Under the Therapeutic Goods Administration regulations in Australia, some Clinical Decision Support Systems may be considered exempt medical devices. The exemption is narrower than it is often assumed to be.
The three criteria
A CDSS is only exempt if it meets all three of the following:
- It supports or provides recommendations to a health professional, for example 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
AI enabled systems do not qualify
With the rapid uptake of artificial intelligence in healthcare, this point is worth stating plainly: an AI enabled CDSS will not meet the exemption criteria. If your software meets all three criteria and is not AI enabled, it is likely an exempt medical device. Exempt, however, does not mean unregulated.
Obligations that still apply to an exempt CDSS
- Notify the TGA within 30 working days of supply, using the CDSS Exemption Notification Form
- Comply with the Essential Principles covering safety, performance, design, manufacture and intended use
- Understand that the TGA can still take regulatory action, including recalls and hazard alerts
- Report adverse events to the TGA
- Comply with the advertising requirements for therapeutic goods
If you are not certain where your software sits, Compliance Management Solutions can help you assess it and identify the regulatory pathway that applies. Please contact our regulatory team to discuss your product.