1.需要办理许可证的企业经营者携带上述材料到当地市级人民政府食品监督管理部门申请营业执照;
2.管理部门受理资料,30个工作日内审核,必要时组织审核;
3.符合条件的,管理部门发行医疗器械经验许可证,不符合条件的,管理部门不予许可,书面说明理由。
办理医疗器械经营许可证需要满足以下要求:
1、含有植入材料介入器材的质量负责人当具有医学相关大专以上学历,三年以上工作经验; 2、含有体外试剂的有1人为主管检验师,具有本科以上学历并检验学;有1人为质量管理人,大z以上学历或者中级以上技术职称;
2、经营三、二类医疗器械体外诊断试剂的面积30平米的办公室,40平米仓库,20立方米医疗器械冷库。
3、经营三类6821、6846、6863、6877需要提供不少于100平使用面积办公室40平米仓库。
1. What is a medical device? Beijing wants to understand the enterprises to see here Medical device: refers to instruments, equipment, appliances, materials or other articles used individually or in combination, including required software; their function on the surface of the body is not obtained by pharmacological, immunology or metabolic means, but may participate and play a certain auxiliary role. 2. How many categories are medical devices divided into? There are three categories: The operation of the first type of medical devices does