SaMD and Software Medical Device Regulation in Australia

1. Key takeaways

The classification rules for software-based medical devices (SaMD) in Australia are items 4.5–4.8 of Schedule 2, added by F2019L01660 and effective from 25 February 2021 (and earlier, from 25 August 2020, for new applications). The widely circulated claim of a SaMD reclassification on 1 November 2024 is in fact a transitional deadline: legacy products already on the market or under assessment had to be re-included in the ARTG under the new classification by that date, and products that missed it must cease supply and be cancelled. Confusing a commencement date with a transitional cut-off is the single most consequential date error in this domain, because it inverts the compliance timeline: the obligations began years earlier than the headline date suggests, and the headline date marks the end of the grace period, not the start of the duty.

2. Legal basis

1. Therapeutic Goods (Medical Devices) Regulations 2002 (F2002B00237, compilation F2026C00883): the software classification rules are Schedule 2 Part 4, items 4.5–4.8; regulation 1.3 provides that software that is a medical device is an active medical device.
2. Addition and commencement: the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019 (F2019L01660) added cl 4.5–4.8, with its Schedules 2 and 3 effective from 25 February 2021; the transitional provisions of the same instrument apply cl 4.5–4.8 to applications made from 25 August 2020, and to “transitional class devices” from 1 November 2024.
3. Transitional deferral mechanism: the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024 (F2024L00686, effective 1 July 2024) added regulation 11.45(4A)–(4C), applying to devices for which an application for a conformity assessment certificate was made between 25 February 2021 and 1 November 2024 and which were not yet included in the Register before 1 November 2024; for them the new classification rules apply from the day after the certificate procedure concludes.
4. Software-related Essential Principles: 13B (version numbers and build numbers, effective 25 February 2021) and 12.1 (including cybersecurity requirements, which from 25 February 2021 operate as a clarification of the existing requirement rather than a new requirement).
5. Exemptions and exclusions: Schedule 4, item 2.15 exempts qualifying clinical decision support system (CDSS) software; there is also an exclusion category, comprising 15 classes, listed in Schedule 1 of the Therapeutic Goods (Excluded Goods) Determination 2018.
6. TGA software exclusion guidance series: an overview page and individual guidances published on 16 March 2026, covering imaging storage and transmission, population analysis, healthcare facility management, clinical workflow, calculators, LIMS/LIS, general health and wellness, communication, health self-management, digital mental health tools, behaviour change and coaching, electronic health records, health alert systems, patient questionnaires, middleware, and other categories.

3. Expert insights

Insight 1: Date confusion is the most expensive error. Writing 1 November 2024 as the date the new rules took effect leads a company to miss the true commencement point (25 February 2021) and thereby misjudge whether it has been in compliance all along. The transitional deadline and the commencement date are two different things and must be stated separately in every document. The cost of the confusion compounds over time: a team that believes the rules start in late 2024 will plan reclassification work late, discover the certificate queue is long, and arrive at the deadline without a submission rather than with one.

Insight 2: Multi-function software must be determined function by function. The exclusion list applies only where every function of the software meets the exclusion conditions; if even one function falls within the device category, the whole product is managed as a device. When we assess AI products we therefore work through a function list item by item, rather than reaching a conclusion about the product as a whole. This granularity protects both directions of error: it prevents an exclusion claim that one medical function would defeat, and it prevents an unnecessary device registration for software whose only medical function is truly peripheral.

Insight 3: Exemption and exclusion have different consequences but are easily conflated. CDSS software travels through the item 2.15 exemption, remains a medical device, and retains notification, adverse event reporting, and advertising obligations; software on the exclusion list is not subject to TGA device regulation at all. The evidentiary burdens and the residual duties of the two routes differ. A product owner must therefore be able to name not only which route the product travels but why, because the supporting analysis is the first thing an auditor or inspector will ask to see.

4. Practical recommendations

1. Maintain a three-column “function — purpose — determination” list for every software product, checking each entry against the section 41BD definition and the exclusion lists, and record the date of the determination and the version of the sources relied upon.
2. For marketed software, verify whether reclassification under cl 4.5–4.8 has been completed; where a deferral under regulation 11.45(4A)–(4C) was relied upon, track the conclusion date of the certificate procedure and re-start the clock from the following day.
3. Prepare cybersecurity evidence as a stand-alone volume mapped to Essential Principles item 12.1, and bring version and build number management under a controlled process mapped to item 13B, so that both files are retrievable on demand during assessment.
4. For AI and adaptive algorithm products, prepare a change management plan in line with the TGA software guidance before release, so that version iteration does not unexpectedly trigger a fresh application (see article 30 for details).

5. Verification checklist

• □ Software classification has been determined under cl 4.5–4.8, distinguishing the commencement date from the transitional deadline
• □ For multi-function software, the exclusion lists have been checked function by function
• □ Whether the item 2.15 exemption or the exclusion list applies has been confirmed
• □ Cybersecurity evidence has been compiled into a volume mapped to Essential Principles item 12.1
• □ Version and build number management is under a controlled process (item 13B)

Regulatory information verified as of 29 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Australian market. Our team manages TGA inclusion and ARTG listing applications, coordinates conformity assessment evidence, and supports post-market vigilance obligations. Business enquiries: info@grzan.cn