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
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
4.经营场所、库房地址的地理位置图、平面图、房屋产权证明文件或者租赁协议
g the business scope of medical devices? Next, Xu Bing willintroduce it to you in detail: 1. The company has increased thebusiness scope of class I medical devices The first type of medicaldevices refer to the medical devices that are sufficient to ensuretheir safety and effectiveness through routine management. A ClassI medical license does not need to apply for a business license. Ifit is making medical devices, it needs to be filed with therelevant department. 2. The company has increased the businessscope of class II medical devices According to the filingrequirements of Class II medical devices, according to theRegulations on the Supervision and Administration of MedicalDevices, all units engaged in the business of Class II medicaldevices need to file with the food and drug regulatory departmentof the city divided into districts. Class II medical devices havemoderate risks and need to be controlled and managed to ensuretheir safe and effective medical devices. Such as: medical sutureneedle, sphygmomanometer, thermometer, electrocardiogram machine,electroencephalography machine, microscope, acupuncture needle,biochemical analysis system, hearing aid, ultrasonic disinfectionequipment, non-absorbable sutures, etc. ask: 1. Commercial office60 square, storage 40 square 2.2 medical professionals are theleaders of the enterprise 3. Product management catalogue Note: Ifthe line of the above 3 points, basically can handle the record ofclass II medical devices Provide materials 1
