Episode Details

This episode demystifies the role of the Designated Marketing Authorization Holder (DMAH) for medical device companies entering Japan. We explore the critical differences between an MAH and a DMAH, outlining how the DMAH model allows foreign manufacturers to retain full ownership and control of their product approvals. Listeners will learn about the key responsibilities of a DMAH under the PMD Act, from regulatory submissions to post-market surveillance, and understand the strategic advantages of choosing an independent partner for long-term market success. Key Questions • What is a Designated Marketing Authorization Holder (DMAH) in Japan? • How does a DMAH differ from a standard Marketing Authorization Holder (MAH)? • Why can't foreign manufacturers register their medical devices directly with Japan's PMDA? • What are the core responsibilities of a DMAH for post-market surveillance? • How does appointing a DMAH give you more control over your product's registration? • What is a Foreign Restrictive Authorization Holder (FRAH) and how does it relate to the DMAH? • Should you appoint your distributor as your DMAH? • What are the risks of tying your market approval to a single commercial partner? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.