(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;申请人隐瞒有关情况或者提供虚假材料的,省、自治区、
(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许可证需要准备哪些
cant; (3) investigate the actual site and review the product;(4) grant the issuance of the class III medical device license.2.Legal basis: Article 14 of the Regulations on Supervision andAdministration 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; if the applicant conceals relevantinformation or provides false materials, province, autonomousregion (3) It shall have storage conditions commensurate with thescale and scope of business, including storage facilities andequipment that meet the requirements of the characteristics of themedical device products; (4) The product quality management systemshall be established and improved, including procurement, purchaseand acceptance inspection, storage, warehouse deliver