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Adverse Event Monitoring & Re-evaluation Measures

This page provides a plain English reference for adverse event monitoring & re-evaluation measures in China's medical device regulatory framework. Full content to be completed during editorial review.

Overview​

See MDSAR 2021 for the primary regulation. This page covers the implementing measure or standard listed above, explaining its scope, key requirements, and relationship to MDSAR 2021.

Official source​

Official texts are published on www.nmpa.gov.cn and the State Council website at www.gov.cn.

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.

Scope​

This measure implements Articles 81-87 of MDSAR 2021, establishing the framework for adverse event monitoring, medical device safety signals, risk re-evaluation, and recalls.

Key Requirements​

  • Manufacturers and registrants must establish adverse event monitoring systems
  • Serious adverse events must be reported to NMPA within 30 days
  • Regular periodic safety update reports (PSURs) required for Class II and III devices
  • NMPA conducts risk re-evaluation based on reported data
  • Manufacturers must implement recalls when safety risks are identified
  • Distributors and medical institutions must report adverse events to manufacturers or NMPA

Relationship to MDSAR 2021​

This measure operationalizes Chapter VI of MDSAR 2021, providing detailed procedures for the adverse event reporting, monitoring, and re-evaluation obligations outlined in Articles 81-87.