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Storage & Distribution Requirements

Overview​

Entities storing or distributing medical devices in Saudi Arabia must hold a valid Medical Device Establishment License (MDEL) in the appropriate category (importer, distributor, or warehouse operator) and comply with SFDA requirements for storage and distribution operations. These requirements are designed to ensure devices reach end users in the same condition as when they left the manufacturer.

MDEL requirement for storage and distribution​

OperationMDEL category required
Importing devices into KSAImporter MDEL
Wholesale distribution within KSADistributor MDEL
Warehousing / third-party logisticsWarehouse MDEL

All MDEL holders must maintain a QMS certified to ISO 13485 (or SFDA.MD/GSO ISO 13485) that covers their storage and distribution activities.

Storage conditions​

Devices must be stored in conditions appropriate to their specifications:

  • Temperature and humidity — controlled and monitored for devices with environmental sensitivity (biologics, diagnostics, devices with specified storage ranges)
  • Cold chain — refrigerated or frozen storage with continuous temperature monitoring and alarm systems for cold chain products
  • Segregation — separation of different device types, lot numbers, and quarantined items
  • Security — appropriate access control to prevent tampering or theft
  • Pest control — documented pest control programme for warehousing facilities
  • FIFO / FEFO — first-in-first-out or first-expiry-first-out stock rotation to prevent expired devices being distributed

Distribution traceability​

MDEL holders involved in distribution must maintain traceability records sufficient to:

  • Identify all devices received (supplier, lot/batch, quantity, date)
  • Identify all devices dispatched (customer, lot/batch, quantity, date)
  • Support a full FSCA or recall — locating and contacting all customers who received a specific lot within a reasonable timeframe

Traceability records must be retained for a period that allows for post-market surveillance and SFDA audit — typically the device lifetime plus at least two years (verify against current SFDA requirements).

Recall readiness​

Distributors must have a documented recall procedure enabling rapid withdrawal of devices from the distribution chain. This includes:

  • Maintained, current customer contact lists
  • Ability to identify affected lot numbers across all customer accounts
  • Clear escalation process to the manufacturer/AR on receipt of an FSCA notification

Transportation​

Transportation of devices must preserve device integrity:

  • Temperature-controlled transport for cold chain products
  • Adequate packaging to prevent damage in transit
  • Validated shipping containers where required

Handling expired or damaged devices​

  • Expired or damaged devices must be quarantined and clearly identified
  • Devices must not be supplied beyond their expiry date
  • Disposal of devices must comply with applicable environmental and waste management regulations

SFDA inspection of distribution operations​

The SFDA may inspect distributor and warehouse facilities as part of market surveillance. Common areas of inspection focus include:

  • Storage condition records and temperature logs
  • Traceability records and stock control systems
  • CAPA records for any quality issues identified
  • Evidence of recall readiness

Further reading​