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。
—— state food and drug administration for medical device licensethe third type of medical equipment is a high risk, take specialmeasures to strictly control and management to ensure the safe andeffective of medical devices, such as common infusion, syringe,intravenous needle, heart stent, ventilator, CT, MRI, etc., itsproducts and production and business activities by the stateadministration, provincial food and drug regulatory authorities andthe municipal food and drug regulatory departments licensingmanagement, respectively issued medical device registrationcertificate, medical device production license and medical deviceb