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GHAD Portal — Electronic Submission

What is GHAD?

GHAD (Arabic: غاد — Unified Electronic System) is the SFDA's single online portal for all medical device regulatory activities. It is the mandatory submission platform for:

  • MDMA applications (new, renewal, variation)
  • MDEL applications (manufacturer, importer, distributor, AR licenses)
  • UDI data submission
  • Adverse event reports
  • Change notifications

All MDMA applications must be submitted through GHAD — paper submissions are not accepted.

Accessing GHAD

The GHAD portal is accessible at the SFDA e-Services website. Both manufacturers and ARs can register for accounts:

  • AR accounts — used for most MDMA submissions on behalf of manufacturers
  • Manufacturer direct accounts — for manufacturers who wish to submit technical files directly without sharing documentation with their AR
Manufacturer direct submission

Foreign manufacturers who have proprietary technical documentation they do not wish to share with their AR can use the direct manufacturer submission option via GHAD. The AR still holds the MDMA certificate and AR license — the split allows documentation confidentiality.

Key GHAD workflows

MDMA application

  1. Register / log into GHAD
  2. Create a new MDMA application
  3. Enter device details (name, classification, intended use, models)
  4. Upload technical file sections per MDS-REQ 1 Annex 3 structure
  5. Submit application — triggers SFDA completeness check
  6. Receive invoice via GHAD — pay online
  7. Monitor application status and respond to queries via GHAD messaging
  8. Download MDMA certificate upon approval

MDEL application

The MDEL (establishment license) is also applied for and managed through GHAD. See MDEL Overview.

UDI submission

UDI data must be submitted via GHAD in the format specified by MDS-REQ 7. See UDI Data Submission.

Application status tracking

GHAD provides real-time status tracking for all submitted applications. Status stages include:

  • Submitted — under SFDA completeness check
  • Invoice issued — awaiting payment
  • Under review — technical assessment in progress
  • Query issued — SFDA has sent a deficiency letter
  • Approved — MDMA certificate issued
  • Rejected — application did not meet requirements

Tips for efficient GHAD submissions

  • Ensure all documents are in PDF format and clearly labelled
  • Upload the technical file in the exact section structure required by MDS-REQ 1 Annex 3
  • Verify all device details (names, models, codes) are consistent across all sections
  • Use the Declaration of Conformity template in Annex 14 of MDS-REQ 1
  • Respond to SFDA queries promptly via GHAD messaging

Further reading