CFDA requires any foreign manufacturers, who do not have a legal entity in China, to appoint a China Agent when they initiate product registration process. This China agent needs to be a fully established legal company with a physical address within mainland China. China agent’s name, address, contact details shall be listed on an application form, product IFU, and labels of all classes of medical devices. China agent also needs to notify the local authority of clinical investigation within China. Once assigned, your China Agent will be the first contact point for mutual communication with CFDA.
Since medical device regulation fundamental reform in 2014, CFDA has launched multiple requirements in respect to the responsibilities of acting as CFDA Agent, such as register product with CFDA, Coordinate the communication, convey relevant regulations and technical requirements to the manufacturer, and report Adverse Events (AEs) to the manufacture and CFDA. On 8th Feb 2017, CFDA published a further Administrative Measure on Medical Device Recall (CFDA No. 29, 2017), which kicks into effect from 1st May 2017 onwards. This regulation details new responsibility and liability for the manufacturer and its CFDA Agent in case of a recall. Actively collecting and reporting adverse events as well as coordinating a recall and correction measures, if it were to happen, require joined efforts between a manufacturer and its legal agent.
To clarify in more details, Foreign Manufacturer has the obligations to inform its CFDA Agent of any case of an Adverse Event directly and provide the Agent active reporting depending on the level of events:
Whenever it happens, and return the attached report form;
This will cover events occurring both in China territory as well as globally with products also sold in China. In addition, the Foreign manufacturer will need to send China Agent a yearly overview on all updates or changes regarding the submitted listed product (group) at CFDA, a Post Market Surveillance report, and Adverse incident AEs (status report) occurred. These reports need to be made available in case CFDA is requesting for information. Besides, China agent will also be responsible for product quality and after-sale related collateral responsibilities.
Facing these changes, legal manufacturer and its China legal agent may need to further address and discuss the required services and responsibilities.