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Labelling & Advertising

Post-market labelling compliance​

Labelling requirements apply throughout the device lifecycle, not just at the time of MDMA application. Key post-market labelling obligations:

  • AR name and address must remain current on all labels — update labelling whenever the AR changes
  • UDI must be present on all labels as required by MDS-REQ 7
  • Arabic labelling must be provided for all home-use (lay user) devices — an ongoing requirement, not a one-time approval

See Labelling & IFU Requirements for label content requirements.

Advertising pre-approval — MDS-REQ 8​

All promotional and advertising materials for medical devices in Saudi Arabia must receive SFDA pre-approval before distribution. This applies to:

  • Print advertising (journals, brochures, catalogues)
  • Digital and online advertising (websites, social media, apps)
  • Materials used at conferences, exhibitions, and trade shows
  • Patient information materials

MDS-REQ 8 sets out the content requirements for approved advertising:

  • Claims must be truthful and supported by evidence in the technical file
  • Claims must not be misleading, exaggerated, or imply MDMA approval constitutes clinical endorsement
  • Advertising materials must reference the MDMA certificate number
  • No prohibited claims (unapproved indications, comparisons not supported by data)

Applying for advertising approval​

Advertising pre-approval is submitted via GHAD or the SFDA's designated advertising submission channel. The AR submits advertising content for SFDA review. Allow sufficient lead time before planned advertising campaigns.

Consequences of non-compliant advertising​

Distributing unapproved advertising can result in:

  • SFDA warning letters
  • Mandatory withdrawal of advertising materials
  • Potential impact on MDMA certificate status
  • Penalties under the Medical Devices Law

Further reading​