Quick answer
A medical device enters Saudi Arabia only with an SFDA marketing authorisation (MDMA) issued in the manufacturer's name through its authorised representative — SAR 15,000 to 23,000 by class, 35 working days — an SFDA-licensed Saudi importer, and release through FASEH. X-ray and CT equipment also needs an NRRC import licence. Safe Hands clears as a licensed customs broker and stores devices in an SFDA-licensed facility provided under your contract.
Medical Devices
Medical devices need three things before they reach a Saudi hospital: an SFDA marketing authorisation in the manufacturer's name, a Saudi importer licensed by SFDA, and release through FASEH. Radiation-emitting equipment also needs an NRRC licence. We clear the shipment as a licensed customs broker, prepare the documents with the licence holders and store devices in an SFDA-licensed facility provided under your contract.
Which Saudi approvals apply to Medical Devices?
| Product line | Approval | Who applies / our role |
|---|---|---|
| Each device model | SFDA MDMA in the manufacturer's name via its authorised representative: Class A SAR 15,000, B 19,000, C 21,000, D 23,000; 35 working days; renewal SAR 5,000 Source | The licence holder applies; we prepare the documents with you |
| Importer / distributor | SFDA medical device establishment licence for a Saudi legal entity Source | The licence holder applies; we prepare the documents with you |
| Each shipment | Import permission in GHAD and release through FASEH with the FASAH declaration Source | Filed on FASAH by Safe Hands as a licensed customs broker |
| Radiation-emitting devices | NRRC import licence on the Amaan platform (free, 5–10 working days) for a radiation practice-licence holder Source | The licence holder applies; we prepare the documents with you |
What do official sources say about Medical Devices?
- MDMA fees for a new authorisation: Class A SAR 15,000, Class B 19,000, Class C 21,000, Class D 23,000; 35 working days. (Source, checked 13 Oct 2026)
- The medical device establishment licence is issued only to a Saudi legal entity; SFDA sets the yearly fee by establishment class. (Source, checked 13 Oct 2026)
- The NRRC import licence for radioactive sources is free, takes 5–10 working days and requires a valid radiation practice licence. (Source, checked 15 Oct 2026)
Where do Medical Devices shipments usually come from?
Medical devices usually come from Germany, the USA, the UK (with a dedicated SFDA-route page for UK medical devices), France, Italy, China and Turkey; whatever the origin, the importer or distributor must be a Saudi legal entity holding an SFDA medical device establishment licence. (Source, checked 13 Oct 2026)
Which freight modes and clearance apply to Medical Devices?
Medical devices clear with SFDA import permission in GHAD and release through FASEH alongside the FASAH declaration, only once the MDMA is issued in the manufacturer's name; radiation-emitting systems also need an NRRC import licence on the Amaan platform. (Source, checked 15 Oct 2026)
Choose the request that fits
Storage for Medical Devices
SFDA-licensed facility provided under your contract.
Frequently Asked Questions
QWho applies for the SFDA marketing authorisation?
The manufacturer, through its Saudi authorised representative; the MDMA is issued in the manufacturer's name. We prepare the shipping and clearance documents with you.
QHow long does an MDMA take and what does it cost?
SFDA lists 35 working days and SAR 15,000 (Class A), 19,000 (B), 21,000 (C) or 23,000 (D) for a new authorisation; renewal is SAR 5,000.
QDoes the importer need an SFDA licence?
Yes. The importer or distributor must be a Saudi legal entity holding an SFDA medical device establishment licence; devices are stored in an SFDA-licensed facility.
QDo X-ray or CT systems need anything else?
Yes. Radiation sources also need an NRRC import licence on the Amaan platform, free and issued in 5–10 working days to the radiation practice-licence holder.
QCan you deliver devices to a hospital project?
Yes. Devices are released through FASEH, held in an SFDA-licensed facility provided under your contract and delivered to the hospital when the room is ready.
QWhen is the customs declaration filed?
Safe Hands, a licensed customs broker, files the FASAH declaration at least 48 hours before arrival, so cargo is released on discharge rather than waiting on documents. For medical devices, it goes with SFDA import permission in GHAD and release through FASEH.
QWhich Saudi gateway will my cargo use?
Sea freight clears at Jeddah Islamic Port (west) or King Abdulaziz Port, Dammam (east); air freight at King Khalid (Riyadh), King Abdulaziz (Jeddah) or King Fahd (Dammam) airports; trucks from the UAE at Al Batha and from Jordan at Al Haditha. Whichever gateway is used, medical devices are released through SFDA's FASEH system.
QHow do I get a quote?
Request a Customs Clearance Quote with your HS code, or message us on WhatsApp; we reply within minutes on WhatsApp. For medical devices, also say whether each model holds an SFDA marketing authorisation (MDMA) and which Saudi importer holds the SFDA medical device establishment licence.
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 →
Other industries we ship for
- Hospitality & FF&E
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- Fit-out Contractors
- Industrial Exporters
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