Skip to main content

SFDA Inspections & Audits

SFDA inspection authority​

The SFDA has the authority to inspect manufacturing facilities — in Saudi Arabia and overseas — for medical device manufacturers seeking or holding MDMA certificates. The inspection assesses compliance with:

  • QMS requirements (ISO 13485 / SFDA.MD/GSO ISO 13485)
  • Technical file accuracy
  • Post-market surveillance processes
  • Labelling and advertising compliance

When does SFDA inspect?​

SFDA inspections are most common for:

  • Class C and Class D device manufacturers — SFDA may require facility inspection as part of MDMA review
  • Post-market surveillance — risk-based inspections of MDMA holders
  • Following adverse events or FSCAs — triggered inspections when safety signals are identified
  • Routine market surveillance — periodic inspections of distributors, importers, and ARs

Class A and B manufacturers are less commonly subject to SFDA site inspection, but it remains an SFDA option for all classes.

Responding to SFDA findings​

If the SFDA issues a non-conformity or inspection finding:

  1. Acknowledge the finding promptly via GHAD or official correspondence
  2. Conduct root cause analysis
  3. Implement corrective actions
  4. Provide a written CAPA response to the SFDA within the specified timeframe
  5. Provide evidence of corrective action implementation

Consequences of non-compliance​

Significant non-conformities can lead to:

  • Suspension or withdrawal of MDMA certificate
  • MDEL cancellation
  • Import alerts and market withdrawal
  • Penalties under the Medical Devices Law

Further reading​