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 registration if your distributor is the MAH?

• What happens to your market access if you want to switch distributors in Japan?

• How can you protect your confidential device information from your commercial partners?

• Why is an independent D-MAH a more flexible long-term strategy?

• What is the Foreign Special Approval System (FSAS) and how does it help foreign manufacturers?

• How does using an independent D-MAH impact your commercial and distribution strategy?

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 [email protected] for tailored support.