What is a China Agent? (境内代理人)
The China Agent is mandatory for all overseas manufacturers of medical devices sold in China. It is defined in MDSAR 2021 Article 39 and has no direct equivalent in the FDA, EU MDR, TGA, or HSA frameworks. Key difference: the China Agent bears joint liability for product quality — it is not a mere administrative representative.
Statutory definition
MDSAR 2021 Article 39 provides:
Overseas medical device registrants or filers shall designate a domestic enterprise legal person (境内企业法人) as agent (代理人). The agent shall assume joint liability with the overseas registrant or filer for the safety and effectiveness of the medical device...
The key elements:
- Mandatory — every overseas manufacturer supplying devices in China must appoint a China Agent
- Enterprise legal person — the Agent must be a company (法人) registered in China; individuals cannot be China Agents
- Joint liability — the Agent is co-responsible with the manufacturer for device safety and quality. This is more than a representation role.
What the China Agent does
| Function | Detail |
|---|---|
| Registration submission | Submits registration or filing application to NMPA on behalf of the overseas manufacturer |
| Named on certificate | China Agent's name and address appear on the registration certificate |
| Adverse event reporting | Submits adverse event reports to NMPA |
| Recall co-ordination | Co-ordinates and executes recalls within China |
| GMP co-operation | Facilitates NMPA overseas GMP inspections |
| Label oversight | Ensures Chinese labelling complies with NMPA requirements |
| NMPA liaison | Primary NMPA contact for all post-market regulatory matters |
What the China Agent is NOT
- Not the importer of record (may or may not be the same entity)
- Not the distributor (though may also act as distributor)
- Not a mere paperwork intermediary — joint liability means real legal exposure
Comparison with other frameworks
| Role | Jurisdiction | Liability |
|---|---|---|
| China Agent (代理人) | China | Joint liability with manufacturer for quality |
| EU Authorised Representative | EU MDR | Representation; can be named in enforcement action |
| US Agent (21 CFR 807.40) | USA | Administrative contact only; no product liability |
| Australian Sponsor | TGA (Australia) | Holds registration; liable as sponsor |
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.