From Europe to Japan: Leveraging Your CE Mark for PMDA Approval

Medical Device Global Market Access · Aug 31, 2025 · 3m

Navigating Japan's rigorous PMDA approval process can be challenging, even for devices that already have a CE mark. This episode demystifies the requirements for a Shonin application, explaining how manufacturers can leverage their existing CE mark data. We break down the critical differences and synergies between the EU and Japanese regulatory systems, from Quality Management Systems and technical documentation to the all-important clinical data requirements and the mandatory role of a local Marketing Authorization Holder (MAH). Key Questions: • Does a CE mark guarantee PMDA approval in…