The device, developed by Curaleaf International in partnership with Jupiter Research, officially entered the Australian Register of Therapeutic Goods on September 15, 2026. Shortly thereafter, on September 17, it was added to New Zealand’s WAND database, expanding its reach across the region. This move addresses a significant regulatory gap in the Australian market, where, despite over one million patients accessing medical cannabis since 2016, the delivery devices themselves frequently lacked formal clinical validation.
Previously, pharmacists and prescribers often relied on unregistered hardware, complicating safety compliance and clinical oversight. By securing Class IIb medical device status, the product offers a controlled system designed to ensure consistent dosing. Curaleaf International CEO Juan Martinez noted that the certification process required substantial investment in safety and performance testing to meet the same standards applied to the medicines themselves. The inhaler, which previously achieved European certification in 2025, is now available in seven countries as part of the company's broader strategy to standardize pharmaceutical-grade cannabinoid delivery.




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