In this article
The ordinary route: ARTG inclusionExempt, excluded and unapproved are differentWhere special pathways fitA careful way to interpret claimsExample: putting the information in contextWhat to check nextFrequently asked questionsDoes “unapproved” always mean unavailable?Does an overseas certification automatically create ARTG inclusion?Read more on this topicOfficial sourcesRelated articles
An ARTG inclusion is a defined regulatory status, but Australian therapeutic goods law also contains exemptions, exclusions and controlled pathways for unapproved goods. These concepts should not be collapsed into the word “approved”.
The ordinary route: ARTG inclusion
Most medical devices need to be included in the ARTG before lawful supply in Australia. Applicants must meet relevant obligations covering classification, evidence and ongoing monitoring. Being included does not mean that every use, modification or advertisement becomes permissible.
Exempt, excluded and unapproved are different
An exempt product may be subject to a specific exemption from inclusion but remains subject to other requirements. An excluded product may fall outside aspects of the framework. An unapproved product has not undergone the same TGA pre-market assessment as an ARTG-included product. These terms describe different circumstances and should not be used interchangeably.
Where special pathways fit
The TGA describes restricted pathways for unapproved medicinal cannabis vaping devices in defined clinical circumstances where registered products are unsuitable. Such mechanisms depend on the particular provisions, authorised parties and import/supply conditions; they do not establish broad availability to the public.
A careful way to interpret claims
Ask which pathway the supplier relies on, which product and user it covers, and what restrictions apply. “Available overseas”, “CE marked” and “works with prescribed cannabis” are not substitutes for an Australian regulatory basis. A person considering clinical use should speak with their health professional.
Example: putting the information in context
A listing says an overseas device is “TGA exempt”. Without a specific legal basis and scope, that phrase cannot tell a reader whether importing, supplying or advertising that device is permitted. It is better to find official pathway information and confirm the intended purpose.
What to check next
- Ask which inclusion, exemption or restricted access provision applies.
- Check whether the provision covers the exact goods and supply activity.
- Do not treat overseas approval as automatic Australian authorisation.
Frequently asked questions
Does “unapproved” always mean unavailable?
Not necessarily: narrowly controlled access pathways can exist, but conditions apply.
Does an overseas certification automatically create ARTG inclusion?
No. Australian requirements and any relevant evidence-recognition process still apply.
Read more on this topic
- Medical Devices & TGA: topic overview
- Understanding the Intended Purpose of Medical Devices
- Essential Principles for Medical Devices Explained
Official sources
- TGA — Medicinal cannabis vaping devices: importers, exporters and manufacturers (7 July 2026)
- TGA — Searching the Australian Register of Therapeutic Goods
- TGA — Medical device inclusion process
This educational information is not individual medical advice. It does not establish the regulatory status or suitability of an unidentified device, and must not be read as authorisation to advertise vaping goods to the Australian public.