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;
10、申请材料应完整、清晰、签字,并逐份加盖公章,所有申请表格电脑打字填写,使用A
The business license of Class III medical devices is as follows:(1) the applicant submits the application materials to the relevantdepartments; (2) the relevant departments accept the application ofthe applicant's application; (3) investigate the actual site andreview the products; (4) grant the issuance of the Class IIImedical device license.2. Legal basis: Article 14 of theRegulations on supervision and Administration of Medical Devicesand applying for the registration of Class II and Class III medicaldevices, the following materials shall be submitted: (1) productrisk analysis data; (2) product technical requirements; (3) productinspection report; (4) clinical evaluation data; (5) productdescription and label samples; 10. The application materials shouldbe complete, clear and signed, and stamped with the official seal.All the application forms should be filled in by computer typingand use A