China SFDA Medical Device Consulting Services

Emergo Group helps medical device and IVD manufacturers obtain regulatory approval from the State Food & Drug Administration (SFDA) in China. We can assist you with many quality assurance, regulatory compliance and clinical research issues as shown below.

China SFDA Medical Device Approval Consulting

Through our Beijing office, we provide full service China SFDA approval consulting for medical devices.

Legal Agent and After Sales Agent Representation

If you have no location in China, we can act as your independent regulatory liaison with the Chinese SFDA.

CCC Mark Certification

Several categories of (mostly) electrical devices require the CCC Mark. We can assist in obtaining certification.

Clinical Trial Research in China

If your device requires supporting clinical data prior to China SFDA review, we can manage clinical trials in China.

English to Chinese Translation for Medical Device Documentation

We offer translation services for clients working with us on Chinese SFDA approval projects.