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

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 Japan? • Can my ISO 13485 certificate satisfy Japan's QMS requirements under MHLW Ordinance No. 169? • What is the STED (Summary Technical Documentation) and how does it differ from my EU Technical File? • Must all documentation be submitted in Japanese? • Will my European clinical data and CER be accepted by the PMDA? • What are the common reasons the PMDA might require a new clinical trial in Japan? • What is a Marketing Authorization Holder (MAH) and why is one essential for market entry? • How does the Medical Device Single Audit Program (MDSAP) affect the process? • What were the key changes in the March 2024 QMS compliance deadline? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.