西城复兴门北京医疗器械三类经营许可证,医疗器械二类备案提供人员库房专业快捷包下证
- 供应商
- 北京星期三企业管理咨询有限公司业务部
- 认证
- 医疗器械三类
- 注册
- 医疗器械二类
- 注册
- 注册公司
- 网络销售备案
- 联系电话
- 15501182773
- 手机号
- 15501182773
- 联系人
- 马胜辉
- 所在地
- 北京市海淀区清河嘉园东区甲1号楼11层1124
- 更新时间
- 2023-11-04 00:00
三类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;
(六)与产品研制、生产有关的质量管理体系文件;1、经营企业提交的《医疗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
iii medical device 1. the business license of class iii medicaldevice is as follows: (1) the applicant submits the applicationmaterials to the relevant department; (2) the relevant departmentaccepts the application of the applicant; (3) investigate theactual site and review the product; (4) grant the issuance of theclass iii medical device license.2. legal basis: article 14 of theregulations on the supervision and administration of medicaldevices for the filing of class i medical devices and theapplication for the registration of class ii and class iii medicaldevices, the following materials shall be submitted: (1) productrisk analysis data; (2) technical re of the product; (3)product inspection report; (4) clinical evaluation data; (5)product specification and label samples; (6) managementsystem documents related to product development and production; 1.distributor of many medical drugs or medical devices submitted bythe trading enterprise, without the operating license, a lot ofproducts can't be sold, for instance