nt departments shall accept the application of the applicant;(3) investigate the actual site and review the products; (4) grantthe issuance of the third III medical device license.2. Legalbasis: Article 14 of the Regulations on the Supervision andAdministration of Medical Devices and applying for the registrationof Class II and Class III medical devices, the following materialsshall be submitted: (1) product risk analysis data; (2) producttechnical requirements; (3) product inspection report; (4); (4)clinical evaluation data; (5) product specification and labelsamples; (6) quality management system documents related to productdevelopment and production; 1. Medical 7. Certificate preparationand certification submitted by the operating enterprise. Theconditions for applying for the business license of Class IIImedical devices are as follows: 1. Having the business site andwarehouse matching the business scope, and having specificrequirements for its specific area; 2. Having the nationallyrecognized professional personnel related to the business pro
（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
7.制证、发证。
办理三类医疗器械经营许可证的条件如下：
1、具有与经营范围相匹配的经营场所和仓库，并对其具体面积有具体要求；
2、具有国家认可的、与经营产品相关专门的在岗人员；
3、具有与经营产品相关的拥
