vestigate the actual site and review the product; (4) grant theissuance of a class III medical device license.2. Legal basis:Article 14 of the Regulations on the Supervision and Administrationof Medical Devices and applying for the registration of Class IIand Class III medical devices, the following materials shall besubmitted: (1) product risk analysis data; (2) product technicalrequirements; (3) product inspection report; (4); (4) clinicalevaluation data; (5) product specification and label samples; (6)quality management system documents related to product developmentand production; 1. Medical 7. Certificate preparation andcertification submitted by the operating enterprise. The conditionsfor handling the business license of three types of medical devicesare as follows: 1. business premises and warehouses matching thebusiness scope with specific requirements for their specific area;2. Specialized personnel related to business products; 3. technicalpersonnel with technical secondary school or above related tobusiness products; 4. quality management system suitable tobusiness me
（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有中专以上学历的技术人员；
4、拥有与经营的医疗器械相适应的质量管理制度
