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;
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、工商行政管理部门出具的《企业名称预
ense 1. The business license of Class III medical devices is as follows: (1) the applicant submits the application materials to the relevant departments; (2) the relevant departments accept the application of the applicant's application; (3) investigate the actual site and review the product; (4) grant the issuance of 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) clinical evaluation data; (5) product description and label samples; 2. The items filled in the Application Form for License of Medical Device Business Enterprises should be complete and accurate; 3. The identity certificate, academic title certificate and appointment documents of the legal representative shall be valid; 4, the enterprise name forecast issued by the administrative department for industry and commerce