title: [Investigation on Medical Device Standards].
abstract: In this paper, Medical Device Standards, including Nation standards and Professional standards are investigated. The major problems that may appear in the Medical Device Standardization are analyzed. Based on the result of the analysis, some policy suggestions on the medical device standardization are put forward, which may help the authority making policy of standardization in Medical Device.
authors.affiliation: Center for Medical Device Evaluation, SFDA, Beijing. xiaoyuan1976@vip.sina.com
authors.forename: Jun
authors.initials: J
authors.lastname: Li
mesh_terms: D002681:China; D004864:Equipment and Supplies / Q000592:standards*