海淀清华大学北京医疗器械二类备案医疗器械三类经营许可证专业代办包下证Zui快七天拿证全程代办

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

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

naged to ensure their safe and effective medical devices. Suchas: medical suture needle, sphygmomanometer, thermometer,electrocardiogram machine, electroencephalography machine,microscope, acupuncture needle, biochemical analysis system,hearing aid, ultrasonic disinfection equipment, non-absorbablesutures, etc. ask: 1. Commercial office 60 square, storage 40square 2.2 medical professionals are the leaders of the enterprise3. Product management catalogue Note: If the line of the above 3points, basically can handle the record of class II medical devicesProvide materials 1. Application for filing of Class II medicaldevices 2. Business license or pre-check name notice 3. Copy of theidentity certificate, education background or professional titlecertificate of the legal