Abstract：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.
刘露，崔馨月，张宇晶，钟佑锦，许伟. 系统综述、循证医学与医疗器械上市前临床评价的探讨[J]. 中国医疗设备, 2019, 34(9): 157-160.
LIU Lu, CUI Xinyue, ZHANG Yujing, ZHONG Youjin, XU Wei. Study of Systematic Review, Evidence-Based Medicine and Pre-marketing Clinical Evaluation of Medical Devices. China Medical Devices, 2019, 34(9): 157-160.
