全国服务热线 15501182773

朝阳芍药居没有人员怎么办北京医疗器械三类经营许可证提供人员库房专业安全包下证

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
让卖家联系我
详细介绍

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;

(四)应当建立健全产品质量管理制度,包括采购、进货验收、仓储保管、出库复核、质量跟踪制度和

vice is as follows: (1) the applicant submits the application materials to the relevant department; (2) the relevant department accepts the application of the applicant; (3) investigate the actual site and review the product; (4) grant the Class III medical device license.2. Legal basis: Article 14 of the Regulations on Supervision and Administration of Medical Devices and application for registration of Class II and Class III medical devices, the following materials shall be submitted: (1) product risk analysis data; (2) product technical re; (3) product inspection report and (4) clinical evaluation data; (4) The product management system shall be established and improved, including procurement, purchase acceptance, storage, warehouse delivery review and tracking system

相关产品

联系方式

  • 地址:北京市海淀区清河嘉园东区甲1号楼11层1124
  • 电话:15501182773
  • 老板:马胜辉
  • 手机:15501182773
  • Email:15501182773
产品分类