New Therapeutic Cannabis Vaporiser Registered Under Australia's Therapeutic Goods Reforms

New Therapeutic Cannabis Vaporiser Registered Under Australia’s Therapeutic Goods Reforms

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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.”

Chris Folkerts, Founder and Chief Executive Officer of Grenco Science, commented on the collaboration with Mood State Medical.

“After nearly 15 years establishing Grenco Science at the forefront of vaporisation technology, this milestone represents a defining moment for Grenco Medical and the future of medically compliant cannabis vaporisation,” Folkerts noted.

“This achievement could not have been possible without the regulatory expertise and dedication of the team at Mood State Medical. Together, we have established a credentialled pathway and a verified product standard for therapeutic cannabis vaporisation technology in Australia, and we are committed to expanding that standard across additional international healthcare markets.”

Clinical context

The TGA has previously advised that medicinal cannabis should be vaporised rather than smoked, citing reduced respiratory risk and improved dose control.

Dry flower accounts for an estimated 80 per cent of medicinal cannabis prescriptions in Australia, with more than 3,500 active authorised prescribers operating in the sector.

The availability of a Class IIb certified therapeutic vaporisation device addresses what clinicians and pharmacists have described as a gap in the regulated market.

Therapeutic vaporisation may be used as part of clinician-directed treatment plans for conditions such as chronic pain, chemotherapy-related nausea and appetite loss, endometriosis-related pain and associated symptoms, epilepsy, multiple sclerosis, palliative care symptom relief, PTSD and anxiety-related conditions.

Device features and availability

The Grenco Medical ELITE II features certified medical grade construction, controlled heating, patented air flow design, a user-friendly interface and a two-year product warranty.

It is available through authorised pharmacy and prescriber channels nationwide and through moodstatemedical.au from June 2026. Mood State Medical is the exclusive Australian sponsor and distribution partner for Grenco Science International.

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