Chinese Journal of Medical Instrumentation 2010;34(5):374-377

Comparative study of device labeling regulation in U.S.A. and China.

Fei LI 1 2 ; Jing WEI ; Yanbin MA ; Zhu LI

Affiliations

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Country

China

Language

Chinese

Abstract

OBJECTIVETo provide references for the evolvement of medical devices labeling and manual administration in China,

METHODSBy 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.

RESULTSThere are five main differences of device labeling regulation between U.S.A. and China: juristic system, administrative scope, administrative target, characteristics and practice,

CONCLUSIONSA 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.