在指南Report on TGA processes and timeframes for the regulation of medical devices and access to market中的Attachment A: Timeframes for regulation of medical devices in Australia时间如下: 关于发补时间,目前未找到官方公布的标准时间,TGA在发出补充资料信函中会写明。如果制造商不能在此时间范围内提供所要求...
d. 主办者递交在ARTG登记申请 e. 在ARTG登记后主办者可以在澳大利亚供应器械 f. 器械上市后持续监控 SUNGO拥有自己的澳洲全资子公司 Sungo Australia Pty Ltd。可为澳洲境外制造商提供以下服务: - 澳洲Sponsor服务; - TGA制造商证据申请; - ARTG注册; - 技术文件编写; - 官方非强制性审核辅导; ...
澳洲TGA的具体定义,要求和程序可以在ARGMD(Australia Registration Guide of Medical Devices)上查询到,包括准入要求、市场监督和管理要求等细节。
澳洲TGA的具体定义,要求和程序可以在ARGMD(Australia Registration Guide of Medical Devices)上查询到,包括准入要求、市场监督和管理要求等细节。 送TA礼物 1楼2024-12-03 08:31回复 扫二维码下载贴吧客户端 下载贴吧APP看高清直播、视频! 贴吧页面意见反馈 违规贴吧举报反馈通道 贴吧违规信息处理公示...
Australia’s Therapeutic Goods Administration (TGA) is responsible for regulating therapeutic goods, including medical devices, to ensure they meet strict safety and performance standards. As part of this process, the TGA requires manufacturers or their representatives to have a local s...
Life sciences companies looking to make therapies and medical devices available in Australia are urged to learn about the Therapeutic Goods Administration (TGA) regulations. This page gives an overview of the TGA, details its approach to regulation and provides tips for achieving compliance. Free Reso...
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 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). ...
goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products. Almost any product for which therapeutic claims are made must be entered in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia. ...
要查询PVC手套在澳大利亚TGA（Therapeutic Goods Administration）的认证信息，您可以访问TGA的官方网站并使用其在线搜索工具。以下是查询过程的一般步骤：访问TGA的官方网站：您可以在浏览器中输入 "TGA Australia" 或 "Therapeutic Goods Administration" 来找到官方网站。导航到 "Database of Medical Devices"：在TGA的...