In this article
Included in the ARTGUnapproved goods and special accessNotified therapeutic vaping goodsPromotional implicationsExample: putting the information in contextWhat to check nextFrequently asked questionsIs a notified nicotine therapeutic vape necessarily ARTG-included?Does a lawful access pathway equal a broad TGA endorsement?Read more on this topicOfficial sourcesRelated articles
Words such as “approved”, “included”, “registered”, “notified” and “authorised” describe different regulatory situations. Using them precisely helps readers distinguish a medical-device listing from a restricted access mechanism or an unsupported marketing claim.
Included in the ARTG
For a medical device, inclusion refers to a public ARTG entry covering its relevant kind and intended purpose. The TGA’s medicinal cannabis device list uses the phrase approved for supply in connection with the listed devices.
Unapproved goods and special access
A product outside the ARTG may be described as unapproved even when particular legal access pathways exist. Those pathways do not necessarily mean the product has undergone the TGA’s pre-market evaluation.
Notified therapeutic vaping goods
For nicotine-dependence therapeutic vapes, the TGA describes products notified as compliant with applicable standards in separate supply arrangements; those products are not thereby ARTG-included or TGA-approved in the same manner as listed medicinal cannabis medical devices.
Promotional implications
A brand should not use “TGA approved” in a broad or ambiguous way. A correct regulatory statement for one medical device or pathway does not necessarily authorise public promotion; advertising restrictions must be considered separately.
Example: putting the information in context
Two websites show the same “Australian compliant” badge. One concerns a listed medicinal cannabis medical device; another describes a notified nicotine vape. The statements refer to different regulatory mechanisms and should not be read as equivalent.
What to check next
- Read the exact wording of the claim and identify the relevant pathway.
- Distinguish ARTG-included medical devices from notified nicotine vapes.
- Remember that authorisation to supply does not automatically permit public promotion.
Frequently asked questions
Is a notified nicotine therapeutic vape necessarily ARTG-included?
No. The TGA distinguishes those products from ARTG-listed medicinal cannabis devices.
Does a lawful access pathway equal a broad TGA endorsement?
No. The pathway and restrictions must be described precisely.
Read more on this topic
- Medical Devices & TGA: topic overview
- Where to Find Official TGA Medical Device Information
- How to Search the Australian Register of Therapeutic Goods
Official sources
- TGA — Medicinal cannabis vaping devices approved in Australia (5 June 2026)
- TGA — Vapes: information for individuals and patients
- TGA — Medicinal cannabis vaping devices: importers, exporters and manufacturers (7 July 2026)
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.