Do your device materials comply with the Therapeutic Goods Advertising Code 2007? Don’t get caught out!

Medical devices and IVDs are almost always supplied with labelling, instructions for use and packaging – which often includes a web address and other marketing materials. The Therapeutic Goods Administration (the TGA) define all of these to be advertisements in relation to therapeutic goods. Whilst we all busily ensure our materials comply with the Therapeutic Goods (Medical Device) Regulations, we often forget they must also meet the requirements of the Therapeutic Goods Advertising Code 2007 also.

For device and IVD manufacturers, not complying with the code can result in review from the Therapeutic Goods Advertising Code Council which could affect your device or IVD on the market and the certification held.  The Therapeutic Goods Advertising Code 2007 can be found here.

The Code defines an advertisement as the following in relation to therapeutic goods as defined in the Therapeutic Goods Act 1989 includes any statement, pictorial representation or design, however made, that is intended whether directly or indirectly, to promote the use or supply of the goods.

Key requirements of the code are as follows:

• Advertisements shall not be likely to arouse unwarranted or unrealistic expectations of the product effectiveness, or mislead consumers to self diagnosing or inappropriately treating serious diseases.
• Contain a claim or implication that the product is infallible, unfailing, magical, miraculous, or that is a certain, guaranteed or sure cure.
• Contain any claim or implication that the goods are safe or cannot cause harm, or that they have no side effects.
• Any representation of scientific information should be presented in an accurate and balanced manner. Published research results shall identify the researcher and financial sponsor of the research.
• Advertisements cannot contain or imply endorsement by government agencies, medical professionals or groups. (in most cases)
• Advertisements cannot include testimonials which breach the Code. All testimonials must be genuine, documented, not misleading and demonstrate typical cases only.

If you have concerns that your device material does not comply fully with the Code, contact KD&A for assistance and guidance. We can work with you to ensure the materials promote the device as required by you, but also comply with the Code.