房山良乡医疗器械三类经营许可证二类备案专业办理快捷包下证

（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；

追溯。

二、三类医疗器械许可证注册需要什么材料

三类医疗器械许可证注册所需材料如下：

1、企业名称与经营范围，注册资本及股东出资比例，股东等身份证明；

2、医疗器械产品注册证书、供应商营业执照、许可证及授权书；

3、质量管理文件等；

4、2个或以上医学专业或相关专业

1) the applicant shall submit the application materials to therelevant departments; (2) relevant departments shall accept theapplication of the applicant; (3) investigate the actual site andaudit the products; (4) grant the issuance of a class iii medicaldevice license. 2. legal basis: article 14 of the regulations onthe supervision and administration of medical devices as for theregistration of class ii and iii, 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; retrospect. 2. what materials arerequired for the registration of the class iii medical devicelicense the materials required for the license registration ofclass iii medical devices are as follows: 1. enterprise name andbusiness scope, registered capital and proportion of shareholdercontribution, shareholders and other identity certificates; 2.medical device product registration certificate, supplier businesslicense, license and authorization letter; 3. managementdocuments, etc.; 4 or 2 or more medical majors or relatedmajors