东城北京站北京医疗器械三类经营许可证,医疗器械二类备案提供人员库房专业快捷包下证
(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;
二、三类医疗器械许可证注册需要什么材料
7、财务人员身份证和上岗证;
8、其它相关材料。对申请材料的要求:1、经营企业提交的《医疗器械经营企业许可证申请表》应有法定代表人签字或加盖企业公章;2、《医疗器械经营企业许可证申请表》所填写项目应填写齐全、准确;3、法定代表人的身份证明、学历职称证明、任命文件应有效;4、工商
ce license.2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices for Class 1, the following materials shall be submitted: (1) product risk analysis data; (2) the product technical requirements; (3) product inspection report; (3) clinical evaluation data; (4) clinical evaluation data; (5) the product specification and label sample; 7. ID card and work certificate of financial personnel; 8, other related materials. Requirements for application materials: 1. The Application Form for Medical Device Enterprise License submitted by the operating enterprise shall be signed by the legal representative or stamped with the official seal of the enterprise; 2, the items filled in the Application Form shall be complete and accurate; 3, the identification certificate of the legal representative, academic title certificate and appointment document shall be valid; 4