December

December 31, 2019

More Class III, Class II Medical Devices and IVDs Exempted from Clinical Trial

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 evaluation, and to make medical […]
December 27, 2019

Eleven Situations Where Real World Data is Used in China, NMPA Guideline Explains

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 by January 13, 2020. Eight […]
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 […]