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.
A Systematic Approach to Japanese Medical Device Submissions is being presented by Michael Halper, President, of Small World Medical and airs on Tuesday, November 10, 2009. For more details or to register for this event, please visit our website at www.fxconferences.com
To learn more about Japanese Translations, please visit ForeignExchange Translations website at www.fxtrans.com
