西城百万庄北京办理医疗器械三类经营许可证没有库房怎么办包下证快捷

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）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。1、经营企业经办人携带上述资料前往监督管理部门申请经营许可；2、工作人员受理资料，并于30个工作日内进行审查，必要时组织核查；3、对符合规定条件的，准予许可并发给医疗器械经营许可证；对不符合规定条件的，不予许可并书面说明理由。1、企业名称与经营范围，注册资本及股东出资比例，股东等sfz明；2、医疗器械产品

e 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) the product specification and label sample; (3) investigate the actual site and review the product; (4) grant the issuance of a class III medical device license.1. The operator of the operating enterprise brings the above information to the supervisory and administrative department to apply for business license; 2. Accept the staff shall examine the materials within 30 working days and organize verification if necessary; 3. Grant the license and issue the operating license of medical devices; and the unqualified conditions shall not permit and explain the reasons in writing.1. Enterprise name and business scope, registered capital and investment proportion of shareholders, shareholders and other sfz Ming; 2. Medical device products