Updated 25 October 2026
Who holds medical device registrations in Saudi Arabia
A manufacturer located outside Saudi Arabia appoints an authorized representative to act on its behalf, and the representative needs an SFDA establishment licence. The Index lists 278 SFDA authorized representatives in Saudi Arabia from the SFDA register, last read on 23 October 2026.
Medical device companies in Saudi Arabia: distributors, importers and makers
General information, not legal advice. Local law varies; take local counsel.
Who may hold a registration in Saudi Arabia
A manufacturer located outside Saudi Arabia appoints an authorized representative to act on its behalf, and the representative needs an SFDA establishment licence. SFDA guidance allows the authorized representative to act as the importer or distributor at the same time.
Partial coverage: the Index has read only part of the SFDA establishment register so far (representatives whose names start with A or B), so this list is a minimum.
Sources: SFDA MDS-G3, Guidance for Medical Device Authorized Representatives, SFDA MDS-REQ 9 (2025).
SFDA authorized representatives in Saudi Arabia: top 50
Ranked by SFDA licences. Each name opens its profile with roles, principals and sources.
- 1122 registrationsDistributor
- 285 registrationsDistributor
- 367 registrationsDistributor
- 457 registrationsDistributor
- 555 registrationsDistributor
- 643 registrationsDistributor
- 739 registrationsDistributor
- 836 registrationsDistributor
- 933 registrationsDistributor
- 1025 registrationsDistributor
- 1124 registrationsDistributor
- 1223 registrationsDistributor
- 1321 registrationsDistributor
- 1421 registrationsDistributor
- 1520 registrationsDistributor
- 1619 registrationsDistributor
- 1718 registrationsDistributor
- 1817 registrationsDistributor
- 1916 registrationsDistributor
- 2015 registrationsDistributor
- 2115 registrationsMaker's own entity
- 2214 registrationsDistributor
- 2314 registrationsDistributor
- 2414 registrationsDistributor
- 2514 registrationsDistributor
- 2614 registrationsDistributor
- 2713 registrationsDistributor
- 2813 registrationsDistributor
- 2913 registrationsDistributor
- 3013 registrationsDistributor
- 3112 registrationsDistributor
- 3212 registrationsDistributor
- 3312 registrationsDistributor
- 3412 registrationsDistributor
- 3512 registrationsDistributor
- 3612 registrationsMaker's own entity
- 3711 registrationsDistributor
- 3811 registrationsDistributor
- 3911 registrationsDistributor
- 4011 registrationsDistributor
- 41Attieh Medico Co. Ltd.Jeddah10 registrationsDistributor
- 4210 registrationsDistributor
- 4310 registrationsDistributor
- 4410 registrationsMaker's own entity
- 459 registrationsDistributor
- 469 registrationsMaker's own entity
- 478 registrationsDistributor
- 488 registrationsDistributor
- 498 registrationsDistributor
- 508 registrationsDistributor
Download all 278 company rows as CSV
Company level only: names that are only a person's name are left out.
How many holders also distribute
254 of the 278 holders listed here (91%) are also independent distributors in the Index: companies that supply the market for makers other than themselves, not a manufacturer, a maker's own entity or a regulatory service firm.
The others: 24 makers' own import or sales entities.
Holders that also distribute in Saudi Arabia: top 20
- 1122 registrationsDistributor
- 285 registrationsDistributor
- 367 registrationsDistributor
- 457 registrationsDistributor
- 555 registrationsDistributor
- 643 registrationsDistributor
- 739 registrationsDistributor
- 836 registrationsDistributor
- 933 registrationsDistributor
- 1025 registrationsDistributor
- 1124 registrationsDistributor
- 1223 registrationsDistributor
- 1321 registrationsDistributor
- 1421 registrationsDistributor
- 1520 registrationsDistributor
- 1619 registrationsDistributor
- 1718 registrationsDistributor
- 1817 registrationsDistributor
- 1916 registrationsDistributor
- 2015 registrationsDistributor
See every independent distributor in Saudi Arabia on the country page.
Medical device registration in Saudi Arabia with CE or FDA clearance
With CE marking or FDA clearance: Either one opens a shorter reliance route.
SFDA reliance route uses approvals from recognised authorities (EEA, FDA, Health Canada, TGA, PMDA, MHRA) to shorten MDMA review; an SFDA licensed authorised representative holds it.
Sources: SFDA MDS-G030, regulatory reliance route for MDMA (recognised authorities: EEA, FDA, Health Canada, TGA, PMDA, MHRA). Confidence in this route: high, checked 23 October 2026. Rules change and differ by device class; confirm with the regulator before you plan a launch date.
How to check it yourself in the official register
SFDA licensed establishments list, medical devices. Filter the list by activity to see licensed authorized representatives.
The register is the record that counts. Check the holder named on your own device's registration before you sign, and again before you change distributors.
What changes if you switch holder
The registration sits in the holder's name, not yours. If the holder is also your distributor, changing or adding a distributor means moving the registration or filing a new one, and where a regulator publishes a transfer process, the current holder has to take part.
Independent holders, firms that hold registrations for makers without selling their products, keep your distributors replaceable.
The article Who holds the registration compares holding it yourself, through an independent holder or through your distributor, and lists the clauses to agree before the first order.
Next step
Registration holders in Saudi Arabia: questions
Who can be a registration holder in Saudi Arabia?
A manufacturer located outside Saudi Arabia appoints an authorized representative to act on its behalf, and the representative needs an SFDA establishment licence. SFDA guidance allows the authorized representative to act as the importer or distributor at the same time.
Can a distributor hold my registration in Saudi Arabia?
In the Index, 254 of the 278 SFDA authorized representatives listed for Saudi Arabia are also independent distributors. SFDA guidance allows an authorized representative to act as the importer or distributor at the same time. Whether your distributor should hold it is a separate decision, because the holder controls market access: see Who holds the registration.
Is there a list of SFDA authorized representatives?
Yes. This page lists the top 50 of the 278 SFDA authorized representatives the Index holds for Saudi Arabia, each linked to its profile, and the CSV carries 278 company rows. The official record is the SFDA licensed establishments list, medical devices.
How do I check who holds a device registration in Saudi Arabia?
Use the SFDA licensed establishments list, medical devices. Filter the list by activity to see licensed authorized representatives.
Sources
- Saudi Food and Drug Authority licensed establishments list, medical devices: 278 establishments, last seen 23 October 2026. Public register.
- NUPCO public tender award lists, Saudi Arabia: 18 establishments, last seen 23 October 2026. Public tender records. A procurement signal, not a licence register.
- Company website (the establishment's own public site): 3 establishments, last seen 23 October 2026. Enrichment, not a registry: segments and principals read from the company's own website.
Index build 25 October 2026. Each establishment is counted once per country after resolving names across sources. Company records only, as the registries publish them.
Registry data. Bastion Hale does not vouch for any establishment.