14 of the Regulations on the Supervision and Administration ofMedical Devices for the filing of Class I medical devices and theapplication for the registration of Class II and Class III medicaldevices, The following materials shall be submitted: (1) productrisk analysis data; (2) technical requirements of the product; (3)product inspection report; (4) clinical evaluation data; (5)product specification and label samples; (6) quality managementsystem documents related to product development and production; 1.The self-guarantee statement of the authenticity of the applicationmaterials submitted by the operating enterprise shall be signed bythe legal representative and affixed with the official seal of theenterprise, Without the official seal, There must be the signatureor seal of the legal representative himself.9. If the applicationmaterials need to be submitted, the applicant (unit) shall indicatethe words "the copy conforms to the original" or the textdescription on the copy, indicate the date and stamp the officialseal of the unit; the individual application shall be signed orsigned.10. The application materials should be complete,
（1）申请人提交申请资料到相关部门；
（2）相关部门受理申请人的申请；
（3）到实际场地进行勘察以及对产品进行审核；
（4）准予颁发三类医疗器械许可证。
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；1、经营企业提交的《医疗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，并逐份加盖公章，所有申请表格电脑打字填写，使用A4纸打印，复印使用A4纸，按照申请材料目录顺序装订成册。
