Through Japan-US Medical Device Harmonization by Doing (HBD), the U.S. FDA, MHLW/PMDA, academia, and industry developed internationally agreed upon standards for global clinical trials related to cardiovascular devices, and addressed regulatory barriers that may delay timely medical device approvals in both countries.
In order to announce the outcome of recent HBD activities and discuss future plans with the public, the HBD East 2019 Think Tank Meeting was held on December 11, 2019 in Tokyo.
Approximately 170 people from regulators, academia and industries in the U.S. and Japan participated in this meeting and the high-profile topics such as utilization of real world evidence and promotion of pediatric medical device development were discussed in addition to providing working group activity updates. In panel discussions, several experts shared their experiences and discussed potential solutions for challenges in the development of medical devices.
Host
Ministry of Health, Labour and Welfare (MHLW)
Pharmaceuticals and Medical Devices Agency (PMDA)
The Japan Federation of Medical Device Associations (JFMDA)
Date
Wednesday, December 11, 2019
9:30 a.m. - 5:30 p.m.
Venue
Nadao Hall, Zenshakyo
Shin-Kasumigaseki Building lobby floor, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo, Japan
Speakers
Outcome
Outcome Statement
Panel Discussion Summary
Program
Please click here for information.
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Regulatory Innovation for Safe and Early Access to Medical Devices in Japan |
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Overview of HBD Activity |
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HBD Steering Committee |
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HBD for Children |
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Challenges and Achievement: Japanese Regulatory View |
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Challenges and Achievement: Japanese Academia View |
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How Should We Develop Medical Devices for a Small Market? |
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Panel Discussion |
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Pre and Post-Market Use and Current Consideration of RWE for Regulatory Use |
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The Effort of Generating Robust RWE Including Registry and Post-market Survey: Japanese Academia View |
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A Multinational Company’s Effort of Utilizing RWE |
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How Can We Generate Robust Real-World Evidence from Real-World Data? |
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Panel Discussion |
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The Approach and Challenges of Entering an Overseas Market |
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The Approach and Consideration of Advancing into Overseas Market |
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Current and Prospective Activities: US Regulatory View |
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Panel Discussion |
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Closing Remarks |
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