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# Australia TGA for Software as a Medical Device: Classification and ARTG Registration

Software that makes patient-specific clinical outputs is regulated as a medical device in Australia — and must be included in the ARTG before it can be supplied. This guide explains how TGA classifies SaMD, what conformity assessment is required at each class, and how international regulatory evidence can support your ARTG application.

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At a glance

Regulator

TGA (Therapeutic Goods Administration)

Framework

Therapeutic Goods (Medical Devices) Regulations 2002

SaMD

Class I–III + AIMD classification

Database

ARTG (Australian Register of Therapeutic Goods)

## How TGA regulates Software as a Medical Device

### SaMD definition under Australian law

Software is a medical device under Australian law if it is intended to be used for a therapeutic purpose — including diagnosing, monitoring, treating, or alleviating a disease or condition. Diagnostic software, clinical decision support tools that provide patient-specific recommendations, and software that controls or monitors a physical medical device all qualify. General wellness apps, administrative software, and clinical decision support that only provides reference information (not patient-specific outputs) are typically excluded.

### TGA classification for SaMD

SaMD follows the same risk-based classification framework as hardware medical devices: Class I (lowest risk), Class IIa, Class IIb, and Class III (highest risk), plus AIMD (Active Implantable Medical Devices). The classification drives the conformity assessment pathway — Class I non-sterile, non-measuring SaMD can self-declare; Class IIa and above require a recognised third-party conformity assessment body.

### ARTG inclusion requirement

All medical devices — including SaMD above certain thresholds — must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. ARTG inclusion is the regulatory gate: a SaMD that is not in the ARTG cannot legally be sold, supplied, or distributed in Australia. The ARTG number is the evidence of compliance displayed in the public register.

### International regulatory reliance

TGA leverages conformity assessment evidence from comparable overseas regulators and from recognised international conformity assessment bodies. CE marking under the EU MDR, FDA 510(k) clearance, and PMA approval are accepted as strong supporting evidence for TGA ARTG inclusion. However, TGA applies its own classification rules independently — a Class IIa device in Europe may be classified differently in Australia, affecting which conformity assessment pathway is required.

## How to get SaMD onto the ARTG

01

Determine whether the software meets the TGA definition of a medical device by reviewing its intended purpose, clinical claims, and any integration with hardware medical devices — TGA has published SaMD guidance aligned with IMDRF principles; general wellness and administrative software that makes no patient-specific clinical outputs typically falls outside scope.

02

Classify the SaMD using TGA's classification rules under Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002 — consider intended use, risk level, whether the software directly drives clinical action, and any integration with life-sustaining hardware; software controlling a life-sustaining device is typically Class III.

03

Conduct the required conformity assessment at the level the classification demands — Class I (non-sterile, non-measuring) can self-declare; Class IIa, IIb, and III require engagement with a TGA-recognised conformity assessment body (CAB); international certification from an EU notified body or comparable regulator can be submitted as supporting evidence.

04

Prepare the technical documentation including: clinical evidence supporting the SaMD's intended use and clinical claims; software lifecycle documentation aligned with IEC 62304 (software development lifecycle for medical device software); and risk management documentation per ISO 14971.

05

Apply for ARTG inclusion through the TGA online portal as the Australian Sponsor — the application must include conformity assessment evidence, clinical evidence summary, labeling, Instructions for Use, and the Australian Sponsor's details; TGA review timelines range from approximately 4 weeks (Class I) to 255 business days (Class III).

## Frequently asked questions

### Does clinical decision support software need TGA registration?

It depends on what the software outputs and how it is intended to be used. Clinical decision support software that provides patient-specific diagnoses, treatment recommendations, or risk scores based on patient data is likely to be a medical device under the TGA's definition and require ARTG inclusion. Software that provides general clinical reference information — drug dosage tables, diagnostic criteria — without patient-specific outputs is less likely to be regulated. TGA has published guidance on CDS classification, and the IMDRF Software as a Medical Device framework is the international reference point TGA applies.

### How does TGA classify SaMD that integrates with a physical medical device?

SaMD that controls, monitors, or drives a physical medical device — particularly a life-sustaining one — is generally classified at a higher risk class than standalone diagnostic software. Software that controls an infusion pump or a ventilator is typically Class III. Software that reads data from a Class IIa wearable device for display purposes may itself be Class IIa. TGA's classification rules require the integrating software to be assessed in the context of its intended function and the risk profile of the hardware it interacts with.

### Can CE marking under EU MDR be used for TGA ARTG inclusion?

CE marking under the EU MDR is accepted by TGA as supporting conformity assessment evidence and substantially strengthens an ARTG application. However, it does not automatically grant ARTG inclusion — the Australian Sponsor must still submit an ARTG application, and TGA will apply Australian classification rules independently. If the Australian classification is higher than the European classification (for example, the device is Class IIb in Australia but Class IIa in Europe), additional conformity assessment evidence may be required to satisfy the Australian requirement.

### What ongoing obligations apply after ARTG inclusion for SaMD?

Post-market obligations for SaMD include: adverse event reporting to TGA (serious incidents must be reported within prescribed timeframes); post-market surveillance — ongoing monitoring of real-world performance, user feedback, and clinical literature; maintaining updated technical documentation; notifying TGA of significant changes to the software that may affect safety or performance (significant changes may trigger a new ARTG application or variation); and ensuring the Australian Sponsor remains the identified responsible entity for Australian supply.

**Disclaimer:** Educational resource only. Regulatory requirements change and vary by product category. Consult an accredited test laboratory or qualified compliance engineer before making certification decisions.

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