China Agent in-country representation for medical devices

ANSWERED ON THIS PAGE:

  • What is the role of the China Agent?
  • What should we consider when choosing a representative in China?
  • What is an After Sales Service Provider?

China’s National Medical Products Administration (NMPA) requires foreign medical device manufacturers to appoint an in-country regulatory representative (Agent) to manage their product registrations. Your Agent is critical to your device registration and success in the China market, so it is important to consider your choice carefully.

China Agent representation through our office in Beijing

Emergo has the experience and resources to help you succeed in China. We understand the importance of independent representation and our experts in Beijing have the regulatory expertise to serve the interests of your company. As your Agent, we can:

  • Submit your registration application and dossier to the NMPA
  • Liaise with the NMPA during the registration process
  • Manage all changes, modifications, renewals or cancellations to your registration certificate
  • Assist with post-market surveillance and vigilance activities and assist with adverse-event reporting, if needed

Emergo acts as an in-country representative to more than 2,000 medical device manufacturers in markets around the world.

Advantages of a third-party China Agent

Some medical device manufacturers choose to appoint their distributor as their China Agent, but there are strong reasons not to do so. An experienced, third-party representative is in the best position to serve the best interests of your company in China. Your Agent must field questions from the NMPA and perform post-market obligations, if necessary.

It is possible to appoint a distributor as your Agent. But this can create unforeseen complications, especially when dealing with inquiries from the NMPA and other complex regulatory matters.

Common questions about China Agent representation for device companies

What is the difference between an Agent and an After Sales Service Provider?

The Agent is your liaison with the NMPA and acts as the local regulatory contact for the device in China. The After Sales Service Provider is responsible for the products on the market from a servicing and maintenance perspective. This role is typically assigned to a distributor and must be identified in the Instructions for Use (IFU).

Who “owns” the China registration – the Agent or the manufacturer?

The manufacturer “owns” the registration and can transfer representatives without the previous Agent’s permission. However, the Agent is listed on both the registration certificate and on the device labeling. This can be problematic from a business relationship standpoint if one of your distributors act as your Agent, and you intend to use multiple distributors in China   

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