Cannabis Inhaler Regulations – Canada
Cannabis inhalers and vaporizers are a popular choice for cannabis consumption for those individuals using cannabis for medical and recreational purposes. Vaporizing may significantly reduce harshness and irritation cased by the high temperatures of smoking. Use of inhalers may be preferable to smoking for public consumption.
Medical devices that contain cannabis or are for use with cannabis are covered by Health Canada in their latest guidance document on regulation of products containing cannabis (1). Medical devices for use with cannabis are required to be compliant with the Medical Device Regulations (MDR) of the Food & Drugs Act in order to ensure appropriate controls for safety, efficacy and quality; while separate requirements under the Cannabis Act will protect against unauthorized device risks to public health and safety.
Cannabis inhalers intended to be sold separately for consuming cannabis for medical purposes qualify as Class II medical devices and are regulated under Health Canada’s Medical Device Regulations. Manufacturers of Class II devices must confirm that they have evidence of compliance with the safety and effectiveness requirements of the MDR. Manufacturers are also required to have a Quality Management System Certificate. Cannabis products to be used with these type of Class II devices exclude finished dosage forms of cannabis [such as prescription drug products containing cannabis].
Medical devices used to deliver a prescription dug product containing cannabis would also be subject to the medical device regulations. Unlike inhalers or vaporizers that are sold separately, the device and cannabis prescription product are “associated” products. The drug product and the medical device will be separately licensed, however both components would be specifically labelled for use together, where labeling for each product cross-references the other product.
Integrated products are those where a medical device component is paired with a prescription drug containing cannabis as a drug-device combination product. These combination products require a DIN as per the Food & Drug Regulations. A separate device licence is not required in addition to a DIN; however, the safety, quality and effectiveness of the device component must also be demonstrated as part of the overall review process for the drug-device combination.
Inhalers fall under the definition of a cannabis accessory under the Cannabis Act, Therefore these devices are subject to the Act’s prohibitions with respect to promotion of products. This includes restrictions on the sale and display to young persons, as well as restrictions on product traits or attributes that appeal to youth. However, a young person who has received a medical document from their doctor may still purchase a cannabis accessory (including a licensed medical device) from a holder of a licence for sale under the Cannabis Regulations.
