Marketing in China: what is the Legal Agent responsible for?

In order to market medical devices in China, manufacturers shall appoint a Legal Agent established in China who plays an important role both in pre-market and post-market phase. In particular, the Legal Agent acts as an interface with the competent Authority, he supports the foreign manufacturer to correctly classify the device for the registration procedure that should be followed, and to determine the needs to carry out clinical trials. Generally, the Legal agent plays a coordination role during the whole registration process with the competent Authority (CFDA). Once obtained, the registration belongs to the Legal Agent, whose reference must necessarily be included in the label. From this moment on, the Chinese Legal Agent will be the CFDA reference to manage any communication to the foreign manufacturer. The Legal Agent must also maintain the registration certificate, its modification and update. Last but not least, the Legal Agent is responsible for claims management, reporting and recall activities.