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類別: CLASSIFICATION
II類醫療器材
中等風險醫療器材，在美國通常需要510(k)許可。例如電動輪椅、輸液泵和手術鋪巾。大多數醫療器材屬於此類。
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
Class II devices present moderate risk and typically need 510(k) in the US (with exemptions). Classification drives testing, clinical expectations, and postmarket burden.
PROCESS / STEPS
- Confirm product code and class.
- Select pathway (often 510(k)).
- Plan performance testing and labeling.
- Maintain QMS and postmarket reporting.
EXAMPLES
- Many infusion pumps and monitoring accessories are Class II.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to II類醫療器材 across 27 authorities in real time.
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