ate the actual site and review the product; (4) grant thethird-class medical device license.2. Legal basis: Article 14 ofthe Regulations on Supervision and Administration of MedicalDevices For the filing of Class I medical devices and theapplication for the registration of Class II and III medicaldevices, the following materials shall be submitted: (1) productrisk analysis data; (2) product technical requirements; (3) productinspection report; (4) clinical evaluation data; (5) productinstructions and label samples; (6) quality management systemdocuments related to product development and production;traceability.2. The materials required for the registration ofmedical device license are as follows: 1. Enterprise name andbusiness scope, registered capital and proportion of shareholdercontribution, identity certificates of shareholders; 2. Medicaldevice product registration certificate, supplier business license,license and letter of authorization; 3. Quality managementdocuments, etc.; 4,2 or more medical professionals or relatedprofessionals;
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；
5、符合医疗器械经营要求的办公场地及仓库证明；
6、公司章程、股东会决议等；
7、财务人员身份证和上
