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類別: CLASSIFICATION
III類醫療器材
美國最高風險類別的醫療器材，需要PMA批准。III類器材維持或支持生命、被植入體內或存在潛在不合理風險。例如心臟起搏器、心臟瓣膜和藥物洗脫支架。
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 III is the highest US risk class—usually PMA—covering life-supporting/implantable or high-risk devices.
PROCESS / STEPS
- Confirm Class III status early in development.
- Plan clinical evidence and manufacturing controls.
- Execute PMA strategy and post-approval commitments.
EXAMPLES
- Pacemakers and many high-risk implants are Class III.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to III類醫療器材 across 27 authorities in real time.
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