d review the product; (4) grant the issuance of the class IIImedical device license.2. Legal basis: Article 14 of theRegulations on Supervision and Administration of Medical Devicesfor the filing of Class I medical devices and the application forthe registration of Class II and III medical devices, the followingmaterials shall be submitted: (1) product risk analysis data; (2)product technical requirements; (3) product inspection report; (4);(5) clinical evaluation data; product description and labelsamples; (6) quality management system documents related to productdevelopment and production; 1. Business license of medical andmedical devices submitted by the operating enterprise. There arethree types of medical enterprise business licenses, among whichthe first class medical device license can be directly handled, theoperation of second class products needs to apply for the recordcertificate of second class medical devices, and the operation ofthird class products needs to apply for the business license ofthird class medical devices. First of all, the operating enterprisemust clarify the conditions for applying for the third type ofmedical device business license and meet the relevantrequirements.(1) It shall have two quality control agencies orquality management personnel suitable for the scale and scope ofits business operations. The quality management personnel shallhave relevant professional qualifications or professional titlesrecognized by the state, and the quality manager shall be on dutyand shall not tak
（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
医疗器械经营许可证。
医疗企业经营许可证一共有三类，其中办理一类医疗器械许可证可以直接办理，经营二类产品是需要办理二类医疗器械经营备案凭证，经营三类产品则需要办理三类医疗器械经营许可证。经营企业必须明确申请三类医疗器械经营许可证的条件并满足相关要求。（一）具有与经营规模和经营范围相适应的质量管理机构或者质量管理人员两个。质量管理人员应当具有国家认可的相关专业学历或者职称，质量管理人应在职在岗，不得在其他单位兼职；（二）具有与经营规模和经营范围相适应的相对独立的经营场所；（三）具有与经营规模和经营范围相适应的储存条件，包括具有符合医疗器械产品特性要求的储存设施、设备；（四）应当建立健全产品质量管理制度，包括采购、进货验收、仓储保管
e part-time jobs in other units; (2) have a relat