Lifecycle of a Medical Device in Saudi Arabia
The regulatory journey of a medical device in Saudi Arabia begins before the device enters the market and continues throughout its entire commercial life. The SFDA regulates every stage, from initial classification through post-market surveillance and eventual withdrawal.
Stage 1 — Determine if your product is a medical device
Review the SFDA definition under the Medical Devices Law. Confirm whether your product qualifies as a medical device or IVD, or falls under a different SFDA regulatory sector (drugs, food, cosmetics). If uncertain, request a borderline determination via your AR.
Stage 2 — Classify the device
Apply the SFDA classification rules in MDS-REQ 1 (aligned with EU MDR) to determine whether your device is Class A, B, C, or D (or the relevant IVD class). Classification determines documentation requirements, QMS certification requirements, review depth, and fees.
Stage 3 — Appoint an Authorized Representative
Foreign manufacturers must appoint a Saudi-licensed AR before any MDMA application can be submitted. The AR must hold (or obtain) a valid AR license via the MDEL system and register on the GHAD portal.
→ Authorized Representative Overview
Stage 4 — Establish a certified QMS
Manufacturers must implement and maintain a Quality Management System certified to ISO 13485 (or the Saudi-specific SFDA.MD/GSO ISO 13485). For Class A and B devices, certification must come from an SFDA-accredited Conformity Assessment Body (CAB) or IAF-accredited CB. SFDA may audit Class C and D manufacturers.
Stage 5 — Prepare the Technical File
Compile the Technical Documentation File (TDF) following MDS-REQ 1 Annex 3. This includes device description, Essential Principles compliance, risk management, design and manufacturing information, labelling and IFU, and clinical evaluation. The documentation must be in English.
Stage 6 — Submit MDMA application via GHAD
The AR (or directly the manufacturer) submits the MDMA application and technical file through the GHAD portal. The SFDA performs an initial submission check, then issues an invoice. After payment, the substantive technical review begins.
Stage 7 — SFDA review and queries
The SFDA reviews the technical file, typically within 3–6 months depending on class and complexity. The SFDA may issue queries (deficiency letters) requiring responses from the manufacturer via the AR. Timely, complete responses reduce review delays.
Stage 8 — MDMA certificate issued
On successful review, the SFDA issues the MDMA certificate in both Arabic and English. The certificate authorises the device to be marketed in KSA and includes the device name, class, AR details, and validity period (typically one to three years).
Stage 9 — Establish UDI
Before or concurrent with market entry, manufacturers must assign a Unique Device Identifier (UDI) to the device and submit UDI data to the SFDA system in compliance with MDS-REQ 7.
Stage 10 — Post-market obligations (ongoing)
Once on the market, ongoing obligations include:
- PMS/PSUR — post-market surveillance reports by device class (annually for Class C/D)
- Adverse event reporting — to the NCMDR for serious incidents
- FSCA management — coordinating field safety corrective actions
- Labelling compliance — Arabic labelling for home-use devices
- Change notification — notifying SFDA of significant device changes
- MDMA renewal — before certificate expiry
Stage 11 — MDMA renewal
The MDMA certificate must be renewed before expiry. Renewal is submitted via GHAD and requires confirmation of continued compliance, updated post-market data, and payment of renewal fees.
Stage 12 — Market withdrawal
If a device is withdrawn from the Saudi market — whether voluntarily or following an SFDA safety action — the AR must notify the SFDA, coordinate any necessary FSCA, and update the device status on GHAD.