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国家zongju、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》。
f the city divided into districts; 03. Three —— state food anddrug administration for medical device license the third type ofmedical equipment is a high risk, take special measures to strictlycontrol and management to ensure the safe and effective of medicaldevices, such as common infusion, syringe, intravenous needle,heart stent, ventilator, CT, MRI, etc., its products and productionand business activities by the state administration, provincialfood and drug regulatory authorities and the municipal food anddrug regulatory departments licensing management, respectivelyissued medical device registration certificate, medical deviceproduction license and medical device business license.