海淀西二旗北京办理医疗器械三类经营许可证没有库房怎么办包下证快捷
类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;办理三类医疗器械经营许可证的办理流程:
1、具有与经营范围相匹配的经营场所和仓库,并对其具体面积有具体要求;
2、具有国家认可的、
medical devices 1. The business license of Class III medical devices is handled as follows: (1) the applicant submits the application materials to the relevant departments; (2) the relevant departments accept the application of the applicant; (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 the Supervision and Administration of Medical Devices Class 1 for the filing of medical devices and the registration of Class II and III medical devices, the following data shall be submitted: (1) product risk analysis data; (2) the product technical requirements; (3) product inspection report; (3) product inspection report; (4) clinical evaluation data; (5) product description and label samples; the process for handling the business license of Class III medical devices: 1. Have business premises and warehouses matching the business scope, and have specific requirements for their specific area; 2. approved by the state