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Permitted & Prohibited Claims

Permitted claims​

Permitted claims are those that are accurate, consistent with the Device Licence, and supported by evidence.

Examples of permitted claims:​

  • "Indicated for the treatment of [condition] in [patient population]" — if this is the licensed indication
  • "Clinically proven to reduce [outcome] compared to [comparator]" — if supported by clinical evidence
  • "CE marked and FDA cleared" — if true, factual statements about other regulatory approvals are permitted
  • Performance claims supported by test data (e.g., filtration efficiency, measurement accuracy)

Prohibited claims​

Claims beyond the Device Licence​

Making claims for indications not covered by the Device Licence is prohibited, even if the off-label use may be clinically accepted.

Health Canada endorsement claims​

Claiming that Health Canada has endorsed or approved the effectiveness of the device is prohibited. Health Canada licences devices based on safety and effectiveness data, but does not endorse products.

False or misleading claims​

Examples of prohibited false/misleading claims:

  • "The safest device on the market" — unless substantiated
  • "100% effective" — rarely scientifically defensible
  • "No side effects" — typically false or misleading
  • Selective presentation of clinical data that creates a misleading overall impression

Unapproved indications​

Advertising a device for a use that is not within the licensed intended use, even if framed as educational content, is generally prohibited.

Enforcement​

Health Canada monitors advertising for compliance. Violations may result in:

  • Warning letters
  • Requests to withdraw or modify advertising
  • Compliance orders
  • Prosecution under the Food and Drugs Act

Competitors, healthcare professionals, and consumers may also report suspected non-compliant advertising to Health Canada.

Legislative source: Food and Drugs Act, RSC 1985, c F-27, s 9 (false advertising); Competition Act, RSC 1985, c C-34 (misleading advertising)