Australia’s SaMD Classification Changes: A Guide for Innovators

Australia’s Therapeutic Goods Administration (TGA) has been progressively reforming its medical device regulations, with software-based devices (SaMD) a major focus.

The most significant reforms took effect from 25 February 2021, introducing new classification rules for SaMD and digital health products. Since then, further updates through 2022–2025 have refined the framework and expanded the acceptance of overseas regulator approvals. These reforms bring Australia into closer alignment with international approaches, while recognising the rapid growth of digital health technologies.

For digital health innovators, the reforms make one thing certain: software is subject to clearer, more robust regulatory oversight.

Updated SaMD Classification Rules

Under the revised framework (effective since 2021), the TGA applies risk-based classification rules to SaMD, taking into account:

• The intended purpose of the software,
• The seriousness of the condition it addresses,
• Whether the software provides diagnosis, monitoring, or treatment support, and
• The intended user (for example, lay users vs health professionals).

This means that:

• Wellness apps and very low-risk digital tools may remain exempt or Class I devices.
• Diagnostic or treatment-related software will generally fall under higher classifications (Class IIa–III).
• AI-driven decision support systems face closer scrutiny, often requiring robust clinical evidence and risk management documentation.

For developers, this raises the bar in terms of regulatory submissions, technical documentation, and quality management system (QMS) requirements.

Recognition of Overseas Regulator Approvals

Since 2018, the TGA has recognised approvals from the FDA and European regulators. From 2022 onwards, this recognition has been expanded to include additional regulators, such as Singapore’s HSA.

This offers advantages, particularly for start-ups planning multi-market entry:

• Reduced duplication of technical documentation,
• Faster time-to-market if approvals are sequenced strategically,
• Potential cost savings on regulatory submissions.

However, overseas approval does not remove the need to demonstrate compliance with Australian-specific requirements, including:

• Labelling,
• Essential Principles,
• Post-market monitoring obligations, and
• A compliant Clinical Evaluation Report (CER).

What This Means for Start-Ups and Digital Health Firms

The TGA reforms highlight why regulatory planning must sit alongside product development:

• Classification decisions drive cost and timelines — a Class IIb diagnostic AI tool will have vastly different evidence requirements compared with a low-risk tracking app.
• Investor expectations are shifting — savvy investors now view regulatory strategy as integral to commercial viability.
• Early mistakes are costly — building a product without clear regulatory intent can lead to redesigns, delays, or compliance failures.

Practical Steps to Prepare

1. Define the intended purpose early — this determines classification and shapes your regulatory strategy.
2. Map regulatory pathways — consider both TGA and overseas regulators to streamline approvals.
3. Integrate QMS principles from the outset — even small firms should embed ISO 13485-aligned processes to ensure evidence traceability.
4. Engage experts early — whether in clinical evidence, risk management, or regulatory submissions, experienced guidance avoids missteps.

Final Thoughts

The TGA continues to strengthen and refine the regulatory framework for SaMD, with reforms beginning in 2021 and ongoing updates through 2025. For innovators, these changes present both a challenge and an opportunity: higher standards for compliance, but also faster routes to market if global approvals are used strategically.

At KD&A, we support innovators in navigating these reforms, ensuring that SaMD products meet regulatory expectations in Australia and abroad.