Selling Products in Australia Without TGA Medical Device Approval

If you want to sell products in Australia and do not yet have TGA medical device approval, the first issue is whether your product is regulated as a therapeutic good under Australian law. If it is a therapeutic good, and specifically a medical device, you generally cannot lawfully supply it in Australia unless it is included in the Australian Register of Therapeutic Goods, known as the ARTG, or a valid exemption or other lawful pathway applies.

This area is governed primarily by the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990, and the Therapeutic Goods Advertising Code. It is also affected by TGA guidance on advertising, labelling, intended purpose, and access to unapproved therapeutic goods, as well as general consumer law under the Competition and Consumer Act 2010 and the Australian Consumer Law.

This guide explains what businesses can and cannot do before they have a compliant TGA pathway in place.

What You Can Do

You can assess whether your product is actually regulated as a medical device in Australia. Not all health, wellness, cosmetic or software products are medical devices. Classification depends heavily on intended purpose and the claims made about the product.

You can sell products that are genuinely outside the therapeutic goods framework, provided you do not make therapeutic claims. If a product is not a therapeutic good, it may still be sold subject to general consumer laws, including the Competition and Consumer Act 2010 and Australian Consumer Law requirements against false or misleading conduct.

You can prepare for future market entry. That includes:

• reviewing classification
• assessing intended purpose
• preparing technical documentation
• reviewing labelling and instructions for use
• checking whether an exclusion or exemption may apply
• appointing an Australian sponsor if required

You can, in limited circumstances, communicate with health professionals only, provided the material is genuinely restricted to that audience. Material accessible to the public may still be treated as consumer advertising even if it was originally intended for professionals only.

You can use certain narrow lawful pathways where they genuinely apply, such as exemption-based or unapproved access pathways. These are not general commercial sales pathways and should not be treated as substitutes for standard market approval.

What You Cannot Do

You cannot lawfully supply a medical device in Australia if it requires ARTG inclusion and is not included, unless a valid exemption, approval or authority applies. Unless exempt, therapeutic goods not in the ARTG cannot be supplied in Australia.

You cannot advertise unapproved therapeutic goods to the public. Goods not included in the ARTG are among the categories that cannot generally be advertised to the general public.

Even if a product has doctor endorsements, positive clinical experience, case studies, practitioner support, or has been used to assist patients with disabilities or other medical conditions, it still cannot be publicly advertised in Australia if it is an unapproved therapeutic good or otherwise not lawfully permitted for public advertising. Clinical benefit does not override the legislative requirements. Endorsements from doctors, health practitioners, clinics or users do not create a right to advertise, and references to treatment outcomes, patient improvement, disability support, rehabilitation benefit or symptom relief may themselves strengthen the therapeutic impression of the product and increase regulatory risk.

You cannot say or imply that a product is TGA approved. Claims such as TGA approved, TGA endorsed or similar government endorsement language are prohibited. If a product is lawfully entered in the ARTG, compliant wording is to state that it is entered in the ARTG and include the ARTG number where appropriate.

You cannot make therapeutic claims and then argue that the product is only a wellness product. If you claim that a product diagnoses, treats, monitors, prevents or alleviates a disease or condition, you may bring it within the medical device framework.

You cannot advertise a device outside its accepted intended purpose. Even if a device is lawfully included in the ARTG, it must not be promoted for uses beyond the intended purpose reflected in its lawful entry.

You cannot use misleading, exaggerated or unsubstantiated claims. Advertising must be accurate, balanced, socially responsible and supported by evidence.

You cannot use restricted or prohibited representations in public advertising without prior approval or permission where required. Serious disease references are heavily regulated under the Act and Code.

You cannot rely on overseas approvals alone. FDA, CE or other overseas approvals do not by themselves authorise supply or advertising in Australia.

The Most Common Mistakes Businesses Make

The most common error is using therapeutic language too early. A company may believe it is selling a general wellness, cosmetic or consumer technology product, but its website, labels, brochures or distributor statements say the product can diagnose, treat, monitor or prevent a condition. That can change the regulatory position.

Another common mistake is publishing professional material on an open website or social channel. If consumers can access it, public advertising rules may apply.

A third common mistake is using TGA approved because a supplier believes ARTG inclusion amounts to endorsement. It does not.

A fourth is assuming that because a product is sold lawfully overseas, it can be sold the same way in Australia. Australian requirements are separate and must be met on their own terms.

Excluded vs Exempt vs Unapproved

These terms are often confused.

Excluded generally means the product falls outside TGA regulation for that category or purpose.

Exempt generally means the product is still a therapeutic good, but does not need ARTG inclusion in limited circumstances. Even then, other legal obligations can still apply.

Unapproved generally means the product is not included in the ARTG and may only be accessed or supplied through limited lawful pathways.

Exempt therapeutic goods may still need to comply with relevant legislative requirements.

Practical Guidance Before You Launch

Before entering the Australian market, businesses should confirm whether the product is a therapeutic good, whether it is a medical device, whether ARTG inclusion is required, and whether any exemption or exclusion truly applies.

All claims should be reviewed across:

• website content
• brochures
• packaging
• instructions for use
• social media
• reseller materials
• testimonials
• training decks

If the product does not yet have a compliant pathway, the safest course is not to supply or publicly advertise it until classification, claims and regulatory route are settled.

Summary

If your product is a medical device in Australia, you generally cannot supply it unless it is included in the ARTG or a valid exemption or other lawful pathway applies. You also generally cannot advertise unapproved therapeutic goods to the public. You must not use TGA approved language, and you must ensure your claims, labels and marketing materials comply with the Therapeutic Goods Act 1989, the Therapeutic Goods Advertising Code, related TGA guidance, and applicable consumer law.

This document is a general information resource only and is not legal advice. Regulatory classification and advertising risk depend on the specific product, intended purpose, claims, audience, and supply pathway.