海淀联想桥北京医疗器械二类备案医疗器械三类经营许可证专业办理经验丰富靠谱周期短Zui快7天下证

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?接下来，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

edle, heart, stents, ventilator, CT, nuclear magnetic resonance, etc., its products and production and business activities respectively by the state administration, provincial food and drug regulatory department and municipal food and drug regulatory departments implement licensing management, respectively issued the medical device registration certificate, medical equipment production license, medical equipment business license. How does Beijing company deal with to increase the business scope of medical equipment? What are the requirements for increasing the business scope of medical devices? Next, Xu Bing will introduce it to you in detail: 1. The company has increased the business scope of class I medical devices The first type of medical