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;
(3)房屋产权证明、租赁协议;
(4)法定代表人、主要负责人、品质管理员的身份、毕业证等证明材料;
作为一个医疗器械资质注册咨询师,我们提供专业的医疗器械二三类资质注册服务,为您提供快捷、便宜的解决方案。如果您的公司需要在朝阳十里河地区注册医疗器械二三类资质,我们将是您的
of Class III medical devices is handled as follows: (1) Theapplicant shall submit the application materials to the relevantdepartments; (2) Relevant departments shall accept the applicationof the applicant; (3) Investigate the actual site and audit theproducts; (4) Grant the issuance of a class III medical devicelicense. 2. Legal basis: Article 14 of the Regulations on theSupervision and Administration of Medical Devices As for theregistration of Class II and III medical devices, the followingmaterials shall be submitted: (1) Product risk analysis data; (2)Technical requirements for the products; (3) Product inspectionreport; (4) Clinical evaluation data; (5) Product specification andlabel samples; (3) Property right certificate and lease agreement;(4) Identity of legal representative, principal person in charge,quality manager, graduation certificate and other certificationmaterials; As a medical device qualification registrationconsultant, we provide professional medical