FENIX PRO

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 Fenix Pro vaporizer is a versatile vaporizer suitable for herbal, waxes, and concentrates. It features a 7th generation ECA technology (Easy care Airpath) that directs the vapor from the quartz heating chamber directly to the mouth tip. On top of that, the airpath glass piece can be removed entirely for easy cleanup. The Fenix Pro has an informative screen that displays the vaporizer status, from the battery level, countdown timer, your current and set temperature. Meanwhile, you have a range of 160°C to 221°C to choose from, and you can switch the shut-off time between 3 or 6 minutes.

Otherwise known as the 'Fury Edge killer'!

A truly easy to use vaporizer with extremely flavourful vapour production

Because we are located in Sydney Australia, and we are a family owned and operated business, you can rest assured that Sydney Vaporizers products will get to you on time, and you will be supporting Australian businesses.

All orders placed before midday AEST will be shipped the same day, and orders placed after midday will be dispatched on the next business day. If you are located in Sydney, Brisbane, Adelaide, Hobart, Launceston, Perth, Canberra or even Darwin, you should receive your order within 1 business day of placing the order (subject to Australia Post).

At Sydney Vaporizers, we strive to provide the best service, and only the highest quality dry herb vaporizers, grinders, vape cases, spare parts and accessories, to service all your aromatherapy needs. If you are in Sydney Australia, or any other town or city in Australia,  and you enjoy dry herb vaporizers and vaping and all things to do with vaping, you have come to the right store.