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).
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.
What you will find here
| Section | What it covers |
|---|---|
| Getting Started | Definitions, who must comply, lifecycle overview |
| Device Classification | Class A / B / C / D rules, IVD classification, MDS-G008 |
| MDMA Registration | Marketing Authorization, TFA route, GHAD portal, timelines |
| Technical Documentation | Technical file structure, Essential Principles, clinical evaluation |
| Authorized Representative & MDEL | AR / LAR obligations, establishment licensing |
| Quality System | ISO 13485, SFDA CABs, inspections |
| Post-Market | Adverse events, FSCAs, PSUR, labelling, MDMA renewal |
| UDI | Unique Device Identification — MDS-REQ 7 |
| Legislation & Regulations | Medical Devices Law, Implementing Regulation, MDS-REQ series |
| GCC & International | GCC harmonisation, IMDRF, multi-market strategy |
| Digital Health & SaMD | Software, AI/ML, connected devices |
| Special Access & Enforcement | Novel devices, compassionate use, SFDA enforcement |
| Resources | Glossary, 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:
- Australia (TGA)
- European Union (EU MDR / IVDR)
- Canada (Health Canada)
- Singapore (HSA)
- United Kingdom (MHRA)
- United States (FDA)
- Saudi Arabia (SFDA) — you are here
Questions, corrections, or contributions? Visit the RAPath hub or open an issue in the GitHub repository.