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Advertising Rules

Overview​

Advertising of medical devices in Australia is regulated under three instruments: the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990, and the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code). Together, these set requirements for accuracy, balance, mandatory statements, and prohibited and restricted representations. Breaching advertising requirements is a criminal offence with significant penalties. The TGA actively monitors advertising compliance and handles complaints.

What is an Advertisement?​

"Advertisement" is broadly defined in the Therapeutic Goods Act to include any statement, pictorial representation, or design intended — directly or indirectly — to promote the use or supply of therapeutic goods. This includes:

  • TV, radio, print, and digital advertising
  • Website content and landing pages
  • Social media posts and sponsored content
  • Brochures and promotional materials
  • Healthcare professional detailing materials
  • Sponsorships where the medical device is promoted

Labels and packaging are not considered advertising for the purposes of the Code (they are governed by the labelling requirements), but the Code does apply to advertising claims made on or about labels.

Key Requirements Under the Advertising Code​

Accuracy and balance All advertising must be accurate, balanced, and not misleading or deceptive. Advertising must not:

  • Overstate the benefits of the device
  • Minimise or omit information about risks or limitations
  • Use unsubstantiated claims
  • Make comparisons with competitor devices that suggest competitors are harmful or ineffective

Consistency with the ARTG entry Advertising claims must be consistent with the device's ARTG-approved intended purpose. You cannot advertise a device for uses beyond its approved indications.

Mandatory statements Advertising for medical devices must include mandatory statements where required. For devices advertised to the public (other than prescription-only goods), the mandatory statement "ALWAYS FOLLOW THE DIRECTIONS FOR USE" or "ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE" must be included. For devices only available through health professionals, the statement "THIS PRODUCT IS NOT AVAILABLE FOR PURCHASE BY THE GENERAL PUBLIC" must be included.

Scientific and clinical claims Claims supported by scientific research must accurately represent that research. Clinical terminology must be used correctly and not in a way that is misleading to the intended audience.

Endorsements and testimonials Endorsements and testimonials are subject to specific requirements. Current health professionals, government bodies, hospitals, and healthcare facilities cannot endorse therapeutic goods in advertising. Social media influencers who receive "valuable consideration" (payment, free products) cannot provide testimonials in advertising.

The claim "TGA approved" is prohibited Using the claim "TGA approved" in any advertising for a therapeutic good is expressly prohibited. The TGA does not approve medical devices — it includes them in the ARTG. Using the ARTG number in advertising is permitted.

Advertising to the Public vs Health Professionals​

Advertising to the public (consumer advertising) The full Advertising Code applies. Many of the most detailed requirements — mandatory statements, prohibited representations, restrictions on disease claims — apply specifically to consumer advertising.

Advertising exclusively to health professionals Some requirements of the Code do not apply to advertising directed solely to health professionals. However, the advertising must still be accurate, balanced, and consistent with the device's ARTG entry. Industry self-regulatory codes (e.g., the MTAA Code of Practice) govern interactions with health professionals.

Who Can Advertise a Medical Device​

Only ARTG-included medical devices (or devices covered by a specific exemption) can be advertised for supply in Australia. Advertising an unapproved device to the public is a criminal offence.

Advertising can be placed by:

  • The sponsor
  • The manufacturer (where they are also the sponsor)
  • Distributors (within the bounds of the ARTG entry's approved intended purpose)
  • Retailers (within the same bounds)

Whoever places the advertising is responsible for compliance with the Code — including distributors and retailers.

Compliance and Enforcement​

The TGA monitors advertising compliance and handles complaints from the public, healthcare professionals, and competitors. Where non-compliant advertising is identified, the TGA can:

  • Issue a substantiation notice requiring the advertiser to justify their claims
  • Issue a direction to cease advertising or make a correction
  • Impose civil penalties or refer for criminal prosecution for serious breaches

Official Sources​