First of all, we must be clear about whatinformation is needed for the three types of business license ofmedical 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) Amongthem, quality manager: required college graduation for three yearsSupervisor inspector: required to graduate for three years oflaboratory 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。