First of all, we must be clear about whatinformation is needed for the three types of business license ofmedical devices; 1. Company license principal and secondary copy 2.Official seal 3. Copy of the office and warehouse room 4. Personnel(mainly the quality manager and the competent inspector) Amongthem, quality manager: required college graduation for three yearsSupervisor inspector: required to graduate for three years oflaboratory related major
那么对于一类,二类,一类由于风险程度低,只需要办理一个普通公司就行,二类具有中度风险,也是需要做一个备案的。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》。
1.一类医疗器械:手术刀柄和刀片、普通止血钳、子弹钳、纱布剥离钳、海绵钳、帕巾钳、皮管钳、器械钳、显微耳针、显微喉针、显微耳钩、显微喉钩、显微
枪形麦粒钳、显微喉钳、显微持针钳、角膜镊、眼用镊、眼用结扎镊、纱布绷带、弹力绷带、石育绷带、创口贴、手术衣、手术帽、口罩、手术垫单、手术洞