海淀皂君庙医疗器械三类经营许可证二类备案专业办理快捷包下证

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；
（六）与产品研制、生产有关的质量管理体系文件；
（七）证明产品安全、有效所需的其他资料。

（2）公司章；

（3）房屋产权证明、租赁协议；

（4）法定代表人、

w to handle the business license of Class III medical device 1.The 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 and apply for the registration ofClass II and III medical devices shall submit the followingmaterials: (1) product risk analysis data; (2) product technicalrequirements; (3) product inspection report; (4) (4) clinicalevaluation data; (5) product specification and label samples; (6)quality management system documents related to product developmentand production; (7) other materials required to prove the safetyand effectiveness of the product. (2) Company seal; (3) Propertyright certificate and lease agreement; (4) Leg