朝阳小营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
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;医疗器械二类备案流程:1、准备执照副本,
3、具有与经营产品相关的拥有中专以上学历的技术人员;
4、拥有与经营的医疗器械相适应的质量管理制度
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。
e is handled as follows: (1) the applicant submits theapplication materials to the relevant departments; (2) the relevantdepartments accept the application of the applicant; (3)investigate the actual site and reviews the product; (4) grant theissuance of the third iii medical device license.2. legal basis:article 14 of the regulations on supervision and administration ofmedical devices for the filing of class i medical devices and theapplication for the registration of class ii and iii medicaldevices shall submit the following materials: (1) product riskanalysis data; (2) product technical re; (3) productinspection report; (4) clinical evaluation data; (5) productinstructions and label samples; filing process of medical devices:1, prepare license copies, 3, technical personnel with technicalsecondary school education related to the products; 4, have a management system suitable to the medical devices 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.
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