The Therapeutic Goods Administration (TGA) medical device regulations for health safety guidelines are responsible for the regulation of medical devices and more.
TGA是澳大利亚政府健康和老年护理部Australian Government Department of Health and Aged Care的外部分支健康产品监管组Health Products Regulation Group (HPRG)的一部分。HPRG包括治疗物品管理局(TGA)和药物管制办公室Office of Drug Control (ODC)。 在TGA中与医疗器械监管相关的部门是Medical Devices and Product Qualit...
TGA Proposes 5 Medical Device Classifications in Line With EU MDR In five separate consultations opened on Wednesday, Australia’s Therapeutic Goods Administration (TGA) proposed new medical device classifications in line with the EU medical device regulation (MDR). The consultations consider the current...
如果您的医疗设备属于I类以外的任何其他类别,您必须向认证机构提供证明,证明您的产品符合相应CE指令的基本要求。 欧盟CE认证Regulation (EU) 2017/746 on in vitro diagnostic medical devices(IVDR)体外诊断医疗器械 “体外诊断医疗器械”是指任何医疗器械包括试剂、试剂产品、校准品、质控品、 试剂盒、仪器、器具、成...
However, Therapeutic Goods Administration (TGA) of Australia has anticipated the need for regulation even in the post-marketing stage of devices and released a draft guidance that spans across the total product life cycle (TPLC). Who does the guidance apply to? The TPLC approach proposed by ...
TGA Proposes 5 Medical Device Classifications in Line With EU MDR In five separate consultations opened on Wednesday, Australia’s Therapeutic Goods Administration (TGA) proposed new medical device classifications in line with the EU medical device regulation (MDR). ...
TGA Medical Device Regulatory Guidance:TGA提供的具体指导文件,涵盖医疗器械的注册和要求。 Australian Guidelines for the Regulation of Medical Devices:详细说明了医疗器械在澳大利亚的监管要求。 通过遵循这些标准和法规,可以确保三段式护颈托在澳大利亚市场的合规性和安全性。
European Union has issued a new version of the Medical Device Regulation (MDR) Recently, the European Union has issued a new version of the Medical Device Regulation (MDR), aimed at improving the safety and quality of medical devices, ensuring their reliability and effectiveness. ...
TGA Review Panel to Review Medicines and Medical Device RegulationFlannigan, Alison Choy
要为您的止痒仪在加拿大获得MDL(MedicalDeviceLicense)认证...2025-01-24 止痒仪办加拿大MDL认证要求 要在加拿大获得医疗器械许可证(MDL)认证,特别是针对止痒仪这类产品,需要遵循以...2025-01-24 止痒仪办欧盟MDR认证注意事项 办理欧盟MDR(MedicalDeviceRegulation)认证时,针对止痒...2025-01-24 ...