Legal and After Sales Agent for Medical Devices and Pharmaceuticals/Drugs in China

When marketing a drug or medical device in China, even if it is through a Chinese distributor, it may be important to have an independent in-country representative for your products that is a legal entity registered in China. This representative serves as the required local entity that deals with the government regarding product registration and renewal, adverse event reporting, etc.

For medical devices, two agents are required. First, to be considered an after sales agent, the business scope described in the business license of the local legal Chinese entity must include a provision that states the after sales agent will "provide technical service and support for the medical device product." Second, for the legal agent, the key responsibilities include — a) reporting any adverse events regarding the medical device that occur inside or outside China to the SFDA and b) handling any recall issues as they arise.

For pharmaceuticals, the SFDA has no requirements for a legal agent or after sales agent.

PBM can act as your local representative in China. Having an independent third party allows for confidentiality of technical information and less reliance on a distributor, whose primary motive may only be sales.


For more information on local representation in China, please see the following PBM publications and/or contact us to discuss your specific needs.

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