Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
As innovation devices and first-of-kind products flood into China market, NMPA seeks to strengthen the clinical-trial approval requirements for certain devices. NMPA published the Catalog
NMPA published the “Guideline on Expert Panel/ Public Advisory Meeting” on December 5, 2019. During the NMPA registration process, Expert Panel weigh the available evidence
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
NMPA published the final version of “Clinical Trial Exemptions Catalog for Medical Devices” on December 20, 2019. It is an effort to implement risk-based clinical
NMPA issued the “Guideline on Real World Data (RWD) Used in Medical Device Clinical Evaluation (Draft)” on December 13, 2019. Feedbacks need to be submitted
Only one out of five medical devices granted Innovative Device Status by NMPA in 2019 were imported. Since domestic and overseas manufacturers have equal opportunity
“Regulation of Medical Device Clinical Trial Quality Management (so called China GCP)” issued on March 1, 2016 specifies that “Clinical trial sites must be on
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
Pic: China Premier Li Keqiang visited the Hainan International Medical Tourism Pilot Zone on Mar 25, 2019. NMPA issued the “Guideline on Real World Data
NMPA announced Recall Notices for 16 imported medical devices in November. Class I recall (the most serious): Edwards Lifesciences: Aortic perfusion cannula Class II and
Grace Palma, CEO of China Med Device, is invited to talk on Precision Medicine Panel of CABA (Chinese-American BioMedical Association) meeting in Boston. Grace will focus
NMPA published unprecedented number of medical device regulations in November, including 21 final guidelines, 14 draft guidelines for feedback and 19 final industry standards. Generic