1, 2022. After October 2020, when the electronic certificates for domestic
The NMPA issued six draft clinical guidelines, for predicate-comparison, on October 25, 2022, soliciting public opinions. Your feedback needs to be submitted by November 21,
Proton Therapy Equipment, by APACTRON Particle Equipment Co., received the innovation approval on September 26, 2022. The NMPA released the review report for the proton
The NMPA issued the “Guideline on Inspection of Quality Management System for Medical Device Registration” on October 10, 2022, implementing from the day of release.
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros for September 2022. These updates are presented by China
The NMPA released the “Draft Guideline on Continuous Glucose Monitoring System” on September 28, 2022, for feedback. Feedback needs to be submitted by October 14,
NMPA In Vitro Diagnostic Reagents The NMPA In vitro diagnostic reagents issued 6 guidelines on September 28, 2022: Guideline on Qualitative Detection In Vitro Diagnostic
The Guangdong government released the “Guideline on Registration of Approved Class II Medical Devices Moving into Guangdong Province (Trial)” to encourage medical device and IVD
The NMPA issued four draft guidelines today on September 28, 2022, soliciting public opinions. Your NMPA guidelines feedback needs to be submitted by October 14,
The NMPA published the 27 registration review guidelines on September 15, 2022, which involve a wide range of indications, from chemistry, hematology to dental and
The NMPA released eleven filing review guidelines on September 1, 2022. Equivalent to FDA’s Acceptance and Filing Reviews, it is intended to be used by