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顺义石园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
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联系手机: 15501182773
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详细介绍

(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;
4、工商行政管理部门出具的《企业名称预先核准通知书》或《工商营业执照》的复印件应与原件相同,复印件确认留存,原件退回;

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

he product; (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 for the filing of Class I medical devices and the application for the registration of Class II and Class III medical devices, The following materials shall be submitted: (1) risk analysis of the product; (2) technical requirements of the product; (3) the product inspection report; (4) clinical evaluation data; (5) the product specification and label samples; (6) quality management system documents related to product development and production; the copies of the Notice and Business License issued by the administrative department for industry and commerce shall be the same as the original; Copy of confirmation and retention, The Original copy is returned; 5. The property certificate and house lease certificate (the lessor shall provide the property right certificate) shall be valid; 6. Resume, educational certificate of the principal and quality manager

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