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朝阳甜水园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
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详细介绍

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;
(五)产品说明书以及标签样稿;
(六)与产品研制、生产有关的质量管理体系文件;

5、房产证明、房屋租赁证明(出租方要提供产权证明)应有效;

6、企业负责人、质量管理人的简历、学历证明或职称证明应有效;

7、企业应根据自身实际建立医疗器械质量管理档案或表格。

8、申请材料真实性的自我保证声明应由法定代表人签字并加盖企业公章,如无公章,则须有法定代表人本人签字

licant submits the application materials to the relevant departments; (2) the relevant departments accept the application of the applicant's application; (3) investigate the actual site and review the product; (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 filing of Class I 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 requirements; (3) product technical requirements; (3) product inspection report; (4) clinical evaluation data; (5) product instructions and label samples; (6) quality management system documents related to product development and production; 5. The property certificate and house lease certificate (the lessor shall provide the property right certificate) shall be valid; 6. The resume, educational background certificate or professional title certificate of the person in charge of the enterprise and the quality manager shall be v

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