经营的单位都需要到所在地设区的市级食品药品监督管理部门备案，二类医疗器械是具有中度风险，需要控制管理以保证其安全、有效的医疗器械。如：医用缝合针、血压计、体温计、心电图机、脑电图机、显微镜、针灸针、生化分析系统、助听器、超声消毒设备、不可吸收缝合线等。

要求：

1.商用性质办公60平，仓储40平

2.2名医学专业人员为企业负责人

3.产品经营目录

注：符合以上3点，基本上就可以办理二类医疗器械备案

提供材料

1.二类医疗器械备案申请书

2.营业执照或预先核名通知书

3.法定代表人、企业负责人、质量负责人的身份证明、学历或者职称证明复印件

ipal food and drug supervision and administration department where the districts are located. The second class medical devices are medical devices with moderate risk and need to be controlled and managed to ensure their safe and effective safety. Such as: medical suture needle, sphygmomanometer, thermometer, electrocardiogram machine, electroencephalography machine, microscope, acupuncture needle, biochemical analysis system, hearing aid, ultrasonic disinfection equipment, non-absorbable sutures, etc. ask: 1. Commercial office 60 square, storage 40 square 2.2 medical professionals are the leaders of the enterprise 3. Product management catalogue Note: If the line of the above 3 points, basically can handle the record of class II medical devices Provide materials 1. Application for filing of Class II