三类医疗器械经营许可证如何办理
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;
(四)临床评价资料;
(五)产品说明书以及标签样稿;4、工商行政管理部门出具的《企业名称预先核准通知书》或《工商营业执照》的复印件应与原件相同,复印件确认留存,原件退回;5、房产证明
business license of Class III medical device is as follows: (1)the applicant submits the application materials to the relevantdepartment; (2) the relevant department accepts the application ofthe applicant; (3) investigate the actual site and review theproduct; (4) grant the Class III medical device license.2. Legalbasis: Article 14 of the Regulations on the 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) product technicalrequirements; (ii) product inspection report; (3) productinspection report; (4) clinical evaluation data; (5) productinstructions and label samples; 4. The copy of Pre-approval ofEnterprise Name or the Industrial and Commercial Business Licenseissued by the administrative department for industry and commerceshall be the same as the original, the copy is confirmed andretained, the original is returned; 5. Real pro