# \#澳大利亚TGA

**URL:** https://witpoise.club/tag/196-tag/196.md

[最新](https://witpoise.club/latest.md) · [类别](https://witpoise.club/categories.md) · [标签](https://witpoise.club/tags.md)

---

## [2026-10-16【TGA】更新 CDSS 监管指导，衔接 11 月 1 日豁免条款修订](https://witpoise.club/t/topic/272)

<div class="topic-metadata">

**Author:** [@Levi](https://witpoise.club/u/Levi)\
**回复:** 0\
**最近更新：:** [2026 年10 月 18 日 07:26 UTC](https://witpoise.club/t/topic/272 "2026-10-18T07:26:10Z")

</div>

原文链接：Understanding clinical decision support system software regulation 相关更新：Clinical decision support system exemptio…

---

## [2026-10-16【TGA】明确 AI 医疗记录助手的医疗器械监管边界](https://witpoise.club/t/topic/271)

<div class="topic-metadata">

**Author:** [@Levi](https://witpoise.club/u/Levi)\
**回复:** 0\
**最近更新：:** [2026 年10 月 18 日 07:21 UTC](https://witpoise.club/t/topic/271 "2026-10-18T07:21:37Z")

</div>

原文链接：Digital scribes 审查结果：Digital scribe review outcomes 更新类型： Artificial Intelligence（AI，人工智能） / Digital Scribes（数字医疗…

---

## [2026-09-30【TGA】更新 AI / 医疗器械软件监管改革路线，聚焦透明度、排除范围与合规](https://witpoise.club/t/topic/267)

<div class="topic-metadata">

**Author:** [@Levi](https://witpoise.club/u/Levi)\
**回复:** 0\
**最近更新：:** [2026 年10 月 12 日 09:50 UTC](https://witpoise.club/t/topic/267 "2026-10-12T09:50:06Z")

</div>

原文链接：Medical devices reforms: software regulation 更新类型： Artificial Intelligence（AI，人工智能） / Medical Device Software（医疗…

---

## [2026-09-16【TGA】更新 AusUDID 角色与职责说明，Sponsor 对 UDI 合规承担法律责任](https://witpoise.club/t/topic/257)

<div class="topic-metadata">

**Author:** [@Levi](https://witpoise.club/u/Levi)\
**回复:** 0\
**最近更新：:** [2026 年9 月 17 日 14:09 UTC](https://witpoise.club/t/topic/257 "2026-09-17T14:09:06Z")

</div>

原文链接：AusUDID roles and responsibilities 更新类型： UDI / AusUDID / Sponsor / Manufacturer / Database 发布机构： 澳大利亚 Therapeut…

---

## [2026-09-11【TGA】临床证据体系更新，正式将计算建模与仿真（CM&S / in silico）纳入医疗器械证据框架](https://witpoise.club/t/topic/235)

<div class="topic-metadata">

**Author:** [@Levi](https://witpoise.club/u/Levi)\
**回复:** 0\
**最近更新：:** [2026 年9 月 12 日 02:56 UTC](https://witpoise.club/t/topic/235 "2026-09-12T02:56:53Z")

</div>

原文链接：Clinical evidence guidelines for medical devices 更新类型： Clinical evidence / Computational modelling & simulation …

---

## [2026-08-25【TGA】实质修订 STI 自测 IVD 临床性能指导，明确最低敏感度/特异度与上市后要求](https://witpoise.club/t/topic/205)

<div class="topic-metadata">

**Author:** [@Levi](https://witpoise.club/u/Levi)\
**回复:** 0\
**最近更新：:** [2026 年8 月 26 日 11:32 UTC](https://witpoise.club/t/topic/205 "2026-08-26T11:32:57Z")

</div>

原文链接：Understanding performance requirements for in-vitro diagnostic (IVD) self-tests for chlamydia, gonorrhoea and syph…

---

## [2026-08-18【TGA】更新 Patient Implant Card 指引，明确 UDI 展示要求](https://witpoise.club/t/topic/204)

<div class="topic-metadata">

**Author:** [@Levi](https://witpoise.club/u/Levi)\
**回复:** 0\
**最近更新：:** [2026 年8 月 18 日 23:43 UTC](https://witpoise.club/t/topic/204 "2026-08-18T23:43:00Z")

</div>

原文链接：Patient implant cards and information leaflets - TGA 更新类型： UDI / Labelling / Implantable Devices / Patient Impla…

---

## [2026-08-05【TGA】发布 UDI 不合规产品的简化 Consent to Supply 路径](https://witpoise.club/t/topic/200)

<div class="topic-metadata">

**Author:** [@Levi](https://witpoise.club/u/Levi)\
**回复:** 0\
**最近更新：:** [2026 年8 月 5 日 11:58 UTC](https://witpoise.club/t/topic/200 "2026-08-05T11:58:00Z")

</div>

原文链接：Consent to supply for medical devices not meeting Unique Device Identification (UDI) requirements 更新类型： UDI / 上市…

---

## [2026-08-04【TGA】更新医疗器械申请审计选择标准](https://witpoise.club/t/topic/199)

<div class="topic-metadata">

**Author:** [@Levi](https://witpoise.club/u/Levi)\
**回复:** 0\
**最近更新：:** [2026 年8 月 4 日 13:10 UTC](https://witpoise.club/t/topic/199 "2026-08-04T13:10:00Z")

</div>

原文链接：Understanding selection criteria for medical device application audits 更新类型： ARTG 申请审计 / 申报策略 / 上市前审核 发布机构： 澳大利…