TGA Guidelines on Software Exclusions: When Your Software Falls Outside Medical Device Regulation
The Therapeutic Goods Administration has shared updated guidance on when certain software does not need to be regulated under Australia’s medical device rules. This depends on what the software is meant to do and how it is used in a clinical setting.
This update addresses the key issues of intended use, functionality, and clinical impact to determine whether the software falls within the purview of the Medical Device TGA regulation or may be excluded from regulation as a medical device under TGA guidelines.
This is a critical regulatory decision point for companies involved in the development of digital health solutions.
Why This Update Matters?
Determining whether software is regulated is one of the most important early decisions in product development.
⦿ Misclassification can lead to unnecessary regulatory burden and compliance costs
⦿ Or worse, regulatory risks if the software is incorrectly excluded under TGA guidelines
⦿ It directly impacts the ARTG Australia inclusion and the medical device regulation pathway
For many companies, especially those building AI tools or digital wellbeing tools, this has been a challenging area.
When is Software a Medical Device?
Software is considered regulated under medical device regulation when it:
⦿ Diagnoses, prevents, or treats a disease
⦿ Influences clinical decisions or patient management
⦿ Provides patient-specific outputs that guide care
In simple terms, if your software is intended to perform a medical purpose, such as diagnosis, monitoring, or influencing clinical decisions, it is likely to be regulated under the TGA medical device regulation.
When is Software NOT a Medical Device?
According to TGA guidelines, software may be excluded if it:
⦿ Supports general wellness (e.g., digital wellbeing tools)
⦿ Manages administrative or operational functions
⦿ Stores or displays data without interpretation
⦿ Provides general medical information without personalization
This is where many companies ask: “When is software not a medical device?”
The answer lies in whether it does not perform a medical purpose and does not influence clinical decision-making or patient management.
However, exclusion depends on intended purpose, claims, and how the software is used in practice, not just functionality.
What does this mean for Manufacturers?
This guidance helps companies:
⦿ Make early regulatory decisions
⦿ Avoid costly rework during submissions
⦿ Define the correct pathway under the TGA medical device regulation and the ARTG Australia requirements
⦿ Accelerate time to market
It is particularly valuable for companies asking: “When is software a medical device?”
Where Companies Often Go Wrong?
Companies may:
⦿ Incorrectly assume their software qualifies for exclusion under TGA guidelines
⦿ Overlook the importance of intended use in labels and claims
⦿ Misunderstand TGA guidelines for AI-based tools
These mistakes can delay approvals or trigger compliance issues.
Where Elexes Can Help?
Elexes helps digital health and software companies make early regulatory decisions on whether their product falls within medical device regulation or qualifies for exclusion under TGA guidelines. Our support includes:
⦿ Assessment of whether software qualifies as a medical device under the TGA regulation
⦿ Determining the applicability of software exclusions under TGA guidelines
⦿ Defining the correct ARTG Australia regulatory pathway
⦿ Aligning product claims and intended use with regulatory strategy
⦿ Supporting global alignment with medical device regulation frameworks
FAQs
When is software considered a medical device under TGA?
Software is considered a medical device when it performs a medical function such as diagnosis, treatment, or influencing clinical decisions based on patient-specific data.
When is software not a medical device?
Software will not be considered a medical device if it is used for general wellness, administrative purposes, or providing non-clinical information and does not impact patient care.
Do excluded software products need ARTG inclusion?
No, software products that are classified as excluded software products do not need inclusion in ARTG Australia and are not subject to TGA regulation.
What are the risks of misclassifying software?
Misclassification risks can cause delays or compliance issues with the TGA or cause companies to waste resources on documentation and approvals.
How do TGA requirements apply to AI-based software?
TGA regulations apply to AI software that has an impact on clinical decisions and outcomes. However, software may be excluded from medical device regulation under TGA guidelines if it does not serve a medical purpose and is intended for general or non-clinical use.
