关键词: font-size:medium, ">医疗器械；技术审评；统一尺度；质量管理体系

Abstract: To explore the importance of unified evaluation criteria in the technical evaluation of medical devices and to introduce the practical experiences of the Center for Medical Device Evaluation， NMPA(CMDE) for the reference of relevant practitioners. Based on examples from CMDE， this study analyzes the existing problems and challenges within the current review system， in conjunction with relevant literature and regulatory policies， and discusses the practice of unifying evaluation criteria. The current quality management system for evaluation has achieved certain results， but there are still many limitations. The CMDE has made numerous beneficial attempts and explorations in promoting the unification of evaluation criteria， continuously improving and optimizing the evaluation process， and enhancing the quality and efficiency of evaluations. Unifying the technical evaluation criteria for medical devices is crucial for improving evaluation quality and efficiency. Through ongoing practical exploration， institutional innovation， and industry collaboration， we can gradually achieve the unification of evaluation criteria， providing more scientific， fair， and efficient support for the regulation of medical devices， and further ensuring their safety and effectiveness.

Key words: font-size:medium, ">Medical device； Evaluation； Criterion； Quality management system