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AR Obligations

Overview​

The full obligations of an Authorized Representative are set out in MDS-REQ 9. The AR is not simply a postal address — they carry significant regulatory responsibility throughout the device lifecycle.

Registration and application obligations​

  • Submit MDMA applications via GHAD on behalf of the manufacturer
  • Ensure all documentation meets SFDA requirements before submission
  • Pay application and registration fees on behalf of the manufacturer (reimbursed by arrangement)
  • Respond to SFDA queries and deficiency letters during review
  • Receive and hold the MDMA certificate

Post-market obligations​

  • Adverse event reporting — report serious incidents and near-incidents to the NCMDR within required timeframes
  • FSCA coordination — manage Field Safety Corrective Actions in Saudi Arabia; issue Arabic and English Field Safety Notices
  • Distribution tracking — maintain records of device distribution in KSA
  • PSUR/PMS — ensure PMS and PSUR data are collected and documented per class requirements
  • MDMA renewal — submit renewal applications before certificate expiry

Change notification​

  • Notify the SFDA of any significant changes to the device (design, intended use, manufacturing site, labelling)
  • Assess whether a change triggers re-submission vs. simple notification

QMS​

The AR must implement and maintain a QMS certified to ISO 13485 (SFDA.MD/GSO ISO 13485). This applies to the AR's own regulatory management activities, not to the device's manufacturing QMS.

Labelling compliance​

  • Ensure the AR's current name and address appear on all device labels, packaging, and IFU
  • Ensure home-use device labels carry Arabic content
  • Obtain SFDA pre-approval for advertising materials (MDS-REQ 8)

Further reading​