美国FDA医疗器械追踪要求介绍
미국FDA의료기계추종요구개소
Introduction of FDA’s Medical Device Tracking Requirements
  • 万方数据
    中国医疗器械信息 중국의료기계신식
    CHINA MEDICAL DEVICES INFORMATION
    2014年 4期 32-36 ,共5页

    方玉%邵玉波%苑富强%李一捷

    방옥%소옥파%원부강%리일첩

    医疗器械%追踪 醫療器械%追蹤
    의료기계%추종
    medical device%tracking
    医疗器械召回的有效实施，需要有完整并有效运行的医疗器械追踪体系与之相配合。针对我国目前尚无专门的医疗器械追踪法规的现状，本文介绍了美国FDA《医疗器械追踪要求》的基本内容。虽然中美双方在国体、政体以及法律架构方面存在较大差异，但FDA对医疗器械追踪要求的法则设计思路仍具有重要的参考价值。
    의료기계소회적유효실시，수요유완정병유효운행적의료기계추종체계여지상배합。침대아국목전상무전문적의료기계추종법규적현상，본문개소료미국FDA《의료기계추종요구》적기본내용。수연중미쌍방재국체、정체이급법률가구방면존재교대차이，단FDA대의료기계추종요구적법칙설계사로잉구유중요적삼고개치。
    An integrated medical devices tracking system in effective operation is needed to sufifciently perform the recal of a medical devices. Seeing the fact that we do not have an act speciifcal y enacted for medical devices tracking system, this article introduced the basic contents of Medical Device Tracking Requirements of FDA. Although China’s political and legal system greatly differ from that of the US, the essential train of thought showed in Medical Device Tracking Requirements remains considerable reference value.
    원문보기 원문다운로드 사이트로이동
저자의 최근 논문