袋、降温贴等，其产品和生产活动由所在地设区的市级食品药品监管部门实行备案管理。经营活动则全部放开，既不用许可也不用备案，只需取得工商部门核发的营业执照即可。
02.
二类——市药监局办理医疗器械经营备案第二类医疗器械是具有中度风险，需要严格控制管理以保证其安全有效的医疗器械，比如我们日常生活中常见的创可贴、避孕套、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;
03.
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
ry and Commerce Department. 02. Class —— municipal food and drugadministration for medical device business for the second type ofmedical equipment is a moderate risk, need to strictly controlmanagement to ensure its safe and effective medical devices, suchas our daily life, band, condoms, thermometer, blood monitor,oxygen generator, atomizer, its products and production activitiesby the provincial food and drug regulatory department licensingmanagement, respectively issued to the medical device registrationcertificate and medical device production license. Businessactivities shall be put on record by the food and drug regulatorydepartments of the city divided into districts; 03. Three —— statefood and drug administration license the third category of medicaldevices is a high risk, take special measures to strictly controland 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 businessactivities by the state administration, provincial food and drugregulatory authorities and the municipal food and drug regulatorydepartments licensing management, respectively issued to themedical device registration certificate, medical device productionlicense, medical device business license. How does Beijing companydeal with to incre
