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From Tokyo to Brussels: Navigating the EU MDR After Japan Shonin

From Tokyo to Brussels: Navigating the EU MDR After Japan Shonin

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 Securing Shonin approval in Japan is a huge regulatory achievement, but it doesn’t guarantee a simple path to the European market. This episode breaks down the key differences between Japan's PMD Act and the EU's demanding Medical Device Regulation (MDR). We explore the critical gaps manufacturers must address in their Quality Management System, technical documentation, clinical evidence, and post-market surveillance strategies to successfully obtain a CE Mark. Key Questions: • Can I reuse my Japanese technical documentation for my CE Mark application? • Why is the EU's Clinical Evaluation Report (CER) more demanding than Japanese requirements? • What is a Periodic Safety Update Report (PSUR) and do I need one for Europe? • How does a Japanese Marketing Authorization Holder (MAH) differ from an EU Authorised Representative? • Is my Japanese QMS automatically compliant with EU standards? • What are the biggest hurdles when moving from the Japanese market to the EU? • Does Shonin approval shorten the timeline for getting an EU CE Mark? 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 info@pureglobal.com for tailored support.
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