Who Needs to Comply?
MDSAR 2021 imposes obligations on every party in the medical device supply chain in China.
Domestic manufacturers (境内生产企业)
Any entity manufacturing medical devices in China must:
- Obtain the relevant registration or filing before placing the device on the market
- Hold a Medical Device Production Licence (for Class II/III) or complete a production filing (for Class I)
- Comply with GMP requirements (NMPA Order No. 53)
- Designate a Responsible Person (质量负责人) with personal accountability for quality
Overseas manufacturers and importers (境外生产企业)
Overseas manufacturers wishing to supply their devices in China must:
- Register or file the device with national NMPA through their China Agent (代理人)
- Appoint a China Agent who is a legal entity registered in China
- Co-operate with NMPA overseas inspections
- Ensure their quality system is compliant (NMPA accepts ISO 13485 for importers)
The China Agent acts as the legal representative in China and bears joint liability for product quality. See China Agent.
China Agents (代理人)
See the dedicated China Agent section for full obligations.
Distributors (经营企业)
Distributors of Class II and Class III devices must hold a Medical Device Business Licence. All distributors must maintain traceability records, conduct incoming inspection, and co-operate with NMPA market surveillance. See Operation Supervision Measures.
Hospitals and healthcare institutions (使用单位)
Hospitals and clinics using medical devices have obligations under MDSAR 2021 to maintain registers for implantable devices, report adverse events, and co-operate with recalls.
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.