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怀柔雁栖北京办理医疗器械三类经营许可证没有库房怎么办包下证快捷

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

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;
5.现场评价;
6.有关部门的行政决定;
7.制证、发证。
办理三类医疗器械经营许可证的条件如下:
1、具有与经营范围相匹配的经营场所和仓库,并对其具体面积有具体要求;
2、具有国家认可的、与经营产品相关专门的在岗人员;
3、具有与经营产品相关的拥有中专以上学历的技术人员;
4、拥有与经营的医疗器械相适应的质量管理制度

ew the products; (4) grant the issuance of the Class III medical device license.2. Legal basis: Article 14 of the Regulations on Supervision and Administration of Medical Devices 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 technical requirements; (3) product inspection report; (4) clinical evaluation data; 5. on-site evaluation; 6. administrative decisions of relevant departments; 7. Certificate making and issuance. The conditions for handling the business license of three types of medical devices are as follows: 1. Having business premises and warehouses matching the business scope with specific requirements for their specific area; 2. State-recognized professional personnel related to business products; 3. Having technical personnel with technical secondary school education or above related to business products; 4. having quality management system corresponding to the operating medical devices

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