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丰台花乡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
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详细介绍

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;

办理三类医疗器械经营许可证的办理流程:
1.向食品药品监督管理局提交医疗器械经营许可证申请材料;
2.食品药品监督管理局数据形式审查;
3.数据正式受理;
4.有关部门的行政审查;
5.现场评价;
6.有关部门的行政决定;
7.制证、发

evice business license are as follows: (1) the applicant submits the application materials to the relevant departments; (2) the relevant departments accept the application of the applicant; (3) investigate the actual site and reviews the product; (4) grant the issuance of the third III medical device license.2. Legal basis: Article 14 of the Regulations on supervision and Administration of Medical Devices and applying for registration of Class II and Class III medical devices, the following materials shall be submitted: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; and (4) clinical evaluation data; Procedures for handling the business license of Class III medical devices: 1. Submit application materials for medical device business license to the Food and Drug Administration; 2. Examination of data form of the Food and Drug Administration; 3. Official acceptance of data; 4. Administrative review of relevant departments; 5. On-site evaluation; 6. Administrative decisions of relevant departments; 7. License making and issuance

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