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朝阳小关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

更新时间:2023-11-04 00:00:00
价格:请来电询价
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
联系电话:15501182773
联系手机: 15501182773
联系人:马胜辉
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详细介绍

(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;
二、三类医疗器械许可证注册需要什么材料
7、财务人员身份证和上岗证;6、企业负责人、质量管理人的简历、学历证明或职称证明应有效;7、企业应根据自身实际建立医疗器械质量管理档案或表格。8、申请材料真实性的自我保证声明应由法定代表人签字并加盖企业公章,如无公章,则须有法定代表人本人签字或签章。9、凡申请材料需提交复印件的,申请人(单位)须在复印件上注明“此复印件与原件相符”字样或者文字说明,注明日期,加盖单位公章;个人申请的须签字或签章。

lysis materials; (2) technical requirements of the product; (3) product inspection report; (4) clinical evaluation materials; (5) product specification and label samples; what materials are required for license registration of class ii and III medical devices; 7. ID card and working certificate of financial personnel; 6. The resume, educational background certificate or professional title certificate of the person in charge of the enterprise and the quality manager shall be valid; 7. The enterprise shall establish the quality management files or forms of medical devices according to its own actual situation.8. The self-guarantee statement of the authenticity of the application materials shall be signed by the legal representative and affixed with the official seal of the enterprise. If there is no official seal, there must be the signature or signature of the legal representative himself.9. If the application materials need to be submitted, the applicant (unit) shall indicate the words "the copy conforms to the original" or the text description on the copy, indicate the date and stamp the official seal of the unit; the individual application shall be signed or signed.


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  • 电话:15501182773
  • 老板:马胜辉
  • 手机:15501182773
  • Email:15501182773
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