西城西四医疗器械三类经营许可证二类备案专业办理快捷包下证

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；

理或者不予核发《医疗器械经营企业许可证》，并给予警告。申请人在1年内不

办理三类医疗器械经营许可证的办理流程：

1.向食品药品监督管理局提交医疗器械经营许可证申请材料；

2.食品药品监督管理局数

o submit the application materials to the relevant departments;(2) relevant departments shall accept the application of theapplicant; (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 andadministration of medical devices as for the registration of classii and iii medical devices, the following materials shall besubmitted: (1) product risk analysis data; (2) technicalre for the products; (3) product inspection report; (4)clinical evaluation data; (5) product specification and labelsamples; (6) management system documents related to productdevelopment and production; the license of medical device operatingenterprise shall not be issued and given a warning. the applicantis not available within 1 year procedures for handling the businesslicense of class iii medical devices: 1. submit the applicationmaterials for medical device business license to the food and drugadministration; 2. number of the food and drug administration