The China National Medical Products Administration (NMPA) 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?
- Submit all registration/record documentation to the NMPA on your behalf.
- Serve as a regulatory liaison between you and the NMPA.
- Collect post-marketing adverse event information and feed back to you, simultaneously submit the report to NMPA.
- Assist with your product recall and report to NMPA.
- Joint and several liability of product quality and after-sale service.
Therefore, as far as the role and responsibilities of agent is concerned, the appointment of an agent is important for you, because a qualified agent is taking care of your products and prevent them from violating the regulations, it certainly is in the first priority before market sale. However, many oversea manufacturers always appoint a distributor to fulfill this important role in the rush to introduce a new product.
If you appoint a distributor as your agent, you will face a series of problems in the future.
If you let your distributor to be your agent, then he will take responsibility to apply for the NMPA 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, NMPA 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 NMPA 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 NMPA 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.
Therefore we recommend oversea manufacturer to select an independent regulatory representative, instead of a distributor.
Chemical Inspection and Regulation Service (CIRS) is an independent firm providing professional medical devices regulatory consulting, certification and testing services to oversea industries. It is the best choice for you.
The Advantage of CIRS:
- Assist with medical device registration, such as medical device classification, dossiers preparation and submission, registration inspection and so on.
- Assist with medical device certificate renewal and alteration.
- Provide GMP guidance and assist with handing with GMP inspection.
- Assist with product recall and collect adverse events information.
- Provide you the change information of regulations when changes affects you devices.