What is DMAH and Why Foreign Manufacturers Need One for Japan

If you're an overseas medical device manufacturer planning to enter the Japanese market, one of the first — and most critical — steps is selecting a DMAH (Designated Marketing Authorization Holder), known in Japanese as Yakuji Dairi-nin (薬事代理人).

What is a DMAH?

Under Japan's Pharmaceutical and Medical Device Act (PMD Act), foreign manufacturers cannot directly hold a marketing authorization (承認/認証) in Japan. Instead, they must designate a Japanese entity — a DMAH — to apply for and maintain the approval on their behalf.

The DMAH acts as the legal responsible party in Japan for the device's regulatory status, post-market surveillance, and adverse event reporting.

Key Responsibilities of a DMAH

A DMAH takes on substantial regulatory obligations, including:

• Submitting the marketing authorization application to PMDA or a Registered Certification Body (RCB)
• Serving as the primary contact for PMDA during the review process
• Conducting post-market surveillance (PMS) and periodic safety updates
• Reporting adverse events and field safety corrective actions (FSCAs) to MHLW/PMDA
• Managing labeling to ensure compliance with Japanese requirements

J-MAH vs. DMAH: What's the Difference?

You may also encounter the term J-MAH (Japan Marketing Authorization Holder). In practice, J-MAH and DMAH refer to the same concept — the entity holding the Japanese marketing authorization. "J-MAH" is the term commonly used in international regulatory contexts, while "DMAH" is the English translation of the Japanese legal term.

How to Select the Right DMAH

Choosing the right DMAH is critical for a smooth market entry. Key criteria include:

Criterion	What to Look For
License type	Must hold the appropriate Manufacturing and Marketing Authorization (第一種〜第三種製造販売業許可)
Therapeutic area expertise	Experience with your device category (e.g., GI endoscopy, orthopedics)
Language capability	English communication for seamless collaboration
Track record	Proven experience with foreign manufacturers
Post-market capabilities	In-house PMS and adverse event reporting systems

Common Pitfalls

• Selecting a DMAH based on cost alone: A low-cost DMAH without deep regulatory expertise can lead to submission delays or rejections.
• Underestimating post-market obligations: DMAH responsibilities don't end at approval — ongoing PMS and reporting are legally required.
• Poor communication: If your DMAH cannot communicate effectively in English, managing the regulatory process becomes unnecessarily difficult.

How MK Consulting Can Help

At MK Consulting, we support overseas manufacturers in selecting and working with the right DMAH for their products. We also provide end-to-end regulatory support — from PMDA submission strategy to document preparation — entirely in English.

Contact us for a free consultation →