Medical Disposables Supplier in Saudi Arabia

Saudi Arabia at a glance

Medical device regulator

Saudi Food and Drug Authority (SFDA): Medical Devices Marketing Authorization (MDMA) under the Medical Devices Law (Royal Decree M/54)

Who files the MDMA

A local manufacturer, the overseas manufacturer, or the overseas manufacturer's licensed Saudi authorised representative, via SFDA's GHAD system

Establishment licence

Authorised representatives, importers, distributors and warehouses each need an SFDA licence (MDS-REQ 9), valid one year and renewable

Public-sector buying

NUPCO (centralised procurement for government health); other government tenders on the Etimad portal

Main sea entry

Jeddah Islamic Port (Red Sea) and King Abdulaziz Port, Dammam (Gulf), with rail from Dammam to Riyadh Dry Port

Non-medical PPE

SASO's PPE technical regulation covers non-medical PPE and excludes PPE intended for medical use

Ships from

India, or our warehouse in Ras Al Khor, Dubai; no office or stock in Saudi Arabia

SFDA marketing authorisation: what applies to disposables

SFDA's requirements document MDS-REQ 1 is direct: a medical device may be made available in the Kingdom, paid or free, only if it is registered with SFDA and has a Medical Devices Marketing Authorization (MDMA). The legal basis is the Medical Devices Law issued by Royal Decree M/54 and its Implementing Regulation. Applications go through SFDA's GHAD system and are submitted by a local manufacturer, an overseas manufacturer, or the overseas manufacturer's authorised representative, which must itself be licensed by SFDA.

SFDA has issued product guidance for two of the biggest disposable lines. Its guidance on medical masks (MDS-G46) requires an MDMA for medical and surgical masks and lists recognised standards including EN 14683 and ASTM F2100; masks for ordinary use must be labelled as non-medical. Its guidance on surgical and medical examination gloves (MDS-G004) treats them as medical devices and recognises standards including ISO 11193-2 for vinyl examination gloves and the EN 455 series.

For gowns, caps, shoe covers and bed sheets, classification follows SFDA's rules, under which non-invasive devices default to Class A. Low-risk devices (not sterile, not measuring, not reusable surgical instruments and not novel) still need an MDMA, but with a reduced file: device description, labelling, an Essential Principles checklist, evidence of conformity, a risk-management file and a post-market surveillance plan. Sterile items, such as an EO-sterilised surgical gown, need the fuller file.

Licences for the importer and authorised representative

SFDA's licensing requirements (MDS-REQ 9, version 2.0, January 2025) apply to every establishment that handles devices. Each must be a legal entity under Saudi law, open a GHAD account and apply through GHAD or the Saudi Business Center. An importer must give SFDA the manufacturer's details and, for an overseas manufacturer, the authorised representative's details, together with a declaration of conformity signed by the manufacturer. Depending on the establishment category SFDA assigns, importers and distributors either need an ISO 13485 (SFDA.MD/GSO ISO 13485:2017) certificate from an accredited body or must show documented compliance with that standard. Licences are issued for one year and are renewable.

The authorised representative needs a separate licence for each manufacturer it represents, and only one authorised representative can be appointed for the same class or general group of devices. In practice an overseas manufacturer therefore works through one Saudi representative per device group, so the choice of partner should be made before the first order.

How the government health sector buys

NUPCO is the centralised procurement company for Saudi Arabia's government health sector. Supplier registration on its iNupco platform asks for Saudi documents (Commercial Registration, GOSI, Saudization, Chamber of Commerce and Zakat and tax certificates), and tenders are bought and answered through its SRM system, so an overseas supplier takes part through a Saudi-registered company. Other government tenders must be published on the Etimad portal under the Government Tenders and Procurement Law.

The provider side is being reorganised. Health Holding lists 20 regional health clusters, and by mid-2026 more than 130,000 Ministry of Health staff had been transferred into ten of them. Each cluster serves a defined region through its hospitals and primary care centres, which is why our city pages for Riyadh, Jeddah, Dammam, Makkah and Madinah quote cluster-level figures.

Ports and inland routes

Ports operated under the Saudi Ports Authority (Mawani) handled 8,317,235 TEU in 2025, up 10.58% on 2024. On the Red Sea, DP World's Jeddah South Container Terminal at Jeddah Islamic Port handled more than 1.3 million TEU in 2025 after a modernisation that lifted its capacity from 1.8 million to 4 million TEU. On the Gulf coast, King Abdulaziz Port in Dammam is linked to Riyadh Dry Port by a 566 km Saudi Arabia Railways container line, and Jubail Commercial Port is being expanded to 2.4 million TEU under a concession awarded in June 2026.

Overland, the King Fahd Causeway (25 km, opened 1986) connects the Eastern Province with Bahrain, and the UAE's Al Ghuwaifat crossing connects to the Kingdom from Abu Dhabi, which is the route for goods held at our Dubai warehouse. Under the GCC Customs Union, duty is collected once at the first point of entry, but SFDA authorisation is still required for goods sold in Saudi Arabia.