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    Challenges in Clinical Evaluation for the EU Versus China

    This article illustrates how to write a Clinical Evaluation Report (CER) based on China’s National Medical Products Administration (NMPA) guidance and how to convert and submit existing EU CER requirements for NMPA, formerly the China Food and Drug Administration (CFDA). The authors compare and contrast the process of converting an MDR compliant CER for submission in China by demonstrating the differences in requirements, outlining specific requirements for China and p...