When marketing a drug or medical device in China, it is important to have an independent in-country representative for your products that is a legal entity registered in China, even if you are marketing through a Chinese distributor.
What is the role of an independent in-country representative in China?
- This representative serves as the required local entity that deals with the China Food & Drug Administration (CFDA) regarding product registration and renewal, adverse event reporting, etc.
How many local agents are required for medical devices?
- There are three local agents required:
- Registration Agent: The company that registers the product is the registration agent.
- After Sales Agent: The after sales agent provides technical service and support for the medical device product. The business scope described in the business license of the local legal Chinese entity must include a provision stating that the after sales agent will provide such services.
- Legal Agent: The legal agent’s key responsibilities include: a) reporting any adverse events regarding the medical device that occur inside or outside China to the CFDA; and b) handling any recall issues as they arise, as well as other regulatory matters.
Are local agents required for pharmaceutical products?
- For pharmaceuticals, the arrangement is completely different from the local agent system for medical devices. For imported drugs, there is no local agent required. The license holder of the product registration is the foreign MAH who owns the certificate of pharmaceutical product (CPP). Thus, after product approval, the CFDA license will show the same MAH’s name as on the CPP.
Why is an independent third party recommended even though my distributor can act as the local agent for my medical device product?
- Having an independent third party allows for confidentiality of technical information and less reliance on a distributor, whose primary motive may only be sales. In cases where your distributor is acting as your local agent, if your distributor does not perform well and you wish to end the relationship, the distributor may attempt to charge a large fee to transfer the existing registrations or refuse to transfer them at all.
Pacific Bridge Medical can act as your local representative in China. If you are interested in our local agent representation services, contact us now for a free consultation with our expert Asia consultants.
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