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[Comparative study of device labeling regulation in U.S.A. and China]
1Liaoning Food and Drug Administration Technical Evaluation Center, Shenyang, 110003. lifei@ldate.org.cn
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 U.S.A. and China: juristic system, administrative scope, administrative target, characteristics and practice,
Conclusions:
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.
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