朝阳八里庄医疗器械三类经营许可证二类备案专业办理快捷包下证
- 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
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;
(七)证明产品安全、有效所需的其他资料。
8、其它相关材料。
医疗器械行业是一个重要的领域,工商注册也是必不可少的步骤。对于想要在医疗器械行业创业的人来说,工商
how to handle the business license of class iii medical device1. the 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 class iii medical device license.2. legalbasis: article 14 of the regulations on supervision andadministration of medical devices for the filing of class i medicaldevices and the application for the registration of class ii andiii medical devices shall submit the following materials: (1)product risk analysis data; (2) technical re of theproduct; (3) product inspection report; (4) clinical evaluationdata; (5) product instructions and label samples; (6) system documents related to product development andproduction; (7) other materials required to prove the safety andeffectiveness of the product.8. other related materials. themedical device industry is an important field, and businessregistration is also an essential step. for those who want to starta business in the medical device industry, industry andcommerce
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