通州张家湾没有人员怎么办北京医疗器械三类经营许可证提供人员库房专业安全包下证
(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:
办理三类医疗器械经营许可证的条件如下:
1、具有与经营范
pplication; (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 supervision and Administration of Medical Devices and applying for the registration of Class II and Class III medical devices, the following materials shall be submitted: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (4) clinical evaluation data; (5) product description and label samples; Procedures for handling the business license of Class III medical devices: The conditions for handling the business license of Class III medical devices are as follows: 1. Have and operation mode