系统综述、循证医学与医疗器械上市前临床评价的探讨

Study of Systematic Review,Evidence-Based Medicine and Pre-marketing Clinical Evaluation of Medical Devices

医疗器械临床评价是评价医疗器械安全有效性的重要方法和手段。在医疗器械注册申报过程中,很多注册申请人对医疗器械的临床评价、系统综述与循证医学的关系混淆不清甚至混为一谈,错误地理解了医疗器械临床评价的要求,降低了工作效率。本文介绍了系统综述、循证医学、医疗器械上市前临床评价的概念,并从医疗器械审评角度探讨了三者之间的关系,以期指导注册申请人更好地做好医疗器械上市前临床评价工作。

Pre-marketing clinical evaluation is an important method to evaluate the safety and effectiveness of medical devices.But in the process of medical devices registration,the relationship between clinical evaluation,systematic review and evidence-based medicine is confused and even conflated by many applicants.The misunderstandings of requirements for clinical evaluation of medical devices have great impact on registration working efficiency.We introduced the concepts of systematic review,evidence-based medicine and premarket clinical evaluation of medical devices,and discussed the relationship between them from the perspective of medical device evaluation in this study,so as to help registered applicants in premarket clinical evaluation of medical devices.