海淀西三旗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
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;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
business license of class iii medical device is as follows: (1)the applicant submits the application materials to the relevantdepartment; (2) the relevant department accepts the application ofthe applicant; (3) investigate the actual site and review theproduct; (4) grant the issuance of the class iii medical devicelicense.2. legal basis: article 14 of the regulations on thesupervision and administration of medical devices for filing andregistration of class ii and iii medical devices shall submit thefollowing materials: (1) product risk analysis data; (2) technicalre of the product; (3) product inspection report; (4)clinical evaluation data; (5) product instructions and labelsamples; and the process for handling the business license of classiii medical devices: (1) the applicant submits the applicationmaterials to the relevant departments; (2) relevant departmentsshall accept the applicants
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