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)
5.企业设施设备情况(原件1份)。(内容包含:经营设施、设备目录、经营质量管理制度、工作程序等文件目录、计算机信息管理系统基本情况介绍和功能说明)(原件1份)
6.企业真实性保证材料(原件1份)。(内容包含:申报材料真实性的自我保证声明,并对材料作出如有虚假承担法律责任的承诺、凡申请企业申报材料时,具体办理人员不是法定代表人或负责人本人的,企业应当提交《授权委托书》
The application for a medical device business license is basedon the "Implementation Rules of Beijing Municipality (2017 RevisedEdition)", and the specific materials to be submitted are asfollows:
1. Application Form for Medical Device Business License (1original)
2. Copy of Business License (original for inspection); (1copy)
3. Identity certificates of the legal representative, enterpriseleader, and quality manager (original copies to be verified),copies of education or professional title certificates (for noncorporate retail enterprises that adopt chain operation throughunified procurement channels, provide copies of the identitycertificate, academic experience, or professional title certificateof the quality manager at the headquarters of the chainenterprise); (Original submission for inspection) (3 copies intotal)
4. Basic information of the enterprise (1 original copy).(Content includes: explanation of organizational structure anddepartment settings, geographical location map and floor plan ofbusiness premises and warehouses (indicating area), copies ofproperty ownership certificate and usage right certificate ofwarehouses, (for entrusted storage, copies of geographical locationmap and floor plan of business premises (indicating area) andwritten agreement signed with the entrusted party, and copies ofthe entrusted party's "Medical Device Business License" should besubmitted)
5. Information on enterprise facilities and equipment (1original copy). (Content includes: directory of operatingfacilities, equipment, quality management system, work proceduresand other documents, introduction to basic information andfunctional description of computer information management system)(1 original copy)
6. Authenticity assurance materials for the enterprise (1original). (The content includes: a self assurance statement on theauthenticity of the application materials, and a commitment to bearlegal responsibility for any false information in the materials. Ifthe specific personnel handling the application materials of theenterprise are not the legal representative or person in charge,the enterprise shall submit a "Power of Attorney".)