北京平谷区时间医疗器械三类经营许可证,医疗器械二类备案办理提供库房服务至上
5. 审核及评审:申请材料递交后,相关部门会进行审核和评审,包括对质量管理体系的合规性、产品技术的合规性、生产场所的合规性等方面的审查。
6. 报告批准:如果申请符合相关要求,审核通过后,相关部门会向申请人颁发三类医疗器械许可证。
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,复印使用A4纸,按照申请材料目录顺序装订成册。
In Beijing, the application for a Class III medical device license requires the following steps: 1. Prepare application materials: In accordance with the Regulations on Supervision and Administration of Medical Devices and relevant provisions, prepare relevant application materials, including the business license of enterprise legal person, product quality management system documents, product registration certificate, product technical documents, product operation manual, production license, etc. 2. Self-inspection preparation: conduct self-inspection of the internal