CATEGORY: REGULATORY PATHWAYS

DMAL Holder (Designated Marketing Authorization Holder)

A Japanese legal entity that holds the marketing authorization for a medical device in Japan. Foreign manufacturers must appoint a DMAL holder for PMDA submissions. The DMAL holder is responsible for QMS compliance, vigilance, and regulatory communication.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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

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

EXAMPLES

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

RELATED GUIDES & TOOLS

SOURCES

PMDA English ↗

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