Notice: Classification of Medical Devices used to Deliver Drugs by Smoking
October 11, 2018
Our file number: 18-106974-557
This notice confirms that a medical device that is manufactured, sold or represented for delivering a drug, including medical cannabis, to a patient through smoking (i.e., the combustion of the drug and subsequent inhalation of the resulting smoke) is considered to be a Class II medical device as per Rule (11) (1) of the Medical Devices Regulations.
A medical device that is used for smoking of a drug for therapeutic use is considered to be an active device. The operation of such a device depends on a source of energy other than energy generated by the human body or gravity. The process of combustion releases energy in the form of heat, and transforms the drug into smoke which is inhaled using the device.
Rule 11(1) of the Classification Rules for Medical Devices listed in Schedule 1 of the Medical Devices Regulations states that “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.”
As per section 26 of the Medical Devices Regulations, a Class II medical device licence is required to sell such a product in Canada.
For information on how to submit a new Class II medical device licence application, please contact the Device Licensing Services Division at (613)-957-7285 or email firstname.lastname@example.org.
Questions or concerns regarding this notice should be directed to email@example.com.
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