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Advertising Rules

Overview​

Advertising of medical devices in Canada is regulated under the Food and Drugs Act and associated regulations. The key principle is that advertising must be truthful, accurate, and not misleading, and must not make claims that go beyond the device's licensed intended use.

What constitutes advertising​

Under the FDA, "advertising" includes any representation by any means for the purpose of promoting the sale of a medical device. This covers:

  • Print and digital advertisements
  • Trade show displays and demonstrations
  • Sales representative materials and presentations
  • Websites and social media content
  • Press releases with product claims
  • Patient education materials that promote use

Key principles​

Claims must match the Device Licence​

Advertising claims must be consistent with the device's licensed intended use as recorded in the Device Licence. Making claims that go beyond the licensed indications is a violation of the Food and Drugs Act, even if those indications might be legitimate uses of the device.

No false or misleading claims​

Advertising must not:

  • Make claims that are false or misleading
  • Create a false impression about the device's safety or effectiveness
  • Omit information that creates a misleading impression
  • Claim the device is endorsed by Health Canada

Comparative advertising​

Comparative claims (e.g., "superior to X") must be substantiated with objective evidence. Unsubstantiated comparative claims may violate the Competition Act as well as the FDA.

Advertising to consumers vs. professionals​

Advertising directed at healthcare professionals is generally subject to fewer restrictions than advertising directed at consumers. However, both must comply with the accuracy and truthfulness requirements.

Compliant claims​

For a claim to be compliant, it must:

  1. Fall within the licensed intended use
  2. Be supported by evidence (the evidence used to obtain the Device Licence, or additional post-market evidence)
  3. Be accurate and not misleading in context

Legislative source: Food and Drugs Act, RSC 1985, c F-27, ss 9 and 20 (advertising offences); Medical Devices Regulations, SOR/98-282