大兴兴丰大街北京医疗器械三类经营许可证，医疗器械二类备案提供进销存软件人员专业快捷包下证

注射器、静脉留置针、心脏支架、呼吸机、CT、核磁共振等，其产品和生产经营活动分别由、省级食品药品监管部门和设区的市食品药品监管部门实行许可管理，分别发给《医疗器械注册证》、《医疗器械生产许可证》、《医疗器械经营许可证》。

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

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(附房屋产权证明文件)复印件5.产品经营目录表

6.产品合格证书

7.上家购销合同、进货渠道

partments implement licensing management, respectively issuedthe medical device registration certificate, medical equipmentproduction license, medical equipment business license. How doesBeijing company deal with to increase the business scope of medicalequipment? What are the requirements for increasing the businessscope of medical devices? Next, Xu Bing will introduce it to you indetail: 1. The company has increased the business scope of class Imedical devices The first type of medical devices refer to themedical devices that are sufficient to ensure their safety andeffectiveness through routine management. A Class I medical licensedoes not need to apply for a business license. If it is makingmedical devices, it needs to be filed with the relevant department.2. The company 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