Clinical Decision Support Software in Australia

Clinical Decision Support Software in Australia: When Is It a Medical Device?

Introduction

As digital health technologies evolve, the boundaries between health apps and medical devices have become increasingly complex. To provide clarity, the Therapeutic Goods Administration (TGA) released updated guidance in October 2025 titled “Understanding Clinical Decision Support Software (CDSS)”, outlining how clinical decision support systems are regulated under the Therapeutic Goods Act 1989 and Medical Devices Regulations 2002.

This guidance is essential for developers, manufacturers, and sponsors of AI-driven health software to understand when a product must be included in the Australian Register of Therapeutic Goods (ARTG)—and when it may qualify for an exemption.

What Is Clinical Decision Support Software (CDSS)?

The TGA defines CDSS as software that enables or supports clinical practice.Examples include:

• Apps that help clinicians interpret symptoms or risk scores;

• Software analysing medical images or laboratory data;

• Systems that generate alerts or reminders based on clinical guidelines.

CDSS may take many forms: mobile apps, web platforms, cloud-based systems, or integrated modules within electronic medical records (EMRs).

Whether or not such software qualifies as a medical device depends on its intended purpose, as defined in Section 41BD of the Therapeutic Goods Act.

Excluded vs. Exempt Software

The TGA distinguishes between excluded and exempt software:

• Excluded software is completely outside TGA regulation under the Excluded Goods Determination 2018 (for example, low-risk administrative tools or general health information apps).

• Exempt software is still considered a medical device but does not need ARTG inclusion. These systems must, however, comply with essential principles of safety and performance, maintain post-market surveillance, and notify the TGA within 30 working days of supply.

  
  

How to Determine if Your CDSS Is Exempt

The TGA’s step-wise approach includes three key questions:

Step 1 – Is the software a medical device?

If the software is intended for diagnosis, monitoring, prediction, treatment, or prevention of disease—or for supporting conception—it is likely to be a medical device.

Step 2 – Is it used to support a health professional?

Only CDSS that assist registered health professionals qualify for exemption consideration. Direct-to-consumer or patient-facing tools do not.

Step 3 – Does it meet all three exemption criteria?

To be exempt, the CDSS must meet all three of the following:

1. Purpose limitation – The software’s sole purpose is to provide or support a recommendation to a health professional about preventing, diagnosing, curing, or alleviating a disease or condition.

2. No direct processing of medical data – It must not directly analyse or interpret medical images, signals, or data from other medical devices or IVDs.

3. Clinical judgment preserved – It must not replace the clinician’s judgment; recommendations must be transparent, evidence-based, and verifiable.

Software in Australia is a TGA key item!

Transparency and the “Glass Box” Principle

A critical concept in the updated guidance is transparency.CDSS that use clear, rule-based logic—such as published clinical scoring systems or guideline-based flowcharts—are considered “glass box” systems and may qualify as exempt.

In contrast, “black box” systems, especially those powered by artificial intelligence or machine learning that produce non-interpretable outputs, are not exempt and require ARTG inclusion.

Examples of Exempt vs. Non-Exempt CDSS

Exempt CDSS Examples:

• An EMR-integrated asthma management module following published National Asthma Council guidelines.

• A risk-assessment tool that calculates thromboembolism risk based on clinical inputs.

• A computerized tonsillitis scoring calculator (e.g., Centor or McIsaac) that supports, but does not replace, clinical judgment.

Non-Exempt CDSS Examples:

• Software that analyses x-rays or ECG signals to identify anomalies.

• Machine learning wound-assessment apps that classify tissue types.

• Systems generating automated diagnoses or treatment plans.

Regulatory Responsibilities for Exempt CDSS

Even when exempt from ARTG inclusion, CDSS developers and sponsors must still:

• Notify the TGA of supply using the CDSS Exemption Notification Form;

• Comply with Essential Principles for safety and performance;

• Report adverse events;

• Follow advertising restrictions for therapeutic goods; and

• Be prepared for TGA audits or recalls if safety issues arise.

Key Takeaways for Developers and Sponsors

1. Intended purpose drives classification: what the software claims to do is decisive.

2. Transparency is critical: AI or opaque algorithms rarely qualify as exempt.

3. Exemption ≠ deregulation: obligations for quality, safety, and vigilance still apply.

4. Document your justification: maintain evidence that your product meets all three exemption criteria.

Conclusion

The TGA’s 2025 update clarifies the balance between innovation and patient safety in Australia’s fast-evolving digital health sector. For manufacturers and startups developing clinical software, understanding these distinctions early can save months of regulatory delay and enable faster market access.

If you’re developing or distributing clinical software in Australia, make sure your intended purpose, design documentation, and evidence base align with the TGA’s framework.

AF Pharma assists global innovators in navigating TGA regulations, including Software as a Medical Device (SaMD) classification, ARTG inclusion, and Australian Sponsor representation.

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