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Adverse Event Reporting — NCMDR

What is the NCMDR?​

The National Centre for Medical Device Reporting (NCMDR) is the SFDA unit responsible for receiving, processing, and investigating adverse event reports related to medical devices in Saudi Arabia. The NCMDR is the Saudi equivalent of the EU EUDAMED vigilance module or the US FDA MedWatch for medical devices.

What must be reported?​

The following must be reported to the NCMDR:

  • Serious incidents — events involving a device that led, or could have led, to patient death, serious deterioration of health, or serious injury
  • Near-incidents — events where a serious incident was only narrowly avoided
  • Device malfunctions — that could, if recurring, lead to a serious incident
  • False positive/false negative results (for IVDs) — where the incorrect result influenced clinical management and caused or could have caused serious harm

Who must report?​

ReporterObligation
Manufacturer / ARPrimary reporting obligation — must report to NCMDR for all incidents involving their registered devices in KSA
Importer / DistributorMust report incidents brought to their attention
Healthcare providersMust report incidents they identify in clinical practice

Reporting timeframes​

Timeframes depend on the severity of the incident:

  • Immediately (within 24 hours) — for incidents involving immediate threat to life (device still in use and posing ongoing risk)
  • Within 2 working days — for serious incidents where the device is no longer in use
  • Within 10 working days — for incidents not fitting the above categories but still requiring reporting
  • Within 30 days — for incidents identified through trend analysis

(Confirm current timeframes against the latest SFDA guidance, as these may be updated.)

How to report — NCMDR process​

Reports are submitted via the GHAD portal or directly to the NCMDR:

  1. Complete the adverse event report form
  2. Submit via GHAD or designated NCMDR reporting channel
  3. SFDA/NCMDR acknowledges receipt
  4. Investigation and follow-up as required by SFDA
  5. Provide supplementary information on SFDA request

Exemptions from reporting​

Not all device-related complaints or incidents require NCMDR reporting. Minor malfunctions with no patient safety impact, user errors with no device fault, and issues already identified and managed through an existing FSCA may be exempt — but manufacturers should apply a conservative reporting approach and consult MDS-REQ 5 for precise exclusion criteria.

Further reading​