Accelerate Market Entry in China with Expert China Agent Services

Yes, a China agent is required for foreign medical device manufacturers to conduct clinical trials in China. Any foreign manufacturer must designate a domestic enterprise legal person as an agent, and this agent is responsible for coordinating and cooperating with the clinical trial processes and Regulatory requirements in China.

In China, the responsibilities of an agent in monitoring adverse events and ensuring medical device safety include:
 

• Assisting medical device registrants and recorders in carrying out adverse event monitoring for medical devices.
• Actively collecting and reporting adverse events and suspicious adverse events to the technical institutions for monitoring purposes as per the provisions of the drug supervision and administration department under the State Council.
• Reporting overseas adverse events and control measures to the state medical devices administration and national monitoring agencies on time after informing and sending a copy to the local provincial drug supervision and administration department.
• Promptly reporting follow-up disposals and risk-related information to the provincial drug supervision and management department where the enterprise is located, and announcing it to the public.
• Cooperating with the investigation of adverse events conducted by technical institutions for monitoring adverse events of medical devices, drug supervision and management departments, and competent health departments.
• Establishing an information transmission mechanism with the designated agent to exchange information on adverse events monitoring and re-evaluation of medical devices promptly.
  
  These responsibilities are aimed at ensuring that safety is maintained and any potential risks associated with medical devices are managed effectively.