Importing Medical Disposables into Saudi Arabia: SFDA MDMA Basics for Distributors

Short answer: in Saudi Arabia every medical disposable needs an SFDA Medical Devices Marketing Authorization (MDMA) before it can be supplied, paid or free. The application is made on SFDA’s GHAD system by the manufacturer or its Saudi authorised representative, and every Saudi company in the chain (authorised representative, importer, distributor, warehouse) needs its own SFDA establishment licence. Selling to government hospitals then means NUPCO registration or Etimad tenders, both of which require a Saudi-registered company.

This guide sets out each step with the SFDA documents behind it, for distributors adding masks, gloves, gowns, caps, shoe covers or bed sheets to their range.

Who needs what

Party	What SFDA requires	Source
Overseas manufacturer	ISO 13485 quality management system; MDMA for each device or device group, filed directly or through its authorised representative	MDS-REQ 1
Authorised representative (in KSA)	SFDA establishment licence for each manufacturer represented; only one representative per class or general group of devices	MDS-REQ 9
Importer	SFDA establishment licence; manufacturer and representative details plus a manufacturer-signed declaration of conformity	MDS-REQ 9
Distributor and warehouse	SFDA establishment licence	MDS-REQ 9
All Saudi establishments	Legal entity under Saudi law; GHAD account; quality management evidence according to the establishment category	MDS-REQ 9

Step 1: Decide whether the product is a medical device

SFDA has issued product guidance for the two highest-volume disposables:

• Masks. MDS-G46 requires an MDMA for medical and surgical masks, submitted electronically through GHAD, and lists recognised standards including EN 14683 and ASTM F2100. Masks for ordinary use must be labelled as non-medical.
• Gloves. MDS-G004 treats surgical and medical examination gloves as medical devices that cannot be circulated without SFDA evaluation under MDS-REQ 1. Recognised standards include SFDA.MD/ISO 11193-1:2022, SFDA.MD/ISO 11193-2:2022 (the part for poly(vinyl chloride) examination gloves) and the EN 455 series.

For other disposables (gowns, caps, shoe covers, bed sheets, couch rolls) the deciding factor is the intended purpose stated by the manufacturer. If the product is marketed for medical use it is a medical device. SFDA’s classification rules start from the principle that all non-invasive devices are Class A unless another rule applies, but the manufacturer must classify each device against the rules in Annex 5 of MDS-REQ 1.

Products sold only as non-medical PPE, for example to food processors, fall outside SFDA’s device route. SASO’s technical regulation for personal protective equipment covers non-medical PPE and explicitly excludes PPE intended for medical or military use. Whether a specific food-industry item falls within the scope of that regulation is a question for your importer and SASO.

Step 2: Appoint the authorised representative and license your company

SFDA’s licensing requirements, MDS-REQ 9 (version 2.0, January 2025), apply to every establishment that handles medical devices. The general requirements include:

• the establishment is a legal entity under Saudi law, or part of one;
• it opens an account on SFDA’s GHAD system and obtains an establishment number;
• it applies through GHAD or the Saudi Business Center;
• depending on the establishment category, importers and distributors either hold an ISO 13485 certificate (SFDA.MD/GSO ISO 13485:2017) from an accredited conformity assessment body or provide documented evidence of compliance, or pass an SFDA inspection;
• it keeps records for at least five years and supplies documents to SFDA within ten days of a request.

Licences are issued for one year or similar renewable periods. The authorised representative must hold a separate licence for each manufacturer it represents, must have a documented agreement with the manufacturer, and SFDA will not license a second representative for the same class or general group of devices. If you plan to import several product lines from one supplier, agree early who holds the representation for each group.

An importer must give SFDA the manufacturer’s information and, for an overseas manufacturer, the authorised representative’s information, together with a declaration of conformity signed by the manufacturer.

Step 3: File the MDMA on GHAD

Under MDS-REQ 1 (version 6.0), the MDMA application is submitted electronically through GHAD’s marketing-authorisation service by a local manufacturer, an overseas manufacturer, or the overseas manufacturer’s authorised representative. The manufacturer must maintain a quality management system to ISO 13485:2016.

For low-risk devices, meaning devices that are not IVDs, not sterile, have no measuring function, are not reusable surgical instruments and are not novel, the technical file is reduced to six items:

1. Device description and specification
2. Information supplied by the manufacturer (labelling)
3. Essential Principles checklist
4. Evidence of compliance with the applicable Essential Principles
5. Risk management file
6. Post-market surveillance plan and report

SFDA can still ask for the full technical documentation at any time, including after the MDMA is issued, and it must be provided within ten days. Sterile items, such as an EO-sterilised surgical gown, need the fuller file. Devices can be grouped in one application where they meet the bundling criteria in Annex 15.

Once approved, the MDMA certificate lists the Medical Device National Listing Numbers, and the declaration of conformity carries the establishment’s Medical Device National Registry (MDNR) number. Significant changes must be notified within ten days. The MDMA must be renewed before expiry, and renewal can be requested 90 days before the expiry date.

Labelling follows the Essential Principles in MDS-REQ 1. The label must show the device name, the manufacturer’s name and registered address, and the details needed to identify the device and its intended purpose. It must not carry the SFDA logo, though it may show the National Listing Number. Devices containing carcinogenic, mutagenic, reprotoxic or endocrine-disrupting substances above 0.1% w/w must say so on the label, which is worth checking for plasticised products such as vinyl gloves. If you private-label, the legal manufacturer still has to be identified.

Step 4: Selling to the government health sector

NUPCO is the centralised procurement company for government healthcare. Supplier registration on its iNupco platform requires Saudi documents: Commercial Registration, GOSI, Saudization, Chamber of Commerce and Zakat and tax certificates. Tender documents are bought and offers submitted through its SRM system, and iNupco is used after award for purchase orders, deliveries and claims.

Other government tenders must be published on the electronic portal supervised by the Ministry of Finance under the Government Tenders and Procurement Law. That portal is Etimad, launched in 2018.

On the provider side, Health Holding lists 20 regional health clusters. Our pages for Riyadh, Jeddah, Dammam, Makkah and Madinah give each cluster’s hospitals, primary care centres and beds.

Step 5: Ports, routes and duty

The Red Sea entry is Jeddah Islamic Port, where DP World’s Jeddah South Container Terminal handled more than 1.3 million TEU in 2025. On the Gulf, King Abdulaziz Port in Dammam connects by a 566 km Saudi Arabia Railways container line to Riyadh Dry Port. Goods held in the UAE can enter overland.

Under the GCC Customs Union, a 5% common external tariff applies to goods from outside the union and is collected at the first point of entry. That does not carry over to registration: goods cleared in another GCC state still need an SFDA MDMA to be sold in Saudi Arabia.

What to ask your overseas supplier for

Before you commit to a disposables line, ask the supplier for:

1. The legal manufacturer’s name and address, and its ISO 13485 certificate.
2. The intended purpose and SFDA risk class the manufacturer assigns to each item.
3. The test reports behind each performance claim (EN 14683 or ASTM F2100 for masks, EN 455 or ISO 11193 for gloves, barrier testing for gowns).
4. A signed declaration of conformity, or confirmation of who will sign it.
5. Labels and instructions that meet MDS-REQ 1, including any substance declarations.
6. Certificates of analysis for the lot.

About WinHyCare: we are a supplier and exporter, not the legal manufacturer, and we hold no SFDA authorisations, licences or NUPCO registration. We ship from India and our Dubai warehouse to Saudi importers and provide spec sheets, certificates of analysis and declarations of the ISO 9001 / ISO 13485 quality standards our goods are supplied to. Documents that must come from the legal manufacturer are confirmed item by item before you order. See how we supply Saudi Arabia.