Japan's D-MAH System: Regaining Control of Your Medical Device

Medical Device Global Market Access · Nov 9, 2025 · 3m

This episode explores the critical strategic choice between appointing a distributor versus an independent Designated Marketing Authorization Holder (D-MAH) for medical device registration in Japan. We break down how using an independent D-MAH allows foreign manufacturers to retain ownership of their marketing approvals, providing essential flexibility in distribution strategy, safeguarding confidential information, and ensuring robust regulatory compliance in the Japanese market. Key Questions: • What is the difference between an MAH and a D-MAH in Japan? • Who legally owns your product…