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Navigating Opportunities in Software as a Medical Device for 2024

The global market for Software as a Medical Device (SaMD) is rapidly expanding, with projections indicating a growth to US$86.5 billion by 2027. Japan, recognizing the potential of SaMD, has implemented policies to foster the development and commercialization of these innovative medical solutions. This presents a lucrative opportunity for European medtech and digital health companies looking to enter or expand in the Japanese market.


Join our webinar to gain comprehensive insights into the Japanese SaMD landscape, including market potential, regulatory framework, health insurance reimbursement, and effective localization strategies. Discover how Kobe’s Biomedical Innovation Cluster, a leading life sciences ecosystem in Japan, can support your business’s growth and success in this dynamic market.




1. Welcome and Introduction
Overview of the MAGIA/FBRI Collaboration
Presenter: Sarah Niemann, Manager International Affairs, Life Science Nord Management GmbH

2. Exploring the Kobe Biomedical Innovation Cluster
Insights into Japan’s premier life sciences ecosystem
Presenter: Takako Yokochi, Senior Coordinator, Medtech Group, FBRI

3. Understanding SaMD in Japan: Market, Regulation, and Reimbursement
A comprehensive guide to navigating Japan’s regulatory landscape
Presenter: Tadanori Yasuda, Group Leader, Medtech Group, FBRI

4. Innovation in Bio-Pharma and Regenerative Medicine
Latest trends and developments
Presenter: Keiko Kobayashi, Chief Coordinator, Drug Discovery & Biomedicine Group, FBRI

5. Case Study: Dürr Dental’s Success in Japan
A firsthand account of entering and thriving in the Japanese market
Presenter: Uwe D. Haul, CEO, Durr Dental Japan K.K.

6. Fostering EU-Japan Business Collaborations
Opportunities for partnering in Japan
Presenter: Daniel Gralki, Consultant, EEN, EU-Japan Centre for Industrial Cooperation


Votre contact à Lyonbiopôle

Simon Gudin

Chargé d'Affaires PME Biotech & Resp. international