中美医疗器械说明书和标签法规管理的比较研究

Comparative Study of device labeling regulation in USA and China

目的为我国完善和发展医疗器械标签和说明书的管理提供借鉴。方法采用内容分析方法,资料是从美国食品药品管理局网站上收集的有关美国管理医疗器械标签和说明书的10个法律文件,并以联邦法规为主进行对比分析。结果中美医疗器械标签和说明书法规的主要差异体现在体系结构、管理范围、管理对象、管理特征和实际使用5个方面。结论美国已建立了一套完整的法律体系管理医疗器械标签和说明书,我国应从中得到启示,分类管理处方器械和非处方器械,建立相关指导原则,以确保医疗器械安全、有效地使用。

OBJECTIVE To provide references for the evolvement of medical devices labeling and manual administration in China,METHODS By content analysis,10 juristic documents relevant to device labeling and manual were collected from FDA website,compared to which,the federal regulation was mainly analyzed. RESULTS There are five main differences of device labeling regulation between USA and China：juristic system,administrative scope,administrative target,characteristics and practice,CONCLUSIONS A set of comprehensive juristicsystem for device labeling has been established by FDA,from which China should draw experience,to administrate the prescription devices and the over-the-counter devices in classification,and set up device labeling guidance,thus guarantee the safety and efficacy of device.