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医疗器械经营许可证代办医疗器械经营许可证如何办理?

彭易Aaron说医疗器械经营许可证代办医疗器械经营许可证应当在所在地市级食品药品监督管理部门提出申请申请需要具备相关条件具有与经营范围和经营规模相适应的质量管理机构或者质量管理人员质量管理人员应当具有国家认可的相关专业学历或者职称

一医疗器械是指通过常规管理即可保证其安全性有效性的产品二医疗器械是需要加以控制的产品三医疗器械是具有较高危险性必须要严格控制的产品对于这三类产品都有具体的目录经营者在遇到困惑的时候可以通过查阅目录来确定分类

医疗器械许可证对人员的

Require

  1. 申请医疗器械经营许可证至少5个人关外的公司好6个人以上增加技术人员一名
  2. 经营范围含B类医疗器械的企业负责人应具有医疗器械相关专业本科以上学历或医疗器械相关专业中级以上职称
  3. 经营范围含D类医疗器械的应配备1名初级验光师以上职称的专业技术人员
  4. 企业负责人和质量负责人不得相互兼任相关产品医疗器械经营许可证代办 , 医疗器械经营许可证如何办理?

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