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
