In Beijing, the application for a Class IIImedical device license requires the following steps: 1. Prepareapplication materials: In accordance with the Regulations onSupervision and Administration of Medical Devices and relevantprovisions, prepare relevant application materials, including thebusiness license of enterprise legal person, product qualitymanagement system documents, product registration certificate,product technical documents, product operation manual, productionlicense, etc. 2. Self-inspection preparation: conductself-inspection of the internal
我们必须清楚办理医疗器械三类经营许可证需要哪些资料;
1、公司执照正副本
2、公章
3、办公和库房房本复印件
4、人员(主要是质量管理人和主管检验师)
其中 质量管理人:要求大专毕业满三年
主管检验师:要求本科毕业满三年检验学相关专业