PMS Report and PSUR: Periodic Documents Scheduled by Risk Class

1. Key takeaways

Saudi periodic post-market documents are layered by risk class: Class C and Class D submit a PSUR (Periodic Safety Update Report) once a year; Class B submits a PSUR every two years; Class A submits a PMS report. These cycles are a practical estimate: the SFDA official documents contain no periodic table that can be directly corroborated, and the actual schedule follows the current SFDA documents and the list issued by the electronic portal. On content, the PSUR is not a new genre built from scratch: its data sources are precisely the adverse event and complaint records, investigation reports, FSCA records and traceability ledger maintained under MDS-REQ 11. At the same time, Annex (6) of MDS-REQ1 V6.0 brings PMCF (post-market clinical follow-up) into the post-market evidence chain, so the PSUR of high-class devices should be mutually supported by PMCF data.

• Class C and D: PSUR annually (practical estimate, to be verified against the SFDA portal).
• Class B: PSUR every two years (practical estimate).
• Class A: PMS report.
• The PSUR must draw on the same data source as the Initial, Follow-up and Final Reports under MDS-REQ 11.
• PMCF data under Annex (6) of MDS-REQ1 V6.0 is the evidence core of a high-class device PSUR.

2. Legal basis

The reporting foundations rest on MDS-REQ 11 and the clinical evaluation annex of the marketing authorisation requirement, while the periodic cycle itself is a practical estimate pending verification against the SFDA electronic platform.

3. Expert insights

1. The cycle is not arbitrary; it corresponds to the product of risk and information volume. Scheduling periodic reporting by risk class is an internationally common regulatory technique: the higher the class and the larger the clinical exposure, the more safety information needs updating and the higher the refresh frequency. Class C and D annual reporting corresponds to categories such as implants, life-supporting devices and high-risk IVDs where a signal, once it appears, has severe consequences; Class B reports every two years; Class A follows the PMS report, consistent with its relatively simplified technical documentation positioning. What Chinese manufacturers must do is not memorise this table but write it into the annual compliance calendar, because PSURs, MDMA renewals, ISO 13485 surveillance audits and UDI data maintenance stack up in the same year; without scheduling, a year-end rush inevitably produces inconsistent data calibres.

2. The PSUR and the three report types of MDS-REQ 11 must share one data source. PSUR quality depends on whether the underlying data are single-sourced. The three report types defined by MDS-REQ 11 (Initial Report, Follow-up Report, Final Report) each carry their own timeline and conclusions, and the PSUR should aggregate these records directly rather than building a parallel statistical calibre. The common failure is that the vigilance department reports cases by jurisdiction deadline while the registration department fills in a separate summary version of the PSUR template; the two sets of figures do not match and become a deficiency at inspection. The workable approach is to make the PMS ticketing system the single data source, export the PSUR from the system on cycle, and generate case reports and summary reports from the same source. The Final Report must state the type of corrective or preventive action taken by the manufacturer or AR; that field should be retained in the PSUR and traceable to a CAPA number.

3. PMCF is the evidence core of a high-class device PSUR. Annex (6) of MDS-REQ1 V6.0 binds clinical evaluation and PMCF together. For Class C and D devices, a PSUR that only says complaints N, recalls 0, without clinical follow-up data support, is hard to sustain. PMCF can be a registry study, literature follow-up, real-world data or the reuse of existing overseas clinical data; the key is proving that it covers the real Saudi user population and use scenarios. Compared with the linkage requirements between PSUR and PMCF plans under the EU MDR, the Saudi drafting puts more weight on connection with safety signals: new risks found by PMCF should flow back immediately as event reports under MDS-REQ 11, not wait to be disclosed in next year’s PSUR. When GRZAN compiles a PSUR, whether new vigilance signals arose in the year is treated as a standalone chapter.

Periodic document updates triggered by changes are covered at https://www.grzan.cn/regulations/saudi/significant-and-non-significant-change-46 , and the linkage between vigilance data and UDI records at https://www.grzan.cn/regulations/saudi/pms-and-udi-data-maintenance-47 .

4. Practical recommendations

• Build the periodic document calendar by risk class: PSUR every 1 year for Class C and D, PSUR every 2 years for Class B, PMS report for Class A (cycle subject to current SFDA documents, a practical estimate).
• Make the PMS ticketing system the single data source and export the PSUR from the system on cycle, eliminating dual calibres between case reports and summary reports.
• Retain the corrective or preventive action type field in the PSUR, traceable to CAPA numbers.
• Build a PMCF data source list for Class C and D devices, stating the covered population, sample size and follow-up method.
• Set a standalone chapter on whether new vigilance signals arose during the year, cross-checked against the MDS-REQ 11 incident ledger.
• Schedule PSUR submission nodes, MDMA renewal, ISO 13485 surveillance audits and UDI data review on the same annual calendar to avoid a year-end pile-up.
• Retain the acceptance receipt issued by the electronic portal after submission, and archive the version number and submission date.
• Check the SFDA electronic service platform periodically for changes in periodic document requirements, and update internal templates whenever a change appears.

5. Verification checklist

• □ The risk class and corresponding periodic document type of every licensed device is registered
• □ The periodic document calendar has been established with advance reminders
• □ The PMS ticketing system is the single data source for the PSUR
• □ The PSUR contains the corrective or preventive action type and CAPA references
• □ The PMCF data source list for Class C and D devices has been archived
• □ The PSUR contains a standalone chapter on new vigilance signals for the year
• □ Periodic document nodes are merged with MDMA renewal and system audit scheduling
• □ Submission acceptance receipts and version numbers have been archived
• □ Periodic document requirements have been verified on the SFDA electronic service platform (the cycle is a practical estimate)

Regulatory information verified as of October 29, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Saudi Arabian market. Our team manages adverse event reporting and recall coordination with the SFDA National Center, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com