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Regulatory Contacts & Further Help

Contacting the SFDA​

The SFDA can be contacted for regulatory queries through several channels:

  • GHAD portal — the primary channel for submitting regulatory queries, MDMA applications, and formal communications
  • SFDA website contact form — for general enquiries not related to active applications
  • Medical Devices Sector helpdesk — contact details published on the SFDA website
  • AR — your Authorized Representative in Saudi Arabia is the primary in-country liaison and should handle most SFDA communications on your behalf
Use your AR for SFDA communications

For foreign manufacturers, all formal SFDA communications should be channelled through the Authorized Representative. Direct contact with the SFDA from the foreign manufacturer (outside the GHAD direct submission option) may not be accepted.

Borderline determination queries​

If you are uncertain whether your product is a medical device, or how it should be classified, contact the SFDA's Medical Devices Sector via your AR. The SFDA can provide formal borderline guidance.

Finding a qualified AR​

The SFDA does not publish an official list of licensed ARs. Recommendations can be sourced through:

  • International regulatory consultancies with Saudi market expertise
  • Industry associations (IMDRF-member contacts)
  • GCC-region medical device trade bodies

Finding an SFDA-accredited CAB​

SFDA-accredited Conformity Assessment Bodies (CABs) for ISO 13485 certification are listed on the SFDA website under Medical Devices → Conformity Assessment Bodies.

RAPath feedback and corrections​

This site is a community reference resource. If you identify inaccuracies or have suggestions for improvement, please open an issue in the RAPath GitHub repository.