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顺义城区北京医疗器械三类经营许可证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

(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;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或签章。9、凡申请材料需提交复印件的,申请人(单位)须在复印件上注明“此复印件与原件相符”字样或者文字说明,注明日期,加盖单位公章;个人申请的须签字或签章。10、申请材料应完整、清晰、签字,并逐份加盖公章,所有申请表格电脑打字填写,使用A4纸打印,复申请人隐瞒有关情况或者提供虚假材料的,省、自治区、直辖市(食品)药品

he issuance of the class III medical device license.2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices for filing and registration of Class II and III medical devices, the following data shall be submitted: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (4) clinical evaluation data; (5) product description and labels; product description and label samples; 8. Self-assurance statement of the authenticity of the application materials shall be signed by the legal representative and affixed with the official seal of the enterprise, if no official seal, with the signature or signature of the legal representative.9. If the application materials need to be submitted, the applicant (unit) shall indicate the words "the copy conforms to the original" or the copy, indicate the date and stamp the official seal of the unit; the individual application shall be signed or signed.10. The application materials shall be complete, clear and signed, and stamped with the official seal one by one. All the application forms shall be filled in by computer typing and printed on A4 paper. If the applicant conceals the relevant information or provides false materials, the 


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