西城木樨地北京医疗器械三类经营许可证,医疗器械二类备案提供进销存软件库房速度快专业方便。
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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;1、经营企业提交的《医疗
医疗器械经营许可证。
其次,经营企业要知晓办理三类医疗器械经营许可证需要准备哪些资料。
(1)提交医疗器械经营企业许可证申请表,法定代表人签字或加盖企业公章;
(2)工商行政管理部门出具的企业名称预核准证明文件或《营业执照》复印件和校验原件;
(3)企业质量管理负责人的身份证、学历或者职称证明复印件及个人简历;质量管理人员的身份证、学历或者职称证明复印件;
(4)经营场所、仓库的地理位置图、平面图(注明面积)、房屋产权证明或者租赁协议复印件;
data; product description and label samples; (6) quality management system documents related to product development and production; 1. Business license of medical and medical devices submitted by the operating enterprise. Secondly, the operating enterprise should know what information it needs to prepare for the three types of medical equipment business license. (1) Submit the application form for the license of the medical device trading enterprise, signed by the legal representative or affix the official seal of the enterprise; (2) The copy of the pre-approval certificate of the enterprise name or the Business License issued by the administrative department for industry and commerce; (3) a copy of the id card, educational background or professional title certificate and personal resume of the quality management manager of the enterprise; a copy of the ID card, educational background or professional title certificate of the quality management personnel; (4) Copy of the geographical location plan, plan (indicated area), the property right certi