This episode demystifies the process of obtaining medical device approval in Japan for companies that already have FDA clearance. We explore the critical differences between the two systems and outline the essential steps manufacturers must take, from appointing a local representative to preparing a Japan-specific submission dossier and navigating clinical data requirements for either Shonin or Ninsho approval.
Key Questions:
• Does FDA clearance guarantee market access in Japan?
• What is a Marketing Authorization Holder (MAH) and why is it essential?
• How does Japan's device classification system determine the approval pathway?
• What is the difference between "Shonin" approval and "Ninsho" certification?
• Is an ISO 13485-compliant QMS sufficient for Japan's Ordinance 169?
• Will the Japanese PMDA accept clinical trial data from the United States?
• What is the Summary Technical Documentation (STED) format?
• How can manufacturers proactively address potential hurdles in the Japanese review process?
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