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  • On-demand Webinar

Overview of Japan IVD Registration

Learn more about the requirements of Japan IVD registration.

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Watch now: Overview of Japan IVD registration

In this webinar, the presenter helps attendees develop a greater understanding of regulatory basics regarding Japan in-vitro diagnostic (IVD) registration, including classification, registration route, involved entities and licenses.

Webinar date 

Oct. 11, 2023


Kotaro Terada, regulatory affairs consultant, Emergo by UL


This webinar will help you gain a better understanding of the unique Japanese requirements not found in other countries.  You will learn practical information intended to equip manufacturers for future IVD marketing submissions.



About the presenter

Kotaro Terada, regulatory affairs consultant 

Kotaro Terada has over 15 years of industry experience, including the design and development of IVDs and regulatory affairs. At Emergo by UL, he assists manufacturers with marketing authorization applications, PMDA pre-sub consultations and more for the registration of IVDs in Japan. He also assists manufacturers with complying with the EU IVDR, including awareness training and regulatory pathway assessment.


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