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 routine SFDA site inspection, but the SFDA retains the authority to inspect manufacturers of all classes, particularly if adverse events, FSCAs, or compliance concerns are identified.

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​