MDMA first, then the shipment
Medical equipment suppliers in Saudi Arabia may not trade a medical device unless it is registered and holds a marketing authorisation from the Saudi Food and Drug Authority (SFDA). This is known as the MDMA. A maker based abroad must appoint an authorised representative in the country, and SFDA licenses that representative for each maker. Medical device companies in Saudi Arabia that import or distribute also need their own SFDA licence. So a quote starts with the MDMA, not with the freight, and we do these checks before we quote, not after.
We are a medical equipment distributor called MediGear, registered in England and Wales. We prepare quotes, documents and freight for healthcare buyers in more than 80 countries. For Saudi Arabia hospital equipment, we look for verified makers whose model already holds an MDMA, or whose representative can get one. Each point below is answered before your engineers and buying team see the quote. Send requests through our buyers page, which needs no account.
Health clusters, specialist hospitals and private groups
We quote for hospitals and other buyers in Saudi Arabia, like:
- Health clusters run by Health Holding
- King Faisal Specialist Hospital, on three sites
- King Fahad Medical City in Riyadh
- Private groups such as Mouwasat and cardiac centres
- KKU Medical City in Asir
- SFDA-licensed service and test firms
- Licensed Saudi importers and distributors
This list of hospitals in Saudi Arabia is only a sample, as public care runs through 20 clusters, which cover all regions. Health care in Riyadh includes King Fahad Medical City, with its heart and cancer centres. Health care in Jeddah includes King Faisal Specialist Hospital, which also has sites in Riyadh and Madinah. The Ministry of Health oversees public and private providers. Among public hospitals, Hail General Hospital opened in November 2025. Government tenders run on Etimad, the Ministry of Finance platform. NUPCO, the national unified buying company, supplies medicines and medical equipment across Saudi Arabia. A private clinic replacing one monitor can send us the model.
SFDA, the MDMA and the authorised representative
The Law of Medical Devices and Supplies, issued in 2021, and its Implementing Regulation set the rules. SFDA lists authorised devices in its national registry, and an MDMA lasts up to three years. Imports follow SFDA's import and clearance rules, MDS-REQ 5. They need the MDMA, the representative's licence and the importer's licence for each shipment. Labels for professional users may be in English, while devices for lay users need Arabic and English.
SFDA also bans devices whose labels say they are for another market only. A device without an MDMA may not be advertised either. We are not a Saudi representative, importer or distributor and give no regulatory advice, but each quote lists the unit's certificates.
NRRC licences, generator registration and annual QC
Radiation falls to the Nuclear and Radiological Regulatory Commission (NRRC). A facility needs a radiation practice licence, applied for on NRRC's Amaan platform, and NRRC aims to decide within 30 working days of a full file. Anyone who plans to import radiation generators must notify NRRC first. After import, the licensed facility registers each generator on the national nuclear registry, with the maker's certificate. For Saudi Arabia X-ray equipment, our quote includes the maker's certificate required for NRRC registration.
NRRC's quality control rules, revised in June 2026, cover X-ray, fluoroscopy, CT, mammography, and dental units, including digital X-ray systems. They require tests when a unit is commissioned or moved, before it is used on patients. After that, most tests are yearly, and some are daily, weekly or every six months. Tests are repeated after major repairs or upgrades. The licensee appoints a radiation safety officer, and the yearly QC report goes to NRRC within three months.
230 V at 60 Hz, SASO plugs and QA providers
Our list for the maker covers:
- Rating and plug. SFDA bars devices built for a supply other than 230 or 400 V, or for any frequency other than 60 Hz. Plugs must fit the SASO 2203 standard.
- Market labelling. A unit labelled for another country only cannot be imported, so we check that the label suits Saudi Arabia.
- Service partner. Service firms need an SFDA licence and staff trained by the maker, and spare parts and consumables can ship with the unit.
- QA testing. Acceptance and yearly QC must be done by recognised, competent providers, so agree who runs them before it ships.
Each open point goes to the maker in writing before the quote. A unit with the wrong rating or label is a banned import, so we check both before anything else.
FASAH, the 48-hour rule and SFDA release
ZATCA runs customs on its FASAH platform, and the importer files directly or through a customs broker. Clearance steps must be done at least 48 hours before the shipment lands. Since 29 October 2025, sea cargo has required its manifest and declaration data in advance. SFDA must also approve the release before the goods reach the port. Each shipment's file includes:
- An invoice certified by a chamber of commerce in the country of origin
- Bill of lading, sent early for the advance data
- A certificate of origin, where the shipment calls for one
- HS codes matched to each item
- The MDMA, licences and declaration of conformity
MEWA, the agriculture ministry, publishes a quarantine guide that covers licensing of local ISPM 15 marking. Quarantine inspectors at the port decide whether goods enter. We found no published import rule for wood packaging, so we ask makers for heat-treated, stamped crates, and we send the papers early so your broker can file in time.
Ports on two coasts and three airports
- Model, site, licence. Send the model, quantity and site by RFQ form or email, with your SFDA licence number.
- MDMA check. A catalogue quote usually follows within 48 hours. It shows certification, lead time, the port and whether the model holds an MDMA.
- Your approval. Nothing goes to the maker until you approve the quote in writing.
- West or east coast. Sea freight goes into Jeddah Islamic Port on the Red Sea, King Abdulaziz Port in Dammam or King Abdullah Port. Air freight goes into Riyadh, Jeddah or Dammam.
Delivery ends at the port or airport you name, and your broker can file the import declaration in FASAH before the shipment arrives. The last leg is yours. The forwarder confirms the route when you order.
Single units and refurbished units
One ultrasound unit for a clinic in Dammam can be quoted on most catalogue lines. A single X-ray machine is quoted the same way, with the NRRC steps above. For tendered projects, see government tender, and rehab teams can browse Rehabilitation and Mobility Aids. Our refurbished range can serve Saudi Arabia only on SFDA's terms. Used devices may not be imported for sale. Refurbished medical equipment is treated as new, so it needs an MDMA before and after refurbishment, and a label showing the refurbishment date. That holds for refurbished cardiovascular and cardiology equipment too. We quote a refurbished unit only where that second MDMA is in place, and if a site wants a new unit instead, we quote that in the same way.
Disclaimer
Buyers in Saudi Arabia should use this page for general planning only, since it makes no offer to supply and gives no legal, regulatory or customs advice. Quotes rest on what the maker can supply, and an order stands only once both sides sign it off in writing. Devices need an MDMA and a licensed importer, and X-ray units need an NRRC licence and registration. Your representative and broker handle clearance and the regulatory side, as we are not a Saudi importer or representative.
Is the model rated for 60 Hz?
SFDA refuses devices built for a supply other than 230 or 400 V and 60 Hz, or without a SASO 2203 plug. For Saudi Arabia medical imaging equipment, send the model and the site, and we'll quote with the MDMA status, the electrical rating and the route.
Frequently Asked Questions
Yes. Clusters and private groups, as well as government hospitals in the Eastern Province and elsewhere, can email connect@medigear.uk or use the RFQ form on the buyers page, with a model number or specification. Licensed distributors, hospital supply companies and medical suppliers in Riyadh can do the same. No account is needed, and replies come by email.
Yes, for trading in Saudi Arabia: a device must be registered and hold SFDA marketing authorisation, be listed in the national registry, and be valid for up to three years. A manufacturer abroad applies through its authorised representative in the country, who holds an SFDA licence for that manufacturer.
Not for sale. SFDA allows used devices only to be returned after servicing or testing abroad, or for maintenance or refurbishment, and then re-exported. A refurbished device is treated as new, so it needs an MDMA before and another after refurbishment, and its label states the refurbishment date.
SFDA's clearance rules require a purchase invoice authenticated by the chamber of commerce in the country of origin, along with the bill of lading, the customs declaration, the MDMA, the licences, and a declaration of conformity. Originals are kept for five years.
NRRC, digital radiography rooms included. The facility holds a radiation practice licence, applied for on the Amaan platform, and registers each generator after import. Anyone intending to import radiation generators must notify NRRC, and QC tests follow at acceptance and then every year.
Jeddah Islamic Port on the Red Sea, King Abdulaziz Port in Dammam on the Gulf coast, or King Abdullah Port; smaller items can fly into Riyadh, Jeddah, or Dammam. We deliver to the one you nominate, and your broker clears the goods in FASAH.
Yes. For Saudi Arabia diagnostic imaging equipment, such as a scanner, single units are quoted on most catalogue lines, and any manufacturer minimum order is shown in our first reply. The model still needs an MDMA and the licensed importer's SFDA licence, which we confirm before quoting.
It can. Customs steps in FASAH must be completed at least 48 hours before arrival, and sea cargo needs advance data, so the forwarder sends documents early. Lead time also depends on stock and the MDMA, and the quote states the route and timing.