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...
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 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. ...
欧盟CE(MDR)是什么? 137心... · 发表于欧盟CE法规专栏 欧盟认证知识——CE认证法规之MDR(Medical Devices Regulation) Eric... · 发表于欧盟检测认证知识中心 MDR法规简介和认证流程 VIACERT App 内打开 欢迎参与讨论 1 1 是否在知乎 App 内阅读全文 取消确认...
TGA RELEASED REGULATION IMPACT STATEMENT (RIS) EXPOSURE DRAFT OUTLINING PROPOSED TIGHTER CONTROLS FOR CONFORMITY ASSESSMENTBased on the TGA assessment, the proposed reforms fulfill the objectives of the RIS. It will help ensurethat high risk medical devices approved do notcompromise public health and ...
- 治疗商品(医疗器械)技术规范(Therapeutic Goods (MedicalDevices) Regulations); - 治疗商品注册指南(Guidance documents for the regulation oftherapeutic goods)中的相关指南和要求。 2. 办理流程: - 步骤1:准备资料 制造商需要准备并整理相关的技术文件和资料,包括产品规格、设计文件、性能评估报告、临床试验数据(...
2004 5 INTRODUCTION The major legislation dealing with the regulation of therapeutic goods in Australia is the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Regulations 1990 (the Regulations) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the Medical Devices Regulations...
在本周三(3月6日)开始的五次单独磋商中,澳大利亚药品管理局(TGA)根据欧盟医疗器械法规(REGULATION (EU) 2017/745,简称“MDR”)提出了新的医疗器械分类规则。 在这五次磋商过程中,TGA分别提出了澳大利亚目前对五种特定医疗器械类型的分类要求,并建议将新的分类规则纳入现有的澳大利亚医疗器械法规或分类变更。
In practice, meaningful regulation of devices is being left toinvestigativejournalists, academics with a specialization in law and medicine, and consumer advocates. Neither the Coalition nor the ALP have wanted to grasp the TGA hot potato, but reform is necessary. ...