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》
nd the right certificate copy, (entrust storage, should besubmitted to the site location map, plan (indicate area) and thewritten agreement signed with the principal party, the principalcopy of the medical device business license) 5. Enterprisefacilities and equipment information (1 original copy).(Contentsinclude: business facilities, equipment catalogue, business qualitymanagement system, working procedures and other documentscatalogue, basic information introduction of computer informationmanagement system and function description) (1 original) 6.Authenticity guarantee materials (1 original).(The contentincludes: the self-guarantee declaration of the authenticity of thedeclaration materials, and the false commitment of assuming legalresponsibility for the materials. If the application materials, thespecific handling personnel is not the legal representative or theperson in charge, the enterprise shall submit the powe
