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In-country Representation

China Med Device can be your In-country Representative (legal agent) in China, which means you don’t need to set up an office locally. Our bilingual and bi-culture team will fulfill your local agent requirements from pre- thru post-market.

In-country representation

China Med Device, as an NMPA qualified legal agent, can fulfill the local agent requirements from pre- through post-market. Overseas manufacturers have no need to set up an office in China. Since your legal agent will be listed on your China certificate, have independent representation will give you flexibility and help you take control of your certificates in China.

Our Expertise

  • Maintain necessary communication channel between clients and NMPA Notify and deliver NMPA regulatory updates
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  • Collect adverse event data and report to NMPA
  • Cooperate with NMPA to investigate, analyze and evaluate the adverse event
  • Coordinate communication during a recall
  • Cooperate with NMPA for surveillance inspection of medical device quality

Requirements to Change Legal Agent, From a Distributor to a 3rd-Party Agent

Letting your distributor be your China legal agent can be complex sometimes. If your current distributor is your legal agent in China, you man face a lot of regulatory and commercial difficulty when you want to switch your distributor. Choosing a 3rd party legal agent like China Med Device can give you independence and flexibility so you can change your distributor based on your market strategy.

Please email info@chinameddevice.com for a complete checklist of legal agent changes in China.