From NMPA to CE Mark: Bridging the Regulatory Gap

Medical Device Global Market Access

This episode breaks down the essential differences between China's NMPA approval and the EU's rigorous MDR CE marking process. We explore the key gaps in regulatory philosophy, clinical data requirements, and post-market surveillance that manufacturers must bridge to expand from the Chinese to the European market. Key Questions: • Is my NMPA approval enough to get a CE mark in Europe? • What is the difference between a Notified Body and the NMPA? • How do EU MDR requirements for a Clinical Evaluation Report (CER) differ from China's? • Why is Post-Market Surveillance (PMS) more demanding under the EU MDR? • What is a Person Responsible for Regulatory Compliance (PRRC) and do I need one? • How does the approach to the Quality Management System (QMS) vary between the two regions? • Can I reuse my technical documentation from China for my EU submission? 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.