营活动分别由国家zongju、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
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 file with therelevant departments. 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
