Distribution and Traceability
This page provides a plain English reference for distribution and traceability under China's NMPA regulatory framework. Full content to be completed during editorial review.
Regulatory basis
- MDSAR 2021 (State Council Order No. 739)
- Adverse Event Monitoring & Re-evaluation Measures
- Relevant NMPA orders and announcements
Key requirements
Requirements for distribution and traceability are set out in MDSAR 2021 and implementing measures. See Legislation & Regulations for the full legislative index.
- NMPA — www.nmpa.gov.cn
- CMDE — www.cmde.org.cn
- NMPA Medical Device Registration Query — datasearch.nmpa.gov.cn
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.
China requires medical device manufacturers, importers, and distributors to establish traceability systems meeting the requirements of MDSAR 2021 Articles 43-45. Key requirements include: unique device identification (UDI) labelling or batch/serial tracking; records of all distribution steps from manufacturer to end-user or patient; ability to implement recalls rapidly; documentation retention for at least 5 years post-expiration; and coordination with NMPA during post-market surveillance. Distributors must maintain records of supply sources and customer information. NMPA has issued detailed guidance on UDI implementation through the Medical Device UDI System.