Research and Practice on Medical Devices Clinical Evaluation
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 Chinas drug regulatory authority,we deeply discuss the clinical evalua-tion reform practice and corresponding achievements under the new edition of the"Regulations for Supervision and Administration of Medi-cal Devices",as well as the research and practice of real-world data application,a new tool for clinical evaluation of medical devices.
Medical deviceClinical evaluationClinical trialReal world data
万方数据
维普
