顺义李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

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。

很多药品或者医疗器械的经销商，如果没有三类医疗器械经营许可证，很多产品就不能卖，比如说体外诊断试剂就属于三类医疗器械，只有有相关证书，才能销售这种产品。

1、2、要办理三类医疗器械经营许可证，必须有相关的营业执照，一般营业执照上的经营范围这一栏，需要明确写道可以销售三类医疗器械。如果没有，需要去工商局办理增项。

3、销售三类医疗器械，你必须要自己的库房，库房里需要设置冷藏库，因为三类医疗器械，是有保温需要的，超过一定的温度，就容易变质影响产品质量，很少有经销商有销售三类医疗

e 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 medical devices, the followingmaterials shall be submitted: (1) Product risk analysis data; (2)Technical requirements for the products; (3) Product inspectionreport; (4) Clinical evaluation data; (5) Product specification andlabel samples; (6) quality management system documents related toproduct development and production; (7) other materials required toprove the safety and effectiveness of the product. Manydistributors of drugs or medical devices can not sell many productswithout the business license of third class medical devices. Forexample, in vitro diagnostic reagents belong to the third classmedical devices, and only with relevant certificates can they sellsuch products. 2. In order to apply for the business license of thethird types of medical devices, there must be a relevant businesslicense. In the business scope of the general business license, itis necessary to be clearly stated that the third types of medicaldevices can be sold. If not, the need to go to the industrial andcommercial bureau for additional items. 3, the sales of the thirdclass of medical equipment, you must want their own warehouse, andthe warehouse needs to set up a cold warehouse, because the thirdclass of medical equipment, is the need for heat preservation,beyond a certain temperature, it is easy to deteriorate and affectthe quality of products, so few dealers have the sale of the thirdclass of medical treatment