Service Item
Agent Service
We provide agent service for manufacturer of import medical devices.

Imported medical device agent service content

1. Handling medical device registration related matters, responsible for liaison between NMPA and overseas registrants

2. Communicate relevant laws and technical requirements to overseas registrants in a timely manner and supervise the implementation

3. To undertake the monitoring of adverse medical events for imported medical devices, and report to the drug regulatory authorities in time for adverse events that occur outside the product.

4. Coordinate product recall after the listing of medical devices and report to the drug regulatory authority

5. Assisting the drug regulatory authority in conducting inspections of overseas registrants

Forum Contact 010-63311696 Policy