SAMD
In Australia, software-based medical devices fall under the TGA's medical device framework, with specific classification rules and a set of carve-outs (some software is excluded altogether, some exempt from ARTG inclusion but still regulated). Devices that are caught must be included on the ARTG via an Australian Sponsor.
At Taylored Consultancy Ltd, we make software compliance clear and stress-free. We help you work out whether and how your software is regulated, then guide you through classification, evidence and ARTG inclusion.
Clearing the path to market -
regulatory and quality expertise that gets your software safe, compliant, and ready for market.
The first step in Australia is working out whether your software is regulated at all. We assess it against the TGA's software-specific rules, exclusions and exemptions.
We determine the correct classification under the TGA's software classification rules, ensuring you follow the right pathway.
We help you put a compliant software development lifecycle and documentation in place.
We help you compile clinical evidence, leveraging comparable overseas approvals where the TGA accepts them.
We build your risk management file, including software and AI/ML risks.
We manage your application for inclusion on the ARTG.
A local Australian Sponsor is required to hold the ARTG entry. We help you put the right arrangement in place.
We help you implement a QMS to ISO 13485, the backbone of software medical device compliance.
Regulations can feel like a headache, but they don't have to be. We make sure you're covered, compliant, and ready to sell - without unnecessary delays or legal pitfalls.
EN 62304 / IEC 62304 - Medical device software lifecycle
IEC 82304-1 - Health software products
IEC 62366-1 - Usability / human factors engineering
ISO 14971 - Risk management for medical devices
ISO 13485 - Medical devices QMS
ISO/IEC 42001 - AI management systems
ISO 9001 - General quality management
It depends on intended purpose: the TGA divides software into fully regulated devices needing ARTG inclusion, exempt products that are regulated but skip ARTG listing, and excluded software that falls outside the framework entirely, for example pure lifestyle or wellness tools. Many founders assume their app is excluded when it's actually exempt or fully regulated, so this determination is worth a formal assessment rather than a guess.
If your software is classified as a regulated medical device, yes, inclusion on the Australian Register of Therapeutic Goods (ARTG) is mandatory before you can legally supply it in Australia. Exempt and excluded software don't require ARTG listing, which is exactly why getting your classification right first saves you from either an unnecessary registration or an unlicensed launch.
An Australian Sponsor is a locally based entity that takes on regulatory responsibility for your device with the TGA if you don't have an Australian presence yourself. This is a legal requirement for ARTG-listed software, not an optional service. We act as Australian Sponsor for overseas SaMD companies so market entry doesn't stall on a local presence you don't yet have.
TGA's software classification rules are built on the same IMDRF risk-based logic used internationally, weighing the significance of the information the software provides against the seriousness of the healthcare situation, but the specific thresholds and category boundaries are set independently by TGA. A classification worked out for the EU or US can't simply be copied across; it needs its own Australian assessment.
TGA expects clinical evidence proportionate to your device's risk classification, demonstrating the software performs as intended and is safe for its stated use. This can include literature-based evidence, real-world performance data or a clinical investigation depending on the claims you're making. Higher-classified software faces closer scrutiny of this evidence during ARTG assessment.
Yes, TGA expects manufacturers of regulated software to operate a quality management system aligned with ISO 13485, covering design controls, risk management and post-market surveillance, not just a one-off technical file. It's assessed as part of your conformity evidence, so building it in from the start is far cheaper than retrofitting it once you're already on the ARTG.
Still have questions? Contact us and we'll be happy to help.
