国家药品监督管理局，医疗器械技术审评中心 发布，为进一步引导医疗器械真实世界研究的规范开展，国家药监局器审中心组织制定了《医疗器械真实世界研究设计和统计分析注册审查指导原则》，现予发布。

　　特此通告。

附件：

医疗器械真实世界研究设计和统计分析注册审查指导原则.pdf

相关网站链接：

https://www.cmde.org.cn/xwdt/shpgzgg/gztg/20240115162832179.html

For additional information regarding this alert, please contact:

VSCB Specialists
 Email：Lisa.liu@vscbcorp.com

The following is an unofficial translation

Subject：Circular on Issuing Guidelines for the Review of the Registration of Real-world Research Designs and Statistical Analyses of Medical Devices (No. 3 of 2024)

Content: The State Drug Administration, medical device Technical Review Center released, in order to further guide the standardization of medical device real-world research, the State Drug Administration's organ review Center organized the development of the "Medical device real-world Research Design and Statistical Analysis registration Review Guidelines", is now released.

We hereby inform you.

Annex: Guidelines for Registration Review of Real-world Study Design and Statistical Analysis of Medical Devices

Related website links:

https://www.cmde.org.cn/xwdt/shpgzgg/gztg/20240115162832179.html

For additional information regarding this alert, please contact:

VSCB Specialists
 Email：Lisa.liu@vscbcorp.com