MENA I KINGDOM OF SAUDI ARABIA
Saudi Arabia
The Saudi Food and Drug Authority (SFDA) regulates medical devices, IVDs and medical supplies in the Kingdom. No medical device may be traded in Saudi Arabia unless it is registered and holds a Medical Device Marketing Authorization (MDMA) from the SFDA.
Regulatory Complexity
HIGH
REGION
MENA
CLASSIFICATION
Class A to D
REGULATORY AUTHORITY
SFDA
Saudi Food and Drug Authority
LOCAL REPRESENTATIVE
Mandatory
Spit Spot Summary
Saudi Arabia operates one of the most developed medical device regulatory systems in the Middle East region, with the Saudi Food and Drug Authority (SFDA) serving as the primary regulatory body. The regulatory framework adopts a risk-based approach similar to international standards, with clear requirements for registration, licensing, and post-market surveillance activities.
PHASE 01
Scoping the Market
IMPLEMENTING REGULATION OF THE MEDICAL DEVICES LAW (ROYAL DECREE M/54)
Who regulates medical devices in Saudi Arabia?
The Saudi Food and Drug Authority (SFDA), through its Medical Devices Sector, regulates medical devices, IVDs and medical supplies placed on the market in the Kingdom.
IMPLEMENTING REGULATION, ART.8 I MDS-REQ-1
Do I need approval before selling a device there?
Yes. No medical device may be traded in the Kingdom unless it is registered and holds a Medical Device Marketing Authorization (MDMA) from the SFDA. The device must be scientifically assessed before it can be circulated.
MDS-REQ-1, ANNEX 5 I MDS-G-008 GUIDANCE ON CLASSIFICATION
How are devices classified?
Devices are classified by risk, from Class A (lowest) to Class D (highest). The manufacturer determines the class using the SFDA's classification rules. IVDs use a separate Class A to D scale.
MDS-REQ-1 I IMPLEMENTING REGULATION, ART. 10.2
Can we sell directly, or do we need someone local?
A manufacturer located outside the Kingdom must appoint an Authorised Representative, a legal person based in Saudi Arabia, authorised in writing, who holds an AR licence obtained through the GHAD System.
PHASE 02
Planning the Submission
MDS-REQ-1 I IMPLEMENTING REGULATION, ART. 22.1
What quality management system does the SFDA require?
The manufacturer must establish, document and maintain a QMS to ISO 13485:2016, or an identical adopted standard and version. Proof of QMS implementation forms part of the MDMA application.
IMPLEMENTING REGULATION, ART. 10.5 & 10.8 I MDS-G012
How long is the MDMA valid, and what happens when a device changes?
The MDMA Certificate is valid for up to three years from issue. After that, the manufacturer or AR renews it before expiry.
For changes during the term: significant changes are reported to the SFDA (approval required) within 10 days; non-significant changes are notified within 30 days.
IMPLEMENTING REGULATION, ART 10.18
What language must labelling be in?
For a professionally qualified user, English labelling is accepted. If the device is intended for a lay person, the label must be in both Arabic and English. Technical documentation is submitted in English unless the SFDA has agreed otherwise.
CONSIDERING SAUDI ARABIA FOR MARKET ENTRY?
SFDA registrations as part of a broader international programme
I have managed SFDA and broader MENA registrations as part of international programmes. I'm happy to discuss the specifics of your situation.
Disclaimer. This country profile is based on publicly available regulatory information and professional analysis. It does not constitute legal advice. Companies must verify all requirements with qualified local legal counsel and regulatory authorities before making market entry decisions. Last updated: 2026/06 — verify with current sources.