石景山医疗器械三类经营许可证二类备案专业办理快捷包下证
三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;
6、公司章程、股东会决议等;7、财务人员sfz和上岗证;8、其它相关材料。
医疗器械是一种用于预防、诊断、治疗或缓解疾病或残疾的工具、设备、仪器或机器。它们包括各种医用产品,如手术器械、医用材料、注射器、心脏起搏器、医疗椅等等。医疗器械行业的发展与
ense of Class III medical device 1. The business license of Class III medical device is as follows: (1) the applicant submits the application materials to the relevant department; (2) the relevant department accepts the application of the applicant; (3) investigate the actual site and review the product; (4) grant the 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) product description; (5) clinical evaluation data; product description and label samples; 6. Articles of association and resolution of shareholders' meeting; 7. financial personnel sfz and work certificate; 8. other related materials. A medical device is a tool, device, instrument, or machine used for the prevention, diagnosis, treatment, or mitigation of illness or disability. They include a variety of medical products, such as surgical instruments, medical materials, syringes, cardiac pacemakers, medical chairs, and much more. The development of the medical device industry and