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Complimentary Webinar
April 9, 2024|2:00 PM ET (US)

Japan Medical Device
Registration & Reimbursement


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?


  • 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


  • Medical Device Executives in business development, regulatory affairs and reimbursement market access


Ames Gross

Ames Gross
Pacific Bridge Medical

Mr. Gross founded Pacific Bridge Medical in 1988 and has helped hundreds of medical companies with regulatory issues and business development in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. In 2008, Medical Device and Diagnostic Industry (MD&DI) magazine named Mr. Gross one of the top 100 executives in the medical business. Mr. Gross is a frequent contributor of articles on Asian medical issues for RAPS, 
Clinica (England), MD&DI (Los Angeles), and other medically oriented journals. He has been a featured speaker on the Asian medical markets at the Medical Design and Manufacturing (MD&M) shows, the Medtrade Home Health Care Exhibition, the Regulatory Affairs Professional Society’s annual and regional meetings, and a variety of other medically oriented meetings and conferences. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

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