、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；
6、公司章程、股东会决议等；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。9、凡申请材料需提交复印件的，申请人（单位）须在复印件上注明“此复印件与原件相符”字样或者文字说明，注明日期，加盖单位公章；个人申请的须签字或签章。10、申请材料应完整、清晰、签字，并逐份加
ion: (2) product technical requirements; (3) product inspectionreport; (4) clinical evaluation data; (5) sample data; productspecifications and labels; the articles of association and theresolution of the shareholders' meeting; 7. The enterprise shallestablish quality management files or forms of medical devicesaccording to its actual conditions.8. The self-guarantee statementof the authenticity of the application materials shall be signed bythe legal 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.9. Ifthe application materials need to be submitted, the applicant(unit) shall indicate the words "the copy" or the original,indicate the date and stamp the official seal of the unit; theindividual application shall be signed or signed.10. Theapplication materials should be complete, clear and signed, andadded o
