朝阳西坝北京医疗器械三类经营许可证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
- 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
(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
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;
6.有关部门的行政决定;
7.制证、发证。
办理三类医疗
t departments; (2) the relevant departments shall accept theapplication of the applicant's application; (3) investigate theactual site and review the products; (4) grant the issuance of thethird 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 for theregistration of class ii and iii medical devices, the followingmaterials shall be submitted: (1) product risk analysis data; (2)product technical re; (3) product inspection report; (3)product inspection report; (4) clinical evaluation data; (5)product instructions and label samples; 6. administrative decisionsof relevant departments; 7. certificate preparation and issuance.handle three types of medical treatment
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