1、User Manual – IFU (with all accessories and reference numbers description)用户手册 – IFU（包含所有附件和参考编号说明
2、 Technical Documentation (Technical File or Normative document) in country of origin 原产国的技术文件（技术文件或规范文件）
General description of the key functional elements关键功能元件的描述
Reference to similar and previous generations of the device参考同类和前几代设备
Drawings with dimensions带尺寸的图纸
Real photos, high quality, high resolution高质量，高分辨率的真实照片，
Raw materials description, type, grade, composition - %, name of material manufacturer 原材料描述、种类、等级、成分-%、材料制造商名称
Labels on the device and its packaging设备及其包装上的标签
Design and Manufacturing Information (containing information on general (high level) understanding of the manufacturing processes. Production Scheme)设计和制造信息（包含对制造过程的一般（高级）理解的信息,生产方案）
3、Risk management file according to ISO 14971符合ISO 14971/的风险管理文件
4、Clinical Evaluation Report according to MEDDEV 2.7/1 rev.4根据 MEDDEV 2.7/1 rev.4 的临床评估报告
5、Test Reports 测试报告
6、 In case of medical substance inside medical device如果医疗器械内有医疗物质
Local Certificate of Registration of pharma substance in the country of origin原产国当地药品注册证
GMP in the country of origin (if available)原产国的良好作业规范（如果有）
7、Vigilance report (according to MEDDEV 2.12/1 rev.8) and Post-marketing surveillance report 警戒报告（根据 MEDDEV 2.12/1 rev.8）和上市后监督报告
8、Usability report according to IEC 62366符合 IEC 62366 的可用性报告
