Quick answer
A US medical device reaches Saudi buyers through an SFDA marketing authorisation filed by the manufacturer or its Saudi authorised representative, an SFDA-licensed importer and a licensed warehouse. SFDA's reliance route lists the US FDA, with a 35–60 working-day review, but devices cleared mainly on substantial equivalence to a predicate are excluded. Safe Hands clears, ships and delivers.
US medical devices: the SFDA facts
| Saudi imports from the USA, 2025 | Optical, measuring and medical instruments USD 1,605 million, of which medical and surgical instruments USD 542 million (checked 10 Oct 2026). (UN Comtrade: Saudi-reported imports, 2025) |
| Recognised regulatory authorities | SFDA relies on authorisations from Australia (TGA), Canada (Health Canada), EU national competent authorities, Japan (PMDA), the UK (MHRA) and the USA (U.S. Food and Drug Administration). (SFDA MDS-G030: Reliance Approach for Medical Devices (v1.0, 9 Sep 2026)) |
| Eligibility | A valid authorisation from at least one recognised authority, and a device identical in design, manufacturing process and intended use. Saudi requirements still apply, such as SBC Part 401 voltage and frequency, Arabic labelling and instructions, and storage temperature and humidity. (SFDA MDS-G030: Reliance Approach for Medical Devices (v1.0, 9 Sep 2026)) |
| Not eligible for reliance | Self-declaration routes, routes based mainly on substantial equivalence to a predicate device, custom-made devices, products with significant post-market recalls or restrictions, and some software and AI-enabled devices. (SFDA MDS-G030: Reliance Approach for Medical Devices (v1.0, 9 Sep 2026)) |
| Quality management | SFDA accepts MDSAP certificates and audit reports as evidence of quality-management conformity. (SFDA MDS-G030: Reliance Approach for Medical Devices (v1.0, 9 Sep 2026)) |
| Review time | 35–60 working days for Classes A to D through the reliance route, for a complete application. (SFDA MDS-G030: Reliance Approach for Medical Devices (v1.0, 9 Sep 2026)) |
| Marketing authorisation | The MDMA application is made by the manufacturer or its Saudi authorised representative through the SFDA e-services portal. (SFDA MDS-REQ 1: medical device marketing authorization (v6.0)) |
| Import and storage | Devices are imported through an SFDA-licensed importer and stored in an SFDA-licensed facility. (SFDA MDS-REQ 9: licensing medical device establishments (v2.0, Jan 2025)) |
| Import VAT | 15% unless the device is in a VAT-exempt category such as qualifying medical equipment; duty follows the 12-digit line. (ZATCA Guideline on Imports and Exports under VAT (May 2026)) |
Facts checked 15 October 2026 at the official sources linked in each row.
How a US device reaches the Saudi buyer
- 1
Class and eligibility
The device is classed under SFDA rules (MDS-G008) and checked against the reliance criteria: the FDA authorisation type decides whether reliance applies.
- 2
MDMA with the reliance form
The authorised representative answers the reliance question in the MDMA application and uploads the Reliance Form signed by the legal manufacturer.
- 3
Licensed importer and storage
The devices are imported through an SFDA-licensed importer; storage is in an SFDA-licensed facility provided under your contract.
- 4
Freight and FASAH
We book the freight and lodge the customs declaration at least 48 hours before arrival.
- 5
Release and delivery
After SFDA and customs release we deliver to the hospital, distributor or project site; non-device lines are imported by Safe Hands as Importer of Record.
Frequently Asked Questions
QDoes SFDA accept a US FDA authorisation?
The US FDA is on SFDA's list of recognised regulatory authorities for the reliance route. Routes based mainly on substantial equivalence to a predicate device are excluded, so the route is confirmed per device.
QWho files the SFDA marketing authorisation?
The manufacturer or its Saudi authorised representative, through the SFDA e-services portal, with the Reliance Form uploaded when the reliance route is used.
QHow long is the SFDA review?
35–60 working days for Classes A to D through the reliance route, for a complete application; it can be 35 working days where prior approval is relied on.
QCan Safe Hands be Importer of Record for the devices?
Devices are imported through an SFDA-licensed importer. Safe Hands handles customs clearance, freight and delivery, and is Importer of Record for the non-device lines such as hospital furniture, fit-out and accessories.
QIs an MDSAP certificate accepted?
Yes. SFDA accepts MDSAP certificates and audit reports as evidence of quality-management conformity.
QWhich Saudi requirements still apply under reliance?
Saudi-specific requirements such as SBC Part 401 voltage, frequency and conductor colours, Arabic labelling, instructions and user interface, and storage and transport temperature and humidity.
QAre software and AI-enabled devices eligible?
They may be excluded from the reliance route depending on intended use, risk, novelty and complexity, as SFDA decides.
QWhere are the devices stored in Saudi Arabia?
In an SFDA-licensed facility provided under your contract, with delivery to the hospital or distributor arranged by Safe Hands.
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 →
Clear and deliver your US devices in Saudi Arabia
Send the device class, FDA authorisation type and the Saudi delivery city; we confirm the SFDA route and clear the shipment.