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類別: REGULATORY PATHWAYS

DMAL持有人（指定上市許可持有人）

持有日本醫療器材上市許可的日本法律實體。外國製造商必須為PMDA提交指定DMAL持有人。DMAL持有人負責QMS合規、警戒和監管溝通。

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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相關術語

承認(日本上市前批准)上市許可持有人(MAH)