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类别: SAFETY SURVEILLANCE
严重不良事件
导致死亡、危及生命、住院、残疾、先天异常或需要医疗干预以防止永久损害的不良事件。严重不良事件触发向监管机构的强制报告。
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 严重不良事件 across 27 authorities in real time.
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