(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;10、申请材料应完整、清晰、签字,并逐份加盖公章,
1、具有与经营范围相匹配的经营场所和仓库,并对其具体面积有具体要求;
2、具有国家认可的、与经营产品相关专门的在岗人员;
3、具有与经营产品相关的拥有中专以上学历的技术人员;
4、拥有与经营的医疗器械相适应的质量管理制度很多药品或者医疗器械的经销商,如果没有三类医疗器械经营许可证,很多产品就不能卖,比如说体外诊断试剂就属于三类医疗器械,只有有相关证
on and Administration of Medical Devices for the filing of Class I medical devices and the application for the registration of Class II and Class III medical devices, The following materials shall be submitted: (1) data on product risk analysis; (2) technical requirements of the product; (3) product inspection report; and (4) clinical evaluation data; 10. Application materials shall be complete, clear and signed, And affix the official seal to each copy, 1. Having the business premises and warehouses matching with the business scope, And have specific requirements for the specific area; 2, with the state recognized, related to the management of products; 3, with a technical secondary school education; 4, with the management of medical devices with the quality management system of the dealers of many drugs or medical devices, Without the operating license, A lot of products can't be sold, In vitro diagnostic reagents, for example, fall into