丰台和义北京医疗器械三类经营许可证二三类专业快捷包拿证
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;
办理三类医疗器械经营许可证的条件如下:
(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;
ss license of class medical devices are as follows: (1) the applicant submits the application materials to the relevant departments; (2) the relevant departments accept the application of the applicant; (3) investigate the actual site and review the products; (4) grant the issuance of the third class medical device license.2. Legal basis: Article 14 of the Regulations on Supervision and Administration of Medical Devices for the filing of Class I medical device products and the application for the registration of Class II and III medical devices, the following materials shall be submitted: (1) risk analysis data of product risk analysis; (2) technical requirements of the product; (3) product inspection report; (4) clinical evaluation data; the conditions for handling the business license of Class III medical devices are as follows: (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) The business site, warehouse of the geographical location plan, plan (indicating the area), the property right certificate or lease copy of the agreement;