On 29/1/2025, the TGA updated all the regulations around importing and supplying Therapeutic Cannabis Vaping Devices (Dry Herb Vaporizers) in Australia.

All the regulations can be found here:

TGA Medicinal Cannabis Hub

Vaporizers registered on the ARTG:

The ONLY vaporizers that pharmacies can LEGALLY hold stock of; in their pharmacy, and the ONLY vaporizers that pharmacies can sell over the counter, directly to a patient, without a SAS-B approval from the TGA, are vaporizers that are registered as medical devices on the Australian Register of Therapeutic Goods (ARTG).

The TGA ONLY wants patients in Australia to use vaporizers that are registered on the Australian Register of Therapeutic Goods (ARTG) as a medical device, because they know that vaporizers registered on the ARTG as a medical device are 100% safe for patients to use.

There are currently 2 vaporizers registered on the ARTG as medical devices: The Mighty Plus MEDIC, and the Volcano MEDIC 2 - ARTG 319028.

The 3 Classes of Medical Devices on the ARTG

Medical devices registered on the ARTG must fall into one of 3 classes.

Class 1 MD, are items such as band aids, covid masks, and other medical devices that are Non Invasive, and not fundamental for supporting life. Class 1 devices are relatively easy to get registered on the ARTG as not much scrutiny is required.

Class 3 Medical devices are devices such as: Pacemakers, Constant Glucose Monitors and Insulin Pumps. Medical devices that are intrusive (must go through the skin) and vital to maintaining life are classifed as Class 3, and require immense scrutiny to be considered to be registered as a Medical Device on the ARTG.

Any medical device that applies medication through respiratory airways, is classified as Class 2A, such as Nebulisers, ventilators and VAPORISERS

To have a Class 2A medical device registered on the ARTG is extremely difficult, as the manufacturing factories must have their premises certified by one of 5 international health bodies (Japan Health, the FDA, Canada Health, the European Health or the TGA) to international medical electrical standards, and then the devices themselves must go to clinical trials to prove the intended use of the device.

Because the Mighty Plus MEDIC and the Volcano MEDIC 2 are registered as medical devices, the TGA knows that they are 100% safe for patients to use, as these medical devices have gone through rigorous testing and certification procedures.

Unapproved Therapeutic Cannabis Vaping Devices:

The TGA has created a pathway for an Australian Licensed business to import other Cannabis Vaporizers into Australia. 

To do this, the Licensed business must sign a declaration that the device (vaporizer) meets the Australian Essential Principles Guidelines (AEPG) for medical devices, and send the declaration to the TGA. If the TGA agrees, the TGA issues the importer with an Item number for that vaporizer. Then the importer must apply to the Office of Drug Control (ODC) for a permit to import that device, using that item number issued by the TGA. Once approved, the ODC then issues the importer with a PERMIT to import that vaporizer, which is valid for 12 months.

Apprx ⅓ of the AEPG focuses on the product labelling, and the user manual. The vaporizer MUST state that it is ONLY FOR USE WITH MEDICINAL CANNABIS FLOWER, and the user manual must also be very specific that the device is ONLY FOR USE WITH MEDICINAL CANNABIS FLOWER.  Dry herb vaporizers, and vaporizers which are labeled: ‘Dry herb vaporizer’ for aromatherapy purposes only, are now ILLEGAL to import, distribute, and sell in a retail setting, or pharmacy in Australia. ONLY devices specifically for Medicinal Cannabis Flower can meet the Australian Essential Principles guidelines.

However, once legally imported into Australia through a licensed business, using permits issued from the ODC, vaporizers which are NOT registered on the ARTG, are now considered to be: ‘Unapproved Therapeutic Vaping Devices (UTVD), and the ONLY LEGAL way an UTVD can be supplied to a patient in Australia, is by obtaining a SAS-B approval for the device, from the TGA.

All UTVD that have been legally imported into Australia, MUST remain in the licensed importers secure warehouse, until a SAS-B approval for that device has been issued. 

All Licensed importers of UTVD, MUST report 6monthly to the ODC as to the location of all devices. If not in the importers secure warehouse, then the importer must have a SAS-B approval for the SALE of that device.

Any licensed importer knowingly breaking these rules faces serious criminal penalties of up to $1mil in fines and up to 7years imprisonment!

SAS-B Approvals for UTVD:

To obtain a SAS-B approval for an ‘Unapproved Therapeutic Vaping Device’ (UTVD), a patient must ask an Authorised Prescriber to send an application to the TGA for a SAS-B approval, for the particular (UTVD) device, for that particular patient. When submitting the SAS-B application, the Authorised Prescriber MUST give clinical reason as to why the patient cannot use a vaporizer that is currently registered on the ARTG (Mighty Plus MEDIC or Volcano MEDIC 2). 

The TGA clearly states that SAS-B approvals will ONLY be granted if there is clinical evidence as to why the patient cannot use an ARTG approved device. The TGA also clearly warns importers of UTVD that once legally imported into Australia, all UTVD must remain in the licensed importers secure warehouse, until a SAS-B approval has been issued.