大兴滨河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

北京公司如何办理增加医疗器械经营范围呢?增加医疗器械经营范围有什么要求呢?接下来，徐冰为您详细介绍：

一、公司增加一类医疗器械经营范围

第一类医疗器械是指，通过常规管理足以保证其安全性、有效性的医疗器械。

一类医疗许可证无需办理经营许可证。如果是生产医疗器械，则需要到相关部门备案。

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。

 on the Supervision and Administration of Medical Devices, all units engaged in the business of Class II medical devices need to file with the food and drug regulatory department of the city divided into districts. Class II medical devices have moderate risks and need to be controlled and managed to 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 equipment, non-absorbable sutures, etc.