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...
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...
加拿大医疗器械法规(Canadian Medical Devices Regulations SOR/ 98 282) 三、产品分类 需要先对器械进行分类,才能按照不同类别准备申请资料: 依据器械的使用风险将医疗器械及体外诊断器械分为四类,依次为Class I、 Class II、Class III、Class IV。当中Class I类器械是最低风险,Class IV类器械风险为最高。 Class ...
Class I体外诊断医疗器械是指公共或个人健康风险最小的医疗器械,如通用体外诊断实验室设备和通用诊断试剂。 也可以进入加拿大分类规则查询网站进行了解:https://laws.justice.gc.ca/eng/regulations/SOR-98-282/page-12.html#h-1022100 四、医疗器械许可证 医疗器械许可证是颁发给II, III, IV类IVD产品的许可证书,...
evaluationcorrectlyandscientificallyandimprovethe registrationefficiency.Fromthepointofviewofregistrationandevaluation,thispaperanalyzedtherequirementsofclinicalevaluationof theclassmedicaldeviceincombinationwiththecurrentlawsandregulationsandprovidethemethodsandessentialsoftheclinical evaluation. Medicaldevice;Clinicalevaluation ...
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. Class I medical device is a medical device with a low degree of risk, and the implementation of routine management can...
Base on the《Administrative Measures for Medical Device Registration》, The clinical trials for Class III medical device with higher risk to human body should be approved by CFDA. CFDA has issued the《Catalogue of Medical Devices need to be approved prior to Clinical Trial》,and will ...
in place the regulations prescribing the class of persons referred to in paragraph (c) of [...] legco.gov.hk (d) 在 研究條例草案第77條擬議新 的第(5)款所 載“ 利害關 係人” 的 定義時,委員請 政府當 局在《 土地業權條例》生 效之前訂立規例, 訂明該定義(c)段中所 述 類別的人...
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 ...
class III device Regulatory affairs A highly regulated 'high risk' medical device–eg, life-support or life-sustaining devices–eg, pacemakers and heart valves, approved by the FDA for use in humans; CIIIDs are also defined as those which pose a potentially unreasonable risk of illness or inju...