约定由第三方提供技术支持;
6.经营无菌和植入类产品的公司需建立计算机管理系统及计算机管理制度,能够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)
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)
hase to sales. Materials required for applying for the MedicalDevice Business License: The medical device business license ishandled according to the Implementation Rules of BeijingMunicipality (2017 Revision), and the specific materials are asfollows: 1. Application Form for Business License of Medical Device(1 original) 2. Copy of Business License (original copy forinspection); (1 copy) 3. The legal representative, head of theenterprise, quality of the identity certificate (check theoriginal), certificate or title certificate copy (for unifiedpurchasing channels, take the chain enterprise headquarters qualityidentity certificate, degree or copy of the title certificate);(submit the original) (copy of 3 copies) 4. Basic information ofthe enterprise (1 original copy).(Content includes: organizationand department set instructions, premises, warehouse location map,plan (indicate area), warehouse of property certificate and theright certificate copy, (entrust storage, should be submitted tothe site location map, plan (indicate area) and the writtenagreement signed with the principal party, the principal copy ofthe medical device business license) 5. Enterprise facilities andequipment information (1 original copy).(Contents include: businessfacilities, equipment catalogue, business quality managementsystem, working procedures and other documents catalogue, basicinformation introduction of