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?
| Entity | MDEL 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 type | Validity |
|---|---|
| Manufacturer license | 5 years |
| AR license | 1 year (annual renewal required) |
| Importer license | As stipulated by SFDA |
| Distributor license | As stipulated by SFDA |
AR License Renewal
The AR license must be renewed annually. The AR must submit a renewal application via GHAD at least 30 days before the current license expires. An expired AR license means the AR cannot legally hold or maintain MDMA certificates — devices marketed under an expired AR license lose regulatory authorization and the company faces enforcement action by the SFDA.
Applying for an MDEL
All MDEL applications are submitted via the GHAD portal:
- Register or log into GHAD
- Select the appropriate MDEL category
- Submit required documentation (company details, QMS certificate, facilities information)
- Pay the application fee
- 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
- MDS-REQ 6 — MDEL requirements
- AR Overview
- MDIL — Medical Device Importing License
- GHAD Portal
AR License Renewal Process: The AR must submit a renewal application via GHAD at least 30 days before the current license expires. Required documentation typically includes updated company information, current ISO 13485 QMS certificate, and evidence of ongoing regulatory compliance. An AR whose license lapses cannot legally hold or maintain MDMA certificates. Devices marketed under an expired AR license lose regulatory authorization — this is treated as a serious regulatory violation and may trigger enforcement action by the SFDA.