TGA Medical Device Advertising: What Your Website Can Claim

TGA medical device advertising has one clear boundary, and it's your device's entry on the ARTG, the TGA's register. Most device ads have to carry 4 things. You need the trade name, an accurate description and an accepted intended purpose. You also need the line Always follow the directions for use. A claim that goes past the ARTG entry is a breach, and so is calling the device TGA approved. You can print the ARTG number on its own instead.

What must every medical device ad include?

Device companies tend to be careful with their claims. They work with test reports and labels all day. So the gaps are often small ones, like a missing line that the code asks for by name.

Section 20 of the Therapeutic Goods Advertising Code lists what a device ad has to contain. That's the TGA's rulebook for health product ads. It covers your website and your social posts, as well as print.

If people can buy the device from your site without seeing it first, you have 2 more jobs. The code asks you to name any ingredient listed in the Poisons Standard, where that applies. It also asks for the health warnings, or a link straight to them.

Some devices are only supplied through a health professional. If you advertise one of those to the public, the code asks for a different line. It reads This product is not available for purchase by the general public.

There's a small exception worth knowing too. An ad with only the name, a picture, the price or the place to buy can skip them. That only holds while it makes no claim about what the device does for your health.

Which device claims does the TGA code rule out?

I made up the 6 lines below for this post. Each one follows a pattern that turns up on device and clinic pages, and none comes from any company. Beside each one is the rule it meets and a safer way to say it.

The TGA approved line is easy to write, and it comes from a good place. The company is proud it did the work to get on the register. But the Therapeutic Goods Act covers any ad "suggesting or implying the goods have been recommended or approved by or on behalf of a government or government authority". The Act does allow you to state the device number, so let the number speak for you.

The safety line feels kind to write. Still, the code says an ad must not represent goods as "safe, or without harm or side-effects". Every device has some risk, so it's better to point people to the warnings.

Clinically proven is a phrase buyers like, and the code doesn't ban it outright. It asks a lot of you, though. An ad that refers to research must "identify the researcher" and the sponsor where you know it. It must also cite the study well enough for a reader to find it.

Testimonials have their own section in the code. It rules out reviews from anyone engaged in making, marketing or supplying the goods, and that includes paid influencers. Any testimonial you do use has to be checked, both the words and the person.

The heart disease line is a restricted representation. That's the code's term for naming a serious condition, and it needs the TGA's approval first. A condition usually counts as serious if it needs a health practitioner to diagnose or treat it.

Why does your ARTG entry set the limit?

Your ARTG entry records the intended purpose the TGA accepted for your device. The code says an ad "must not be inconsistent with any indication or intended purpose accepted in relation to the inclusion of the goods in the Register". So the entry works like a fence around your copy.

One detail surprised me when I read the law closely. The definition of intended purpose lists the places a maker states it. One of them is "any advertising material applying to the device". So your website can become evidence of what you intend the device for.

That's why the verbs matter so much. Supports, measures and monitors are modest claims. Treats, heals and prevents are bigger claims. They need to be in the entry before they go on your page.

The Act has a separate offence for advertising a device for a purpose outside its entry. The penalty can be up to 12 months in prison, 1,000 penalty units or both. For a company, the civil penalty for an ad that breaks the code can reach 50,000 penalty units.

Devices that aren't on the ARTG yet need extra care. The Regulations stop public ads for a device that is missing from the register and has no exemption. That can catch pre-launch pages and coming soon posts, which are easy to forget about.

Does the code apply to pages you write only for clinicians and hospital buyers?

The code and the Act's main advertising rules step back for ads aimed only at health professionals. The Act's wording is ads "directed exclusively to" health practitioners and some other groups, like hospital buyers. So a brochure sent to surgeons can say more than a public web page.

The tricky word is exclusively. Many device websites serve buyers, patients and clinicians on the same open pages. A page anyone can open is hard to call exclusive. So it's safer to write it to the public rules.

If you do need to say more to clinicians, give them their own section behind a sign-in. Keep the public pages to the ARTG wording and the required line. That way each reader gets the right level of detail.

My guide to the TGA advertising code in 2026 covers the wider rules, including medicines. For Instagram and LinkedIn, read the guide to what clinics can post under the TGA rules on social media.

What if your clinic sells or recommends a device?

Plenty of clinics sell devices, like a physio selling a brace or a sleep clinic selling a mask. When you describe that product, the device rules apply to your clinic too. The law covers anyone who advertises the goods, and not only the company that makes them.

Your service still sits under AHPRA, the national agency behind the rules for registered health practitioners. So a single page can face both sets of rules. The device line follows the TGA code, and the line about your care follows AHPRA's guidelines.

The simplest fix is to keep the 2 apart on the page. Describe the consultation in one place, and the product in another with its required line. It's easier for a patient to read too.

If your clinic sells hearing aids, the audiology marketing guide covers the extra wording for that field. For device companies, I write website copy for medical device companies to the ARTG entry. Every page is checked by All Clear Audit, the 301-check audit I built.

Did the advertising code change in 2026?

Yes, but not for devices. An amendment to the code took effect on 30 September 2026. It swapped the old medicine labelling orders for the new ones, called TGO 115 and TGO 116.

The device section wasn't touched. So the 4 required items and the online shop rules read the same as before. If your device pages were in good shape last month, they still are.

How did I put this together?

How I put this together. I read the code, the Act and the Regulations on the federal legislation site. Every quote is word for word. I wrote the 6 example lines myself, as composites of patterns I've seen.

I checked the September 2026 amendment line by line, to confirm the device section stayed the same.

• This is a guide, not legal advice. Ask a lawyer about your own ads.
• The example lines are made up, and they come from no company or clinic.
• Your ARTG entry is the final word on your intended purpose, so read it first.
• Some devices have extra wording rules under other orders, which this post doesn't cover.
• Penalty units change in value over time, so I haven't turned them into dollars.

Related reading:

• The TGA advertising code in 2026: what your brand can and cannot say
• What your clinic can post under the TGA rules on social media
• TGA rules for advertising supplements
• Audiology marketing in Australia
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