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;
(六)与产品研制、生产有关的质量管理体系文件;
(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)具有与经营的医疗器械相适应的质量管理制度。
经营企业要知晓办理三类医疗器械经营
The business license shall be handled as follows: (1) Theapplicant shall submit the application materials to the relevantdepartments; (2) Relevant departments shall accept the applicationof the applicant; (3) Investigate the actual site and audit theproducts; (4) Grant the issuance of a class III medical devicelicense. 2. Legal basis: Article 14 of the Regulations on theSupervision 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; (3) It shall have storageconditions commensurate with the scale and scope of business,including storage facilities and equipment that meet therequirements of the characteristics of the medical device products;(4) The product quality management system shall be established andimproved, including procurement, purchase and acceptanceinspection, storage, warehouse delivery review, quality trackingsystem and the reporting system of adverse events; (5) It shallhave the ability of technical training and after-sales servicesuitable with the medical devices it operates. (6) It shall have aquality management system suitable for the medical devices inoperation. Secondly, the operating enterprises should know tohandle the three types of medical equipment business