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RAPath · Saudi Arabia (SFDA)

Welcome to the RAPath guide for medical device regulation in the Kingdom of Saudi Arabia (KSA). This site covers the full lifecycle of a medical device — from classification and market authorization through to post-market surveillance and establishment licensing — under the framework administered by the Saudi Food and Drug Authority (SFDA).

Regulatory reference only

This site is a plain-language reference resource. It is not legal or regulatory advice. Always verify requirements against current SFDA guidance and consult a qualified regulatory professional for your specific device.

Regulatory Pathway Map​

Click a phase to expand — each card links to the relevant section of this guide.

Getting Started
What is a Medical Device?
SFDA definition under the Medical Devices and Supplies Regulation — scope and key terms.
Read definition →
Getting Started
Regulatory Framework
SFDA Medical Devices Sector, Medical Devices Law (2017), and MDS-REQ guidance series.
View framework →
Getting StartedKey step
Who Must Comply?
MDMA, MDEL, and AR/LAR obligations for manufacturers, importers, and distributors.
Check obligations →

What you will find here​

SectionWhat it covers
Getting StartedDefinitions, who must comply, lifecycle overview
Device ClassificationClass A / B / C / D rules, IVD classification, MDS-G008
MDMA RegistrationMarketing Authorization, TFA route, GHAD portal, timelines
Technical DocumentationTechnical file structure, Essential Principles, clinical evaluation
Authorized Representative & MDELAR / LAR obligations, establishment licensing
Quality SystemISO 13485, SFDA CABs, inspections
Post-MarketAdverse events, FSCAs, PSUR, labelling, MDMA renewal
UDIUnique Device Identification — MDS-REQ 7
Legislation & RegulationsMedical Devices Law, Implementing Regulation, MDS-REQ series
GCC & InternationalGCC harmonisation, IMDRF, multi-market strategy
Digital Health & SaMDSoftware, AI/ML, connected devices
Special Access & EnforcementNovel devices, compassionate use, SFDA enforcement
ResourcesGlossary, useful links, official SFDA portals

The regulator​

The Saudi Food and Drug Authority (SFDA) is the national regulatory body responsible for overseeing the safety, quality, and efficacy of medical devices in the Kingdom of Saudi Arabia. Its Medical Devices Sector administers all aspects of device regulation, from pre-market authorization to post-market surveillance, in accordance with the Medical Devices and Supplies Regulation (Medical Devices Law) and its Implementing Regulation (2021).

The SFDA is a member of the International Medical Device Regulators Forum (IMDRF) and has aligned its regulatory framework closely with international best practice — particularly the EU MDR 2017/745 — while maintaining distinct Saudi-specific requirements, procedures, and the GHAD electronic submission system.

Key concepts at a glance​

  • MDMA — Medical Device Marketing Authorization: required for all devices before they may be marketed in KSA
  • TFA — Technical File Assessment: the single registration pathway since 2022
  • GHAD — SFDA's unified electronic system for all submissions
  • AR / LAR — Authorized Representative / Local Authorized Representative: mandatory in-country contact for foreign manufacturers
  • MDEL — Medical Device Establishment License: required for manufacturers, importers, distributors, and ARs
  • NCMDR — National Centre for Medical Device Reporting: handles adverse event and vigilance submissions
  • MDS-REQ series — SFDA's primary guidance documents covering classification, technical files, QMS, UDI, advertising, and more

Part of the RAPath suite​

RAPath provides free, open regulatory reference guides for multiple jurisdictions:

Questions, corrections, or contributions? Visit the RAPath hub or open an issue in the [GitHub repository](https://github.com/RAPath/ra