大兴亦庄北京医疗器械三类经营许可证可全包代办专业快捷包下证
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(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;10、申请材料应完整、清晰、签字,并逐份加盖公章,办理三类医疗器械经营许可证的办理流程:
1.向食品药品监督管理局提交医疗器械经营许可证申请材料;
2.食品药品监
nt's application; (3) investigate the actual site and review the 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 application for the registration of Class II and III medical devices, the following data shall be submitted: (1) product risk analysis data; (2) product inspection report; (4) clinical evaluation data; 10, complete, clear and signed, and the process for handling the business license of Class III medical devices: 1. Submit the application materials for medical device business license to the Food and Drug Administration; 2. Food
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