Cannabis legislation in Canada has come with its fair share of legislative amendments. Bill C-51 not only enacted the Cannabis Act; it also introduced a number of amendments and transitional provisions relating to the Criminal Code and the Controlled Drugs and Substances Act, among others.
One change that passed almost unnoticed was the amendment to the Medical Devices Regulations (the "Regulations").
On October 17, 2018, section 3(2) of the Regulations was amended to specify that the Regulations do not apply to drugs containing cannabis. At the same time, Health Canada thought it wise to clarify when a cannabis accessory might be considered a medical device and published a notice concerning medical devices used to deliver drugs through the inhalation of smoke.
A product that combines both a medical device component and a prescription drug containing cannabis component is considered to be a drug-device combination product. According to Health Canada's policies, this type of product is licensed under the Food & Drug Regulations, i.e.it requires a Drug Identification Number (DIN). Aligned with new section 3(2) of the Regulations, a separate device licence is not required in addition to a DIN.
Conversely, a product that is represented for use in consuming cannabis for medical purposes and is intended to be sold separately, such as a vaporizer, is a medical device.
Similarly, a device that is manufactured, sold or represented for delivering a drug, including medical cannabis, to a patient through smoking is considered to be a medical device. "Smoking" means delivery by the combustion of the drug and subsequent inhalation of the resulting smoke.
According to Health Canada, a medical device that is used for smoking of a drug for therapeutic use is considered to be an active device, since it depends on a source of energy other than energy generated by the human body or gravity.
Under Rule 11(1) of the Classification Rules for Medical Devices set out in Schedule 1 to the Regulations, "an active device, including any dedicated software, intended to administer drugs, body fluids or other substances to the body or withdraw them from the body is classified as Class II."
Because devices for inhaling medical cannabis are classified as Class II devices, persons who wish to market such devices must apply for a licence before selling and/or importing their product in or into Canada. With certain exceptions, importers and distributors of such Class II medical devices must themselves hold an establishment licence.
In addition, persons who manufacture, sell, import or distribute Class II medical devices must comply with the provisions of the Regulations. Specifically, they must maintain a distribution record in respect of the medical devices and must maintain records of complaints; they are subject to mandatory problem reporting requirements and must also comply with Health Canada rules regarding product recalls.
For the moment, Health Canada makes no express distinction between devices used for the consumption of medical cannabis and devices used for recreational cannabis. The question of whether a device is characterized as a "medical device" is therefore highly factual and depends on information about its use and the claims made in connection with the product. The Life Sciences team at Fasken has extensive experience in this area and is available to advise manufacturers, distributors and industry entrepreneurs.