Saudi Authorized Representative (AR) Services

The Authorized Representative Is a Regulatory Governance Role. For manufacturers established outside the Kingdom, the Saudi regulatory pathway requires a locally established Authorized Representative to represent the manufacturer in relation to the Medical Devices Law and its Implementing Regulation. The AR role should be treated as an ongoing regulatory interface, not as an address-only service.

Strengthen Your Saudi AR Governance

When This Support Is Needed

A manufacturer established outside the Kingdom of Saudi Arabia requires legal representation under the Medical Devices Law

Appointing an independent Saudi Authorized Representative to maintain control over registrations rather than commercial distributors

Transitioning representation to a compliant, licensed Authorized Representative with full GHAD portal capability

Establishing robust post-market vigilance, complaint escalation, and field safety corrective action (FSCA) governance

What We Challenge Before Submission

Is the Authorized Representative agreement structured to protect manufacturer IP while fulfilling statutory obligations?

Can the AR provide immediate access to technical files and clinical data upon official SFDA inspection request?

How quickly does the manufacturer notify the AR of design modifications, adverse events, or global field safety notices?

Are commercial distributors and local importers operating cleanly under the AR's regulatory umbrella?

Does the AR hold an active, valid establishment license for all relevant medical device categories in the Kingdom?

Our Saudi AR Support Scope

Authorized Representative selection, qualification, and onboarding support in the Kingdom

Manufacturer-AR mandate and legal agreement drafting in accordance with SFDA regulations

Alignment of device categories, product listings, and legal manufacturer corporate data

AR establishment-licensing coordination under MDS-REQ 9 where applicable

MDMA communication, dossier submission, and petition tracking in the GHAD system

Direct liaison with SFDA technical evaluators during pre-market reviews and audits

Technical documentation retention, security, and immediate access protocols

Post-market complaint intake, vigilance triage, and serious incident escalation pathways

Field Safety Corrective Action (FSCA) and recall communication governance

Change-notification protocols and regulatory variation management

Record-retention and supply chain traceability interface maintenance

Governance Model:

We establish who must know what, by when, and which records must be available in Saudi Arabia when SFDA asks for evidence. That governance becomes critical during vigilance, inspections, recalls and significant changes.

Appoint a Licensed Saudi Authorized Representative

Our In-Kingdom regulatory team provides independent Authorized Representative services, manages GHAD filings, and maintains complete regulatory governance.

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