Boasting the second-largest medical device market in the world, it is no small wonder that Japan appeals to manufacturers. However, the Japanese market is also highly regulated, which can mean slow approval times and increased costs. When launching a medical device in Japan, it is key for managers to understand the structure, contents and various challenges associated with Japanese regulatory submissions in order to control these costs and manage regulatory timelines.

This audio conference provides a complete overview of the typical Japanese medical device submission, including labeling and linguistic requirements. Our speaker outlines the different types of submissions and the structure of each, and provides details on the specific information that must be included in the final dossier.

This audio conference covers:

• Japanese medical device submission components
• How to structure submissions
• What technical and non-technical information to include
• Japanese instructions for use and labeling
• What needs to be translated

About the speaker:

Michael Halper is president of Small World Medical, a medical device services firm specializing in helping non-Japanese companies enter the Japanese market. He has held many different positions ranging from Japanese Regulatory Affairs Specialist to Director of Sales & Marketing, and has a proven track record of successfully obtaining approval and launching new devices into the Japanese market.

Michael has lived in Japan and worked for a variety of companies, including medical device firms in the orthopedics and cardiology space. He has an International MBA with a focus on Japanese language and culture from the University of Memphis / Osaka University of Economics.

Who should attend?

• Regulatory Affairs
• Clinical Affairs
• Global Managers
• Marketing Managers
• Senior Management