Under the Therapeutic Goods Administration (TGA) regulations in Australia, some Clinical Decision Support Systems (CDSS) may be considered exempt medical devices — but only if they meet specific criteria.
A CDSS is only considered exempt if it meets all three of these:
✔️ It supports or provides recommendations to a health professional (e.g. for prevention, diagnosis, or treatment)
✔️ It does not directly analyse medical images or signals from another medical device
✔️ It does not replace the clinical judgement of a health professional
🚨 With the rapid uptake of AI in healthcare, it’s critical to note that AI-enabled CDSS will NOT meet the exemption criteria.
👉 If your software meets all three (and is not AI-enabled), it’s likely an exempt medical device — but regulatory obligations still apply.
⚠️ Even for exempt CDSS, you must:
• Notify the TGA within 30 working days of supply using the CDSS Exemption Notification Form
• Ensure compliance with the Essential Principles (safety, performance, design, manufacture, and intended use)
• Be aware that the TGA can take regulatory action (e.g. recalls or hazard alerts)
• Report adverse events to the TGA
•Comply with advertising requirements for therapeutic goods
📩 Not sure where your software stands? Contact us to help assess your medical device and guide you through the regulatory pathway.