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?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
tion license the third category of medical devices is a high risk, take special measures to strictly control and management to ensure its safe and effective medical devices, such as common infusion, syringe, intravenous needle, heart stent, ventilator, CT, NMR, etc., its products and production and business activities by the state administration, provincial food and drug regulatory authorities and the municipal food and drug regulatory departments licensing management, respectively issued to the medical device registration certificate, medical device production license, medical device business license. How does Beijing company deal with to increase the business scope of medical e? What are the re for increasing the business scope of medical devices? Next, Xu Bing