1、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;办理三类医疗器械经营许可证的办理流程:
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,只有有相关证书,才能销售这种产品。
2、要办理三类医疗器械经营
pplication materials to the relevant departments; (2) the relevant departments accept the application of the applicant; (3) investigate the actual site and review the products; (4) grant the issuance of the Class III medical device license.2. Legal basis: Article 14 of the Regulations on the Supervision 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) product risk analysis materials; (2) technical requirements for the product and (3) product inspection report; Procedures for handling the business license of Class III medical devices: 3. Technical personnel with a technical secondary school degree or above related to the business products; 4. Dealers of many drugs or medical devices with a quality management system suitable for the medical devices operated, Without the operating license, A lot of products can't be sold, In vitro diagnosti