证》。
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?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。
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
devices The first type of medical devices refer to the medicaldevices that are sufficient to ensure their safety andeffectiveness through routine management. Class I medical licensedoes not need for a business license. If it is making medicaldevices, it needs to file with the relevant departments. 2. Thecompany has increased the business scope of class II medicaldevices According to the filing requirements of Class II medicaldevices, according to the Regulations on the Supervision andAdministration of Medical Devices, all units engaged in thebusiness of Class II medical devices need to file with the food anddrug regulatory department of the city divided into districts.Class II medical devices have moderate risks and need to becontrolled and managed to ensure their safe and effective medicaldevices. Such as: medical suture needle, sphygmomanometer,thermometer, electrocardiogram machine, electroencephalographymachine, microscope, acupuncture needle, biochemical analysissystem, hearing aid, ultrasonic disinfection equipment,non-absorbable sutures, etc. ask: 1. Commercial nature of theoffice 60 square, storage 40 square 2.2 medical professionals arethe leaders of the enterprise 3. Product management catalogue Note:To meet the above 3 points, basically can handle the record ofclass II medical devices Provide materials 1. Application forfiling of Class II medi
