Japan is the third largest medical device market in the world. However, being successful in Japan requires investigating a number of factors before registration. What are these key factors? Once the decision is made to go forward, how will your device be classified? What documents are needed for the product application dossier? What documents are needed for a Foreign Manufacturing Registration (FMR) application and a Quality Management System (QMS) application? Will your foreign clinical data be accepted in Japan? Would it be better to let your distributor register your device there or use an independent third party DMAH? What is the best strategy to maximize device reimbursement? How are devices reimbursed in Japan and what other factors can influence device reimbursement?

During this session, you will learn:

• Best strategies to register your device in Japan
• What is needed for dossier submission, FMR, and QMS
• How does the DMAH system work
• Best strategies to get device reimbursement