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Advertising & Promotional Claims

BR-unique

Advertising of medical devices in Brazil is regulated by ANVISA and, for devices used by healthcare professionals, by the relevant professional councils (CFM for physicians, CFO for dentists, CFF for pharmacists). The rules are more restrictive than in many other markets.

Key rules for medical device advertising​

  • Claims must not exceed the device's registered intended use (finalidade prevista) as stated in the ANVISA registration.
  • Advertising directed at the general public is restricted for prescription-only or hospital-use devices.
  • Comparative advertising (claiming superiority over a competitor's device) must be based on scientific evidence and must not be misleading.
  • Testimonials from healthcare professionals in advertising require disclosure of any commercial relationship.
  • Before-and-after images in advertising are prohibited unless supported by clinical data from the device's registration dossier.

ANVISA may take enforcement action against advertising that misleads consumers or promotes devices for indications not covered by the ANVISA registration.

Official sources

Verify all information against official ANVISA sources before making regulatory decisions.