Comparative study of device labeling regulation in U.S.A. and China
Li, F.; Wei, J.; Ma, Y.; Li, Z.
Zhongguo Yi Liao Qi Xie Za Zhi 34(5): 374-377
2010
ISSN/ISBN: 1671-7104 PMID: 21179718 Document Number: 645749
To provide references for the evolvement of medical devices labeling and manual administration in China, 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. There are five main differences of device labeling regulation between U.S.A. and China: juristic system, administrative scope, administrative target, characteristics and practice, 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.