(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;lDevices for the filing of Class I medical devices and theapplication for the registration of Class II and Class III medicaldevices, the following materials shall be submitted: (1) riskanalysis data of the product; (2) technical requirements of theproduct; (3) product inspection report; (4) clinical evaluationdata; if the applicant conceals relevant information or providesfalse materials, province, autonomous region and (3) It shall havestorage conditions commensurate with the scale and scope ofbusiness, including storage facilities and equipment that meet therequirements of the characteristics of the med
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