China: More Medical Devices and IVD Reagents Not Subject to Local Clinical Trials and Clinical Evaluation

On July 24, China’s NMPA issued a new list of medical devices not subject to clinical evaluation. This announcement is effective now. Now, device companies want to review the Clinical Evaluation Exempt Catalogue before checking the Clinical Trial Exempt Catalogue. For product registration, if the device is not subject to clinical evaluation, accordingly, the device will not need a local clinical trial in China. If the device does not require clinical evaluation or a CER report, it will need to provide a document showing its correlation to a similar device already registered in China. In this case, the risk between the new device to be registered and its China predicate must be clearly explained and accepted by the NMPA.


Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

Source used in the article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8478389/