China Agent (代理人) — Introduction
The China Agent is a mandatory legal role with no direct parallel in the FDA, EU MDR, TGA, or HSA frameworks. It is one of the most important China-unique features for overseas manufacturers to understand.
Under Article 39 of MDSAR 2021, every overseas manufacturer of medical devices sold in China must appoint a China Agent (境内代理人). The Agent must be a legal entity registered in China (not an individual).
The China Agent is not merely an administrative contact — it bears joint liability with the overseas manufacturer for product quality and regulatory compliance.
What does joint liability mean in practice?
Joint liability means that if the device causes harm, or if regulatory violations occur, NMPA can take enforcement action against either the overseas manufacturer or the China Agent (or both). The Agent cannot shield itself by claiming it was just a paperwork intermediary.
Core functions of the China Agent
- Registration holder: The China Agent is named on the NMPA registration certificate as the domestic contact
- Adverse event reporting: Must submit adverse event reports to NMPA on behalf of the overseas manufacturer
- Recall co-ordination: Must co-ordinate and execute recalls within China
- GMP co-operation: Must facilitate NMPA overseas inspections
- Label review: Must ensure Chinese labelling complies with NMPA requirements
Where to go next
For the full China Agent guide, see the dedicated China Agent section.
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.