Illegal marketing of medical devices

Medical devices

Medical devices include a wide range of products used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition.

Requirements to advertise medical devices in Canada

The advertising of medical devices is regulated in Canada under the:

Food and Drugs Act
Medical Devices Regulations

All medical devices are classified based on the risk set out in the Medical Devices Regulations.

Class I devices:

have no authorized indications
must obtain a medical device establishment licence

Class II devices:

must obtain a medical device licence
are authorized by Health Canada for specific indications
must be advertised within the scope of their authorized indications

Class III and IV devices:

must obtain a medical device licence
present an increasing level of potential risk
are authorized by Health Canada for specific indications
must be advertised within the scope of their authorized indications

For more information regarding the authorization of medical devices, consult Safe Medical Devices in Canada.

Additional restrictions may apply for some medical devices, as outlined in the Food and Drugs Act and the Medical Device Regulations. For more information, please contact us at drug-device-marketing@canada.ca.