1. 医疗器械CE认证(MDD认证)概述: 《医疗器械指令》(MedicalDevice Devices 92/42/EEC),1995年1月1日生效,1998年6月13日强制实施。所有医疗器械制造商或其授权的代表应确保将要进入欧洲经济区(EEA)的医疗器械必须满足该指令要求。 2. 医疗器械CE认证(MDD认证)适用范围: 包括了医疗设备以及它的配件,任何仪器、器...
治疗产品理事会(TPD)的医疗器械局是监督和评估加拿大诊断和治疗性医疗设备的安全性,有效性和质量的国家机构。 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《...
The Case Studies in Medical Devices Design series consists of practical, applied case studies relating to medical device design in industry. These titles complement Ogrodnik's Medical Device Design and will assist engineers with applying the theory in practice. The case studies presented directly ...
The foreign enterprise engaged in Class Ⅰ medical device, including Class Ⅰ in vitro diagnostic (IVD) reagents shall apply for the record keeping to CFDA. The application materials shall contain following dossiers:1. <Imported Class Ⅰ Medical Device R
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。
注1:https://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls注2:https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices注3:https://www.fda.gov/medical-devices/medical-device-recalls/ge-healthcare-recalls-nuclear-medici...
1.食品药品法(Food and Drugs Act (R.S.C., 1985, c. F-27)) 2.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、Cla...
(1CenterforADRMonitoringofChongqing,Chongqing400014 China;2BioengineeringCollegeofChongqingUniversity Chongqing400044 China)Abstract:ObjectiveToinvestigatetheoccurrenceofseriousmedicaldevicerisksandprovidereferenceforthepost-marketingmedicaldeviceriskmanagementthroughstatisticalanalysison272casesofFDAclassImedicaldevicerecalls....
to sell their products in China are required to obtain pre-market approval from the Chinese Food and Drug Administration (CFDA). The approval of Class I medical device is known as the Medical Device Record, of which the procedure is different from Registration of Class II/III medical device...
high risk level) medical devices as well as Class D (i.e. high individual risk and [...] legco.gov.hk 現時,該制度涵蓋本地製造商、入口商、認證評核 機構、第II級 (即中⎯⎯低風險水平)、第III級 (即中⎯⎯高風險水平) 及第IV級 ( 即高風險水平) 醫療儀器,以及D級 (即高個體...