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类别: DOCUMENTATION
医疗器械标签
与医疗器械相关的所有标签、使用说明（IFU）和宣传材料。标签要求因管辖区而异——FDA要求英文，PMDA要求日文，NMPA要求中文。
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 labeling includes labels, IFU, and promotional materials. It must match the cleared/approved intended use and meet language and UDI rules of each market.
PROCESS / STEPS
- Define label hierarchy and IFU content.
- Align claims with clinical/regulatory authorization.
- Localize languages; apply UDI.
- Control revisions after design or safety changes.
EXAMPLES
- Promotional websites can be regulated labeling if they make device claims.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 医疗器械标签 across 27 authorities in real time.
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