Latest / Medical Device Global Market Access
Unlocking the Japanese MedTech Market: The DMAH Strategy
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…
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