Planning to take your products to Japan? Japan represents an 18-billion-dollar market for medical device manufacturers, and 40% of that is imports. However, entering the Japanese marketplace requires careful forethought and planning.

In this audio conference we provide an overview of the regulatory process in Japan including detailed timelines, cost estimates, and common mistakes made during market entry. The first part of the presentation will focus on the time and cost associated with a Japanese device submission, as well as outlining the steps needed to prepare for a submission. In the second part, our speaker discusses the initial steps of any Japanese submission and explains the difference in device classifications and approval categories. From there, we move on to common pitfalls and shortcomings of most foreign device submissions. This will include a detailed look at the different data and analysis needed, as well as a cultural section on dealing with Japanese reviewers, market authorization holders (MAH) and distributors.

This audio conference covers:

• Estimating cost and timelines for a Japanese medical device submission
• How to prepare for a Japanese submission
• What data to include
• How to apply for FMA and prepare for a QMS audit
• How to classify your device
• Common dos and don'ts

About the speaker:

Michael Halper is president of Small World Medical, a medical device services firm that specializes 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?

• CEOs/Presidents
• VPs/Directors of Regulatory Affairs
• International Regulatory & Clinical Managers
• Business Development Managers
• International Marketing Managers

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.

To learn more about Japanese translations, please visit ForeignExchange Translations website by clicking here