1) 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; (7) other materials required toprove the safety and effectiveness of the product. 4, to theindustrial and commercial bureau for additional items, is the needto take the industrial and commercial bureau staff to check thewarehouse, you are the best First of all, the operating enterprisemust clarify the conditions for applying for the third type ofmedical device business license and meet the relevant requirements.(1) It shall have two quality control agencies or qualitymanagement personnel suitable for the scale and scope of itsbusiness operations. The quality management personnel shall haverelevant professional qualifications or professional titlesrecognized by the state, and the quality manager shall be on dutyand shall not take part-time jobs in other units; (2) having abusiness commensurate with the scale and scope of business
（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；
（七）证明产品安全、有效所需的其他资料。
4、去工商局办理增项，是需要带着工商局的工作人员来查看库房的，你**
经营企业必须明确申请三类医疗器械经营许可证的条件并满足相关要求。
（一）具有与经营规模和经营范围相适应的质量管理机构或者质量管理人员两个。质量管理人员应当具有国家认可的相关专业学历或者职称，质量管理人应在职在岗，不得在其他单位兼职；
（二）具有与经营规模和经营范围相适应的
