朝阳垡头没有人员怎么办北京医疗器械三类经营许可证提供人员库房专业安全包下证
(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;
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;、工商行政管理部门出具的《企业名称预先核准通知
relevant departments shall accept the application of the applicant; (3) investigate the actual site and review the products; (4) grant the issuance of the third III medical device license.2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices, Class 1, shall submit the following materials: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (4) product inspection report; (4) clinical evaluation data; product specification and label samples; (6) quality management system documents related to the product development and production; requirements for the application materials: 1. The Application Form for Medica