To the outsider, the Japanese regulatory process may seem obscure. But with the internationally harmonised Japanese Pharmaceutical and Medical Devices Law now fully implemented, things aren’t so complex as you may think.
Join our guest speaker, Hajime Kawasaki from Japan – Kawasaki-san will take a look at how things work in Japan and how you can leverage work already done for European (CE) approvals.
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About the speaker:
Hajime Kawasaki is an administrative lawyer in Japan with Kawasaki Legal Services, established in 2002. He is an expert in Japanese regulatory affairs for medical devices and also provides services on European CE- marking for Japanese clients.