A UK manufacturer cannot apply to SFDA directly. Everything goes through a Saudi-licensed Authorised Representative — and since 2020 there is no shortcut route for anyone, whatever mark your device already carries.
SFDA issues a Medical Devices Marketing Authorisation (MDMA) to a legal entity that holds a Saudi establishment licence. A UK company cannot hold one. In practice this means the application is filed by, or through, an Authorised Representative licensed in the Kingdom.
The Authorised Representative is not a mailbox. It holds a separate SFDA licence for each manufacturer it represents, carries continuing duties towards the regulator, and remains responsible until it is formally replaced or your devices leave the market.
Separately, whoever imports, distributes or warehouses your product in the Kingdom needs its own establishment licence. Those are different licences held by different companies, and confusing the two is the most common structural mistake we see.
SFDA uses four risk classes, A to D, with its own classification rules. The manufacturer is responsible for the classification, and where rules conflict the highest applicable class wins. Getting this wrong changes the fee, the evidence and the review.
You, with usThe AR applies for its establishment licence through SFDA's GHAD system, naming you as the manufacturer it represents. Before it can be appointed it must confirm to SFDA that no other representative already holds the same class or general group of devices for you.
Us, with the representativeConformity with SFDA's Essential Principles, a quality system certified to ISO 13485:2016, declaration of conformity, risk management file, post-market surveillance plan, summary of safety and clinical performance, labelling and instructions for use, and a UDI carrier on the label.
You, assembled by usThe MDMA application is filed electronically in SFDA's unified system. Fees are paid at submission and are not refundable if the file is incomplete — which is why we do not submit until it is.
Representative, managed by usSFDA states a maximum of 35 working days where all requirements are met. In practice the clock is driven by how quickly deficiency questions are answered — that is the part we run.
UsUDI data must be present in SFDA's Saudi-DI database when the device is placed on the market, with record updates inside ten working days. Adverse events are reported to the National Center for Medical Devices Reporting on a two, ten or thirty day clock depending on severity, and a field safety corrective action must be reported within two days of the FSCA letter. Renewal can be filed from 90 days before expiry.
Shared — we run the calendar| Item | Fee, SAR | Review |
|---|---|---|
| Marketing authorisation — Class A | 15,000 | 35 working days |
| Marketing authorisation — Class B | 19,000 | 35 working days |
| Marketing authorisation — Class C | 21,000 | 35 working days |
| Marketing authorisation — Class D | 23,000 | 35 working days |
| Renewal | 5,000 | — |
| Label, IFU or advertising update | 1,100 | — |
| Authorised Representative licence | 2,600 per year | term 1–10 years |
SFDA fee schedule for medical device marketing authorisation, May 2025 edition — unchanged from the December 2024 edition. Establishment licence fees for importers and distributors are separate and are set by establishment category, not by device risk class. Fees are payable to SFDA and are billed to you at cost.
SFDA once ran a reliance route for devices approved by the five GHTF founding jurisdictions — Australia, Canada, Japan, the USA and the EU/EFTA. SFDA stopped accepting applications through that route in 2020. What remains is a single assessment of your technical file, and it applies equally to a device cleared by the FDA and to one that has never been approved anywhere.
Two consequences follow, and they cut in opposite directions.
On UKCA specifically. UKCA and the MHRA have never appeared on an SFDA recognised list — not in the current framework, and not in the superseded one, which named the EU and EFTA rather than the United Kingdom. If a provider tells you a UKCA mark shortens SFDA review, ask them to show you the document. There isn't one.
The representative licence is issued per manufacturer, and SFDA requires the representative to confirm that no other representative holds the same class or general group of your devices. You may use different representatives for different device groups — but never two for the same one.
That single rule decides how much freedom you keep. If your distributor is also your Authorised Representative, then the entity that sells your product also controls the appointment that lets it be sold. Replacing them becomes a regulatory exercise, not a commercial one, and it happens at the worst possible moment — when the relationship has already broken down.
The representative's duties run continuously: annual confirmation to SFDA that the submitted information is still accurate, cooperation in post-market surveillance, reporting incidents that occur outside the Kingdom for devices traded inside it, and notifying the authorities if a device becomes critically unavailable. Responsibility does not end when a contract does — it ends when a replacement is appointed or the devices leave circulation.
How we structure it. The representative we appoint holds the licence and nothing else. It does not buy, sell or distribute your product, and its contract with you is separate from any distribution agreement. Changing distributor then costs you a conversation, not a re-registration.
Most of this already exists if you hold CE or FDA clearance. The assessment tells you exactly which pieces are missing before anyone spends money on fees.
Arabic matters more than people expect. Information supplied for devices intended for use by lay persons must be provided in both Arabic and English. If your device is professional-use only the requirement is narrower — which is one of the first things the assessment establishes, because translation is rarely the cheapest line in the budget.
| Date | Change |
|---|---|
| Jan 2025 | Revised requirements for licensing medical device establishments, including the representative's duties, exclusivity confirmation and the current fee and validity table |
| Mar 2025 | New guidance mapping ISO 13485 requirements to SFDA's own |
| Jul 2025 | Revised manufacturing paths guidance — the legal manufacturer files the authorisation, including in contract manufacturing arrangements |
| Aug 2025 | First guidance covering digital health products: software as a medical device, mobile health, digital therapeutics, wearables and AI-enabled devices |
| Jul 2026 | New risk communication guidance, and a new version of the advertising requirements covering social media content |
Fee schedule unchanged since December 2024. The core marketing authorisation requirements document remains at version 6.
Send us the device, its class and where you already hold approvals. You will get the sequence, the full cost including SFDA fees, the document gaps and an honest view of whether Saudi Arabia is the right first market at all.
Check your routeOr reach us directly — mail@bcabusiness.co.uk · +44 7342 901002 · WhatsApp
We cite the document and its version because in this area the wrong citation is worse than none: several superseded SFDA guidances remain published and are still quoted by consultancies as if current. Where SFDA does not publish a figure openly, we confirm it with the authority during the assessment rather than repeating a number from a blog. This page is re-checked quarterly and after any SFDA circular affecting devices.