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Purpose
Sponsors of medical devices must follow 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 TGA administers the Act and the Code. In the event of inappropriate advertising for medical devices, we'll take required action. If necessary, we can issue infringement notices or take court action.
Advertisements
Advertising is any statement, image, or design aimed to promote the use or supply of a therapeutic good. Examples include:
- statements, images, and designs promoting a device
- device information (label and packaging)
- electronic material posted on the internet (websites, social media)
- articles and advertorials published in magazines and newspapers (digital or hard copy)
- displays on posters and notices
- photographs, film, broadcast material and video recordings.
What you can advertise
You can generally advertise to consumers if 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.
What you can’t advertise
There are things you can’t say in advertising.
‘Prohibited representations’ include language that refers to preventing, curing, treating, or diagnosing serious conditions. Examples include cancers, HIV, sexually transmitted infections (STI’s) and mental illness.
You can only refer to other serious conditions and diseases including diabetes, asthma, and cataracts if you have our approval first.
This kind of wording is 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.
Examples
Compliant advertising example
Non-compliant advertising example
Page history
Changed title from 'General requirements for advertising personalised medical devices to consumers' to 'Advertising personalised medical devices'.
Added introductory paragraph.
Renamed first subheading from 'What the TGA means by advertisements' to just 'Advertisements'. Rewrote first paragraph. Slight refinement of list.
Addition of subheading 'Examples'.
Renamed subheading from 'This is a compliant advertisement' to 'Compliant'. Updated list content.
Renamed subheading from 'This is a non-compliant advertisement' to 'Non-compliant'. Updated list content.
Renamed final section from 'Additional resources and information' to 'More information'. Distilled the content to just the links.
Original publication.
Changed title from 'General requirements for advertising personalised medical devices to consumers' to 'Advertising personalised medical devices'.
Added introductory paragraph.
Renamed first subheading from 'What the TGA means by advertisements' to just 'Advertisements'. Rewrote first paragraph. Slight refinement of list.
Addition of subheading 'Examples'.
Renamed subheading from 'This is a compliant advertisement' to 'Compliant'. Updated list content.
Renamed subheading from 'This is a non-compliant advertisement' to 'Non-compliant'. Updated list content.
Renamed final section from 'Additional resources and information' to 'More information'. Distilled the content to just the links.
Original publication.