1. 第二类医疗设备 ... and Human Services) 认可为「第二类医疗设备」(Class II medical device)。zhidao.baidu.com|基于51个网页 2. 第二类医疗仪器 ...lthWay,美国食物及药品管理局(FDA)认可为第二类医疗仪器(Class II Medical Device)可 ...$5000 医疗级空气净化机 He…adroo.hk|基于9个网页©...
1. Medical Device(医疗器械): 指仪器、设备、器具、机器、用具、植入物、体外试剂或其他类似或相关物品,包括任何组件、零件或附件,其主要预期用途是用于人类疾病或其他状况的诊断、治疗、缓解、预防或监测,或者旨在影响人体的结构或功能。 2. Class I/II/III(I/II/III 类医疗器械): FDA 根据风险程度将医疗器械...
Class II Medical Device (excluding in vitro diagnostic reagents) 翻译结果2复制译文编辑译文朗读译文返回顶部 正在翻译,请等待... 翻译结果3复制译文编辑译文朗读译文返回顶部 Class II medical devices (excluding in vitro diagnostic reagents) 翻译结果4复制译文编辑译文朗读译文返回顶部 ...
具体来说,Class I类设备适用于通知程序,Class II类设备适用于认证和批准程序,Class III和Class IV类设备仅适用于批准程序。 一般情况下,现存的Class I和Class II类设备由医疗器械信息和技术援助中心 (MDITAC)及韩国国家医疗器械安全信息研究所 (NIDS)认证;新产品以及Class III、Class IV类设备则由MFDS直接审核。
The Class II medical device is the medical device that is moderate-risk and requires strict control and management to ensure their safety and effectiveness. The Class III medical device is the medical device that is high-risk and requires special measures to strictly control management to ensure ...
afor a class II medical device inteded to be used with another class II device, provide a list of all medical device that this device is inteded to be used or function iwth, includeing their medical device licence number 正在翻译,请等待...[translate]...
Device&Medical device “medical device” 一词涵盖了用于治疗、缓解、诊断或预防疾病或异常身体状态的多种产品。也指Medical Devices Regulations中所指的器械,但不包括任何拟用于动物的器械。 Device(根据《食品和药品法》第2条的定义)——指为以下目的而制造、销售或代表的任何物品、仪器、设备或配件,包括其任何组件...
Thispaperisaimedtoguidetheapplicantstodotheclinicalevaluationcorrectlyandscientificallyandimprovethe registrationefficiency.Fromthepointofviewofregistrationandevaluation,thispaperanalyzedtherequirementsofclinicalevaluationof theclassmedicaldeviceincombinationwiththecurrentlawsandregulationsandprovidethemethodsandessentialsoftheclin...
Class II Portable Contec Atomizer Medical Mesh Nebulizer Machine for Kids 1 Introduction The Mesh Nebulizer forms nebulizing effect by the following actions, the high-frequency vibration of piezoelectric ceramic piece leads to the deformation of micro plate, so that the...
These Class III Devices Exempted for Clinical Trial: Cardio/Neurosurgery, Radiation, Imaging, Ophthalmology and More NMPA issued the “Clinical Pathway Recommendations for Certain Categories of More Class II & III Medical Devices and IVDs Exempted from Clinical Trials ...