Importer and distributor guide

In this guide

References reviewed: October 2026

The short answer: to import or distribute medical devices in the Kingdom, your establishment needs:

• a licence from the Saudi Food and Drug Authority (SFDA) before it starts the activity;
• quality management system evidence under SFDA.MD/GSO ISO 13485:2017, in the form your establishment category sets;
• a valid Marketing Authorization (MA) for every device it circulates;
• written procedures for transport, storage, traceability and reporting, applied in practice.

The official references for this guide are at the end of the page.

Who this guide is for

• Establishments that import medical devices into the Kingdom or distribute them within it.
• Their sales outlets are part of the activity. SFDA defines a sales outlet as a place where medical devices are sold, including shops, showrooms, markets, kiosks and online stores belonging to an import and distribution establishment.
• Retail is not a separate activity among those the licensing requirements license. A sales outlet belongs to an import and distribution establishment, so anyone selling to the public from one will find their requirements here.
• This guide does not cover importers and distributors of optics, who have specific provisions in some clauses.

What SFDA requires of your establishment

SFDA requires the following, grouped by topic:

Licence and legal entity

• A legal entity under the laws of the Kingdom, or being part of one that makes the establishment legally responsible for its activities. Proof is submitted with the licence application.
• An establishment account in SFDA's Ghad e-system, with an establishment number.
• An SFDA licence for the establishment, its branches and its warehouses before any regulated activity, kept valid for as long as it operates.
• Payment of the licence fee per the table of terms and fees. The importer and distributor licence is annual, by establishment category.
• Appointment of a person to deal with SFDA, holding a suitable qualification in a relevant field.
• Branches and sales outlets, online stores included, listed in the main licence, any change updated, and continuous supervision of how the requirements are applied there.
• A warehouse licence, or an SFDA third-party storage licence. A distributor with sales outlets only may use a storage area inside the establishment that suits the quantity it stores.
• An undertaking, submitted with the licence application, to apply the documented transport and storage procedure, and another to apply the documented traceability procedure.
• Notifying SFDA of any change to the information submitted for the licence within 10 days of the change.
• Applying to renew the licence; you may apply up to 60 days before the current licence expires.
• Renewing the warehouse licence or third-party storage licence before it expires.
• Informing SFDA immediately if the establishment can no longer meet the licensing conditions.

Quality management system

• Importers and distributors in categories A and B: a certificate of conformity with quality management system requirements under SFDA.MD/GSO ISO 13485:2017 or equivalent, from a conformity assessment provider accepted by SFDA.
• The certificate issuer is an office inside the Kingdom licensed by SFDA, or an office outside it holding accreditation from the International Accreditation Forum (IAF).
• Importers and distributors in categories C and D: documented evidence of applying the quality management system under the same standard, or an SFDA inspection report. Either one is enough.

The devices you circulate

• No medical device may circulate in the Kingdom until it holds a valid Marketing Authorization from SFDA.
• With every device: a valid Marketing Authorization certificate, the declaration of conformity signed by the manufacturer, the Unique Device Identification (UDI) per the published UDI requirements, the identifying information, and the contact details of the manufacturer and its authorized representative where the manufacturer is outside the Kingdom.
• A high-risk device for use outside healthcare facilities is dispensed only on prescription, and the dispensing records are kept for at least 5 years.
• SFDA approval before publishing any advertising material for a medical device, whether aimed at lay users or healthcare professionals. Importers and distributors apply separately through SFDA's e-services portal, and that approval is valid for one year.
• Importers and distributors do not import or distribute any device subject to a withdrawal or suspension decision, and stop circulating a device when the manufacturer's field safety corrective action letter says so.
• When contracting an external party for servicing: checking that it holds an SFDA medical maintenance services licence. Servicing devices your establishment did not sell needs that licence itself.
• After-sales service: stating the services before the contract or sales invoice; a warranty of at least two years set by the manufacturer, which you pass on to the customer; stating inspection, labour and part prices before the service starts; supplying rare spare parts within 14 days of the request.
• Reselling, lending or donating a used device: it holds a valid Marketing Authorization and has not passed the expected life the manufacturer set; SFDA and the manufacturer or its authorized representative are notified; the procedures and records are documented.

Import and customs release

• Importing for circulation requires a Marketing Authorization for the devices and an importer licence.
• Applying for release through SFDA's clearance services system or the Fasah platform, with the required documents attached.
• Release documents: the purchase invoice certified by the Chamber of Commerce, the bill of lading, the customs declaration, and the consignment's declaration of conformity on the form SFDA sets. SFDA checks the Marketing Authorization, the authorized representative licence and the importer licence itself, without them being attached; they must be valid.
• Where transport or storage needs a set temperature or humidity: an electronic temperature and humidity data logger in every parcel of every consignment, active from shipment, with its serial number on one of the consignment's documents.
• Remaining shelf life at the port of arrival: at least 40% of the shelf life for a product whose shelf life is under one year, and at least 7 months for one whose shelf life is over one year.
• Keeping the originals of the release documents for 5 years from the release date, and submitting them to SFDA on request.

Transport and storage

• The storage area has high-quality electronic temperature and humidity measuring devices: connectable to and readable by electronic systems, fixed at different places and heights per an effective temperature map, and calibrated and monitored on a continuous periodic basis. Sales outlets are exempt from this clause.
• A quarantine place, clearly marked, for devices released without disposal rights, seized by SFDA, returned, recalled, damaged or expired, monitored until they are disposed of.
• Tracking the quantity and expiry date of stored devices through periodic inventory.
• A contingency plan for power cuts, or a backup power generator that starts on its own when the power fails, if you hold devices that need cooling or air conditioning. Either one is enough.
• Notifying SFDA when the design or area of the storage zone changes.
• Means of transport: clean and fit for purpose, never an open vehicle. It protects the devices from the environment and the weather, and carries safety equipment and temperature and humidity measuring devices active from the start of transport until delivery.
• Notifying SFDA when the type or size of the means of transport changes, and referring to the transport requirements in the external carrier's contract.
• Following the manufacturer's instructions for transporting and storing the device, and asking the manufacturer or its authorized representative for any missing information.
• Sterile devices: their packaging is protected from wetting, direct sunlight and dirt. A sterile device whose packaging has lost its integrity is considered non-sterile.
• Transport and storage staff: suitable information, experience and training, suitable clothing and equipment, and the ability to handle items with special conditions.
• A documented procedure for transporting and storing devices per the manufacturer's instructions.

Traceability, reporting and safety

• Providing and applying effective traceability procedures that document the supply, distribution and use of devices.
• Documenting and activating written procedures for raising and following up device reports, and corrective actions on safety alerts, with the National Center for Medical Devices Reporting (NCMDR).
• Complying with the post-market surveillance requirements published on SFDA's website.
• Reporting any device that breaches the law and its regulation, giving SFDA its supply, sale and quantity data and who received it. A handling plan is submitted within 5 days and carried out after SFDA approves it.
• Reporting incidents and complaints related to transport or storage to the NCMDR.
• Informing the NCMDR of delays or unavailability linked to a potentially high risk to the delivery of medical services.
• Destroying expired or damaged devices under a documented procedure with a specialised body, with a destruction record kept for at least 3 years and given to SFDA on request.

The incident-reporting deadlines fall on others: 2 days for a serious public health threat, 10 days for an incident that led or could have led to death or serious injury, and 30 days for other incidents. These fall on manufacturers, authorized representatives and healthcare providers. Importers and distributors carry the traceability system and the reporting procedures above.

Records and inspection

• A database archiving all related data, documents and operations, easy to access and retrieve, for at least 5 years.
• Keeping transport and storage documents for at least 3 years, and storage-condition monitoring records, temperature mapping documents included, for at least one year.
• Giving SFDA documents and information within 10 days of its request, and letting inspectors review and verify documents during visits.
• Answering inspection findings on the form sent with the report, with a corrective action plan, within the period SFDA sets. You have at most three chances to amend the plan, then you carry it out and notify SFDA when it is done.

The documents your establishment needs

You receive your documents as Word files in your establishment's name, and you review and approve them your own way before you submit them — and we guide you step by step to issuing your approved edition.

The importer and distributor package holds 83 files:

• 8 core documents;
• 15 procedures;
• 60 forms and records.

The counts follow the establishment's activity and its answers, and every document code starts with your establishment's code.

Core documents (8)

• Start here: first steps to run the quality system
• Declaration of preparation of the quality management system documents
• Quality manual
• Quality policy and objectives
• Decision appointing the management representative for the quality system
• Organization chart and job descriptions
• Forms and records (a combined booklet for printing)
• Master document list and record retention periods

Procedures (15)

Forms and records (60)

A separate Word file for every form, with a filling guide. Some of the forms that serve SFDA duties directly:

• F-04 Temperature and humidity monitoring record
• F-07 Traceability record: incoming and outgoing
• F-16A Incident report form for the NCMDR
• F-23 Measuring equipment, calibration and verification register
• F-27B Expiry and inventory follow-up record
• F-34 Destruction record
• F-39 Record retention schedule
• F-41 Delay and unavailability register and NCMDR notice
• F-42 Register of high-risk devices dispensed on prescription
• F-45 Undertaking to apply the procedures submitted to SFDA
• F-46 Power-cut contingency plan and its test record

What we add from practice, which is not SFDA text: some of the package is a practical arrangement we suggest; leaving it out is not a breach of a published duty. It includes:

• a periodic traceability drill with a response time your establishment sets;
• a periodic test of the contingency plan or the backup power generator;
• reviewing supplier licences at an interval your establishment sets;
• a log of changes to licence data.

Preparation steps

A suggested order, each step building on the one before:

1. Set up the legal entity and open the Ghad account.
2. Establish your category and your QMS evidence route: a certificate for categories A and B; documented evidence or an inspection report for categories C and D.
3. Decide your storage arrangement: a licensed warehouse, third-party storage, or an area inside the establishment if you have sales outlets only.
4. Equip the storage area and the means of transport: measuring devices and the temperature map, the quarantine place, and a contingency plan where needed.
5. Write and apply the transport and storage procedure and the traceability procedure, then sign the two undertakings.
6. Appoint the person who deals with SFDA, and train the transport and storage staff.
7. Apply for the licence, list your branches and sales outlets, and pay the fee.
8. Before your first shipment: check each item's Marketing Authorization, its authorized representative's licence, its remaining shelf life and the data logger.

9. After licensing:

   • notify SFDA of any change within 10 days;
   • renew before expiry;
   • keep records for their periods.

Questions for your activity

Do I need a warehouse licence if I only have sales outlets?
No. A distributor with sales outlets only may use a storage area inside the establishment that suits the quantity it stores; the other transport and storage requirements still apply.

Is my online store a sales outlet?
Yes. The sales outlet definition includes online stores belonging to an import and distribution establishment, so its details go in your main licence and are updated when they change.

Do I need an ISO 13485 certificate as an importer?
It depends on your category: categories A and B need a certificate of conformity from a provider accepted by SFDA; categories C and D may use documented evidence or an SFDA inspection report.

How long do I keep release documents?
The originals, for 5 years from the release date, given to SFDA on request.

What do I do when an item I hold is recalled or suspended?

• Stop importing and distributing it.
• Carry out what the manufacturer's letter says, including stopping circulation.
• Keep the stock in the quarantine place until it is disposed of.

May I service devices I did not sell?
Only if your establishment holds an SFDA medical maintenance services licence.

Do I report a shortage of an item to the NCMDR?
Yes, when the delay or unavailability is linked to a potentially high risk to the delivery of medical services.

Questions we ask to tailor your documents to your activity

References