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；4、工商行政管理部门出具的《企业名称预先核准通知书》或《工商营业执照》的复印件应与原件相同，复印件确认留存，原件退回；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定代表人签字并加盖企业公章，如无公章，则须有法定代表人本人签字9、凡申请材料需提交复印件的，申请人（单位
inistration of Medical Devices for the filing of Class I medicaldevices and the application for the registration of Class II andClass III medical devices, The following materials shall besubmitted: (1) product risk analysis data; (2) technicalrequirements of the product; (3) product inspection report; (4)clinical evaluation data; (5) product specification and labelsamples; 4, the copy of the "enterprise name pre-approval notice"or "industrial and commercial business license" issued by theindustrial and commercial administrative department should be thesame as the original, Copy of confirmation and retention, TheOriginal copy is returned; 5. The property certificate and houselease certificate (the lessor shall provide the property rightcertificate) shall be valid; 6. The resume, educational backgroundcertificate or professional title certificate of the person incharge of the enterprise and the quality manager shall be valid; 7.The enterprise shall establish the quality management files orforms of medical devices according to its own actual conditions.8.The self-guarantee sta
