The next step is to appoint a Legal Agent and After Sales Agent located in China who will coordinate and control your medical device registrations for CFDA approval.
The third step for CFDA approval is to pay attention to demonstrate proof of home country approval using a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG). For Foreign manufacturers, they have to submit a notarized quality system certificate such as ISO 13485 or proof of US FDA QSR compliance.
For Class II and III devices, submit your device to the CFDA for testing. Testing is carried out by a CFDA authorized laboratory. Clinical trials conducted in China may be required for some devices, including high-risk and implantable devices.
And then, what do you have to know for CFDA approval For Class III and IV medical devices, prepare Chinese Registration Standard dossier, including testing results, and submit to CFDA for approval.
At last, you have to do for CFDA approval is to prepare application for an Import Medical Device Registration Certificate (IMDRC) and submit it for CFDA approval. Class II and III submissions will also include the Registration Standard dossier.