MDMA Overview
Medical Device Marketing Authorization (MDMA) — what it is, who needs it, the TFA pathway, and the key steps from application to certificate.
MDMA-2 — Technical File Assessment (TFA)
The Technical File Assessment (TFA) route — Saudi Arabia's single MDMA registration pathway since 2022, and how it differs from the cancelled GHTF route.
GHAD Portal — Electronic Submission
An overview of the SFDA's GHAD unified electronic system — how to register, submit MDMA applications, manage MDEL licensing, and track application status.
SFDA Review Timelines
Approximate SFDA review and approval timelines for MDMA applications by device class, and factors that affect review duration.
Device Grouping
SFDA rules for grouping multiple devices in a single MDMA application — conditions, limits, and practical guidance.
Special Device Types
SFDA regulatory approach for special device categories — radiation-emitting devices, devices incorporating medicinal substances, custom devices, novel devices, and export-only imports.