、三类医疗器械经营许可证办理方式如下:
(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;
关资质全部带上,还需要带上质量人员的相关资料。(二)具有与经营规模和经营范围相适应的相对独立的经营场所;
(三)具有与经营规模和经营范围相适应的储存条件,包括具有符合医疗器械产品特性要求的储存设施、设备;
(四)应当建立健全产品质量管理制度,包括采购、进货验收、仓储保管、出库复核、质量跟踪制度和不良事件的报告制度等;
(五)应当具备与其经营的医疗器械产品相适应的技术培训和售后服务的能力。
(六)具有与经营的医
vant departments; (2) the relevant departments accept theapplication of the applicant; (3) investigate the actual site andreview the products; (4) grant the issuance of the Class IIImedical device license.2. Legal basis: Article 14 of theRegulations on Supervision and Administration of Medical Devicesfor the filing of Class I medical devices and the application forthe registration of Class II and III medical devices, the followingdata shall be submitted: (1) product risk analysis data; (2)product technical requirements; (3) product inspection report; (4)clinical evaluation data; (5) product instructions and labelsamples; all qualifications, and relevant data of qualitypersonnel.(2) having a relatively independent business sitecommensurate with the scale and scope of operation; (3) It shallhave storage conditions commensurate with the scale and scope ofbusiness, including storage facilities and equipment that meet therequirements of the characteristics of medical device products; (4)The product quality management system shall be established andimproved, including procurement, purchase and acceptanceinspection, storage, warehouse delivery revie