关键词: font-size:medium, ">医疗器械；风险管理；安全性；注册；血液透析

Abstract: Objective： Based on the clinical application of hemodialysis concentrates， this study explores the specific requirements and objectives of the newly revised "Guidelines for Registration and Review of Hemodialysis Concentrates". Methods： Through literature analysis， combined with the revision process of registration review guidelines， analyze the risk points of blood dialysis concentrate products， and explain the changes in the new version of evaluation requirements.Results： Pre market evaluation， as a crucial step in market access for hemodialysis concentrates， plays an important role in ensuring product quality. The new version of the guiding principles keeps pace with the times and adapts to the current product development and registration application situation. Conclusion： The new guiding principles clarify the principles and requirements for the safety and effectiveness evaluation of concentrate products， effectively unify the evaluation scale， and serve the high-quality development of the industry.

Key words: font-size:medium, ">Medical devices；Risk management；Safety； Registration； Hemodialysis