Entering the Japanese Medical Device Market: Regulatory Pathways, Consultation Opportunities, and Practical Insights
September 1, 2026 |
7:00 PM – 8:30 PM ET
September 2, 2026 |
8:00 AM – 9:30 AM JST
Learn how your company can become part of Japan’s medtech ecosystem.
Entering the Japanese Medical Device Market: Regulatory Pathways, Consultation Opportunities, and Practical Insights
September 1, 2026 |
7:00 PM – 8:30 PM ET
September 2, 2026 |
8:00 AM – 9:30 AM JST
Entering the Japanese Medical Device Market: Regulatory Pathways, Consultation Opportunities, and Practical Insights
September 1, 2026 |
7:00 PM – 8:30 PM ET
September 2, 2026 |
8:00 AM – 9:30 AM JST
Interested in expanding your business into the Japanese market? Join Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for a free online Workshop on September 1, 2026 designed to help U.S. small and mid-sized medtech companies better understand the opportunities, requirements, and resources available for entering the Japanese market.
Japan is the world’s fourth-largest medical device market and is well positioned to serve as an important gateway to the broader Asia-Pacific region. PMDA will provide practical information on Japan’s medical device regulatory framework, scientific advice services, and review processes, including key considerations for companies preparing to enter the Japanese medical device market.
You will also learn about services offered by PMDA and the PMDA Washington, D.C. Office, including how to seek advice and who to contact when you are ready to take the first step toward entering the Japanese market. In addition, U.S. medtech companies with experience operating in Japan will share their market entry journeys, lessons learned, and practical insights. The workshop will also include an interactive Q&A session, providing an opportunity to engage directly with PMDA and industry speakers on regulatory matters.
Don’t miss this opportunity to gain practical insights, get your questions answered, and learn how your company can become part of Japan’s vibrant medtech ecosystem.
What You’ll Gain
- Practical information on Japan’s medical device regulatory framework, scientific advice services, and review processes, including key considerations for companies preparing to enter the Japanese medical device market.
- Insight into the scientific advice services offered by PMDA and the PMDA Washington, D.C. Office, including how to seek advice and who to contact when you are ready to take the first step toward entering the Japanese market.
- Opportunities to hear directly from leaders at U.S. medtech companies with experience operating in Japan as they share their market entry journeys, lessons learned, and practical insights.
Program
Learn about Japan’s regulatory framework, consultation services, and medical device review process, then hear firsthand lessons on entering and succeeding in the Japanese market. Stay tuned for a full agenda with session and speaker details.
*Agenda as of 7/22
| Session Title | Speaker |
|---|---|
| Opening Remarks | Dr. Akihiro Ishiguro, Head of PMDA Washington, D.C. Office, PMDA |
| Japan’s Medical Device Market and Opportunities for Global Companies | Kenichi Ishibashi, Senior Scientist, Office of Medical Devices Inspection, PMDA |
| PMDA Consultation Services and First Points of Contact | Dr. Akihiro Ishiguro, Head of PMDA Washington, D.C. Office, PMDA |
| Medical Device Review in Japan: Practical Considerations for Market Entry | Dr. Shin Iwamoto, Deputy Review Director, Office of Medical Devices I, PMDA |
| Journey to Japan (Part 1): Perspectives from U.S. Medtech Companies Operating in Japan | Inspire Medical Systems, Inc |
| Journey to Japan (Part 2): Perspectives from U.S. Medtech Companies Operating in Japan | To Be Announced |
| Interactive Discussion/Q&A | – Kenichi Ishibashi, Senior Scientist, Office of Medical Devices Inspection, PMDA – Dr. Akihiro Ishiguro, Head of PMDA Washington, D.C. Office, PMDA – Dr. Shin Iwamoto, Deputy Review Director, Office of Medical Devices I, PMDA |
| Closing Remarks | Abby Pratt, Senior Vice President, Global Strategy & Analysis and Department Deputy, AdvaMed |
Panelist
Kenichi Ishibashi, Senior Scientist, Office of Medical Devices Inspection, PMDA
Kenichi Ishibashi, Senior Scientist, Office of Medical Devices Inspection, PMDA
Experience:
- 2021 – present
Senior Scientist, PMDA
MDSAP Regulatory Authority Council(RAC) Chair (2022-2023), A member of MDSAP RAC (2024 – Present) - 2014 – 2021
Junior Scientist, Office of Standards and Compliance for Medical Devices, PMDA
Assessment to MDSAP Auditing Organizations and Registered Certification Bodies(RCBs) - 2008 – 2014
Principal Inspector, Office of Manufacturing and Vigilance for Medical Devices, PMDA
A member of GHTF SG3, IMDRF MDSAP and ISO TC210; QMS Inspection to domestic & oversea manufacturers - 2006 – 2008
Inspector, Non-clinical and Clinical Compliance, PMDA
Clinical Inspection to HealthCare Facilities, PMS Inspection to Pharmaceuticals Companies
Akihiro Ishiguro, Head of PMDA Washington, D.C. Office, PMDA
Akihiro Ishiguro, Head of PMDA Washington, D.C. Office, PMDA
Dr. Akihiro Ishiguro, PhD is the Head of Pharmaceuticals and Medical Devices Agency (PMDA) Washington D.C. Office. His work at PMDA began in 2004 when PMDA was established, allowing him to experience the contribution of post marketing drug safety, new drug review, review management, and regulatory science research promotion. He had the opportunity to join projects to develop regulatory guidelines in the field of Clinical Pharmacology such as the MHLW guidelines (e.g., Drug Interaction, Population Pharmacokinetics, Exposure Response Analysis) and the ICH guidelines (e.g., Qualification of Genomic Biomarkers, Genomic Sampling). He had also worked as a leader in the field of Pharmacokinetics in Offices of Drug Review, PMDA; a leader of Omics working group, Project across multi-offices in PMDA; a regulatory chair of the ICH M12 (Drug Interaction Studies) expert working group. He received his PhD degree in Pharmaceutical Sciences from the Chiba University, Japan in 2009.
Abby Pratt, Senior Vice President, Global Strategy & Analysis and Department Deputy, AdvaMed
Abby Pratt, Senior Vice President, Global Strategy & Analysis and Department Deputy, AdvaMed
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