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Changing Your China Agent

This page outlines the formal process for changing your China Agent, required documentation, NMPA approval timeline, and continuity of regulatory responsibility during the transition.


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.

Disclaimer

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 step-by-step process for changing China Agent: (1) Obtain written approval from current Agent; (2) New Agent prepares change application with MDSAR 2021 Article 39 compliance documentation; (3) Submit change request to NMPA including new Agent company registration, legal representative details, and authorization letter from overseas manufacturer; (4) NMPA reviews and issues amended registration certificate with new Agent name; (5) Timeline is typically 5–10 working days after submission. Include note: overseas manufacturer remains responsible during change period.