relevant departments shall accept the application of theapplicant; (3) investigate the actual site and review the products;(4) grant the issuance of the third III medical device license.2.Legal basis: Article 14 of the Regulations on Supervision andAdministration of Medical Devices For the filing of Class I medicaldevices and the application for the registration of Class II andIII medical devices, the following materials shall be submitted:(1) product risk analysis data; (2) product technical requirements;(3) product inspection report; (4) clinical evaluation data; (5)product instructions and label samples; (6) quality managementsystem documents related to product development and production; (7)other materials required to prove the safety and effectiveness ofthe product.2. The materials required for the registration of threemedical 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 relatedprofessional certificates, identification and resume;
三类医疗器械经营许可证如何办理
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；
（七）证明产品安全、有效所需的其他资料。
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岗证；
8、其它相关材料。
