China Med Device, as an NMPA qualified legal in-country representation 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 In-Country Representation 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 firstname.lastname@example.org for a complete checklist of legal agent changes in China.