) The applicant shall submit the application materials to therelevant departments; (2) Relevant departments shall accept theapplication of the applicant; (3) Investigate the actual site andaudit the products; (4) Grant the issuance of a class III medicaldevice license. 2. Legal basis: Article 14 of the Regulations onthe Supervision and Administration of Medical Devices As for theregistration of Class II and III medical devices, the followingmaterials shall be submitted: (1) Product risk analysis data; (2)Technical requirements for the products; (3) Product inspectionreport; (4) Clinical evaluation data; (5) Product specification andlabel samples; (6) quality management system documents related toproduct development and production; 4. The copy of the "Notice ofPre-approval of Enterprise Name" or "Industrial and CommercialBusiness License" issued by the administrative department forindustry and commerce shall be the same as the original, the copyshall be confirmed and retained, and the original shall bereturned; 5. The property certificate and house lease certificate(the lessor shall provide the property right certificate) shall bevalid; 6. The resume, educational background certificate orprofessional title certificate of the person in charge of theenterprise and the quality manager shall be valid; 7. Enterprisesshall establish the quality management of medical devices accordingto their own actual conditions
）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；
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
