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Adverse Event Reporting

This page provides a plain English reference for adverse event reporting 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 adverse event reporting are set out in MDSAR 2021 and implementing measures. See Legislation & Regulations for the full legislative index.

Official Sources
Disclaimer

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.

Reporting Requirements​

  • Who reports: Manufacturers, distributors, hospitals, users, and healthcare professionals
  • What to report: Serious adverse events and unexpected adverse events; suspected causal relationship not required
  • When to report: Within 30 days of awareness for serious events; annual report for non-serious events
  • Where to report: Manufacturer (for non-serious); NMPA via CDRMP system for serious events
  • Required information: Device identification, event description, outcome, patient demographics, reporter information

Key Reporting Channels​

  1. CDRMP (China Drug/Device Registration and Management Platform): www.nmpa.gov.cn/datasearch/
  2. NMPA adverse event portal: Direct submission for manufacturers and healthcare providers
  3. Yellow Card system: For healthcare professionals and public

Manufacturer Obligations​

  • Conduct post-market surveillance (PMS) and periodic safety update reports (PSUR)
  • Assess signal detection and causal relationship
  • Implement corrective actions (labeling updates, recalls) as needed
  • Notify NMPA of significant safety findings within timeframe specified in implementing measures

Reference Documents​

Report forms and detailed procedures available on www.nmpa.gov.cn under 'Adverse Event Reporting' and 'Guidance Documents'