application materials to the relevant departments; (2) therelevant departments shall accept the application of theapplicant's application; (3) investigate the actual site and reviewthe products; (4) grant the issuance of the third III medicaldevice license.2. Legal basis: Article 14 of the Regulations on theSupervision and Administration of Medical Devices for the filing ofClass I medical devices and the application for the registration ofClass II and Class III medical devices, The following materialsshall be submitted: (1) product risk analysis data; (2) technicalrequirements of the product; (3) product inspection report; (4)clinical evaluation data; (5) product specification and labelsamples; (6) quality management system documents related to productdevelopment and production; 1. The Application Form for MedicalDevice Business Enterprise License submitted by the operatingenterprise shall be signed by the legal representative or affixedwith the official seal of the enterprise; 2. Application formedical Device Business Enterprise License
(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《医疗器械经营企业许可证申请表》应有法定代表人签字或加盖企业公章;2、《医疗器械经营企业许可证申请