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类别: REGULATORY PATHWAYS

DMAL持有人（指定上市许可持有人）

持有日本医疗器械上市许可的日本法律实体。外国制造商必须为PMDA提交指定DMAL持有人。DMAL持有人负责QMS合规、警戒和监管沟通。

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 Japan, a Designated Marketing Authorization Holder (DMAL) is the local entity that holds marketing authorization and postmarket duties for foreign manufacturers.

PROCESS / STEPS

  1. Select a qualified DMAL with device expertise.
  2. Contract quality, vigilance, and communication SLAs.
  3. Align Japanese labeling and PMS processes.
  4. Reassess on portfolio or manufacturing changes.

EXAMPLES

  • US OEMs typically cannot hold Shonin approvals directly without a Japanese DMAL structure.

RELATED GUIDES & TOOLS

SOURCES

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相关术语

承认(日本上市前批准)上市许可持有人(MAH)