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Medical Device Establishment License (MDEL)

What is an MDEL?​

The Medical Device Establishment License (MDEL) is a licence issued by the SFDA to establishments involved in manufacturing, importing, distributing, warehousing, or acting as an Authorized Representative for medical devices in Saudi Arabia.

No establishment may operate in these roles in Saudi Arabia without a valid MDEL.

Who needs an MDEL?​

EntityMDEL required?
Foreign manufacturer (no Saudi entity)Not directly — but AR must hold MDEL
Manufacturer with Saudi legal entity✅ Yes (manufacturer category)
Authorized Representative (AR)✅ Yes (AR license — annual renewal)
Importer✅ Yes (importer category)
Distributor✅ Yes (distributor/wholesale category)
Warehouse operator✅ Yes (warehouse category)

MDEL categories and validity​

MDEL typeValidity
Manufacturer license5 years
AR license1 year (annual renewal required)
Importer licenseAs stipulated by SFDA
Distributor licenseAs stipulated by SFDA
AR license is annual

The AR license must be renewed annually. The AR must submit a renewal application via GHAD before the license expires. An expired AR license means the AR cannot hold or maintain MDMA certificates — a serious regulatory gap.

Applying for an MDEL​

All MDEL applications are submitted via the GHAD portal:

  1. Register or log into GHAD
  2. Select the appropriate MDEL category
  3. Submit required documentation (company details, QMS certificate, facilities information)
  4. Pay the application fee
  5. SFDA reviews and issues the MDEL

QMS requirement for MDEL holders​

All MDEL holders must implement and maintain a QMS certified to ISO 13485 (or SFDA.MD/GSO ISO 13485). The QMS certificate must be submitted with the MDEL application and kept current.

Storage and distribution requirements​

MDEL holders involved in storage and distribution must comply with SFDA requirements for device storage conditions, temperature controls (where applicable), and distribution records.

Further reading​