← 所有术语
类别: CLASSIFICATION
III类医疗器械
美国最高风险类别的医疗器械，需要PMA批准。III类器械维持或支持生命、被植入体内或存在潜在不合理风险。例如心脏起搏器、心脏瓣膜和药物洗脱支架。
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类医疗器械 across 27 authorities in real time.
START FREE →