DMAH: Designated Marketing Authorization Holder-Summary Ver.

​A DMAH lets a foreign medical device or IVD manufacturer sell products in Japan and hold the marketing approval in its own name — without setting up a Japanese subsidiary.

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Why DMAH is the Best Route for Foreign Manufacturers
Foreign manufacturers have three ways to enter the Japanese market. 
The killer advantage of DMAH: You retain control of your product approval while outsourcing the complex Japanese regulatory work — and you can change your sales distributor anytime without touching your approval.　

What Is a DMAH?
A DMAH (Designated Marketing Authorization Holder) is a licensed Japanese company that acts as your legal representative in Japan under the Foreign Special Approval System.

• References
  • "Designated Marketing Authorization Holder (DMAH), 「選任外国製造医療機器等製造販売業者」" ​（https://www.japaneselawtranslation.go.jp/en/laws/view/3213#je_ch5sc2at3, PMD Act, Article 23-2-17​. *shown as "designated holder of marketing authorization for foreign-manufactured medical devices" ）
  • Foreign Manufacturer Approval　https://www.pmda.go.jp/review-services/drug-reviews/foreign-mfr/0008.html​　
• You (the foreign manufacturer) are the Foreign Special Approval Holder — the official owner of the product approval.
• The DMAH is your in-country agent, legally responsible for:
  • Filing the marketing approval / certification application
  • Managing QMS quality compliance and GVP post-market safety
  • Acting as the official liaison with PMDA and MHLW
  • Incoming inspection, release testing, labeling, adverse-event reporting

Four Core Advantages

1. No Japanese subsidiary required Skip the cost and time of establishing a company, office, and hiring the three statutory controllers ("San-yaku") required by the PMD Act.
2. You keep the approval in your name Unlike the "distributor-as-MAH" model, your product license is never "held hostage" by a local partner.
3. Full flexibility over sales channels Because regulatory responsibility (DMAH) and commercial distribution are decoupled, you can appoint, change, or run multiple distributors freely — without any impact on your approval.
4. Faster, expert-driven market entry A specialized DMAH firm with PMDA experience handles filings, QMS audits, and FMER registration far faster than an in-house team would.

What a DMAH Does for You
A DMAH handles the full regulatory lifecycle in Japan on your behalf:

• Regulatory filings — Marketing approval and certification applications, STED preparation, QMS conformity assessment, and Foreign Manufacturer Establishment Registration (FMER)
• Quality control (QMS) — Incoming inspection, release testing, and domestic quality oversight
• Post-market safety (GVP) — Adverse event collection and reporting, recall management, and periodic safety reports
• Labeling & promotion — Package insert updates, statutory Japanese labeling, and review of promotional materials
• Authority liaison — Direct communication with PMDA, MHLW, and certification bodies​

Categorization of DMAH by business origin