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China Agent vs Importer vs Distributor

This page clarifies the distinct regulatory roles and liabilities of China Agents, importers, and distributors under MDSAR 2021. Each entity has separate legal obligations and liability exposure.

Regulatory basis​

  • MDSAR 2021 Article 39 β€” China Agent definition and joint liability
  • NMPA Order No. 47 β€” 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 a comparison table with rows for China Agent, Importer, and Distributor showing: (1) Definition under MDSAR 2021, (2) Regulatory registration responsibility, (3) Liability exposure, (4) Post-market obligations, (5) Whether multiple entities can be same company. For example: China Agent must be a domestic enterprise legal person with joint liability for safety/quality; Importer is the entity legally responsible for importing goods into China territory; Distributor is the end-stage seller to hospitals/clinics with no mandatory registration or joint liability.