Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
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
The NMPA issued the “Announcement on the transformation of 92 mandatory industry standards and research projects for medical devices into recommended industry standards and research
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in August 2022. These updates are presented by China
The NMPA released the draft version of “Registration Guideline for Radio Frequency Aesthetic Devices” on August 26. 2022 for feedback. Opinions need to be submitted
The NMPA published eighteen industry standards on August 22, 2022, to guide manufacturers for local type testing and regulatory approval: YY/T 0325-2022 Disposable sterile urinary
The NMPA issued Q&A for 34 common issues aroused in medical device type testing and registration. Full List of NMPA common issues If you have