朝阳亚运村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
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、
f 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 Medical Device Enterprise License submitted by the operating enterprise shall be signed by the legal representative with the official seal of the enterprise; 2. The items filled in the Application Form for Medical Device Enterprise License shall be complete and accurate; 3