Abstract： Objective To develop an evaluation model for medical device-related events (MDRE) monitoring system in medical institutions,which can be used to evaluate the MDRE system comprehensively and scientifically,and provide a scientific method for administrative authorities to assess medical institutions in China.Methods Index weight was established by Delphi method.A comprehensive assessment of MDRE monitoring system was established by system analysis method.Mathematical model was established by fuzzy comprehensive evaluation method.Results The evaluation model established in the study was suitable for assessment,and could provide scientific guidance for national administrative authorities to evaluate MDRE.Conclusion The evaluation index,index weight and other data in the comprehensive evaluation system should be improved continuously during practical application.