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 linguisitc 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.
Japanese Medical Device Submission Requirements & Structure is being presented by Michael Halper, President, of Small World Medical and airs on Thursday, February 18, 2010. For more details or to register, please visit our site at www.fxconferences.com
Showing posts with label japanese device submission. Show all posts
Showing posts with label japanese device submission. Show all posts
Friday, January 22, 2010
Friday, October 9, 2009
A Systematic Approach to Japanese Medical Device Submissions
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
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
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