朝阳安贞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
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;
(六)与产品研制、生产有关的质量管理体系文件;
医疗器械二类备案流程:
cal devices is as follows: (1) the applicant submits the application materials to the relevant departments; (2) the relevant department accepts the application of the applicant's application; (3) investigate the actual site and review the product; (4) granting 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 the application of registration of Class II and III medical devices, the following data shall be submitted: (1) product risk analysis data; (2) product requirements; (2) product technical requirements; (3) product inspection report; (4) clinical evaluation data; (5) product description; product description and label samples; (6) quality management system documents related to product development and production; Class II filing process of medical devices: