海淀万寿寺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
- 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
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;办理三类医疗器械经营许可证的办理流程:(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。
二、第三类医疗器械经营许可证办
medical devices 1. the business license of third iii medicaldevices is handled as follows: (1) the applicant submits theapplication materials to the relevant departments; (2) the relevantdepartments accept the application of the applicant's application;(3) investigate the actual site and review the products; (4) grantthe issuance of the third iii medical device license.2. legalbasis: article 14 of the regulations on the supervision andadministration of medical devices for class 1 and the registrationof class ii and iii medical devices shall submit the followingmaterials: (1) product risk analysis data; (2) product technicalre; (ii) product technical re; (3) productinspection report; (4) clinical evaluation data; (5) productinstructions and label samples; and the process for handling thebusiness license of class iii medical devices: (1) the applicantshall submit the application materials to the relevant departments;(2) relevant departments shall accept the application of theapplicant; (3) investigate the actual site and audit the products;(4) grant the issuance of a class iii medical device license. 2.third class medical device business license office
展开全文