TGA Med Dev Guidance: Software Exclusions from Medical Device Regulations

Introduction

The Therapeutic Goods Administration (TGA) released multiple New & updated guidances on 16 March 2026, that provides clarity on when certain software products may be excluded from medical device regulatory requirements.

With the rapid growth of digital health technologies, this guidance helps distinguish between software that requires regulation and software that can be safely excluded based on its intended use and risk profile.

Background

As digital health solutions such as mobile apps, platforms, and healthcare software systems continue to expand, regulators face the challenge of ensuring patient safety without over-regulating low-risk tools.

This guidance outlines specific categories of software that may not be considered medical devices, provided they meet defined criteria. The goal is to support innovation while maintaining appropriate regulatory oversight.

Purpose of the Guidance

The purpose of this guidance is to help developers and stakeholders understand when software products can be excluded from TGA regulation.

It aims to:

• Clarify regulatory boundaries for digital health software

• Reduce unnecessary regulatory burden

• Encourage innovation in low-risk health technologies

• Ensure that higher-risk software remains appropriately regulated

Categories of Software Exclusions

The guidance describes multiple categories of software that may qualify for exclusion based on their functionality and intended use.

General Health and Wellness Software

Software designed to promote general health or wellness, such as fitness or lifestyle apps, may be excluded when it does not provide medical advice or treatment.

Digital Mental Health Tools

Consumer-facing tools like apps or websites that support mental well-being may be excluded if they do not perform clinical diagnosis or therapeutic intervention.

Health Alert Systems

Software that provides alerts to healthcare professionals may be excluded if it supports decision-making without directly controlling or influencing clinical outcomes.

Middleware for Health Systems

Middleware that enables communication or integration between systems may be excluded when it does not process or interpret clinical data independently.

Calculator Software

Software that performs calculations may be excluded if it is based on simple, transparent logic and does not provide complex clinical interpretation.

Electronic Health Records and Laboratory Systems

This guidance also covers systems used in healthcare infrastructure.

Electronic Health Records (EHRs) and laboratory systems (LIMS/LIS) may be excluded when they are used for data storage, management, and organisation, without influencing clinical decisions.

Population and Workflow Software

Population-based analytics software may be excluded when it is used for public health insights rather than individual patient care.

Similarly, clinical workflow management software may be excluded when it supports administrative processes without directly impacting diagnosis or treatment.

Image and Communication Software

Software used solely for image storage and transmission may be excluded if it does not modify or interpret medical images.

Communication tools that facilitate interaction between patients and healthcare providers may also be excluded when they do not perform clinical functions.

Patient Engagement and Behavioural Tools

This guidance includes several consumer-focused tools.

Patient survey software, including PROMs questionnaires, may be excluded when used for data collection rather than clinical decision-making.

Behavioural coaching and lifestyle management tools, as well as health self-management software, may also be excluded when they support users without providing direct medical intervention.

Health Facility Management Software

Software used for the administration and management of healthcare facilities may be excluded when it focuses on operational efficiency rather than clinical outcomes.

Across all categories, this guidance emphasizes a central principle: software may be excluded if it does not pose a significant risk to patient safety and does not perform direct clinical functions such as diagnosis, treatment, or decision-making.