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类别: SAFETY SURVEILLANCE
器械缺陷
与医疗器械的标识、质量、耐用性、可靠性、安全性或性能相关的任何不足。器械缺陷可能但不一定导致不良事件，必须作为上市后监管的一部分进行评估。
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
Device deficiency (especially in clinical investigations) refers to inadequacy of a device related to identity, quality, durability, reliability, safety, or performance—including malfunctions—whether or not an adverse event occurred.
PROCESS / STEPS
- Capture deficiencies during trials and commercial use separately from clinical outcomes.
- Assess whether deficiency could lead to serious adverse events if it recurred.
- Report per clinical investigation plan and regulatory rules.
- Feed findings into design changes and risk management.
EXAMPLES
- A cracked housing discovered during a clinical trial is a device deficiency even if no patient was harmed.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 器械缺陷 across 27 authorities in real time.
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