General requirements for advertising personalised medical devices to consumers

Does your product meet the definition of a medical device? If so, you will need to make sure you understand the rules for advertising therapeutic goods to consumers. There are legal requirements you must meet under:

• the Therapeutic Goods Act 1989 (the Act)
• the Therapeutic Goods Advertising Code (the Code)
• other relevant laws including the Competition and Consumer Act 2010.

The Therapeutic Goods Administration (TGA) is responsible for administering the Act and the Code. We will take appropriate regulatory action when advertising for medical devices does not comply with therapeutic goods advertising requirements. We have powers to issue infringement notices or commence court action if needed.

What the TGA means by ‘advertisements’

A wide range of material can be advertising. Any statement, image, or design that is intended, whether directly or indirectly, to promote the use or supply of a therapeutic good is advertising. Examples include: 

• statements, images, and designs promoting a device
• information you provide with the device that might induce someone to use or supply the product (including the label and packaging)
• articles and advertorials published in magazines and newspapers (digital or hard copy)
• displays on posters and notices
• photographs, film, broadcast material and video recordings
• electronic transmissions and material posted on the internet, including websites and in social media (including any comments, reviews or tags in social media posts that promote the use of supply of the device).

What you can advertise

You can generally advertise to consumers as long as your medical device is:

• included in the Australian Register of Therapeutic Goods (ARTG)

OR

• exempt from ARTG inclusion because it is custom-made

OR

• a patient-matched medical device that is not included in the ARTG, providing you have submitted a transition notification.

There are legal requirements around what you can say in advertisements and you must ensure you comply with them at all times. This includes ensuring your advertisements support the safe and proper use of the medical device and contain information that is accurate, substantiated and not misleading.

What you can’t advertise

There are some specific things you can’t say in advertising.

‘Prohibited representations’ include wording that refers to preventing, curing, treating, or diagnosing certain serious conditions (including cancers, HIV, STI’s and mental illness).

You can only include refer to other serious conditions and diseases including diabetes, asthma and cataracts if you have our approval first. This kind of wording is known as a ‘restricted representation’. You can apply for approval to use restricted representations in your advertisement. We will consider whether what you’ve said is accurate, balanced and not misleading.

This is a compliant advertisement

1. Advertisements can provide balanced, factual, and substantiated information.
2. Advertisements for medical devices must contain and prominently display either of the following mandatory statements:
   • ALWAYS FOLLOW THE DIRECTIONS FOR USE
   • ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE.
3. Advertisements for medical devices must contain sufficient information for consumers to locate or request details about any scientific or clinical studies referenced.
4. Advertisements for medical devices that refer to scientific or clinical research must identify the financial sponsor of the research where the advisor knows or ought reasonably to have known that information.

This is a non-compliant advertisement

1. Advertisements must not state or imply that the advertised good is effective in all cases, or a guaranteed cure.
2. Wording referring to serious conditions and diseases is only allowed to be included in your advertisement if we have approved you to do so.
3. Advertisements must not state or imply that another device is ineffective or harmful.
4. Advertisements cannot contain either explicit or implied endorsement of the product by health professionals or medical researchers.
5. Advertisements cannot include phrases like ’TGA approved’ or similar.
6. Advertisements for medical devices must contain and prominently display either of the following mandatory statements:
   • ALWAYS FOLLOW THE DIRECTIONS FOR USE
   • ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE.

Additional resources and information

Check our answers to frequently asked questions on advertising personalised medical devices.

Use our checklist to assess your compliance with legal requirements for advertising to consumers.

The TGA advertising hub contains guidance and learning resources for advertisers. It also contains updates and information about the regulation of therapeutic goods advertising.

You can seek advice from a regulatory affairs consultant or obtain independent legal advice.

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