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;
(六)与产品研制、生产有关的质量管理体系文件;
(七)证明产品安全、有效所需的其他资料。
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;
ision and Administration of Medical Devices for the filing of Class I medical devices and application for the registration of Class II and III medical devices shall submit the following materials: (1) product risk analysis data; (2) technical requirements (3) product; (3) product inspection report; (4) clinical evaluation data; (5) product instructions and label samples; (6) quality management system documents related to product development and production; (7) other materials required to prove the safety and effectiveness of the product. Requirements for the application materials: 1. The Application Form for Medical Device Business Enterprise License submitted by the operating enterprise shall be signed by the legal representative or affixed with the official seal of the enterprise; 2. The items filled in the Application Form for License of Medical Device Business Enterprises should be complete and accurate; 3. The identity certificate, ac