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Unapproved Therapeutic Goods — Medicines

Scope Note​

This page covers therapeutic goods that are commonly searched alongside medical devices but are not medical devices. MDMA and psilocybine, medicinal cannabis, and therapeutic vaping goods are regulated as medicines (or in some cases biologicals) under the Therapeutic Goods Act 1989 — not as medical devices.

RAPath AU covers medical devices and IVDs only. These products are outside the scope of this site. This page provides a brief orientation and direct links to the relevant TGA sources.

Why These Are Not Medical Devices​

The medical device definition in Section 41BD of the Act requires that a product achieves its intended purpose by physical, mechanical, or chemical means — not primarily through pharmacological, immunological, or metabolic means.

MDMA, psilocybine, medicinal cannabis, and therapeutic vaping goods all achieve their therapeutic effects primarily through pharmacological action on the body. They are therefore medicines, not medical devices, and are regulated under the medicines framework (Part 3-2 of the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990).

MDMA and Psilocybine​

From 1 July 2023, MDMA (for PTSD) and psilocybine (for treatment-resistant depression) became the world's first psychedelic substances to be approved by a national medicines regulator for therapeutic use. In Australia, these are regulated as Schedule 8 controlled medicines that authorised psychiatrists may prescribe under a specific authorised prescriber framework.

These are not medical devices. Access is through the Authorised Prescriber pathway under the medicines framework, not the SAS pathway for medical devices.

👉 MDMA and psilocybine — TGA

Medicinal Cannabis​

Medicinal cannabis products (including CBD oils, THC products, and combination products) are regulated as medicines in Australia. They are not medical devices. Access pathways include the Special Access Scheme (for medicines), Authorised Prescriber (for medicines), and through ARTG-listed products where available.

The regulatory framework for medicinal cannabis is separate from and unrelated to the medical device framework. Sponsors, importers, and prescribers must comply with both Commonwealth and State/Territory controlled substances legislation.

👉 Medicinal cannabis — TGA

Therapeutic Vaping Goods​

Therapeutic vaping goods — nicotine vapes and e-cigarettes used for therapeutic purposes such as smoking cessation — are regulated as medicines in Australia (not medical devices). Non-therapeutic vaping goods are regulated under different legislation.

The regulatory landscape for vaping goods has changed significantly in recent years. Nicotine vaping products require a prescription and ARTG inclusion (as medicines) for legal supply.

👉 Therapeutic vaping goods — TGA

Looking for Medical Device Unapproved Access?​

If you are looking for information on accessing medical devices that are not included in the ARTG, the relevant pathways are covered in the Unapproved Device Access section of this site:

Official Sources​