保证产品从购进到销售整个过程的有效质量跟踪和追溯。
申请医疗器械经营许可证所需材料:
医疗器械经营许可证办理依据《北京市实施细则(2017年修订版)》,具体提交材料如下:
1.《 医疗器械经营许可申请表》(原件1份)
2.《营业执照》复印件(交验原件);(复印件1份)
3.法定代表人、企业负责人、质量负责人的身份证明(查验原件)、学历或者职称证明复印件(对于统一采购渠道,采取连锁经营的非法人零售企业,提供连锁企业总部质量负责人身份证明、学历或者职称证明复印件);(交验原件) (复印件共3份)
4.企业基本情况(原件1份)。(内容包含:组织机构与部门设置说明、经营场所、库房的地理位置图、平面图(注明面积)、库房的产权证明及使用权证明复印件、(委托贮存的,应提交经营场所地理位置图、平面图(注明面积)和与被委托方签署的书面协议复印件、被委托方的《医疗器械经营许可证》复印件)
whole process from purchase to sale. Materials required for applying for the Medical Device Business License: The medical device business license is handled according to the Implementation Rules of Beijing Municipality (2017 Revision), and the specific materials are as follows: 1. Application Form for Business License of Medical Device (1 original) 2. Copy of Business License (original submitted for inspection); (1 copy) 3. The legal representative, head of the enterprise, qua