Latest / Medical Device Global Market Access
Beyond FDA Clearance: Unlocking Japan's PMDA Approval
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…
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