BOUNDLESS CFX+

SYDNEY VAPORIZERS NO LONGER IMPORTS OR SELLS THIS VAPORIZER

If this vaporizer has been legally imported into Australia through a licensed business; using permits issued by the ODC, then this vaporizer is an: 'Unapproved Therapeutic Vaping Device'

Unapproved Therapeutic Cannabis Vaping Devices

The Therapeutic Goods Administration (TGA) has established a regulatory pathway that permits an Australian-licensed entity to import certain cannabis vaporizers into Australia.

Under this pathway, the licensed importer must execute a declaration confirming that the device complies with the Australian Essential Principles Guidelines (AEPG) applicable to medical devices and submit this declaration to the TGA. Where the TGA is satisfied that the declaration demonstrates compliance, it will issue an item number specific to that vaporizer. The importer must then apply to the Office of Drug Control (ODC) for an import permit, referencing the issued item number. Upon approval, the ODC will grant a permit authorising the importation of the device, which is valid for a period of 12 months.

Approximately one third of the AEPG requirements relate to product labelling and instructions for use. Accordingly, the vaporizer and its accompanying user manual must clearly and unequivocally state that the device is for use only with medicinal cannabis flower. Vaporizers described or labelled as “dry herb vaporizers,” or as being intended for aromatherapy or non-medicinal purposes, do not meet the AEPG requirements and are therefore unlawful to import, distribute, or supply in a retail or pharmacy setting within Australia. Only devices expressly intended for use with medicinal cannabis flower are capable of complying with the Australian Essential Principles.

Once imported into Australia by a licensed entity pursuant to an ODC permit, vaporizers that are not included on the Australian Register of Therapeutic Goods (ARTG) are classified as Unapproved Therapeutic Vaping Devices (UTVDs). The sole lawful mechanism by which a UTVD may be supplied to a patient in Australia is pursuant to a Special Access Scheme Category B (SAS-B) approval issued by the TGA.

All UTVDs that have been lawfully imported must remain secured within the licensed importer’s approved warehouse until a valid SAS-B approval has been granted for the specific device. Licensed importers are required to submit six-monthly reports to the ODC detailing the location of all UTVD stock. Where a device is not held within the importer’s secure warehouse, the importer must hold a corresponding SAS-B approval authorising the supply of that device.

Any licensed importer who knowingly contravenes these regulatory requirements may be subject to severe criminal penalties, including fines of up to AUD $1,000,000 and/or imprisonment for a term of up to seven years.

SAS-B Approvals for Unapproved Therapeutic Vaping Devices

To obtain a SAS-B approval for an Unapproved Therapeutic Vaping Device, a patient must request that an Authorised Prescriber submit an application to the TGA for that specific device and for that individual patient. The SAS-B application must include a clear clinical justification demonstrating why the patient is unable to use a vaporizer that is currently registered on the ARTG, such as the Mighty+ MEDIC or the Volcano MEDIC 2.

The TGA has expressly stated that SAS-B approvals will only be granted where there is sufficient clinical evidence supporting the patient’s inability to use an ARTG-registered device. The TGA has also reiterated to importers that all UTVDs, once legally imported, must remain within the licensed importer’s secure warehouse unless and until a SAS-B approval has been issued permitting their supply.

The Boundless CFX+ is a lightweight device with an intuitive interface and durable design. You’ll be able to enjoy advanced dry herb vaporization technology that gives you complete control over your sessions. This new generation vape is portable, allowing you to take your herbs on the go!

A palm-sized, dry herb vaporizer, this new generation vape is extremely portable, allowing you to take your herbs on the go. The Boundless CFX+ is suited for all levels of users and you can choose precise temperatures ranging from 100°F - 420°F (38°C - 22°C). The device fully charges in less than an hour and lasts for six to eight sessions per charge. Perfect for avid smokers looking for an alternative, or anyone looking to switch from combustion-based smoking.

This vape combines all the features you need in one package. It features a non-combustion heating technology and an air path that has been atomized by zirconia, creating a smooth draw and cool vapor. The Boundless CFX+ fully charges in less than an hour and lasts for six to eight sessions per charge.

This unit is suited for all levels of users, whether you’re an at-home or on-the-go vapor enthusiast. The Boundless CFX+ offers an upgraded vaporization experience with precision temperatures ranging from 38°C – 220°C and control over your session times. The Boundless CFX+ offers four preset temps for quick use if you’re looking for a straightforward session.

Known for continuously enhancing and upgrading its lineup, Boundless Technology makes sure its devices drive technology and effectiveness at the forefront. The extended vapor path allows for more significant hits, higher temperatures, and total extraction. Your dry herbs will be heated evenly and efficiently, but you’ll also be ripping fluffy clouds of vapor right out of the box.