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Foreign manufacturer
Needing to understand when and how a Saudi Authorized Representative is appointed.
AUTHORIZED REPRESENTATIVE · SFDA
Saudi Authorized Representative Support for Medical Devices
We help foreign manufacturers understand the Authorized Representative role and organize agreements, responsibilities, and records without confusing legal representation with consulting support.
A service built around the client’s actual starting point
Authorized Representative or distributor
Organizing working interfaces, records, and follow-up with the manufacturer.
Compliance team
Reviewing obligations and risks before signing or transferring an agreement.
What does the review and support cover?
- Assess the representation need and boundaries between parties.
- Review agreement provisions from regulatory and operational perspectives.
- Build a responsibility matrix for registration, changes, and post-market work.
- Organize communication, documentation, and records between manufacturer and local party.
A practical pathway that connects the regulatory decision to evidence and documentation before submission.
Map the parties
Understand the manufacturer structure, device groups, local parties, and existing contracts.
Assign obligations
Connect every obligation to a clear owner and verifiable output.
Review the agreement
Assess scope, duration, termination, obligation transfer, and relevant requirements.
Operate the relationship
Define follow-up for applications, changes, records, and regulatory communication.
Direct answers before engagement
Is Basier an Authorized Representative?
This page describes advisory and pathway support. It does not state that Basier acts as a manufacturer’s Authorized Representative unless a separate agreement exists and all licensing requirements are met.
Is the Authorized Representative the same as the distributor?
Roles may overlap in some structures, but they involve distinct contractual and regulatory responsibilities that should be defined for each case.
Can an Authorized Representative be changed?
A change can require arrangements for transferring responsibilities, records, and obligations. The applicable agreements and requirements should be assessed before execution.
References used for this content
These links are reference points. The latest version and case-specific requirements should be verified before a regulatory decision is made.
DIRECT CONTACT
Start with a clear assessment before submission
Share the device, target market, and current dossier status. We collect only the information needed to respond to your request.