China Agent! A Regulatory Representative, NOT A Distributor

The China Food and Drug Administration (CFDA) ask oversea medical device manufacturers with no office in China to appoint an in-country china agent, which has a legal entity established in China, and certified with a Business License. Nevertheless, a China agent is more like a regulatory, rather than a distributor. It is always confused by a lot of oversea companies, who usually deem an agent is a distributor as well. So what is the difference between two roles? Let's have a regulatory look and get the better understanding.

What is the role and responsibilities of your China agent?

1. Submit all registration/record documentation to the CFDA on your behalf.
2. Serve as a regulatory liaison between you and the CFDA.
3. Collect post-marketing adverse event information and feed back to you, simultaneously submit the report to CFDA.
4. Assist with your product recall and report to CFDA.
5. Joint and several liability of product quality and after-sale service.

If you let your distributor to be your agent, then he will take responsibility to apply for the CFDA registration certificate of your product, that is, he will have all dossiers used to register, which includes critical technical info, supply chain info, manufacturing info, CFDA certificate, etc. In this case, he might be your China boss and even kick you out of this game. what is worse, a conflict of interest may occur in the event of recall and/or incident reporting between and your distributor. The distributor concentrates on the sales and marketing, instead regulatory affair. So they may not provide you the change information of regulations or timely warning when changes affects you devices.

We can take a very typical case for example, and this a very common case we dealt with. Firstly you appointed a distributor to be your China agent and he completed the CFDA registration for you, everything looked perfect, but one day, you would like to break up the commercial relationship with that distributor and switch to a new one, however, you will find that you absolutely cannot do this because based on Chinese regulations you much have the original CFDA certificate, okay, so where is your certificate? Undoubtedly, it is hold by your first distributor, you will be so scared that guy kept such a core document and you even didn’t know until now. This common case is easily understood, the distributor know much better about Chinese culture and regulations than the oversea manufacturer, so the day you appointed your distributor to be your China agent, the day you lost control of him.

1. Assist with medical device registration, such as medical device classification, dossiers preparation and submission, registration inspection and so on.
2. Assist with medical device certificate renewal and alteration.
3. Provide GMP guidance and assist with handing with GMP inspection.
4. Assist with product recall and collect adverse events information.
5. Provide you the change information of regulations when changes affects you devices.

What is more, CIRS is now offering the China Medical Device Regulatory Assistant Program (MDRAP), which is a unique cost-efficient regulatory assistant program to help you reduce business risks associated with regulatory affairs, remove barriers to entry and save your cost greatly.

If you want more information about China agent, please contact us for a free.