What the SFDA requires
| Marketing authorization (MDMA) | A medical device may be sold in Saudi Arabia only if it is registered with the SFDA and holds a medical device marketing authorization. The manufacturer or its Saudi authorised representative applies. (SFDA MDS-REQ 1: medical device marketing authorization (v6.0)) |
| Authorised representative | A Saudi establishment licensed by the SFDA for each manufacturer it represents, with a documented agreement; it represents the manufacturer before the SFDA, reports incidents and ensures after-sales service. (SFDA MDS-REQ 9: licensing medical device establishments (v2.0, Jan 2025)) |
| Importer and storage | The importer of a medical device must hold an SFDA establishment licence, keep the MDMA, declaration of conformity and UDI with each device, and store devices in an SFDA-licensed warehouse. (SFDA MDS-REQ 9: licensing medical device establishments (v2.0, Jan 2025)) |
| MHRA reliance | Since 9 September 2026 the SFDA reliance approach accepts approvals from the UK MHRA (and other reference regulators) for the MDMA, where the device is identical and Saudi labelling, instructions, language and voltage requirements are met. Self-declaration routes without an independent assessment are excluded. Review: 35–60 working days for Class A–D. (SFDA MDS-G030: reliance approach for medical devices (v1.0, 9 Sep 2026)) |
| UK–GCC trade deal | Concluded on 20 May 2026 and not yet in force; standard duty applies until it is. (GOV.UK: UK–GCC trade deal (20 May 2026)) |
Who does what
| Party | Role |
|---|---|
| UK manufacturer | Holds the MHRA, UKCA or CE approval, the technical file and the quality system; appoints one Saudi authorised representative. |
| Saudi authorised representative (SFDA-licensed) | Files the MDMA (the reliance route where it applies) and handles SFDA, vigilance and post-market duties. |
| SFDA-licensed importer | Imports the device, keeps the MDMA, declaration of conformity and UDI with each device, and stores it in an SFDA-licensed warehouse. |
| Safe Hands | Customs clearance as a licensed customs broker, freight from the UK, delivery; importer of record and SABER for the non-device lines; storage of non-regulated accessories. |
Lines we import directly
Items that are not medical devices follow SABER by HS code, and Safe Hands can be the importer of record:
- Hospital furniture
- Fit-out materials for clinics and hospitals
- Consumables that are not medical devices
- Non-regulated accessories, stored at our Riyadh warehouse
Whether an item is a medical device is decided by SFDA classification.
UK trade in this category
| Optical, measuring and medical instruments (HS 90) | USD 290 million in 2025 (USD 254 million in 2024). (UN Comtrade: Saudi-reported imports from the UK, HS 90 and 9018) |
| Medical and surgical instruments (HS 9018) | USD 36 million in 2025 (USD 30 million in 2024). (UN Comtrade: Saudi-reported imports from the UK, HS 90 and 9018) |
Sources
- SFDA MDS-REQ 1: medical device marketing authorization (v6.0)
- SFDA MDS-REQ 9: licensing medical device establishments (v2.0, Jan 2025)
- SFDA MDS-G030: reliance approach for medical devices (v1.0, 9 Sep 2026)
- GOV.UK: UK–GCC trade deal (20 May 2026)
- UN Comtrade: Saudi-reported imports from the UK, HS 90 and 9018
Official pages, checked 10 October 2026. SFDA classification and the route are confirmed per device.
Frequently Asked Questions
QCan Safe Hands be the importer of record for UK medical devices?
Medical devices are imported through an SFDA-licensed importer or the manufacturer's Saudi authorised representative. Safe Hands handles customs clearance, freight and delivery, and is importer of record for the non-device lines.
QDoes the SFDA accept MHRA approval?
Yes, through the reliance approach published on 9 September 2026, for identical devices that meet Saudi labelling, language and voltage requirements. Self-declaration routes without an independent assessment are excluded.
QHow long does the reliance review take?
35–60 working days for Class A–D devices with a complete application.
QDo we need a Saudi authorised representative?
Yes. A foreign manufacturer appoints one SFDA-licensed authorised representative, which files the MDMA and handles SFDA and post-market duties.
QWhere can medical devices be stored in Saudi Arabia?
In an SFDA-licensed warehouse. Our Riyadh warehouse holds the non-device lines and non-regulated accessories.
QIs UKCA or CE enough for Saudi Arabia?
No. The device still needs an SFDA marketing authorization; an MHRA approval can support it through the reliance route.
QWhat about hospital furniture and fit-out?
Items that are not medical devices follow SABER by HS code, and Safe Hands can import them as importer of record.
QDoes the UK–GCC trade deal cut duty?
Not yet. It was concluded on 20 May 2026 and is not in force; standard duty applies until it is.
QDo labels need Arabic?
Labels and instructions must meet SFDA language requirements; Arabic is required for lay users.
QWho decides if a product is a medical device?
SFDA classification, not the importer. We confirm the route per product before shipping.
Our credentials
- Licensed customs broker
- ZATCA customs clearance
- TGA Freight Forwarder & Broker Licence
- 42/00008120
- ISO certification
- ISO 9001:2015 AMER300621 · ISO 45001:2018 AMER300622
- Verify · Certification body's certificate check
- Head office · Warehouse
- 7273 Fatimah Al Zahraa Rd, Riyadh 12837 · Al Sulay industrial district, Riyadh
Safe Hands Shipping Line is the trade name of شركة الايدي الامينة (Al Aidi Al Amina Company). All credentials →
Get an Importer of Record (IOR) Quote
Send the product list and whether each item is a medical device; our team replies with the route and a written quote.