China Acceptance of Foreign Biocompatibility Reports

In Asian Market, Preclinical, Regulatory by Anney Majewski

The most recently revised “Medical Device Registration” and “in vitro diagnostic reagents Registration” (China Food and Drug Administration Order No. 4 an No. 5) came into effect October 1, 2014. To address some of the frequently asked questions received since then, CFDA have included additional requirements.

One of the major changes incorporated in the new requirements involves specifications on biocompatibility tests performed on medical devices. Biocompatibility reports that were created outside of China are now being accepted in a notification; however, this is only true if the tests were conducted in a laboratory located outside of China that is GLP certified. When the report is submitted, the foreign laboratory’s certifications or documents of compliance must be provided.

This is great news if you are a manufacturer located outside of China who is looking to get your product on the Chinese market and you already had biocompatibility testing conducted in a GLP certified laboratory. The amount of biocompatibility testing that needs to be repeated in a CFDA certified laboratory in China would be reduced.

Additional areas that were adjusted in the revisions include “the implementation of the new mandatory standard product review before accepting questions”, “the information submitted clinical evaluation of medical devices”, “the purpose of registration of medical devices” and more. You can read the original notification at


Anney Majewski is the Marketing Communications Specialist at NAMSA, focusing on expanding the overall knowledge and understanding in the medical device industry. She obtained a BBA in Marketing from the University of Toledo as well as an A.S. in Psychology from Monroe County Community College.