Reforms Tracker
A consolidated quick-reference for regulatory reforms affecting Australian medical device sponsors and manufacturers. Always verify reform status and dates against official TGA sources.
👉 What's new for medical devices — TGA
Currently In Effect
New TGA AI and SaMD guidance February 2026 Clarifies AI regulated under existing SaMD framework; no separate AI-specific regime. Classification remains based on intended purpose and clinical context, not AI features. TGA
How to Track Changes
- What's new for medical devices — TGA
- TGA email subscription
- 🔔 GitHub Issues — regulatory changes
- 💬 GitHub Discussions — regulatory updates