Authorized Representative for Medical Devices in Saudi Arabia: Requirements, Duties, and Appointment

A Saudi Authorized Representative is not simply a mailing address or filing intermediary. It is a licensed regulatory role operating within a defined agreement with the manufacturer, interacting with SFDA and carrying responsibilities that extend into the post-market phase. Appointment is a governance and risk decision, not only a market-entry formality.

1. What does the Authorized Representative do?

Under MDS-REQ9, the Authorized Representative represents the manufacturer in interactions with SFDA, supplies requested information or documents, cooperates in post-market activities, and supports handling of safety risks and incidents for devices covered by the agreement. The scope should be explicit and understood by both parties.

2. Licensing and scope are not administrative details

The current requirement calls for a separate Authorized Representative license for each represented manufacturer and addresses exclusivity for the same class or general group within the defined scope. Align the legal manufacturer identity, device groups, and license status before connecting the relationship to an MDMA plan.

3. What should the agreement cover?

• Activities performed on behalf of the manufacturer in dealings with SFDA.
• The type or group of devices covered by the mandate.
• Post-market duties and exchange of safety, complaint, and incident information.
• Duration, termination or non-renewal mechanics, and notices.
• Transfer of obligations and records when a replacement is appointed.
• A responsibility matrix assigning each action, record, owner, and deadline.

4. How should a manufacturer select an AR?

Do not make price the only criterion. Test competence in the device category, dossier review, correspondence control, record retention, license monitoring, vigilance support, escalation rules, response times, and management of commercial conflicts.

5. An AR is not automatically the distributor

One organization may contract for more than one activity, but each should be licensed and governed separately. Regulatory representation differs from importation, distribution, and storage. Combining roles without clear boundaries may create dependency or commercial conflicts.

6. What happens when the AR changes?

Do not manage the change as a commercial contract cancellation alone. Plan continuity, transfer of obligations and records, ownership of open submissions, complaint and vigilance responsibilities during transition, and the notifications and actions required by SFDA.

Pre-appointment checklist

1. Confirm the legal manufacturer and represented device scope.
2. Verify the current license and scope through an official source.
3. Review the agreement against MDS-REQ9.
4. Create a responsibility matrix for submissions, changes, vigilance, and complaints.
5. Define record ownership, access, retention, and transfer.
6. Design the exit and transition process before the relationship begins.

References: [1] [2] [3]