Regulatory Framework Overview
The Saudi Food and Drug Authority (SFDA)
The Saudi Food and Drug Authority (SFDA) is the national government body responsible for regulating medical devices — and drugs, food, cosmetics, and pesticides — in the Kingdom of Saudi Arabia (KSA). Within the SFDA, the Medical Devices Sector (formerly the Medical Devices National Competence Center) administers all aspects of device regulation.
The SFDA's remit covers:
- Pre-market authorization (MDMA) — reviewing and approving technical files
- Establishment licensing (MDEL) — licensing manufacturers, importers, distributors, and ARs
- Post-market surveillance — monitoring device safety, processing adverse event reports
- Vigilance — coordinating field safety corrective actions and recalls
- Enforcement — inspections, import alerts, and market withdrawal
The legal framework
| Instrument | Role |
|---|---|
| Medical Devices and Supplies Regulation (CoM Resolution No. 337) | Primary law — defines medical devices, establishes MDMA requirement, sets out obligations |
| Implementing Regulation of the Medical Devices Law (2021) | Detailed implementation — technical file content, classification, QMS, post-market obligations |
| MDS-REQ series (MDS-REQ 1–9+) | SFDA guidance documents — the practical rulebooks for registration, QMS, UDI, vigilance, advertising, AR, MDEL |
| MDS-G series | Supplementary technical guidance — classification (MDS-G008), SaMD, labelling, etc. |
The SFDA has deliberately aligned its framework with EU MDR 2017/745 and EU IVDR 2017/746. Classification rules in MDS-REQ 1 are essentially identical to the 22 EU MDR classification rules. Manufacturers familiar with EU regulatory processes will find many structural parallels — but cannot substitute CE marking for SFDA MDMA approval.
The registration process at a glance
All medical devices — regardless of risk class — must obtain Medical Device Marketing Authorization (MDMA) from the SFDA before being marketed in Saudi Arabia. Since 2022, the single pathway is:
- Appoint an Authorized Representative (AR) — mandatory for foreign manufacturers
- Classify the device — using MDS-REQ 1 classification rules (Class A → D)
- Prepare the Technical File — following MDS-REQ 1 Annex 3 structure
- Apply via GHAD — the SFDA's unified electronic submission portal
- Pay the application fee — invoiced by SFDA after submission check
- SFDA review — may include queries; approval issued as MDMA certificate
- Comply post-market — PMS, vigilance, UDI, MDMA renewal
The GHAD portal
GHAD (Arabic: غاد) is the SFDA's Unified Electronic System for all medical device regulatory submissions. It is the single platform for:
- MDMA applications and renewals
- MDEL applications
- AR licensing
- UDI data submission
- Adverse event reports
All applicants — manufacturers and ARs — must register on GHAD before submitting. Foreign manufacturers may submit directly via GHAD if they do not wish to share confidential technical documentation with their AR; this is an unusual but permitted option.
Key participants
| Role | Description |
|---|---|
| Legal manufacturer | Entity responsible for design and manufacture; holds technical responsibility |
| Authorized Representative (AR / LAR) | Saudi-licensed entity acting as official liaison with SFDA for foreign manufacturers |
| Importer | Entity importing devices into KSA; must hold MDEL |
| Distributor | Entity distributing within KSA; must hold MDEL |
| Healthcare provider | Hospitals, clinics — hold adverse event reporting obligations |
Where Saudi Arabia sits globally
Saudi Arabia is one of the largest medical device markets in the Middle East, driven by strong healthcare investment under Vision 2030 and a rapidly growing population. The SFDA is an active member of the International Medical Device Regulators Forum (IMDRF) and chairs the Global Harmonization Working Party (GHWP), reflecting its ambitions for international regulatory alignment.
The KSA market is also linked — through the Gulf Cooperation Council (GCC) — to the UAE, Bahrain, Kuwait, Oman, and Qatar. GCC harmonisation creates additional market access opportunities for registered manufacturers.