2、法律依据：《医疗器械监督管理条例》第十四条
第一类医疗器械产品备案和申请第二类、第三类医疗器械产品注册，应当提交下列资料：
（一）产品风险分析资料；
（二）产品技术要求；
（三）产品检验报告；
（四）临床评价资料；
（五）产品说明书以及标签样稿；
（六）与产品研制、生产有关的质量管理体系文件；。
6、公司章程、股东会决议等；
7、财务人员身份证和上岗证；5、房产证明、房屋租赁证明（出租方要提供产权证明）应有效；6、企业负责人、质量管理人的简历、学历证明或职称证明应有效；7、企业应根据自身实际建立医疗器械质量管理档案或表格。8、申请材料真实性的自我保证声明应由法定代表人签字并加盖企业公章，如无公章，则须有法定代表人本人签字或签章。
ection report; (4) clinical evaluation data; (5) productinstructions and label samples; (6) quality management systemdocuments related to product development and production;6. Articlesof association and resolution of shareholders' meeting, etc.; 7. IDcard and working certificate of financial personnel; 5. Propertycertificate and house lease certificate (property right certificateprovided by the lessor) shall be valid; 6. CV of the principal andquality manager shall be valid; 7. The enterprise shall establishquality management files or forms of medical devices according toits actual conditions.8. The self-guarantee statement of theauthenticity of the application materials shall be signed by thelegal representative and affixed with the official seal of theenterprise. If there is no official seal, there must be thesignature or signature of the legal representative himself.
