（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；5、房产证明、房屋租赁证明（出租方要提供产权证明）应有效；6、企业负责人、质量管理人的简历、学历证明或职称证明应有效；7、企业应根据自身实际建立医疗器械质量管理档案或表格。8、申请材料真实性的自我保证声明应由法
evices for filing of Class I medical devices and application forregistration of Class II and Class III medical devices, thefollowing materials shall be submitted: (1) product risk analysisdata; (2) product technical requirements; (3) product inspectionreport; (4) clinical evaluation data; (5) product instructions andlabel samples; (6) quality management system documents related toproduct development and production;6. Articles of association ofthe company and resolutions of the shareholders' meeting, etc.; 7.ID card and working certificate of financial personnel; propertycertificate and house lease certificate (property right certificateof the lessor) shall be valid; the principal and quality managershall be valid; 7. The enterprise shall set up quality managementfiles or forms of medical devices according to its actualconditions.8. The self-guarantee statement of the authenticity ofthe
