U.S. Commercial Service Japan
Embassy of the United States of America

Tokyo, JapanJuly 2024

Dear AllThe Commercial Service of the U.S. Embassy in Tokyo provides a variety of support for promoting
exports of U.S. products and services to Japan. Since 2011, we also started assisting Japanesecompanies to invest in the U.S. by serving as the contact point of the investment promotion
program called “Select USA.” The U.S. Embassy and Select USA is committed to providing Japanesecompanies with up-to-date information about investing in the United States.
As part of this program, we are pleased to announce that we will be sponsoring the 11th “US
Medical Device Market Entry Seminar - US Market is Your Gateway to the World -” on Friday,
September 6, hosted by GLOBIZZ CORPORATION of Los Angeles, California, an expert of the U.S.
healthcare market and FDA application.
The United States continues to be the largest medical technology market and the most important
market for Japanese healthcare-related companies. The “Medical Device Industry Vision 2024”
released by the Ministry of Economy, Trade and Industry this March also indicated that theimportance of developing the global market, especially the U.S. market, which is the largest market
in the world, as a direction that domestic medical device manufacturers should aim for.
In this seminar, we will give presentations regarding the importance of obtaining FDA approval. Not
only a US-based consultant will give a lecture on the latest trends in FDA regulations and key pointsof the US medical device business but also a European consulting company will explain an overview ofthe European Medical Device Regulation (MDR) and the benefits of having FDA approval when getting anapproval in Europe.
The U.S. Embassy and Commercial Service hopes that this seminar will be a meaningful for all those whoare considering expansion into the U.S. healthcare market, as well as for companies interested in thepotential of the U.S. market.
We kindly ask you to resister by the registration deadline.
Sincerely yours

Senior Commercial Officer,U.S. Embassy in Tokyo
Daniel Lew(Note: This is not an endorsement or recommendation of the relevant company as a U.S. government agency.)

1-10-5 Akasaka, Minato-ku, Tokyo 107-8420 Japan
Tel: +81-3-3224-5060 Fax: +81-3-3224-5064
Email: Office.Tokyo@trade.govwww.buyusa.gov/japan/

11th “U.S. Medical Device Market Entry Seminar”- US Market is Your Gateway to the World ■ Date and Time

September 6th, 2024（Fri）15:00 ～ 18:00■ Place

OTEMACHI FINANCIAL CITY, GBHT
1-9-2 Otemachi, Chiyoda-ku, Tokyo 100-0004,JAPANhttps://www.gbh-tokyo.or.jp/access■ HostGLOBIZZ Corp.

■ Co-hostGlobizz Japan■ Sponsor

U.S. Embassy in Japan, Qtics Medical■ TargetParticipants

Medical device manufacturers and their affiliated organizations*Please do not apply from companies in the same industry or companies competing withthe host.
Free■ ParticipationFee■ L a ng u ag e
■ Seating Capacity■ Registration

I n qu i ry

100 seatsfrom the link

■ Registration
Deadline■Japanese, English

Or from the QR

Friday, August 23
We will close as soon as the maximum number of participants is reached. Please
note that we may not accept more than one person from a single company if thenumber of participants reaches the maximum number.
About the Seminar:
GLOBIZZ CORPORATION Ms. Nagao Email: tokyo@globizz.net
About seminar registration：
U.S. Embassy, Commercial Service Mr. Hanawa Email: hiroyuki.hanawa@trade.gov◆ Program◆

15：00

Opening remarks by Globizz Corp.

15：05

Greetings from the U.S. Department of Commerce and Introduction of Select USA・・・U.S, Embassy, Commercial Service

15：10

Attractiveness of the U.S. Market and Key Points of the U.S. Medical Device Business・・・Globizz Consulting (U.S.)
Takahiro Haruyama, President Key points of the U.S. market and the U.S. medical device business, and points tokeep in mind when considering expansion to the U.S. market
FDA Consulting by Physicians
・・・ Globizz Consulting （U.S.）Tomoko Asagami M.D., Ph.D, M.B.A, Lead Researcher
 FDA regulatory overview, key points for FDA approval, FDA latest trends
Overview of European MDR/IVDR and the advantage of having an FDA Approval when Entering
the European Market・・・QTICS Medical （Hungary） Tóth András

15：30

15：50
16：10

16：30
16：35
16：55
17：00

Quality System Regulation (QSR) and FDA Inspections
・・・Globizz Japan（Japan）Miyuki Nagao, Senior Manager
 FDA inspection process and latest trends, overview of QSR and key points, transitionto QMSRIntroducing Globizz Services
Q&A Session
Closing RemarksBusiness Card Exchange and Networking Event※Program is subject to change.

This event, sponsored by the U.S. Embassy, Commercial Section, is for Japanese companies that are considering importing U.S. products
or services in the purpose of supporting the relevant U.S. company’s business activities in Japan, but does not constitute an official
endorsement, certification, or recommendation of the company, its products or services by the U.S. government agency.