December 26, 2019

China Innovative Device Status: Only 20% Claimed by U.S./ European Manufacturers

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 for this program, U.S. and […]
December 18, 2019

NMPA Update: 846 Hospitals Certified to Conduct Clinical Trials

“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 the NMPA filed institutions for […]
December 16, 2019
Medical Device Classification & Registration in China

Medical Device Classification & Registration in China – 4 Things You Must Know

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 the matters worse, specific regulatory […]
December 13, 2019

Real World Data Clinical Guideline Published Today; China Med Device Pioneered in the Program

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 (RWD) Used in Medical Device […]
December 11, 2019

16 Devices Recalled in November; One Class I Recall

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 Class III recall: GE: Patient […]