海淀皂君庙北京医疗器械三类经营许可证二三类专业快捷包拿证

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；

（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；

（5）经营地平面设计图，仓库平面设计图。

申请办理三类医疗器械许可证的规定

（1）场所和仓库总面积规定：与经

nse of class III medical devices 1. The business license of Class III medical devices is handled as follows: (1) The applicant shall submit the application materials to the relevant departments; (2) Relevant departments shall accept the application of the applicant; (3) Investigate the actual site and audit the products; (4) Grant the issuance of a class III medical device license. 2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices As for the registration of Class II and III medical devices, the following materials shall be submitted: (1) Product risk analysis data; (2) Technical requirements for the products; (3) Product inspection report; (4) Clinical evaluation data; (5) Product specification and label samples; (3) Property right certificate and lease agreement; (4) Identity of legal representative, principal person in charge, quality manager, graduation certificate and other certification materials; (5) Operation floor plan design drawing, warehouse floor plan design drawing. Provisions on applying for a class III medical device license (1) The total area of the place and the warehouse provisions: and