Selecting a China Agent
This page provides practical guidance on selecting a qualified China Agent, including verification steps, capability assessment criteria, and contractual considerations to protect both parties.
Regulatory basis
- MDSAR 2021 Article 39 — China Agent definition and joint liability
- NMPA Order No. 47 — registration and filing administration measures
- NMPA guidance on agent change procedures
See the China Agent overview for context.
Content on this site is written with AI assistance and is intended as a navigation aid only. Always verify against official NMPA sources before making regulatory decisions. Not affiliated with NMPA or any Chinese Government body. Not legal or regulatory advice.
Add guidance on Agent selection criteria: (1) Must be a registered enterprise legal person (法人) in China with valid business license; (2) Should have prior NMPA agent experience or medical device industry knowledge; (3) Must have dedicated staff for post-market compliance and NMPA liaison; (4) Check Agent's track record via NMPA PDMS (publicly disclosed medical device system) for any enforcement actions or recalls; (5) Confirm Agent capacity to handle adverse event reporting and GMP inspection logistics; (6) Obtain written agreement specifying liability allocation, fee structure, and termination terms.