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類別: SAFETY SURVEILLANCE
器材缺陷
與醫療器材的標識、品質、耐用性、可靠性、安全性或性能相關的任何不足。器材缺陷可能但不一定導致不良事件，必須作為上市後監管的一部分進行評估。
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 器材缺陷 across 27 authorities in real time.
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