Australian healthcare company Mood State Medical has registered the Grenco Medical ELITE II therapeutic cannabis vaporiser on the Australian Register of Therapeutic Goods (ARTG), providing patients, pharmacists and prescribers with a new regulated vaporisation option.
The device is classified as a Class IIb medical device, the highest risk classification applicable to portable therapeutic cannabis vaporisation devices, under the Therapeutic Goods Administration’s (TGA) revised therapeutic vaping framework introduced in 2025.
A changing regulatory landscape
Under the TGA’s 2025 reforms, therapeutic vaporisation devices may only be supplied in Australia where they are ARTG-listed, or where they have been individually approved under the Special Access Scheme – Category B or Authorised Prescriber pathways.
To date, only four approvals under the new legislative framework have been granted for vaporisation devices in Australia, despite a high volume of unapproved products on the market.
The limited number of existing ARTG-listed alternatives have also remained at price points that are difficult for many patients to reach amid cost-of-living pressures.
The Grenco Medical ELITE II is now available through pharmacies nationwide, opening a regulated and more affordable therapeutic vaporisation pathway for Australia’s more than one million medical cannabis patients.
International regulatory credentials
In addition to the TGA Conformity Assessment Certificate and ARTG inclusion, the device holds a Health Canada Medical Device Licence and is registered with MedSafe in New Zealand, placing it within three of the more rigorous medical device regulatory frameworks internationally.
Addressing a gap in patient access
James Murray, Chief Executive Officer of Mood State Medical, described the registration as a step forward for patient access and clinical confidence in Australia’s medicinal cannabis sector.
“Australia has more than one million active medicinal cannabis patients, and the overwhelming majority of prescriptions are for dry flower – yet patient access to a regulated, competitively priced vaporisation device has not kept pace,” Murray explained.
“The ARTG listing of the Grenco Medical ELITE II changes that. It brings a fully certified, internationally benchmarked device into the Australian market at a price point that improves affordability for patients and gives prescribers and pharmacists a regulator-backed product they can recommend with confidence.”
