关键词: font-size:medium, ">安全；有效；技术审评；基本原则；风险管理

Abstract: Medical device evaluation plays very important role in the process of medical device registration. This article elaborates the role of “Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices” and “Medical devices-Application of Risk Management to Medical Devices”in the process of evaluation， as well as how to implement evaluation scientifically， so as to provide relevant professionals with evaluation mindset and review focuses.

Key words: font-size:medium, "> , Safety； Effective； Evaluation； Essential principles； Risk management