Changing Your Authorized Representative
Why changing an AR is significant
In Saudi Arabia, the MDMA certificate is held in the AR's name — not the manufacturer's. Changing your AR therefore directly affects your device registration status and requires regulatory action.
The change process
To change your AR:
- Appoint the new AR — the new AR must hold (or obtain) a valid MDEL AR license
- Execute a new AR contract — properly authenticated and legalised
- Notify the SFDA via GHAD — submit a change notification with the new AR's details
- Update the MDMA certificate — the SFDA will issue an updated certificate reflecting the new AR
- Update all labelling — labels, packaging, and IFU must be updated to show the new AR's name and address
Commercial implications
Until the SFDA processes the AR change and issues an updated MDMA certificate, devices labelled with the old AR's details may face distribution complications. Plan AR changes carefully:
- Allow sufficient time for SFDA processing (weeks to months)
- Coordinate labelling artwork changes in advance
- Ensure the old AR cooperates — they must consent to the transfer and release the MDMA certificate
Risk of distributor-as-AR
This process illustrates why using a distributor as AR creates risk. If you wish to change distributors, the existing distributor (as AR) controls the MDMA certificate. A non-cooperative former distributor can significantly delay market re-entry with new distribution arrangements.