[Home](/)/[Resources](/resources)/TGA Advertising Code AustraliaMedical DevicesTGA # TGA Advertising Code Compliance for Medical and Health Hardware The Therapeutic Goods Advertising Code 2021 governs how therapeutic goods — including medical devices and health-adjacent hardware — can be promoted in Australia. What makes it genuinely dangerous for hardware companies is the intended purpose trap: the claims you make in advertising can reclassify your product as a medical device, triggering ARTG registration requirements you never anticipated. Understanding where the lines sit before you launch is dramatically cheaper than remediation after enforcement. Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Faustralia-tga-advertising-code) At a glance Code reference Therapeutic Goods Advertising Code 2021 Enforcement body TGA (Therapeutic Goods Administration) Key prohibition Disease cure/treatment claims without evidence Self-regulatory body Ad Standards (delegated complaints) ## Key concepts — where hardware companies get caught ### What counts as 'advertising' under the TGA framework The Therapeutic Goods Act 1989 (s3) defines advertising broadly: any statement, pictorial representation, or design that is intended — or is likely — to promote the use or supply of a therapeutic good. This captures product pages, app screenshots, social media posts, influencer content, unboxing videos seeded by your PR team, and even the product name itself if it implies a therapeutic function. You do not need to intend for something to be an advertisement — if it promotes use of the goods, it is one. ### The 'intended purpose' trap — when hardware becomes a medical device A product's regulatory classification in Australia is determined by its intended purpose, not its physical form. A wrist-worn sensor that you describe as tracking 'heart health' or 'detecting atrial fibrillation' in any advertising or labelling material is likely to be treated as a Class IIa or higher medical device requiring ARTG inclusion — regardless of whether you intended it as a fitness product. The TGA's guidance on software and digital health tools makes clear that functional claims, not hardware specs, drive classification. ### Prohibited claims — what you cannot say under any circumstances Section 10 of the Therapeutic Goods Advertising Code 2021 prohibits claims that: imply the product can cure a disease; use language that creates fear or exploits vulnerability; cite clinical studies in a way that is misleading about the evidence base; claim to be endorsed by a government body (unless true); or compare the product to a prescription medicine. The prohibition on disease-cure claims is absolute — 'may help manage' is not the same as 'treats', but both require substantiation by evidence appropriate to the claim. ### Permitted vs restricted claims — the evidence hierarchy The Code distinguishes permitted claims (general health maintenance, wellbeing, performance in healthy people) from restricted claims (therapeutic claims requiring substantiation). Restricted claims require evidence of a kind and level commensurate with the claim — the stronger the claim, the more rigorous the evidence required. A claim that your device 'helps you sleep better' is lower risk than 'clinically proven to reduce sleep apnoea events', which requires Level I or II evidence (RCTs or systematic reviews). ### Testimonials, before/after images, and endorsements Section 17 of the Code prohibits testimonials and before/after representations in advertising for Schedule 4 or Schedule 8 medicines. For medical devices and other therapeutic goods, testimonials are permissible but must accurately reflect typical results and must not be misleading. You cannot cherry-pick best-case testimonials or use paid endorsers without clear disclosure. Healthcare professional endorsements require that the professional genuinely holds the credentials claimed and that their statement reflects their actual professional opinion. ### Digital advertising — social, paid search, and influencer content The Code applies to advertising in any medium, including paid social media, Google Ads, YouTube pre-rolls, and content produced by influencers or brand ambassadors on your behalf. The 'your behalf' test is broad — if you provided product, payment, or significant guidance on messaging, the content is yours for regulatory purposes. Platform-specific constraints (character limits, no-click destination requirements) do not reduce your obligations under the Code. ## Pre-launch advertising review process 01 Map every claim in your advertising materials — headline, body copy, images, video transcripts, app store description, unboxing guide — against the intended purpose stated on your ARTG entry (if listed) or your product labelling. Any claim that goes beyond the stated intended purpose is a red flag. 02 Classify each claim as: (a) general health/wellbeing claim (lower risk, still needs to be truthful); (b) therapeutic claim about a healthy person (restricted — requires substantiation); or (c) disease prevention/treatment/cure claim (prohibited unless supported by commensurate evidence and the product is listed/registered for that indication). 03 For each restricted claim, assemble your evidence dossier. The TGA's Guidance on levels of evidence for health claims provides the hierarchy. Don't rely on overseas clinical data without verifying it is from populations and conditions relevant to Australian consumers. 04 Run a pre-launch review against the Therapeutic Goods Advertising Code 2021 checklist — available on the TGA website. If your product sits near the medical device boundary, obtain a formal opinion from a TGA-experienced regulatory consultant before launch. Post-launch remediation costs vastly more than pre-launch review. 05 Implement a monitoring program for your advertising post-launch. The Code's obligations are ongoing — a claim that was accurate at launch may become misleading if the evidence base changes, if competitors emerge with different claims, or if your product's actual user data diverges from the claim. 06 Train your marketing team and any external agencies on the Code's requirements. The TGA can name individuals in enforcement proceedings, not just corporate entities — and agency-produced content produced at your direction remains your compliance responsibility. 07 If you receive a complaint from Ad Standards (the self-regulatory body that handles complaints under delegation from TGA for consumer advertising), respond promptly within the stated timeframes. Failure to respond escalates the matter to the TGA for regulatory action, which carries civil penalties of up to $1.1 million per contravention for a body corporate. ## Frequently asked questions ### Does the TGA Advertising Code apply to fitness trackers and smartwatches? It depends entirely on how you advertise the product and what intended purpose you communicate. A fitness tracker described as measuring 'steps and calories' is a general wellness product. The same hardware advertised as 'monitoring your heart rhythm for irregular beats' or 'detecting early signs of atrial fibrillation' is making therapeutic claims that bring the product squarely within the TGA's advertising framework — and may also trigger a requirement for ARTG listing as a medical device. The advertising claim itself can create the regulatory classification. ### Can you use customer testimonials for health hardware products? Yes, for most therapeutic goods — but with restrictions. Testimonials must reflect typical results rather than exceptional outcomes, must not be misleading, and must be clearly identified as testimonials. For prescription medicines and certain other higher-risk goods, testimonials are prohibited entirely. Healthcare professional endorsements require genuine credentials and genuine opinions. Paid influencer testimonials must be disclosed as commercial arrangements. Testimonials that imply a disease treatment or cure require the same evidentiary substantiation as any other therapeutic claim. ### What is the penalty for breaching the Therapeutic Goods Advertising Code? The penalty regime was significantly strengthened by the Therapeutic Goods Amendment (2019 Measures No. 1) Act. Civil penalties for advertising contraventions can reach $1.1 million per contravention for a body corporate, and $220,000 for an individual. The TGA can also issue infringement notices (on-the-spot fines), require mandatory corrective advertising at your cost, and seek injunctions. Repeat or systemic contraventions attract aggravated penalties. Ad Standards can also require withdrawal of non-compliant advertising under the self-regulatory pathway before formal TGA action. ### How do intended purpose statements in labelling affect what you can advertise? Your intended purpose statement — on the label, in the Instructions for Use, and in your ARTG application — sets the ceiling of what you can legitimately claim in advertising. Advertising claims must be consistent with and not exceed the approved intended purpose. If your ARTG entry describes a device as a 'general wellness monitoring device', advertising it as a 'clinical-grade cardiac monitoring system' is inconsistent with the registered purpose and potentially both a TGA advertising breach and a misleading conduct issue under the ACL. Conversely, if you want to make expanded therapeutic claims, you must first expand or amend your ARTG entry to match. **Disclaimer:** Educational resource only. Regulatory requirements change and vary by product category. Consult a qualified legal or compliance professional before making decisions. 🇦🇺 Australia roadmap for your product Every standard, document, and test that applies — free, no account required. See your free roadmap[ Want an expert to take your product through 🇦🇺 Australia compliance for you? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. See compliance services](/services) Learn this properly In-depth course that teaches the full process, not just this one answer. [Start the course — $149](/courses/44-australia-rcm-marking-electronics-cabling)[Prefer to read? Get the book — $24.99](/books/44-australia-rcm-marking-electronics-cabling) Related guides * [Australia TGA Software Medical DeviceAustralia TGA for Software as a Medical Device (SaMD): Class I–III classification, ARTG inclusion pathways, IEC 62304/ISO 14971 documentation, and EU MDR reliance for Australian registration.](/guides/australia-tga-software-medical-device) * [Australia TGA Class I DevicesAustralia TGA Class I medical devices: ARTG inclusion by sponsor, Essential Principles self-assessment, ISO 13485 QMS expectations, and post-market adverse event reporting.](/guides/australia-tga-class-i-devices) * [UAE Medical Device RegistrationMedical device registration in the UAE under the Emirates Drug Establishment (EDE, formerly MOHAP): agent and import permit re…](/guides/uae-medical-device-registration)