Warehouse guide

In this guide

References reviewed: October 2026

The short answer: a warehouse that stores medical devices needs:

• a warehouse licence from the Saudi Food and Drug Authority (SFDA) before it starts the activity;
• a full-time qualified technical manager;
• proof that it meets the transport and storage requirements: an equipped storage area monitored against a temperature map, with calibrated temperature and humidity instruments, a quarantine place, traceability by lot or serial number, periodic inventory, and written procedures.

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

Who this guide is for

• Establishments licensed, or applying to be licensed, as a medical device warehouse.
• Warehouses that rent space inside them to other establishments (third-party storage) carry extra duties, in the last table.
• Importers or distributors that store at a licensed warehouse will find their duties in the importer and distributor guide.

What SFDA requires of your warehouse

SFDA requires the following, grouped by topic:

Licence

• No regulated activity before licensing. An establishment that stores devices holds a warehouse licence or a third-party storage licence, and renews it before it expires.
• Proof of the establishment's legal entity per general clause (2).
• A full-time technical manager for the warehouse: a medical device engineer or technician, or qualified in a relevant field.
• Proof of applying the transport and storage requirements.
• An undertaking not to store any medical device that breaches SFDA's requirements.
• Warehouse licence application documents in the licensing procedures guide: updating the commercial account to add the warehouse activity, the municipality licence or a MODON or economic-city contract by location, the area set aside for storage, the technical manager's qualification, and the title deed or lease.
• The warehouse licence costs 800 SAR per year; a third-party storage licence is also 800 SAR per year.
• Applying to renew the licence; you may apply up to 60 days before the current licence expires.
• Notifying SFDA of any change to the information submitted for the licence within 10 days of the change.
• Complying with any circular, condition or requirement on transport or storage that SFDA or the competent authorities issue.

The items you store

• Devices to be stored or transported hold a valid Marketing Authorization or import permit.
• Following the manufacturer's labelling instructions on temperature, humidity, wetting, light, vibration, package orientation and stacking limit, and asking the manufacturer or its authorized representative for anything missing.
• Where the labelling says Room Temperature and the manufacturer does not define it, SFDA's definition is 15–30 °C.
• 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.

The storage area

• An area designed or prepared for storing medical devices: clean, with enough space for cleaning and inspection, enough light to read device data and signs, and enough ventilation with filters against dust and contaminants. It is equipped with personal protective equipment, handling and moving equipment, and safety equipment such as fire extinguishers and hoses.
• Surfaces and shelves raised above the floor and below the ceiling, made of or covered with a non-porous material that can be cleaned safely; pallets may be used.
• 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.
• Temperature mapping is a study of how temperature probes are distributed over a set period and space in three dimensions, to monitor and record temperature and find the warmest and coldest points.
• 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.
• Security measures that prevent unauthorised access to the warehouse.
• A contingency plan for power cuts, or a backup power generator that starts on its own when the power fails, if you hold items that need cooling or air conditioning under the manufacturer's instructions. Either one is enough.
• Notifying SFDA when the design or area of the storage zone changes.

Traceability and inventory

• Being able to trace devices released without disposal rights, seized, stored, issued, returned, recalled, expired and damaged, by batch or lot number or by serial number.
• Knowing the remaining quantity and storage location of every stored item.
• Tracking the quantity and expiry date of stored items through periodic inventory.
• The transport and storage requirements give an example traceability record with its columns: device, manufacturer, lot or serial number, customer, expiry date, quantity, and remaining quantity with its count and location.

Transport

• 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.
• Electronic temperature and humidity measuring devices in the vehicle to the same specification, active from the start of transport until the consignments are delivered.
• Notifying SFDA when the type or size of the means of transport changes.
• When contracting an external carrier: referring in the contract to the transport requirements and to the manufacturer's instructions for transporting the device.

Staff, procedures and reporting

• Transport and storage staff have suitable information, experience and training, suitable clothing and equipment, and the ability to handle items with special conditions.
• Documented procedures for transporting and storing devices per the manufacturer's instructions. The requirements recommend eleven items for the procedure, among them quarantine, inventory, and what to do when conditions depart from what is required.
• Reporting to the National Center for Medical Devices Reporting (NCMDR) incidents and complaints about devices being transported or stored, and any devices that breach the post-market surveillance requirements.
• 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.

Records

• Keeping the transport and storage documents SFDA lists for at least 3 years. They include licences, Marketing Authorizations, release decisions, instructions for use, written procedures, traceability records, staff qualifications and purchase invoices.
• Keeping storage-condition monitoring records, temperature mapping documents included, for at least one year.
• A database archiving all related data, documents and operations, easy to access and retrieve, for at least 5 years.
• Giving SFDA documents and information within 10 days of its request, and letting inspectors review documents during visits.

If you rent space to other establishments

• A valid warehouse licence held by the renting warehouse.
• A separate third-party storage licence for each rented space, not used for or moved to another warehouse.
• An attested contract with each tenant naming both parties and their duties, the zones and spaces, and who is responsible for unloading, stacking, loading, transport and delivery.
• Documenting and keeping records of all procedures and transactions related to tenants.
• Not cancelling the warehouse licence while any tenant still holds a valid third-party storage licence.

The documents your warehouse 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 warehouse package holds 113 files:

• 10 core documents;
• 28 procedures;
• 75 forms and records.

The counts follow the establishment's activity and its answers, such as cold chain, renting to others, and destruction.

Core documents (10)

The eight shared documents (start here, the declaration, the quality manual, the quality policy and objectives, the management representative decision, the organization chart and job descriptions, the forms booklet, and the document list with retention periods), plus two warehouse documents: its activity requirements and their records.

Procedures (28)

The fifteen shared quality system procedures (from document control P-01 to customer order review P-15), plus 13 warehouse procedures:

Forms and records (75)

The shared quality system forms, plus 17 warehouse forms:

• F-83 Register of storage zones, their conditions and sources
• F-84 Temperature mapping report for the zone and the means of transport
• F-85 Sensor and calibration register
• F-86 Temperature and humidity readings for each zone
• F-87 Receipt record and release or rejection decision
• F-88 Traceability, balance, locations and parties record
• F-89 Periodic inventory report and balance differences
• F-90 Quarantine register, status cards and nonconformity entries
• F-91 Disposition decision for quarantined items and destruction record
• F-92 Shipping record and trip readings
• F-93 Third-party storage contracts and licences register
• F-94 Tenant balance statement and notices
• F-95 Staff files, qualifications and equipment
• F-96 File proving compliance with the transport and storage requirements
• F-97 Power outage and backup power generator test record
• F-98 SFDA circulars register and their effect
• F-99 Third-party storage site visit and review of its readings

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, and your establishment sets its intervals in its procedure. It includes:

• a daily reading of each zone;
• a monthly reconciliation of book against physical stock;
• yearly sensor calibration with an interim check;
• repeating the temperature map periodically and after every change;
• periodic tests of the backup power generator or the contingency plan;
• checking SFDA circulars every three months;
• giving release and quarantine decisions to the technical manager.

Does a warehouse need ISO 13485?

General clauses 6 and 7 of the licensing requirements name the local manufacturer, the authorized representative, and the importer and distributor for QMS evidence; they do not name warehouses. What the warehouse requirements ask for is proof of meeting the transport and storage requirements.

The transport and storage requirements recommend that the procedure be part of a quality management system under SFDA.MD/GSO ISO 13485:2017 or equivalent. Your package includes the shared quality system documents.

Preparation steps

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

1. Update the commercial account to add the warehouse activity, and prepare the municipality licence or site contract and the title deed or lease.
2. Appoint the full-time qualified technical manager.

3. Equip the storage area:

   • shelving, ventilation, lighting and safety equipment;
   • the quarantine place;
   • security measures;
   • a contingency plan or backup power generator if you hold cooled items.

4. Carry out the temperature mapping, fix the measuring devices per the map, and calibrate them.
5. Equip the means of transport, or set up the carrier contract.
6. Write and apply the transport and storage procedures, and set up the traceability and inventory records.
7. Train and equip the staff, and keep their qualifications.
8. Apply with proof of meeting the transport and storage requirements and the undertaking not to store non-compliant devices, and pay the fee.

9. After licensing:

   • notify SFDA of any change to the design or area, or to the means of transport;
   • report changes to licence data within 10 days;
   • renew before expiry.

Questions for your activity

Do I need a backup power generator?
Only if you hold items that need cooling or air conditioning under the manufacturer's instructions. A contingency plan for power cuts, or a generator that starts on its own, is then enough.

How long do I keep temperature mapping documents and temperature readings?
At least one year. The other transport and storage documents are kept for at least three years.

Can I rent space in my warehouse to other establishments?
Yes, on these conditions:

• a valid warehouse licence;
• a separate third-party storage licence for each rented space;
• an attested contract with each tenant;
• records of each tenant's transactions.

What do I do with expired, damaged or recalled items?
Keep them in the marked quarantine place and monitor it until they are disposed of. For destruction, follow a documented procedure with a specialised body and write a record you keep for 3 years.

Do I put the transport requirements in the carrier's contract?
Yes. When contracting an external carrier, the contract refers to the transport requirements and to the manufacturer's instructions.

May I store an item that has no Marketing Authorization?
No. Items stored or transported hold a valid Marketing Authorization or import permit, and your licence application includes an undertaking not to store a non-compliant device.

Questions we ask to tailor your documents to your warehouse

References