关键词: font-size:medium, ">医疗器械；临床评价；临床试验；真实世界数据

Abstract: Clinical evaluation is a set of ongoing activities that use scientifically sound methods. Medical devices clinical evaluation is an activity that verify the safety， clinical performance and/or effectiveness of the medical device through the assessment and analysis of clinical data. This article reviews the development process of medical devices clinical evaluation when marketing approval regulation of medical devices was gradually implemented since 1990. Through analyzing the key issues and proposing solution of medical device clinical evaluation during the review and approval system reform.And summarizing the research achievements of the Clinical Evaluation working group of the International Medical Device Regulatory Forum led by China's drug regulatory authority， we deeply discuss the clinical evaluation reform practice and corresponding achievements under the new edition of the “Regulations for Supervision and Administration of Medical Devices”， as well as the research and practice of real-world data application， a new tool for clinical evaluation of medical devices.

Key words: font-size:medium, ">Medical device；Clinical evaluation；Clinical trial；Real world data