pplication 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 onSupervision and Administration of Medical Devices for the filing ofClass I medical devices and application for the registration ofClass II and Class III medical devices, the following data shall besubmitted: (1) product risk analysis data; (2) product technicalrequirements; (3) product inspection report; (4) clinicalevaluation data; (5) product description and label samples; (6)quality management system documents related to product developmentand production; 6. Articles of association and resolutions ofshareholders' meeting; 7. ID card of financial personnel andworking certificates; 8. other related materials. Medical equipmentclass filing process: 1, to prepare a copy of license, officialseal, the actual business address this copy, rental contract 2,need to provide a quality administrator, medical relatedprofessional graduate full 3 years of 3, online medical devicesafter class record audit data through offline material 4, medicalequipment class wholesale enterprises also need to be
（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；
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。医疗器械二类备案流程：1、准备执照副本，公章，实际经营地址房本复印件，租房合同2、需要提供一名质量管理员，医学医护相关专业毕业满3年的3、网上提交医疗器械二类备案审核资料通过后线下交材料 4、经营医疗器械二类批发的企业还需要准
