海淀苏州桥医疗器械三类经营许可证二类备案专业办理快捷包下证

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。

医疗器械经营许可证是医疗器械经营企业必须具备的，开办第二类医疗器械经营企业，应当向省、自治区、直辖市人民政府药品监督管理部门备案；

开办第三类医疗器械经营企业，应当经省、自治区、直辖市人民政府药品监督管理部门审查批准，并发给《医疗器械经营许可证》。

依据《医疗器械经营监督管理办法》，

ow to handle the business license of third iii medical devicesis as follows: (1) the applicant submits the application materialsto the relevant departments; (2) the relevant departments acceptthe application of the applicant's application; (3) investigate theactual site and review the products; (4) grant the issuance of thethird iii medical device license.2. legal basis: article 14 of theregulations on supervision and administration of medical devicesfor the filing of class i medical devices and application for theregistration of class ii and iii medical devices shall submit thefollowing materials: (1) product risk analysis data; (2) technicalre (3) product; (3) product inspection report; (4)clinical evaluation data; (5) product instructions and labelsamples; (6) management system documents related to productdevelopment and production; (7) other materials required to provethe safety and effectiveness of the product. the medical devicebusiness license is necessary for the medical device tradingenterprise, and the establishment of the second class medicaldevice trading enterprise shall be filed by the drug regulatorydepartment of the people's government of the provincial, autonomousregion or municipality directly under the central government; theestablishment of a class iii medical device trading enterpriseshall be examined and approved by the drug regulatory department ofthe people's government of the province, autonomous region ormunicipality directly under the central government, and a medicaldevice trading license shall be issued. according to the measuresfor the supervision and administration of medical deviceoperation,