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:
| Class | Required report | Update frequency |
|---|---|---|
| Class A | PMS Report | As needed; available on SFDA request |
| Class B | Periodic Safety Update Report (PSUR) | At least every 2 years |
| Class C | PSUR | Annually |
| Class D | PSUR | Annually |
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 2 These intervals commence from the date of first MDMA certificate issuance. 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
- MDS-REQ 5 — PMS and vigilance requirements
- MDS-REQ 4 — Clinical Evaluation (PMCF component)
- Adverse Event Reporting
- MDMA Renewal
For devices imported or distributed in Saudi Arabia, the Authorized Representative must ensure effective communication channels exist to collect PMS data from healthcare facilities, importers, and distributors. The AR is responsible for consolidating this data and submitting it to the manufacturer's global PMS system. Robust data collection systems should be documented and regularly reviewed for completeness and timeliness.