【检查研究】TGA发布医疗器械临床证据指南 澳大利亚医疗产品管理局(Therapeutic Goods Adminstration,TGA)于2017年2月28日发布了医疗器械临床证据指南(Clinical evidence guidelines: Medical device)。 指南发布目的 该指南旨在给医疗器械的制造商(包括体外诊断试剂)在临床证据内容构成、临床评价过程中产生的临床数据和临床证...
来源:Manufacturer Evidence for medical devices including IVD medical devices | Therapeutic Goods Administration (TGA) https://www.tga.gov.au/manufacturer-evidence-medical-devices-including-ivd-medical-devices 6.3.2注册所需资料 可参考指南Australian regulatory guidelines for medical devices (ARGMD) | Thera...
According to Australian regulatory guidelines, health care-related products are expected to consistently maintain a high standard of quality throughout their life cycle. Once a product is approved, the agency continues to monitor it through various vigilance activities. This means manufacturers should pur...
TgAD/GSS mice (n = 15) displayed a more aggressive clinical phenotype than TgGSS mice (n = 20). Based on a clinical scoring system (see Methods) the onset of ataxia (stage A2) occurred at 106.1 ± 6.0 days (~3.5 months) in TgAD/GSS mice compared with 132.1 ±...
The TGA has guidelines for which documents are needed and when while seeking approval for devices. Achieving TGA compliance is highly dependent on your ability to provide comprehensive, complete and accurate documentation throughout the life cycle of your medical device. Learn More ...