# \#SaMD

**URL:** https://witpoise.club/tag/341-tag/341.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…

---

## [2026-09-30【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…

---

## [2026-09-17【FDA】拒绝放宽部分影像 AI 软件的 510(k) 要求](https://witpoise.club/t/topic/256)

<div class="topic-metadata">

**Author:** [@Levi](https://witpoise.club/u/Levi)\
**回复:** 0\
**最近更新：:** [2026 年9 月 17 日 13:58 UTC](https://witpoise.club/t/topic/256 "2026-09-17T13:58:28Z")

</div>

原文链接：Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Device…

---

## [2026-09-11【FDA】正式将心血管机器学习通知软件 Class II 分类及 Special Controls 编入 21 CFR 870.2380](https://witpoise.club/t/topic/239)

<div class="topic-metadata">

**Author:** [@Levi](https://witpoise.club/u/Levi)\
**回复:** 0\
**最近更新：:** [2026 年9 月 14 日 03:38 UTC](https://witpoise.club/t/topic/239 "2026-09-14T03:38:06Z")

</div>

原文链接：Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification …

---

## [2026-09-10【ANMAT】明确 SaMD 判定与强制注册边界，包含 wearable 中的软件功能](https://witpoise.club/t/topic/236)

<div class="topic-metadata">

**Author:** [@Levi](https://witpoise.club/u/Levi)\
**回复:** 1\
**最近更新：:** [2026 年9 月 12 日 13:43 UTC](https://witpoise.club/t/topic/236 "2026-09-12T13:43:11Z")

</div>

原文链接：ANMAT actualiza los criterios regulatorios para software como dispositivo médico (SaMD) 更新类型： SaMD / Software cl…

---

## [2026-08-18【FDA】发布生成式 AI 医疗器械监管讨论文件并正式征求意见](https://witpoise.club/t/topic/203)

<div class="topic-metadata">

**Author:** [@Levi](https://witpoise.club/u/Levi)\
**回复:** 0\
**最近更新：:** [2026 年8 月 18 日 23:26 UTC](https://witpoise.club/t/topic/203 "2026-08-18T23:26:00Z")

</div>

原文链接：Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedb…

---

## [2026-08-06【IMDRF】：正式发布医疗器械软件 PCCP 最终文件](https://witpoise.club/t/topic/195)

<div class="topic-metadata">

**Author:** [@Levi](https://witpoise.club/u/Levi)\
**回复:** 0\
**最近更新：:** [2026 年8 月 6 日 12:15 UTC](https://witpoise.club/t/topic/195 "2026-08-06T12:15:00Z")

</div>

原文链接：Essential Principles and Content of Predetermined Change Control Plans 更新类型： 医疗器械软件 / PCCP / 软件变更管理 发布机构： Inter…