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类别: REGULATORY PATHWAYS
上市许可持有人(MAH)
在特定管辖区持有医疗器械上市监管批准的法律实体。在中国（NMPA）和日本（PMDA），外国制造商必须指定本地MAH/DMAL持有人。
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
In China, the Marketing Authorization Holder (MAH) is the legal entity responsible for device registration and post-market duties. Foreign manufacturers generally cannot hold NMPA certificates directly.
PROCESS / STEPS
- Select a qualified Chinese MAH partner or establish a local entity.
- Define contractual duties for registration, vigilance, and quality agreements.
- Submit dossiers under MAH identity; maintain change notifications.
EXAMPLES
- A US OEM appoints a Chinese MAH for Class II registration and AE reporting.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 上市许可持有人(MAH) across 27 authorities in real time.
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