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。
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
es should be taken to strictly control and manage to ensure thesafe and effective medical devices, such as common infusion set,syringe, intravenous needle, heart stents, ventilator, CT, NMR,etc., their products and production and business activities shallbe administered by the state administration, provincial food anddrug regulatory authorities and municipal food and drug regulatoryauthorities, and issue the Medical Device Registration Certificate,Medical Device Production License and Medical Device BusinessLicense respectively. How does Beijing company deal with toincrease the business scope of medical equipment? What are therequirements for increasing the business scope of medical devices?Next, Xu Bing will intr