The 13th US Medical Device Market Entry Seminar: Latest FDA Regulations and the US Market for Medical Devices – Unexpected Pitfalls Revealed Through Extensive Experience｜Event｜A portal supporting medical device development

The 13th US Medical Device Market Entry Seminar: Latest FDA Regulations and the US Market for Medical Devices – Unexpected Pitfalls Revealed Through Extensive Experience

2026.8.28

第13回米国医療機器進出セミナー最新の医療機器FDA規制と米国市場～多くの経験から見えた、意外な落とし穴～

Globits will be hosting the "U.S. Medical Device Market Entry Seminar," sponsored by the U.S. Embassy, on September 11, 2026.
This seminar is designed for companies considering entering the US market for medical devices. We will cover the latest trends in FDA regulations, key points for responding to inspections, and practical information necessary for market entry. Furthermore, we will invite a guest speaker from Europe to discuss the latest trends in the EU MDR (European Medical Device Regulation) and efficient expansion strategies for the US and European markets.
On the day of the event, consultants from the United States and Europe will be visiting Japan, and after the seminar, there will be an opportunity for participants to network and exchange business cards. We will also be accepting individual consultations regarding market entry into the United States and Europe, as well as regulatory compliance.
This will be a valuable opportunity for companies considering expanding into overseas markets to gain useful information, so please join us.

■Date and Time: Friday, September 11, 2026, 14:30-16:40 *Networking reception from 16:55-18:00 ■Venue: Global Business Hub Tokyo (Otemachi)
3F, Otemachi Financial City Grand Cube, 1-9-2 Otemachi, Chiyoda-ku, Tokyo
https://www.gbh-tokyo.or.jp/access
■Organizers: GLOBIZZ Corp., GLOBIZZ Japan Co., Ltd. ■Supported by: U.S. Embassy in Japan, Commercial Section ■Participants: Medical device manufacturers and their affiliated organizations *Applications from competitors and companies that compete with the organizers will not be accepted.
■Participation fee: Free ■Languages used: Japanese, English ■Capacity: 100 people (40 people for the social gathering)
■Registration: 13th US Medical Device Market Entry Seminar Registration Form
■Application Deadline: September 4th (Friday). Applications will close once the maximum number of participants is reached. If the maximum number of participants is reached, we may have to decline applications from multiple people from the same company.
■Inquiries Regarding the Seminar Content:
GLOBIZZ CORPORATION Miyakoshi Email: tokyo@globizz.net
Regarding seminar registration:
U.S. Embassy, Commercial Section, Hanawa Email: hiroyuki.hanawa@trade.gov
■Program Details
Please see here .