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©...
翻译结果1复制译文编辑译文朗读译文返回顶部 一类二类医疗器械inteded与其他II类设备使用的所有医疗设备,提供了一个列表,这要使用的设备是inteded或功能iwth的,includeing医疗器械经营许可证号 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... ...
According to the "Regulations on the Supervision and Administration of Medical Devices" (No. 739), medical devices are classified and managed according to the degree of risk. The Class II medical device is the medical device that is moderate-risk and requires strict control and management to ens...
would be classifiedasClassIImedical device(i.e. medium - low risk level) and subject to statutory [...] legco.gov.hk legco.gov.hk 陳健波議員察悉,非矯視性隱形眼鏡會被 分類為第II級(即中⎯⎯低 風險水平)醫療儀器,並 在醫療儀器建議的規管架構下受到法定管制,但非 ...
evaluationcorrectlyandscientificallyandimprovethe registrationefficiency.Fromthepointofviewofregistrationandevaluation,thispaperanalyzedtherequirementsofclinicalevaluationof theclassmedicaldeviceincombinationwiththecurrentlawsandregulationsandprovidethemethodsandessentialsoftheclinical evaluation. Medicaldevice;Clinicalevaluation ...
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