Analysis of Similarities and Differences between Guidance of Magnetic Resonance Diagnostic Devices Clinical Evaluation and Guidance of Medical Device Clinical Evaluation

Abstract

Clinical evaluation of medical devices plays an important role in the life cycle of medical devices. This paper introduces guidance of magnetic resonance diagnostic devices clinical evaluation and guidance of medical device clinical evaluation issued by CFDA. Their similarities and differences of the framework and content are analyzed, especially the definition, clinical evaluation methods and support data. By comparison, the clinical evaluation work of registration applicants can be more scientific and reasonable. At the same time, it can also be used for reference by the food and drug administration departments in evaluating the clinical evaluation of other products.