Software developers + SMEs: If your app makes therapeutic claims, the following applies to you.

More and more Australian SMEs are building software that edges into the health space — sleep apps, symptom checkers, monitoring tools, AI‑driven insights. But the moment your software starts diagnosing, predicting, preventing, treating or monitoring a condition, you’ve crossed into medical device territory under the Therapeutic Goods Act.

And once you’re in that category, your advertising must comply with the Therapeutic Goods Advertising Code — even if you’re “just a software company”.

Here’s what that means in practice.

1. Your claims determine your regulatory status

It’s not the codebase, the UI, or the business model that makes your product a medical device — it’s the claims you make.

If you say your app can:

detect sleep apnoea
predict heart issues
monitor asthma
assess mental health
guide treatment decisions

…you’re making therapeutic claims, and the TGA will treat your product as a regulated medical device.

If your product is excluded (e.g., general wellness apps), you must avoid therapeutic claims or you lose that exclusion instantly.

2. If consumers can see your advertising, the full rules apply

Even if your intention is to market only to clinicians, if consumers can access the content — even accidentally — you must comply with the full consumer advertising rules.

Your advertising must include:

an accurate description of the device
the trade name
the intended purpose
mandatory statements and warnings

And you must not include:

“TGA approved” claims
unproven performance claims
health professional endorsements
references to serious diseases (e.g., cancer, HIV) without approval

Penalties apply even if the breach was unintentional.

3. Developer documentation ≠ advertising — but be careful

Technical, scientific or clinical information intended for health professionals can be exempt from consumer rules only if it’s not promotional.

If you’re publishing:

API docs
white papers
validation data
clinical performance summaries

…these must be factual, balanced, and not accessible to the general public if they contain promotional elements.

4. Want to advertise only to health professionals? Lock it down.

To avoid consumer advertising rules, you must restrict access using methods such as:

Ahpra verification
secure login
professional‑only platforms
hospital/clinic email domain checks
IP‑restricted portals

If even one consumer can access it, the exemption is lost.

5. SMEs are most at risk — because they move fast

Common SME pitfalls:

marketing teams using “diagnose” or “monitor” without realising the regulatory impact
app store descriptions written like consumer ads
landing pages accessible to everyone
performance claims not backed by evidence
assuming “software isn’t a medical device”

The TGA cares about your claims.

Bottom line for developers and SMEs

If your software behaves like a medical device, the TGA will treat it like one. If your advertising looks promotional, the TGA will regulate it. If consumers can see it, the full Code applies.

Build smart. Advertise carefully. Protect your product — and your business — from avoidable compliance risk.