Watch now: Japan regulatory requirements – Medical device software
Our Emergo by UL expert will equip you with the knowledge and insights needed to successfully introduce your SaMD products to the Japanese market.
Webinar date
Aug. 8, 2024
Speaker
Kenji Yashiro, manager, Quality and Regulatory Affairs program, Emergo by UL
As the global market for medical device software (SaMD) expands, navigating the regulatory landscape becomes increasingly critical for manufacturers. While many regions share similar regulatory approaches, Japan presents unique challenges and opportunities.
This webinar will help you better understand the knowledge and insights needed to introduce your SaMD products to the Japanese market successfully.
About the presenter
Kenji Yashiro, manager, Quality and Regulatory Affairs program, Emergo by UL
Kenji Yashiro has more than 20 years of medical device regulatory knowledge and extensive technical experience in device development, manufacturing and quality control. His background includes 40+ medical device registration submissions in Japan, pre-submission consultations with the Pharmaceuticals and Medical Devices Agency (PMDA), more than 10 years of experience with risk management files compliant with ISO 14971, over a decade of regulatory strategy research in Japan and more than three years managing Marketing Authorization Holder (MAH) responsibilities.
Yashiro manages Emergo Japan’s Regulatory Affairs consulting team. In this role, he has peer-reviewed numerous regulatory filings and reports. Prior to Emergo, he held device development, manufacturing and quality control positions in the medical device industry as well as roles in regulatory affairs consulting.
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