title: [Comparative study of device labeling regulation in U.S.A. and China].
abstract: 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.
authors.affiliation: Liaoning Food and Drug Administration Technical Evaluation Center, Shenyang, 110003. lifei@ldate.org.cn
authors.forename: Fei
authors.initials: F
authors.lastname: Li
authors.forename: Jing
authors.initials: J
authors.lastname: Wei
authors.forename: Yanbin
authors.initials: Y
authors.lastname: Ma
authors.forename: Zhu
authors.initials: Z
authors.lastname: Li
mesh_terms: D002681:China; D003625:Data Collection; D018795:Device Approval / Q000331:legislation & jurisprudence*; D011356:Product Labeling / Q000331:legislation & jurisprudence*; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration