全国服务热线 15501182773

海淀定慧寺北京医疗器械三类经营许可证二三类专业快捷包拿证

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;

医疗器械二类备案流程: 1、准备执照副本,公章,实际经营地址房本复印件,租房合同 2、需要提供一名质量管理员,医学医护相关专业毕业满3年的 3、网上提交医疗器械二类备案审核资料通过后线下交材料 4、经营医疗器械二类批发的企业还需要准备库房 可全程免费指

II medical devices is as follows: (1) The applicant shall submit the application materials to the relevant departments; (2) Relevant departments shall accept the application of the applicant; (3) Investigate the actual site and audit the products; (4) Grant the issuance of a class III medical device license. 2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices As for the registration of Class II and III medical devices, the following materials shall be submitted: (1) Product risk analysis data; (2) Technical requirements for the products; (3) Product inspection report; (4) Clinical evaluation data; Medical equipment class filing process: 1, to prepare a copy of the license, official seal, the actual business address room this copy, rental contract 2, need to provide a quality administrator, medical care related professional graduate full 3 years 3, medical equipment class filing online audit data after offline material 4, medical equipment class wholesale enterprises also need to prepare the warehouse can be the free

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