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類別: SAFETY SURVEILLANCE
嚴重不良事件
導致死亡、危及生命、住院、殘疾、先天異常或需要醫療干預以防止永久損害的不良事件。嚴重不良事件觸發向監管機構的強制報告。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
A serious adverse event (SAE) in the device context generally involves death, life-threatening illness/injury, permanent impairment, hospitalization, or medical/surgical intervention to prevent permanent damage—definitions vary slightly by jurisdiction and vigilance rules.
PROCESS / STEPS
- Triage complaints with seriousness criteria and causality assessment.
- Report within statutory clocks (e.g., FDA MDR timelines; EU vigilance timelines).
- Initiate risk assessment, CAPA, and field actions when trends or severity warrant.
- Document decisions even when not reportable.
EXAMPLES
- Unintended extended hospitalization after device malfunction typically meets seriousness criteria for evaluation as a reportable event.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 嚴重不良事件 across 27 authorities in real time.
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