三类——国家药监局办理医疗器械许可证第三类医疗器械是具有较高风险，需要采取特别措施严格控制管理以保证其安全有效的医疗器械，比如常见的输液器、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
tegory of medical devices is a high risk, take special measuresto strictly control and management to ensure its safe and effectivemedical devices, such as common infusion, syringe, intravenousindwelling needle, heart stent, ventilator, CT, NMR, etc., itsproducts and production and business activities by the stateadministration, provincial food and drug regulatory authorities andregional municipal food and drug regulatory departments licensingmanagement, respectively issued to the medical device registrationcertificate, medical device production license, medical devicebusiness license. How does Beijing company deal with to increasethe business scope of medical equipment? What are the requirementsfor increasing the business scope of medical devices? Next, Xu Bingwill introduce it to you in detail: 1. The company has increasedthe business scope of class I medical devices The first type ofmedical devices refer to the medical devices that are sufficient toensure their safety and effectiveness through routine management. AClass I medical license does not need to apply for a businesslicense. If it is making medical devices, it needs to be filed withthe relevant 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 divide
