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海淀世纪城北京医疗器械三类经营许可证,医疗器械二类备案提供人员库房专业快捷包下证

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
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)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;
(七)证明产品安全、有效所需的其他资料。
产品检验报告应当符合国务院药品监督管理部门的要求,可以是医疗器械注册申请人、备案人的自检报告,也可以是委托有资质的医疗器械检验机构出具的检验报告。
符合本条例第二十四条规定的免于进行临床评价情形的,可以免于提交临床评价资料。
医疗器械注册申请人、备案人应当确保提交的资料合

ts; (4) grant the issuance of the third-class medical device license.2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices and apply for the registration of Class II and III medical devices shall submit the following materials: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (4) (4) clinical evaluation data; (5) product specification and label samples; (6) quality management system documents related to product development and production; (7) other materials required to prove the safety and effectiveness of the product. The product inspection report shall meet the requirements of the drug regulatory department under The State Council, and may be the self-inspection report of the medical device registration applicant or record holder, or the inspection report issued by a qualified medical device inspection institution. Those who are exempted from clinical evaluation in accordance with the provisions of Article 24 of these Regulations may be exempted from the submission of clinical evaluation data. The medical device registration applicant and the record holder shall ensure that the submitted d


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