Skip to main content

Post-Market Surveillance & PSUR

PMS obligations overview​

All device classes in Saudi Arabia must maintain active Post-Market Surveillance (PMS) — systematically collecting and analysing data from marketed devices. The outputs differ by class:

ClassRequired reportUpdate frequency
Class APMS ReportAs needed; available on SFDA request
Class BPeriodic Safety Update Report (PSUR)At least every 2 years
Class CPSURAnnually
Class DPSURAnnually

Class A — PMS Report​

The PMS Report for Class A devices must include:

  • Summary of PMS data collected (complaints, adverse events, literature data)
  • Analysis findings and conclusions
  • Any CAPAs taken as a result

The PMS Report is maintained internally and must be made available to the SFDA on request.

Class B, C, D — PSUR​

The Periodic Safety Update Report (PSUR) is a more comprehensive document including:

  • Full PMS data summary
  • Risk-benefit determination conclusions — updated assessment of overall device risk-benefit
  • PMCF results — data from post-market clinical follow-up studies
  • Sales volume data — to contextualise the rate of adverse events
  • Analysis of any new safety signals
  • Summary of any FSCAs or recalls in the reporting period
  • Updated CAPA records

Class B manufacturers must update the PSUR at least every two years; Class C and D manufacturers must update annually.

PMS data sources​

PMS data should be gathered from multiple sources:

  • Complaints and adverse event reports received
  • NCMDR feedback and communications
  • Published scientific literature (systematic review)
  • PMCF study data
  • Data from equivalent devices on other markets
  • Incident databases from IMDRF member regulators

PMCF (Post-Market Clinical Follow-up)​

PMCF is the structured, ongoing collection of clinical data for devices already on the market. For Class C and D devices, the SFDA expects an active PMCF programme. PMCF data feeds into the PSUR and the CER at renewal.

Further reading​