First of all, we must be clear about what information is needed for the three types of business license of medical devices; 1. Company license principal and secondary copy 2. Official seal 3. Copy of the office and warehouse room 4. Personnel (mainly the quality manager and the competent inspector) Among them, quality manager: required college graduation for three years Supervisor inspector: required to graduate for three years of laboratory related major
检查手套,指套、洗耳球、阴道洗涤器、气垫、肛门袋,圈、集尿袋、引流袋等;
2.二类医疗器械:如体温计、血压计、助昕器、制氧机、避孕套、针灸针、心电诊断仪器、无创监护仪器、光学内窥镜、便携式超声诊断仪、全自动生化分析
仪、恒温培养箱、牙科综合治疗仪、医用脱脂棉、医用脱脂纱布等;
3.三类医疗器械:如植入式心脏起搏器、体外震波碎石机、病人有创监护系统、人工晶体、有创内窥镜、超声手术刀、彩色超声成像设备、激光手术设备、高频电刀、微波治疗仪、医用核磁共振成像设备、X线治疗设备、医用高能设备、人工心肺机、内固定器材、人工心脏瓣膜、人工肾、呼吸麻醉设备、一次性使用无菌注射器、一次性使用输液器、输血器、CT设备等。