Registration process in China
In China medical devices are divided in three risk level categories: class I, class II and class III. For the higher risk classifications there is again a division in requirements. For this reason it is important to have the confirmation of the classification before starting the registration process. Also the Clinical performance of your devices become more and more important. It is therefore important to realize upfront what your clinical position is with your devices in the Chinese market.
To access the Chinese market with a medical device, you must acquire the Medical Device Registration Certificate from the China Food and Drug Administration (CFDA). In case you do not have a subsidiary in China, you have to appoint a local legal agent and service agent to deal with registration and after-sales service.