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.
Medical Distributor Search in China
Using our huge database of Chinese distributors, we can help you indentify and qualify appropriate partners in all Chinese provinces.
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.
Click on the image to download this PDF of the medical device approval process in China
