Post-Market Surveillance
This page provides a plain English reference for post-market surveillance 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 post-market surveillance 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.
Post-market surveillance (上市后监测) is mandated by MDSAR 2021 Articles 48-52. Manufacturers must establish and implement surveillance programmes proportionate to device risk. Requirements include: systematic collection of real-world performance data; monitoring of adverse events through direct communications, healthcare provider reports, and user complaints; assessment of device performance against registration dossier claims; documentation of trends and safety signals; reporting to NMPA if significant issues are identified; and cooperation with NMPA during regulatory inspections. NMPA may require enhanced surveillance for Class III devices, newly registered devices, or devices with identified safety concerns. Surveillance records must be retained for minimum 5 years. CMDE publishes post-market surveillance guidance and data collection templates.