体温计、血压计、制氧机、雾化器等，其产品和生产活动由省级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》和《医疗器械生产许可证》。经营活动由设区的市级食品药品监管部门实行备案管理;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。
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
ricts; Class III —— State Food and Drug Administration formedical device license Class III medical devices have a high risk,Special measures need to be taken to strictly control and ensuresafe and effective medical devices, Such as common infusion sets,syringes, intravenous indwelling needles, heart stents,ventilators, CT, MRI, etc., Its products and production andbusiness activities shall be licensed by the State GeneralAdministration of China, the provincial food and drug regulatoryauthorities and the food and drug regulatory authorities of thecity divided into districts respectively, The Medical DeviceRegistration Certificate, Medical Device Production License andMedical Device Business License shall be issued respectively. Howdoes Beijing company increase the business scope of medicalequipment? What are the requirements for increasing the businessscope of medical devices? Next, Xu Bing will introduce to you indetail: first, the company increases the business scope of a classof medical devices The first type of medical devices refer to themedical devices that are sufficient to ensure their safety andeffectiveness through routine management. A Class I medical licensedoes not need to apply for a business license. If the manufactureris a medical device, it needs to file with the relevantdepartments. 2. The company has increased the business
