丰台东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

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。

ed by the General Administration of China, provincial food anddrug regulatory authorities and the food and drug regulatoryauthorities of the cities divided into districts, and shall beissued medical Device Registration Certificate, Medical DeviceProduction License and Medical Device Business Licenserespectively. How does the Beijing company handle to increase thebusiness scope of medical devices? What are the requirements forincreasing 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.Class I medical license does not need for a business license. If itis making medical devices, it needs to be filed with the relevantdepartments. 2. The company has increased the business scope ofclass II medical devices According to the filing requirements ofClass II medical devices, according to the Regulations on theSupervision and Administration of Medical Devices, all unitsengaged in the business of Cla