医疗器械说明书国际协调文件研究和思考

目的进一步完善医疗器械说明书管理,提高医疗器械说明书质量.方法总结国内经验文献,介绍国际医疗器械监管机构论坛(IMDRF)协调文件《医疗器械和诊断器械说明书、标签原则》所汇集的国际经验.结果IMDRF国际协调文件分十个章节定义和分类汇总了医疗器械说明书、标签所应包含的基本原则.结论根据医疗器械说明书监管现状和借鉴国际监...

Research and Thinking of International Coordination Documents for Medical Device Labeling

Objective To further improve the regulation of medical device Introduction for Use(IFU)and improve the quality of medical device Introduction for Use(IFU).Methods Summarize domestic regulatory experience and deficiencies through literature research,and introduce the international experience gathered from the IMDRF coordination document Principles of Labelling for Medical Devices and IVD Medical Devices.Results The IMDRF international coordination document categorizes ten chapters to define and summarize the basic principles that medical device instructions and labels should contain.Conclusion According to the current status of medical device specification supervision and drawing on international supervision experience,improvement suggestions are proposed in terms of refining the IFU requires to improve the quality of the instructions,e.g.dynamic adjustment of IFU management requirements,strengthen the management of IFU for home used medical devices,and improving the standardization and rationality of medical device IFU content.We should continue to maintain effective management of medical device IFU.