Saudi Arabia
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.
Do you also make medicines? SFDA recognises no foreign mark for devices — but for medicines it names the MHRA as a stringent authority, which cuts a new-drug review from 405 working days to 280. The medicines page for Saudi Arabia →
If you are not established in Saudi Arabia
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.
Six steps, in this order
- 01
Classify the device
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 us - 02
Appoint and license the representative
The 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 representative - 03
Assemble the technical documentation
Conformity 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 us - 04
Submit through GHAD
The 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 us - 05
Review and questions
SFDA 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.
Us - 06
After approval
UDI 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
Official fees and review time
The fee climbs with the class. The review period does not — thirty-five working days is the published maximum for all four, which is why the class you argue for changes the budget far more than it changes the calendar.
Marketing authorisation fee by SFDA risk class. Bars are proportional to the fee; the review period is identical across all four. Renewal SAR 5,000 · label, IFU or advertising update SAR 1,100 · Authorised Representative licence SAR 2,600 per year, term one to ten 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. Build the full sheet for your class →
Does your CE, UKCA or FDA approval help?
Not as a shortcut. Not for anyone.
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.
- The bad news for anyone quoting you a fast track. Timelines and fees that vary by "standard versus abridged" are describing a pathway that closed six years ago. There is one route and one published review period.
- The good news, such as it is. Because nothing shortcuts, a UK manufacturer is not disadvantaged here relative to an American or German one. Your existing approvals still earn their keep — as supporting evidence inside the dossier, and because the technical file you built for them is most of the file SFDA wants.
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.
Who holds what, and why it matters later
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.
What we do here, and what we do not
We do
- Confirm the class under SFDA's rules and price the route before you commit
- Identify, vet and contract the Saudi representative, on terms that keep it independent of distribution
- Build the dossier against the Essential Principles and manage translation and legalisation
- Run the submission and every deficiency question until the authorisation issues
- Hold the calendar afterwards: UDI records, reporting deadlines, renewal at 90 days
We do not
- Act as your Authorised Representative — that licence must sit with a Saudi-established entity
- Sell or distribute your product, or take any margin on it
- Take on manufacturer liability, technical claims or the classification decision itself
- Promise an approval date. SFDA's 35 working days assumes a complete file and no questions
- Quote you a fast track that does not exist
What we will ask you for
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.
- Device description, intended purpose and variants in scope
- Proposed classification and your rationale
- ISO 13485:2016 certificate for the quality system
- Declaration of conformity
- Technical documentation against the Essential Principles
- Risk management file
- Post-market surveillance plan
- Summary of safety and clinical performance
- Labels, packaging and instructions for use
- UDI assignment and carrier format
- Existing approvals and certificates, wherever held
- Your commercial plan for the Kingdom — it changes the structure
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.
What moved in 2025 and 2026
- Jan 2025Revised requirements for licensing medical device establishments, including the representative's duties, exclusivity confirmation and the current fee and validity table
- Mar 2025New guidance mapping ISO 13485 requirements to SFDA's own
- Jul 2025Revised manufacturing paths guidance — the legal manufacturer files the authorisation, including in contract manufacturing arrangements
- Aug 2025First guidance covering digital health products: software as a medical device, mobile health, digital therapeutics, wearables and AI-enabled devices
- Jul 2026New 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.
Two weeks to a written route
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.
Or reach us directly — mail@bcabusiness.co.uk · +44 7342 901002 · WhatsApp
27 August 2026
Sources
- MDS-REQ 1 — Requirements for Medical Devices Marketing Authorization, version 6
- MDS-REQ 9 — Requirements for Licensing Medical Devices Establishments, version 2, January 2025
- MDS-G008 — Guidance on Medical Devices Classification, version 2, December 2022
- MDS-REQ 7 — Requirements for Unique Device Identification, version 4
- MDS-REQ 11 — Requirements for Post-Market Surveillance of Medical Devices, version 2
- SFDA schedule of medical device marketing authorisation fees, May 2025
- SFDA circulars discontinuing the GHTF route, August and December 2020
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.