Comparative study of device labeling regulation in U.S.A. and China / 中国医疗器械杂志

ABSTRACT

<p><b>OBJECTIVE</b>To provide references for the evolvement of medical devices labeling and manual administration in China,</p><p><b>METHODS</b>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.</p><p><b>RESULTS</b>There are five main differences of device labeling regulation between U.S.A. and China juristic system, administrative scope, administrative target, characteristics and practice,</p><p><b>CONCLUSIONS</b>A set of comprehensive juristic system 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.</p>