A working checklist for anyone writing, approving or publishing digital marketing content for a medical device in Australia. Run any piece of content, website page, ad, email or social post against this before it goes live.
This is a practical reference, not legal advice. If you are ever in doubt about whether your marketing complies with the law, please obtain legal advice from a qualified professional.
1. Before you write a word: can this device be advertised to the intended audience?
- The device is included on the ARTG, or is legitimately exempt. Before advertising a medical device to the public, confirm that it is included in the ARTG or is covered by a lawful exemption, such as an applicable patient-matched or custom-made medical-device exemption. Different rules may apply to advertising secured and directed exclusively to verified health professionals, but off-label promotion remains prohibited.
View the TGA Advertising personalised medical devices here. - You know whether this content counts as “advertising” to the public under the TGA’s definition. Content may constitute advertising where its purpose or effect is to promote the use or supply of the device. This can include websites, social posts, blogs, emails, influencer content and linked material. Genuinely factual, balanced and non-promotional information may be treated differently.
View the TGA Advertising legal framework here. - Confirm that every express and implied claim remains within the device’s intended purpose and ARTG inclusion. Do not promote an off-label use, including in material directed exclusively to health professionals.
- Remember TGA compliance doesn’t displace the Australian Consumer Law. A claim can still be false, misleading or deceptive even if it doesn’t breach a device-specific TGA provision.
2. Words and claims you can never use, full stop
- Do not describe a device as “TGA approved”, “TGA certified”, “TGA registered” or “TGA endorsed”. These expressions can misleadingly suggest that the TGA has approved or endorsed the product. Where appropriate, you may accurately state that the device is included in the ARTG and provide its ARTG number.
- Never state or imply the device is effective in all cases, or a guaranteed cure. Words like “the best” or “works fastest” need evidence against other products in the market, not just confidence.
- Never state or imply a competitor’s device is ineffective or harmful, unless you can back it with the same standard of evidence a comparative claim requires.
- Do not use an endorsement or testimonial from a person or organisation prohibited under the Advertising Code, including current or former health practitioners, health professionals and medical researchers, or prohibited government and healthcare bodies and their relevant representatives.
View TGA’s Applying the Advertising Code rules: general requirements here.
3. Prohibited representations: references that require a specific TGA permission
- Do not refer expressly or by implication to a prohibited disease, condition or action unless a specific TGA permission applies. Prohibited representations include references to neoplastic diseases such as cancer, sexually transmitted diseases, HIV/AIDS, hepatitis C, mental illness and abortifacient action. The TGA may permit a prohibited representation in limited circumstances where it is necessary for public health or for the appropriate use of the goods.
Read TGA’s Restricted and prohibited representations in advertising here
4. Restricted representations: conditions you can only reference with approval
- If the content expressly or implicitly refers to a serious disease, condition, ailment or defect, confirm that the representation is covered by a current TGA approval or permission and that every condition attached to it is satisfied. This applies even if the reference isn’t a direct therapeutic claim; implication is enough to trigger the rule.
Read Applying the advertising code rules: restricted representations from the TGA here. - Check the list of representations the TGA has already approved for your device category before assuming you need a fresh application.
Read TGA’s Advertising permissions here.
5. Testimonials and endorsements
- No testimonials or endorsements from anyone barred under the Code: current or former health practitioners, health professionals, medical researchers, government authorities, hospitals or healthcare facilities, or employees/contractors of any of those.
- If an organisation representing consumers or health professionals endorses the device, the ad must disclose the organisation’s name and whether they received payment or valuable consideration for the endorsement.
- Where payment or other valuable consideration must be disclosed, make the relationship clear and prominent in the advertisement. Wording such as “paid partnership” may assist, but disclosure does not make an otherwise prohibited or non-compliant testimonial lawful.
Read the TGA’s guidelines on testimonials and endorsements in advertising here.
6. Advertising directly to health professionals (more latitude, but conditions apply)
- Confirm that the material is genuinely secured so that only verified health professionals can access it. A login by itself is not enough unless professional status has first been verified through an appropriate process, such as checking relevant registration details, obtaining suitable employer confirmation or using another robust verification method.
- Remember off-label promotion is never allowed, even in gated content aimed only at clinicians.
Read Advertising to health professionals so that consumer rules do not apply from the TGA here.
7. Social media specific checks
- Comments, reviews and user-generated images appearing on or linked to your social content can become testimonials or endorsements forming part of the advertisement. Monitor them and remove or manage content that causes the advertisement to become non-compliant.
- Influencer and sponsored content must clearly disclose commercial relationships. Do not use a current or former health professional to provide, or appear to provide, a testimonial or endorsement of the device.
- The advertiser remains responsible for content produced with generative AI or automated tools. Review AI-generated captions, images and claims against the same legal and evidentiary requirements as human-created content before publication.
Read the TGA’s guide to advertising therapeutic goods on social media here. - Check every page, study, testimonial, overseas website or social account linked from the advertisement. Linked material may be treated as part of the advertisement.
- Watch disease-awareness or educational content built for SEO. It can become device advertising where it directly or indirectly promotes a particular product, even without naming it outright.
- Remember public content available to Australians may need to comply even where the advertiser, platform or manufacturer is based overseas.
8. If a health practitioner or clinic is part of the campaign (Ahpra overlay)
Where the content also advertises a health service delivered by a registered practitioner (not just the device itself), Ahpra’s rules apply in addition to the TGA’s.
- No testimonials about clinical care or outcomes anywhere in the practitioner’s or clinic’s own advertising, including reposted or embedded Google reviews. This is separate from, and stricter than, the TGA’s testimonial rules. Independent reviews on a third-party platform are not necessarily the clinic’s advertising merely because they exist. However, republishing, embedding, selectively displaying or linking to testimonials can bring them into the clinic’s advertising.
- Don’t create an unreasonable expectation of beneficial treatment.
- Before-and-after photographs require particular care. They must be genuine, must not be edited or presented misleadingly, and must not create an unreasonable expectation that other patients will achieve the same result. Additional profession- or procedure-specific rules may apply.
View TGA’s guidelines for advertising a regulated health service, Ahpra here.
9. Final checks before publishing
- Confirm that the advertisement contains an accurate description of the medical device, the applicable mandatory statement directing consumers to read and follow the directions for use, and every relevant health warning or advisory statement. Check the Code for the precise wording and prominence requirements, including the special rules for short-form advertisements and devices not available for purchase by the general public.
Read the mandatory statements and other information required in advertising from the TGA here. - Any clinical or scientific reference is something a reader can actually locate and verify, and the funder of that research is disclosed if known.
- Comparative claims are accurate, verifiable and not misleading, and don’t exploit a gap in the reader’s knowledge.
Read TGA’s guide on applying the advertising code rules: general requirements here.
Where to Check the Current Rules
- Where to go for the source material. The TGA Advertising Hub is the central index for every guidance page linked above, and it’s the first place to check when a rule changes.
- For anything involving a registered practitioner advertising their own services, cross-check against the Ahpra Advertising Hub as well.
This checklist reflects TGA and Ahpra guidance as published at the time of writing. Both bodies update their guidance periodically, so treat this as a starting point for review, not a substitute for checking the current source page before a high-stakes campaign goes live.
