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二类医疗器械备案需要什么材料和条件

二类医疗器械都包括哪些?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医疗器械监管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

第二十九条规定从事医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

二类医疗器械备案需要提供的资料

  1. 企业营业执照副本复印件
  2. 法定代表人身份证及学历证明
  3. 企业负责人身份证明及学历证明
  4. 质量负责人身份证明及学历证明
  5. 租赁凭证及租赁合同
  6. 办公场地平面图及仓库平面图。Related products:二类医疗器械包含哪些?

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