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大兴兴华大街北京医疗器械三类经营许可证可全包代办专业快捷包下证

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;10、申请材料应完整、清晰、签字,并逐份加盖公章,所有申请表格电脑打字填写,使用A4纸打印,复印使用A4纸,按照申请材料目录顺序装订成册。申请人隐瞒有关情况或者提供虚假材料的,省、自治区、直辖市(食品)药品监督管理部门或者接受委托的设区的市级(食品)药品监督管理机构对申请不予受理或者不予核发《医疗器械经营企业许可证》,并给予警告。申请人在1年内不得再次申请《医疗器械经营企业许可证》。申请人以欺骗、贿赂等不正当手段取得《医疗器械经营企业许可证》的,(食品)药品监督管理部门应当撤销其《医疗器械经营企业许可证》,给予警告,并处1万元以上2万元以下罚款。申请人在3年内不得再次

risk analysis data; (2) product technical requirements; (3) product inspection report; (4) clinical evaluation data; 10. The application materials shall be complete, clear, signed, stamped with official seal, all application forms shall be filled in by computer, printed on A4 paper, copied on A4 paper, and bound in order with the list of application materials. Where the applicant conceals the relevant information or provides false materials, the (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government or the (food) drug regulatory agency of the entrusted city shall not accept the application or issue the Medical Device Trading Enterprise License and give it a warning. The applicant shall not apply for the Medical Device Business Enterprise License again within one year. Where the applicant obtains the Medical Device Trading Enterprise License by improper means of cheating or bribery, the (food) and drug regulatory department shall revoke the Medical Device Trading Enterprise License, give a warning and impose a fine of not less than 10,000 yuan but not more than 


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