Saudi Arabia’s surgical instrument market combines imported brands with a small but policy-backed local manufacturing base. If you are sourcing in the Kingdom, the first useful question is not “who sells scissors and forceps?”. It is “who actually makes them, who imports them, and who holds the regulatory responsibility?”. This guide sorts the Saudi companies listed in the SurgiFacts.com directory into those roles. It summarises the Saudi Food and Drug Authority (SFDA) rules that shape every purchase and sets out what buyers should check before they order.
SurgiFacts.com is an independent directory and does not make or sell instruments. Company facts below were checked on each company’s own website on 30 October 2026.
How the Saudi surgical instrument market is organised
When you look for suppliers in Saudi Arabia, you will meet four kinds of company. They carry different responsibilities, so it helps to keep them apart:
- Saudi-based manufacturers. These companies say they produce medical devices in the Kingdom. Under SFDA rules a local manufacturer needs its own establishment licence and, where production is involved, an industrial licence from the Ministry of Industry and Mineral Resources.
- International manufacturers supplying Saudi Arabia. These makers are based in Germany, Pakistan, South Korea, Turkey and elsewhere. They reach Saudi hospitals through a licensed authorised representative (AR), a legal entity based in the Kingdom, and through local importers.
- Importers and distributors. These are Saudi companies that buy from manufacturers and sell to hospitals, clinics and laboratories. Many also handle installation, training and after-sales service.
- Public-sector buyers. The largest is NUPCO, the national company that runs unified procurement, warehousing and distribution of medicines, medical devices and supplies for public hospitals. NUPCO’s own overview page describes this role.
One company can hold several roles, for example distributor and authorised representative. What matters is which licence covers which activity and product.
SFDA basics: what has to be in place before an instrument is sold
Saudi Arabia regulates medical devices under the Law of Medical Devices (Royal Decree M/54) and its Implementing Regulation, which the SFDA administers. The points that matter most for surgical instrument buyers are these:
- Marketing authorisation (MDMA). Article 10.1 of the Implementing Regulation states that “the manufacturer shall obtain a Marketing Authorization Certificate from the SFDA before circulating any medical device in the Kingdom.”
- Risk classes A to D. Article 21.1 sorts devices into four risk classes: A (low), B (low to medium), C (medium to high) and D (high). The manufacturer classifies each device under the SFDA’s published rules.
- Authorised representative for overseas manufacturers. Representing manufacturers located outside the Kingdom is a licensed activity in its own right. The SFDA’s Requirements for Licensing Medical Device Establishments (MDS-REQ 9, version 2.0, January 2025) require a separate AR licence for each manufacturer represented. The AR must also have a documented agreement with the manufacturer.
- Establishment licences. The same document lists the establishment types that need an SFDA licence, including local manufacturers, authorised representatives, importers and distributors, warehouses and maintenance providers. A manufacturer licence runs for five years. Manufacturers must appoint a full-time technical manager and a full-time quality manager.
- Quality management system. MDS-REQ 9 requires manufacturers, importers and distributors in its establishment categories A and B to hold a certificate of conformity to SFDA.MD/GSO ISO 13485:2017 or an equivalent. Categories C and D must show compliance through evidence or an SFDA inspection. These are categories of establishment, set by an SFDA questionnaire, and are separate from device risk classes.
- Documents that travel with each device. Under Article 10.12, licensed importers and distributors must ensure that each device comes with:
- its marketing authorisation certificate
- a declaration of conformity signed by the manufacturer
- a Unique Device Identification (UDI) with a machine-readable code
- labelling information
- contact details for the manufacturer, and for the AR if the manufacturer is outside the Kingdom
- Export certificates. If you are buying from a Saudi manufacturer for export, Article 12.1 allows the SFDA to issue a Free Sale Certificate. The manufacturer must be licensed in the Kingdom and the device must hold a marketing authorisation.
The SFDA publishes a searchable Licensed Establishments List. You can filter it by licence type, including Local Manufacturer, Authorized Representative and Importer/Distributor. It is the quickest independent way to check what a company tells you about its status.
This is general information, not legal or regulatory advice. Requirements depend on the product, its intended use and its classification, and the SFDA updates its requirement documents regularly. Check the current version on sfda.gov.sa or with a licensed authorised representative before you make commitments. For the certificates themselves, see the SurgiFacts.com guide to medical certifications.
Localisation: why “Saudi-made” matters to buyers
Local production of medical devices is an explicit policy goal. The Health Sector Transformation Program, one of the Vision 2030 realisation programmes, lists “nationalizing the pharmaceutical, medical devices and supplies, and vaccination industries” among its measures in its 2021 delivery plan. The same plan includes “increasing local security stocks of essential medicines, supplies and medical devices.” The programme’s Health Sector Transformation Report 2024 has a dedicated “Localization of Health Industries” section. That section covers medical device and supply factories in the Kingdom and agreements included in the Mandatory List of National Products for the healthcare and pharmaceutical sector.
Government procurement carries this policy into practice. The Local Content and Government Procurement Authority (LCGPA) runs the national products mandatory list and the local content preference mechanisms. NUPCO handles unified procurement for public hospitals. As a result, “Saudi-made” is a claim with commercial weight in public tenders, so verify it rather than assume it. Ask where the instruments are produced and under which SFDA manufacturer licence.
Featured Saudi manufacturer: All Care Surgical
All Care Surgical (Riyadh)
Overview. All Care Surgical describes itself as a manufacturer of “Saudi-Made” surgical instruments. Its website says the brand belongs to Kullu Al-Riayah Industries Group, which it calls “a leading manufacturer of high-quality surgical instruments based in Saudi Arabia.” The site footer describes the range as “Saudi-Made surgical instruments by Kulu Al-Riayah Industries Group, Riyadh”. The company also states “over 100 years of experience.” It does not say whether this refers to the group, its people or a partner, so ask if the history matters to you.
The wider group’s website, allcare.sa, presents All Care Group as investing in Saudi businesses since 2009. The group lists “Surgical & Dental Instruments – manufacturing and supply of high quality surgical and dental instruments” among its Saudi-based joint venture projects with technical partners. The partners are not named, so ask about them during due diligence.
Location. The contact page gives the office address as Al Nemer Center 2, Al Olaya, Riyadh, open Sunday to Friday. The website does not publish a separate factory address.
Categories and specialties. The company states a catalogue of “14,000 Surgical Instruments”. The products page organises them into more than 30 bilingual (Arabic and English) groups, from general scissors, forceps and retractors to specialty sets for neurosurgery, cardiovascular, thoracic, maxillofacial, ENT, gynaecology, urology, plastic and ophthalmic surgery, plus sterilisation products.
Product examples listed on the site:
- Scissors: Metzenbaum, Mayo, Iris and Lister scissors, plus operating, dissecting, suture and bandage scissors.
- Artery forceps: Mosquito, Kelly, Crile, Kocher, Pean, Halsted, Rochester and right-angle patterns.
- Retractors: Langenbeck, Farabeuf, Volkmann, Army-Navy and Senn patterns, plus abdominal and skin retractors.
- Scalpels: scalpel handles and blades, disposable scalpels and handles, and microsurgical scalpels.
- Bone surgery: bone holding forceps, rongeurs, curettes, chisels, gouges, elevators, cutters, saws and osteotomes.
- Sterilisation: containers, instrument trays, baskets, cassettes and drums.
Design and manufacturing information (as stated by the company). The home page describes:
- ergonomic designs
- “precision-machined components”
- corrosion-resistant stainless steel finishes
- optional gold-plated rings “for enhanced grip and longevity”, a feature usually associated with tungsten carbide insert instruments
The company says it is “a Saudi-based manufacturer” that plays “an active role in strengthening local medical device production and reducing dependency on imports”. It also says that “with local production and efficient logistics” it can keep availability consistent. Its About page links this to Vision 2030 and job creation in the Kingdom. It also says it presented its range at WHX Dubai (next edition: WHX Dubai 2027).
What the website does not show. On the date checked, the site did not publish the following:
- a quality management system certificate, such as ISO 13485
- SFDA licence or marketing authorisation numbers
- a factory address
- an OEM or private-label offer
- a list of export markets
That does not mean they do not exist: ask for them, and check the manufacturer licence on the SFDA Licensed Establishments List.
Other Saudi-based manufacturer in the directory
Rameem Medical Company (Jeddah)
Rameem describes itself as “an ambitious manufacturer of orthopaedic implants in Saudi Arabia”. It lists its address in the industrial district of Jeddah. Its product groups include lower-limb plates (for example distal femur and high tibial osteotomy plates), pelvic reconstruction and screws. Its certifications page states:
- ISO certification from SGS, without naming the standard on that page
- that its products “have obtained approval” from the SFDA
Rameem says its work is aligned with Vision 2030. It makes implants, not reusable hand instruments, so it is relevant mainly to orthopaedic buyers, who should ask for the marketing authorisation of each implant system.
Distributors and suppliers in Saudi Arabia
The other Saudi companies in the directory describe themselves as distributors, suppliers or authorised agents. They sell products made by other companies, mostly overseas manufacturers. They are not manufacturers, and the brands they carry are not Saudi-made unless the brand owner says so.
Dome Medical Company (Jeddah)
Dome describes itself as “Saudi-owned” with “35+ years of healthcare heritage – since 1990”. It has three product lines: surgical meshes, surgical instruments and abdominal wall solutions. The company says its instruments are “carefully selected from leading European, American, and Asian manufacturers”. The range covers general surgery, laparoscopy, cardiac and thoracic surgery (including MICS and VATS), neurosurgery and spine, orthopaedics, ENT and plastic surgery, with complete department sets and retractor systems. Named partner brands include DynaMesh (described as German-engineered) and Fasciotens. It states that it is “ISO 13485 certified and SFDA compliant”.
Sadeem Medical (Riyadh)
Sadeem says it was founded in Saudi Arabia in 2008 “by a group of medical experts”. Its product menu lists international brands by category:
- surgical instruments from Surtex, Surgimax and Mayo Med
- sutures from Atramat
- laparoscopy products from Sejong Medical
- orthopaedics from Ortho Select
Sadeem’s own page describes Sejong Medical as a Korean laparoscopic instrument manufacturer established in 1996. Sejong is a South Korean company, not a Saudi one.
Raqwani Medicals (Al-Khobar)
Yahya Ahmed Raqwani Company for Medical Supplies describes itself as “a distributor of Medical Instruments, Surgical Supplies, Sanitary & Hygiene Items, Protective apparels and accessories”. Its surgical supplies range includes percussion hammers, prep shaving kits, ring cutters, sterilisation pouches and surgical gloves. It suits consumables and basic items rather than specialist instrument sets.
Gulf Horizon International Medical (Jeddah)
Gulf Horizon says it supplies, installs and maintains diagnostic, critical care, surgical and laboratory equipment. Its surgical and operating room range covers operating tables, surgical lights, electrosurgical units and anaesthesia units. Its relevance is OR equipment rather than hand instruments. Parts of its website showed placeholder content when checked, so confirm details directly.
SOMATCO (Riyadh)
SOMATCO (Saudi Overseas Marketing & Trading Company) describes itself as a supplier of laboratory equipment, medical supplies and scientific instruments. It says it carries more than 30,000 items from international manufacturers.
Dental specialists: Masar Medical and Kafou Dent (Riyadh)
- Masar Medical describes itself as a dental equipment specialist with “over two decades” of experience and authorised distributor status with its manufacturers. Profile: Masar Medical. Website: masarmedical.net.
- Kafou Dent is listed in the directory as a Kafou Group company and exclusive agent for dental brands. Much of its website was template content when checked, so confirm its brand portfolio directly. Profile: Kafou Dent. Website: kafoudent.com.
At a glance: Saudi companies in the directory
| Company | City | Role (as stated by the company) | Relevant range |
|---|---|---|---|
| All Care Surgical | Riyadh | Saudi-based manufacturer | Reusable surgical hand instruments, scalpels, sterilisation containers |
| Rameem Medical Company | Jeddah | Saudi-based manufacturer | Orthopaedic trauma implants |
| Dome Medical Company | Jeddah | Distributor (international manufacturers) | Surgical instruments and sets, meshes, abdominal wall systems |
| Sadeem Medical | Riyadh | Distributor of international brands | Instruments, sutures, laparoscopy, orthopaedics |
| Raqwani Medicals | Al-Khobar | Distributor | Surgical supplies, consumables, emergency equipment |
| Gulf Horizon International Medical | Jeddah | Equipment supplier | OR, diagnostic, ICU and laboratory equipment |
| SOMATCO | Riyadh | Supplier and distributor | Laboratory and medical equipment |
| Masar Medical | Riyadh | Authorised dental distributor | Dental equipment and consumables |
| Kafou Dent | Riyadh | Dental agent and supplier | Dental materials |
International manufacturers supplying Saudi Arabia
Most of the instrument ranges carried by the Saudi distributors in this guide are made overseas. Those makers are not Saudi companies, even when a Saudi distributor sells them under an exclusive agreement. The examples in this guide are Sejong Medical (South Korea), sold through Sadeem, and the European, American and Asian manufacturers whose instruments Dome distributes.
If you are a hospital or distributor looking to bring in a new range, the best-known instrument manufacturing clusters are Sialkot in Pakistan and Tuttlingen in Germany. The SurgiFacts.com Top 5 Pakistani manufacturers and the German manufacturers guide are good starting points. Remember the SFDA sequence: the overseas manufacturer needs a licensed authorised representative in the Kingdom and a marketing authorisation for the device before a Saudi importer can circulate it. Agree early who will hold and pay for the marketing authorisation, because it decides who controls the product’s registration in the market.
How this list was put together
This article covers the Saudi Arabia listings in the SurgiFacts.com directory. We included every company listed under Saudi Arabia that met all of these criteria:
- It has a working official website.
- Its products are relevant to surgery, surgical supplies, OR equipment or dentistry.
- Its business role (manufacturer, distributor or supplier) could be confirmed from its own pages.
All Care Surgical appears first because it holds the SurgiFacts.com featured placement for this article. The order reflects that placement and the split between manufacturers and distributors. It is not an objective market ranking and says nothing about size, quality or market share.
Facts are attributed to each company’s website as checked on 30 October 2026. We did not inspect any facility or verify any certificate. Before you buy, do your own due diligence, including a check on the SFDA Licensed Establishments List. Our article on how to check a medical instrument supplier sets out a general checklist.
Questions to ask before you buy
- Which SFDA licence do you hold, and for which activity? Ask for the licence type (local manufacturer, authorised representative or importer/distributor) and the number, then check it on the SFDA list.
- Does this exact product have a marketing authorisation? A category on a website is not an authorisation. Ask for the MDMA certificate that covers the specific catalogue numbers you are buying.
- Where is it made? For a “Saudi-made” claim, ask for the production address and which steps happen in the Kingdom (forging, machining, heat treatment, finishing, passivation, packaging).
- Who is the legal manufacturer on the label? For imported brands, ask for the manufacturer’s name and country, the authorised representative’s details and the signed declaration of conformity.
- Which quality system certificate applies? Ask for the ISO 13485 certificate, its issuing body and its scope, and confirm that the scope covers the products you are buying.
- What comes with each delivery? Check for UDI labelling, instructions for use, reprocessing guidance and warranty or repair terms.
Frequently asked questions
Are there surgical instrument manufacturers in Saudi Arabia?
Yes, though there are few of them compared with the import market. In the SurgiFacts.com directory, All Care Surgical in Riyadh describes itself as a manufacturer of Saudi-made reusable surgical instruments. Rameem Medical Company in Jeddah manufactures orthopaedic implants. The SFDA Licensed Establishments List can be filtered by the “Local Manufacturer” licence type if you want to check a company’s status independently.
Is All Care Surgical a Saudi or a Pakistani company?
Saudi. All Care Surgical describes its instruments as Saudi-made, names Kullu Al-Riayah Industries Group in Riyadh as the brand owner, and gives its office in Al Olaya, Riyadh. It should not be confused with Sialkot exporters that sell similar patterns. Its website does not publish a factory address, so ask where production takes place.
Can a foreign manufacturer sell instruments directly to Saudi hospitals?
Not without local regulatory cover. Under the SFDA framework, a manufacturer outside the Kingdom needs a licensed authorised representative based in Saudi Arabia. Each device needs a marketing authorisation before it can be circulated, and importers and distributors need their own SFDA establishment licences.
What is the SFDA MDMA?
MDMA stands for Medical Device Marketing Authorization. It is the certificate the SFDA issues before a medical device can be circulated in the Kingdom. The manufacturer, or its authorised representative, applies with a technical file whose depth depends on the device’s risk class (A to D).
How long is an SFDA marketing authorisation valid?
Article 10.5 of the Implementing Regulation says the certificate is valid for up to three years from its date of issue, and Article 10.7 requires the manufacturer or authorised representative to renew it before it expires. When you buy, check the expiry date on the certificate that covers your catalogue numbers, especially for tenders that run for several years.
Can one MDMA application cover a whole instrument range?
Article 10.4 allows different medical devices to be bundled into a single marketing authorisation application, as set out in the SFDA’s MDMA requirements. How far a range of scissors, forceps and retractors can be grouped depends on those requirements, so ask the authorised representative how your catalogue will be split.
Do instrument labels have to be in Arabic?
Not always. Article 10.18 says English labelling is accepted if the device user is professionally qualified, and that labels must be in both Arabic and English when the device is intended for a lay person. Surgical instruments for hospital staff usually fall into the first group, but check the requirement for each product.
Which risk class are reusable surgical instruments in?
The SFDA uses four classes, A (low) to D (high), and the manufacturer classifies each device under the SFDA’s published rules. The class depends on the device and its intended use, and it decides how much technical documentation the marketing authorisation needs. Ask your supplier which class it has assigned to each instrument family and why.
What does SFDA.MD/GSO ISO 13485:2017 mean on a requirement?
It is the version of ISO 13485 cited in the SFDA’s establishment licensing requirements (MDS-REQ 9), which ask certain manufacturers, importers and distributors for a certificate of conformity to it “or an equivalent”. Most overseas makers hold ISO 13485:2016 certificates. Ask your authorised representative to confirm that the certificate you hold is accepted.
Does a CE mark or FDA clearance replace SFDA authorisation?
No. Article 10.1 requires the manufacturer to obtain an SFDA marketing authorisation before any device is circulated in the Kingdom. Evidence from other markets can support the technical file, but check the current MDMA requirements on the SFDA website for what is accepted.
Can I bring instrument samples to a Saudi exhibition without an MDMA?
Article 8.3 lets the SFDA exclude certain devices from marketing authorisation, including samples used in exhibitions, festivals or workshops. An SFDA import permit is still required for them under the agency’s import and clearance requirements. Apply for it well before the event.
What is the SFDA National Registry?
Under Article 8.2, once a device has its marketing authorisation it is listed in the National Registry, and that listing counts as its registration. When a supplier says a product is “registered with the SFDA”, ask for the marketing authorisation certificate that sits behind the listing.
Does UDI apply to instruments sold in Saudi Arabia?
Article 10.17 requires manufacturers to comply with the SFDA’s Unique Device Identification requirements, with exclusions set by the SFDA, and Article 10.12 expects a UDI with a machine-readable code to travel with each device. Ask your supplier how it applies UDI to reusable instruments and their packaging.
What happens when the manufacturer’s details change?
Article 10.8 says the information submitted through the SFDA’s electronic system must be updated within 10 days of a material change, or 30 days for a non-material one. A change of factory address, legal manufacturer or authorised representative should therefore be raised with the AR straight away.
Can my Saudi distributor also act as authorised representative?
Yes, a company can hold both roles if it has the right licences. Under MDS-REQ 9, the authorised representative needs a separate AR licence for each manufacturer it represents and a documented agreement with that manufacturer. Check both licences on the SFDA Licensed Establishments List.
What if I want to change distributor later?
Plan for it in the first contract. The marketing authorisation is in the manufacturer’s name but is filed through the authorised representative, so agree in writing how the AR role, the files and the account access will be handed over if the relationship ends. The Implementing Regulation provides for licences to be transferred; check the SFDA’s current procedure.
Does “Saudi-made” help in public tenders?
It can. The Local Content and Government Procurement Authority runs the national products mandatory list and local content preference mechanisms, and NUPCO handles unified procurement for public hospitals. Whether a preference applies depends on the tender, so read the tender documents and ask the supplier for proof of where the instruments are made.
How do public hospitals in Saudi Arabia buy instruments?
Much public-sector demand goes through NUPCO, which describes itself as running unified procurement, warehousing and distribution of medicines, devices and supplies for public hospitals. Private hospitals and clinics usually buy through licensed distributors. Either way, the product needs its SFDA authorisation first.
Can I export instruments from a Saudi manufacturer to other Gulf countries?
Yes, but each country has its own regulator and registration. Article 12.1 allows the SFDA to issue a Free Sale Certificate for licensed local manufacturers whose devices hold a marketing authorisation, and many importing authorities ask for that kind of document. Compare Saudi options with others on the Saudi Arabia country page before you decide.
Where can I meet Saudi suppliers in person?
The Global Health Exhibition is a large healthcare event held in Riyadh. Its organiser announced that the next in-person edition will be held from 25 to 28 October 2027 at the Riyadh Exhibition and Convention Center. In 2026 a digital forum runs in its place. See the directory entry for Global Health Exhibition 2027. All Care Surgical says it has presented its range at WHX Dubai, which many Gulf suppliers attend. Our November 2026 exhibitions calendar covers events earlier in the season.
Find Saudi suppliers in the directory
To compare every Saudi listing, start with the Saudi Arabia country page or the medical instrument suppliers and distributors in Saudi Arabia page. If you have a specific requirement, such as a Saudi-made instrument range, an authorised representative for your brand or a distributor for a tender, describe it in the free request form. SurgiFacts.com will point you to companies that may fit. Saudi companies not yet listed can apply to be added to the directory, and distributors looking for new instrument lines can register as a distributor.