The risks of not using TGA-approved goods

21 Sep 2026 Estimated read time: 4 min read

Using unapproved dental products can lead to regulatory, legal and disciplinary consequences. Here's what practitioners need to know.

A recent alert from the ADA regarding the use of DIY biological indicators[1] has bought the issue of checking Therapeutic Goods Agency (TGA) approval for products to the front of practitioner’s minds.

On this occasion, a system of using DIY biological indicators, then posted to an external facility for verification came under scrutiny and was ultimately found not to align with the requirements of AS/NZ 5369:2023 which is the relevant Australian guidance.

This scenario does however also open a broader question – as dental products can be purchased through numerous avenues – what checks do we, as registered dental practitioners need to make, and what are the consequences if we don’t use TGA approved goods?

The Therapeutic Goods Agency is the national regulatory body for all therapeutic goods and medicines, and has the primary function of protecting the public by ensuring that all therapeutic goods supplied within Australia are safe, effective and of high quality. It lists approved products on its public database, the Australian Register of Therapeutic Goods (ARTG). While there are some lawful exemption pathways, the best way to think about this as a registrant is: “if it’s not TGA-approved, then I shouldn’t use it, as I cannot be sure it is safe.” Remember, this also applies to products that you may buy online from overseas, and technically, you would be considered the importer of those products.

So, what are the consequences to the practitioner of not using TGA-approved products?

Regulatory action by the Dental Board and Ahpra

Any dental practitioner may face a complaint, investigation, or disciplinary action if their conduct is considered unsafe, unethical, or outside accepted professional standards.

Ahpra and National Boards have recently stated that unsafe use of unapproved therapeutic goods may jeopardise a practitioner's right to practise[2], with new guidance on prescribing off-label, unapproved or compounded medicines released on 16 September 2026.[3]

TGA enforcement action

The TGA can investigate practitioners who unlawfully import, supply, advertise, or use unapproved therapeutic goods. Potential consequences include of breaching the requirements of the TGA include:

Infringement notices and fines
Direction notices
Prevention notices
Civil penalties
Criminal prosecution in serious cases – for example where conduct involves deliberate unlawful importation, supply, or marketing of unapproved therapeutic goods.

The TGA has recently issued infringement notices against registered health practitioners for allegedly importing unapproved therapeutic goods without the required approvals[1] so practitioners need to be mindful that it is not a hollow threat. It can and does occur.

Professional negligence and civil liability

While we would hope that the potential deleterious consequences to a patient of using a non-approved product would be apparent, it is also important to note that if a patient suffers harm from a non-approved product, the dentist may also be subject to a professional negligence claim. The fact the product in question was sought through an unapproved pathway would likely NOT cast the clinician in a good light as this process progressed.

It is important to note that use of a non-ARTG product is not necessarily unlawful, and certain unapproved therapeutic goods may be legally accessed through approved pathways such as the:

Special Access Scheme (SAS)
Authorised Prescriber Scheme
Clinical Trial pathways

However, these pathways have specific requirements and obligations[2] that MUST be met.

Take away message

If the product is a medical device, dental material, cosmetic injectable, whitening product, bone graft material, implant component, or medication, the key question you need to ask is whether it was: