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Authorized Representative (AR / LAR) Overview

What is an Authorized Representative?​

An Authorized Representative (AR) — also referred to as a Local Authorized Representative (LAR) — is a Saudi-licensed entity (individual or company) appointed by a foreign manufacturer to act as the official liaison with the SFDA for all regulatory matters related to medical devices.

Foreign manufacturers without a physical office or legal entity in Saudi Arabia cannot register or market devices without a licensed AR.

Why is an AR required?​

The SFDA requires an AR because:

  • It ensures there is always a legally accountable Saudi entity accessible to the SFDA for queries, inspections, and enforcement actions
  • All regulatory submissions to the SFDA (including MDMA applications) must be made through a licensed Saudi entity
  • Post-market obligations — vigilance reporting, FSCAs, recall coordination — require an in-country point of contact

What the AR does​

The AR's obligations are set out in MDS-REQ 9 and include:

  • Holding and maintaining the MDMA certificate on behalf of the manufacturer
  • Submitting MDMA applications via GHAD and managing the registration lifecycle
  • Communicating with the SFDA on all regulatory queries, inspections, and actions
  • Post-market compliance — reporting adverse events to NCMDR, coordinating FSCAs
  • Change notifications — notifying the SFDA of significant device changes
  • Labelling compliance — ensuring AR name and address appear on all device labels, IFU, and packaging
  • MDMA renewal — submitting renewal applications before certificate expiry

The AR's name on labels​

The AR's name, address, and contact information must appear on device labels, packaging, and IFU. This is a mandatory labelling requirement under MDS-REQ 1. Changing your AR therefore requires updating all labelling — a significant logistical consideration.

AR vs. distributor: avoiding conflicts of interest​

Many manufacturers designate their Saudi distributor as their AR. While convenient, this creates a risk:

AR controls the MDMA certificate

The MDMA certificate is held in the AR's name. If the AR is also your exclusive distributor, changing distributors becomes extremely complicated — the new distributor cannot market the device until a new MDMA (or MDMA transfer) is processed. Using an independent AR service provider gives the manufacturer full control over commercial decisions.

Direct manufacturer submission option​

Foreign manufacturers who wish to keep their technical documentation confidential from their AR may submit the technical file directly to the SFDA via GHAD using a manufacturer account. The AR still holds the MDMA certificate and AR license. This dual-access model is unique to the Saudi system.

Further reading​