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