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.
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.
- Maintain necessary communication channel between clients and NMPA Notify and deliver NMPA regulatory updates
- 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
Please email firstname.lastname@example.org for a complete checklist of legal agent changes in China.