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MDS-REQ 9 & Supply Chain
Medical Device Establishment Licensing & Local Supply Chain
Market Access Depends on Both Device Authorization and Licensed Local Activities. SFDA separately licenses medical-device establishments according to their activity. Importers, distributors, Authorized Representatives, warehouses and other establishments may have activity-specific licensing obligations under MDS-REQ 9 and the Medical Devices Law framework.
When This Support Is Needed
Establishing a new commercial entity or subsidiary for medical device importation or distribution in Saudi Arabia
Securing or renewing an SFDA Establishment License for Authorized Representatives, Importers, or Distributors
Aligning storage warehouses, 3PL logistics facilities, and transportation controls with SFDA Good Storage Practices
Ensuring local supply chain partners maintain full traceability and compliance with the Medical Devices Law
What We Challenge Before Submission
Does the commercial entity hold the exact establishment activity license required for its distribution operations?
Do storage and transportation facilities have continuous, calibrated temperature and environmental logging?
Are contractual quality agreements in place between the overseas manufacturer, AR, importers, and distributors?
Can the local warehouse execute a rapid product quarantine or physical recall within statutory SFDA timelines?
Is the appointed technical manager properly registered and authorized in the GHAD system?
Our Establishment Licensing Support Scope
Establishment activity and license-scope assessment (Manufacturer, Importer, Distributor, AR, Warehouse)
Authorized Representative establishment qualification and licensing under MDS-REQ 9
Importer and distributor commercial role and regulatory boundary mapping
Warehouse storage facility inspection readiness (temperature, humidity, pest control, segregation)
GHAD unified portal establishment-registration and account management
Quality Management System (QMS) and standard operating procedure development for local operations
Technical manager and qualified person appointment qualification requirements
Supply-chain complaint escalation, product hold, and vigilance reporting interfaces
Batch/serial traceability and commercial distribution record-control governance
Establishment license renewal, activity scope expansion, and site amendment support
Layered Regulatory Approach:
Device authorization and establishment licensing are separate regulatory layers. We make sure the MDMA strategy and the local commercial model work together rather than being developed independently.
Obtain Your SFDA Medical Device Establishment License (MDEL)
Our supply-chain specialists structure MDS-REQ 9 establishment licensing, implement storage QMS procedures, and register facilities in GHAD.