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    • 『make out to order of』 鐪夊北棣佸洷鐑﹀箍鍛婁紶濯掓湁闄愬叕鍙?mbaynet.com

    二类医疗器械经营备案

    发布时间:2022-05-21

    二类医疗器械是指,对其安全性、有效性应当加以控制的医疗器械。包括X线拍片机、B超、显微镜、生化仪等都属于二类医疗器械。二类医疗器械经营备案则是经营以上器械需要取得的备案。

    《医疗器械督管理条例》第三十条规定:从事第二类医疗器械经营的,由经营企业向所在地设区的市级人民政府食品药品监督管理部门备案并提交其符合本条例第二十九条规定条件的证明资料。

    《医疗器械督管理条例》第二十九条规定:从事医百疗器械经营活动,应当有与经营规模和经营范围相适应的经营场所和贮存条件,以及与经营的医疗器械相适应的质量管理制度和质量管理机构或者人员。

    想要申办二类医疗器械经营备案的企业必须具备的条件:

    1、质检机构负责人应具有大专以上学历或中级以上职称。

    2、企度业负责人问应具有中专以上学历或初级以上职称。

    3、企业应具备相应的答产品质量检验能力。

    4、企业内初级以上职称工程技术人员应占有职工总数的相应比例。

    5、应有与所生产产品及规模相配套的生产、仓储场地及环境。

    6、企业应收集并保存与企业生产、经营有关的法律、法规、规章及有关技术标准。

    7、具有相应的生产设备。

    8、生产无菌医疗器械的,应具有符合规定的生产场地。

    • 地址

      邯郸市邯山区光明南大街148号城市新秀小区1-1805
    • 联系电话

      电话:13703109979 手机: 13703109979 邮箱:[email protected]
    • 医械注册
    • 医械许可证
    • 医械备案
    • 体系辅导/法规培训
    • CE/FDA认证
    • 临床评价/试验
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