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》
三类医疗器械许可证经营范围包括:医用电子仪器设备，医用光学器具、仪器及内窥镜设备，医用磁共振设备，医用X射线设备，手术室、急救室、诊疗室设备及器具。售卖医疗器械必须办理经营许可
证，根据相关法律规定，国家食品药品监督管理局逐步推行医疗器械经营质量规范管理制度。医疗器械经营质量管理规范由国家食品药品监管管理局组织制定。
ment signed with the principal party, the principal copy of the medical device business license) 5. Enterprise facilities and equipment information (1 original copy).(Contents include: business facilities, equipment catalogue, business quality management system, working procedures and other documents catalogue, basic information introduction of computer information management system and function description) (1 original) 6. Authenticity guarantee materials (1 original).(The content includes: the self-guarantee declaration of the authenticity of the declaration materials, and the false commitment of assuming legal responsibility for the materials. If the application materials, the specific handling personnel is not the legal representative or the person in charge, the enterprise shall submit the power of attorney The business scope of the third class medical device license includes: medical electronic instruments and equipment, medical optical instruments, instruments and endoscope equipment, medical magnetic resonance equipment, medical X-ray equipment, operating room, emergency room, medical room equipment
