Watch now: Medical device regulatory requirements - new Japanese guidelines
Japan’s medical device market is one of the most robust markets in Asia, but its regulatory system can prove confusing. Before deciding to sell your device in the Japanese market, it is important to understand how the regulations apply, which steps to take, and what resources you’ll require to complete the process.
Dec. 14, 2022
This presentation reviews some of the most complex aspects of the Japanese registration process, including:
- JMDN codes – Device classification and predicates.
- Clinical data requirements and PMDA pre-submission meetings.
- Registration routes (Todokede, Ninsho, Shonin).
- QMS (Ordinance 169) requirements.
- Role of the Marketing Authorization Holder (MAH).
About the presenter:
Kenji Yashiro, manager quality & regulatory affairs program, Emergo by UL
Kenji Yashiro has more than 20 years of medical device regulatory knowledge, combined with 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 PMDA, more than 10 years of experience with risk management files compliant with ISO 14971, more than 10 years of regulatory strategy research in Japan, and more than three years managing 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.