Background
    The sale of medical devices in Canada is regulated under the:
    Food and Drugs Act
    Medical Devices Regulations

    Scope and Classification
    As defined in Section 2 of the Food and Drugs Act, a medical device in Canada is any instrument or component used to treat, diagnose, or prevent a disease or abnormal physical condition. A medical device does not include any device that is intended for use in relation to animals. Medical devices can be used to:

    • diagnose, treat, mitigate, or prevent a disease, disorder, abnormal physical state, or any of the corresponding symptoms;
    • restore, modify, or correct the body structure or function;
    • diagnose or prevent pregnancy;
    • care for people during pregnancy or at or after the birth of the offspring

    Medical devices range from adhesive bandages, toothbrushes, and contact lenses to complex devices such as x-ray units, insulin pumps, and pacemakers. They also include diagnostic devices, such as cancer screening tests, blood glucose monitors, and pregnancy test kits. Health Canada groups medical devices into Class I, Class II, Class III, and IV based on the expected level of risk to a person’s health and safety. Class I medical devices (e.g., a thermometer) pose the lowest risk to users. Class IV medical devices (e.g., a peacemaker) pose the highest risk. Health Canada also maintains the Keyword Index to Assist Manufactures in Verifying the Class of Medical Devices to assist manufactures in confirming the classification of medical device products.

    Regulatory Requirements
    Health Canada issues the following two types of licences in Canada:

    • Medical Device Licences (MDL)- issued for Class II, III, and IV medical devices
    • Medical Device Establishment Licences (MDEL)- issued to companies that import or distribute Class I, II, III, and IV medical devices or companies that manufacture Class I medical devices

    With only a few exceptions, AliExpress does not allow the sale of Class III or Class IV medical devices to Canada market. To import or sell Class II medical devices, a seller is required to hold a Medical Device Licence (MDL) or a Medical Device Establishment Licence (MDEL) issued by Health Canada.Health Canada maintains a searchableMDLdatabaseand anMDELdatabase.

    Labeling Requirements
    Medical devices sold in Canada must meet the labeling requirements for medical devices. Medical devices must be labeled in both French and English. Label information must be set out on the outside of the package. The information must be visible to enable the intended user to make an informed choice with respect to the device. Labeling requirements include but are not limited to:

    • name of the device;
    • name and address of the manufacturer;
    • identifier of the device;
    • control number for the case of a Class III or IV device;
    • indication of what the package contains if the item inside is not self-evident, expressed in terms appropriate to the device, such as the size, net weight, length, volume or number of units;
    • the word “Sterile”, if the manufacturer intends the device to be sold in a sterile condition;
    • expiry date of the device;
    • unless self-evident to the intended user, the medical conditions, purposes and uses for which the device is manufactured, sold or represented, as well as the performance specifications of the device if those performance specifications are necessary for proper use;
    • directions for use;
    • special storage conditions applicable to the device.

    Illegal Marketing Practices
    No illegal marketing practices for medical devices are allowed. No person shall label, sell or advertise any device in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its intended use. In addition, according to Section 3 of the Food and Drugs Act, no one shall sell, label or advertise any device to the general public as a treatment, preventative or cure for any of the diseases. Examples of illegal marketing include:

    • omitting or downplaying risks such as side effects, warnings and precautions;
    • exaggerating the effectiveness or making efficacy claims not supported by what was authorized by Health Canada;
    • advertising or promoting unauthorized (off-label) claims;
    • advertising unauthorized medical devices;
    • misleading endorsements such as a testimonial for unauthorized claims of “Health Canada approved” or “Health Canada endorsed” or similar terms. Only claims of Health Canada authorization are permitted;
    • other misleading claims.

    AliExpress
    December 31, 2021