Curaleaf International, part of Curaleaf Holdings, Inc. (TSX: CURA) in partnership with Jupiter Research LLC, announced that its Que Medical Inhalation Device (QMID) is available in Australia, following the registration by Australia's Therapeutic Goods Administration (TGA), on 15 September 2026. One year after receiving EU Medical Device Registration, QMID is listed as a Class IIb Medical Device in the Australian Register of Therapeutic Goods (ARTG), making it the first device intended for the delivery of Cannabis Sativa L. extracts via inhalation by the patient to receive regulatory approval in Australia. QMID has also been added to the Web Assisted Notification of Devices (WAND) database operated by Medsafe, New Zealand's medicines and medical device regulatory, on 17 September 2026, making the device available to prescribers in New Zealand.

Dr Mikael Sodergren, Chief Medical Officer at Curaleaf International, commented, "This registration means that, for the first time, clinicians in Australia and New Zealand can prescribe a liquid cannabis inhalation device that has been formally approved and delivers standardised dosing, in the same way as other medicines. That reflects the level of clinical evidence, safety testing and regulatory scrutiny required before a new technology reaches patients."  

Juan Martinez, Curaleaf International CEO, added: "We are proud that QMID is the first liquid cannabis inhalation device to be approved under both EU and Australian medical device frameworks. We are grateful to the TGA for the rigour and engagement it brought to this process. Its insistence that devices meet the same standards as the medicines they deliver is exactly right, and it is what makes this registration meaningful for patients. Together with Jupiter, we have invested heavily to meet that bar, and we intend to bring the same standard to more patients wherever the regulatory pathway allows, starting with New Zealand."

The registration marks a breakthrough in the evolution of Australia's medical cannabis market, where more than one million patients have accessed treatment under the country's prescribing framework since it was established in 2016¹, and represents the next step in Curaleaf International's strategy to expand access to pharmaceutical-grade cannabinoid delivery technologies worldwide.

The registration also addresses a long-standing gap in the Australian market. While medicines themselves are prescribed through the TGA's approved pathways, the devices used to inhale them have largely remained outside the ARTG. Prescribers and pharmacists have reported difficulty obtaining approvals for unregistered batteries, leaving some patients with their prescribed medicine but no compliant means of using it, and the regulator has repeatedly called for clinical justification where unapproved devices are used. QMID gives clinicians a registered alternative: a device whose safety and performance have been formally assessed, rather than one supplied outside the regulatory framework.

QMID became the first handheld liquid inhalation device for consistent medical cannabis administration to achieve certification as a Class IIa medical device under the European Medical Device Regulation (EU) 2017/745 in May 2025. Following its European certification, QMID has continued its international rollout and is now available in seven countries, with Australia joining following a multi-year regulatory process to secure inclusion in the ARTG, and New Zealand through Medsafe's WAND notification process, with Vicki Partridge Pty Ltd acting as both Australian and New Zealand sponsor.

Curaleaf International and Jupiter Research have made significant investments over several years in the engineering, safety testing and regulatory work required to bring QMID through two medical device frameworks. That investment reflects a shared view that patients using inhaled cannabis-based medicines should have the same assurance of device quality and consistency that applies to any other medicine.

Designed to provide energy to the product to facilitate aerosolization of the medicine, QMID offers patients and prescribers:

• A controlled delivery system designed to support consistent dosing and comparable clinical data.
• A compact and simple design for discreet medical use.
• Reusable hardware compatible only with approved cartridges.

The TGA's registration of QMID, and its listing in New Zealand, reflects a positive shift and maturing regulatory pathway for certified cannabis-based medical devices in Australasia. The device is the first of its kind internationally and demonstrates a commitment to innovation and product development, and to the safe and consistent delivery of prescribed cannabis-based medicines.