朝阳三里屯北京医疗器械二类备案医疗器械三类经营许可证专业办理经验丰富全程代办周期短快7天下证

二、公司增加二类医疗器械经营范围

二类医疗器械备案要求，根据《医疗器械监督管理条例》凡是从事二类医疗器械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

cording to the filing re of class ii medical devices,according to the regulations on the supervision and administrationof medical devices, all units engaged in the business of class iimedical devices need to file with the food and drug regulatorydepartment of the city divided into districts. class ii medicaldevices have moderate risks and need to be controlled and managedto ensure their safe and effective medical devices. such as:medical suture needle, sphygmomanometer, thermometer,electrocardiogram machine, electroencephalography machine,microscope, acupuncture needle, biochemical analysis system,hearing aid, ultrasonic disinfection e, non-absorbablesutures, etc. ask: 1.