e business license of Class III medical devices is handled asfollows: (1) the applicant submits the application materials to therelevant departments; (2) the relevant departments accept theapplication of the applicant; (3) investigate the actual site andreview the products; (4) grant the issuance of class III medicaldevice license.2. Legal basis: Article 14 of the Regulations on theSupervision and Administration of Medical Devices for the filing ofClass I medical devices and the application for the registration ofClass II and Class III medical devices, The following materialsshall be submitted: (1) product risk analysis data; (2) technicalrequirements of the product; (3) product inspection report; (4)clinical evaluation data; (5) product specification and labelsamples; (6) quality management system documents related to productdevelopment and production; 1. The self-guarantee statement of theauthenticity of the application materials submitted by theoperating enterprise shall be signed by the legal representativeand affixed with the official seal of the enterprise, Without theofficial seal, There must be the signature or seal of the legalrepresentative himself.9, where the application materials need tosubmit a copy, the applicant (unit)
1、三类医疗器械经营许可证办理方式如下：
（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
