Investigation and Final Report Deadlines: The 15-Day, 30-Day and 60-Day Tiers

1. Key takeaways

MDS-REQ 11 V2.0 sets a separate three-tier deadline structure for investigations and final reports: 15 days where no testing or technical evaluation is needed; 30 days where the device must be tested within Saudi Arabia; 60 days where the device must be sent abroad for testing. The anchor for tiering this set of figures is the testing location and the necessity of testing, unrelated to event severity. Reports come in three types: the Initial Report is submitted within the deadlines described in articles 41 and 42; the Follow-up Report must be submitted with reasons when the investigation exceeds 30 days and is assessed by the SFDA; the Final Report must contain all information and details, the measures taken and the final recommendations, and must specify the type of corrective or preventive action taken by the manufacturer or the AR.

• No testing or technical evaluation needed: conclude the investigation within 15 days.
• Testing within Saudi Arabia: 30 days.
• Testing abroad: 60 days, but only if the company proves domestic testing is not feasible.
• The Follow-up Report is triggered at day 30 of any investigation, independently of the tier.
• The Final Report must name the type of corrective or preventive action, tying it to the CAPA system.

2. Legal basis

The three investigation tiers and the three report types are set out in MDS-REQ 11 itself, supported by the parent law, the implementing regulation, and the inspection and quality system requirement that governs record retention.

3. Expert insights

1. The deadline tracks the difficulty of obtaining evidence, not event severity. Where article 42 tiers the three reporting deadlines by the nature of the risk, this article tiers the three investigation deadlines by the route to evidence. MDS-REQ 11 assigns 15 days, 30 days and 60 days to no-testing-or-technical-evaluation, domestic testing and testing abroad respectively, which shows what the legislator cares about: how much time a company objectively needs to get the evidence in hand to reach an investigation conclusion. An event causing no personal injury but requiring the device to be dismantled for testing lands in the 30-day or 60-day tier; a serious event with clear on-site records needing no testing falls in the 15-day tier instead. The implication for corporate management is that investigation priorities cannot be ranked by severity intuition; they must be ranked by the evidence route. When GRZAN builds PMS ticketing systems for clients, whether testing is needed and whether testing is domestic or abroad are set as mandatory fields precisely so that deadlines are generated automatically.

2. The 60-day tier is not a bonus; it is a tier the company must prove its way into. Sending a device abroad for testing means cross-border logistics, export and re-import customs clearance, and third-party laboratory scheduling. Sixty days looks generous, but the company must first demonstrate that the device cannot be tested within Saudi Arabia, otherwise the SFDA will assess the case against the 30-day or even the 15-day tier. That burden of proof sits with the company, not the regulator. The practical method is to issue a testing feasibility statement when the investigation opens, listing the laboratories available domestically, the missing equipment or capability, and the name and qualifications of the laboratory abroad that will be used. This statement both supports the 60-day tier and proves in later inspections that the company did not use foreign testing to buy time.

3. The 30 days of the Follow-up Report and the 30-day investigation tier are not the same thing. The document provides that an investigation exceeding 30 days triggers a Follow-up Report with reasons, assessed by the SFDA. Those 30 days are a progress-notification trigger, an independent rule separate from the 30-day domestic-testing tier. A case in the 60-day tier still triggers the Follow-up Report obligation on day 30, and must give reasons and accept SFDA assessment. A company that assumes the 60-day tier means one report at day 60 will miss the day-30 progress report. The closing requirements of the Final Report are also often underestimated: it must not only state conclusions but must specify the type of corrective or preventive action taken by the manufacturer or the AR. That wording binds the report to the CAPA system; an investigation report without CAPA numbering and effectiveness records will not survive an inspection.

The tiering of reporting deadlines is covered at https://www.grzan.cn/regulations/saudi/ncmdr-adverse-event-reporting-timelines-42 , and the scheduling of periodic documents at https://www.grzan.cn/regulations/saudi/pms-report-and-psur-by-risk-class-45 .

4. Practical recommendations

• Set whether testing is needed and the testing location (domestic or abroad) as mandatory fields in the PMS ticketing system, and let the system generate the investigation deadline automatically.
• Build a three-tier calendar reminder: a mandatory review node on day 7 of the 15-day tier, day 20 of the 30-day tier and day 25 of the 60-day tier.
• When intending to use the 60-day tier, issue the testing feasibility statement at the same time, listing the domestic capability gaps and the qualifications of the laboratory abroad, and archive both.
• Configure Follow-up Report trigger reminders for every investigation exceeding 30 days, with the reasons covering completed steps, outstanding steps and the expected completion date.
• Fix a corrective or preventive action type field in the Final Report template, cross-referenced to internal CAPA numbers, so no case closes without a CAPA.
• Establish pre-arranged communication with at least one laboratory in Saudi Arabia with the relevant testing capability to shorten the evidence chain.
• If a device must leave the country for testing, confirm the export and re-import clearance path in advance so clearance time does not eat into the 60-day window.
• Retain all investigation reports and correspondence under the QMS requirements of MDS-REQ 10 so they can be produced during inspections.

5. Verification checklist

• □ The ticketing system has built-in automatic generation of the three-tier deadlines
• □ Mid-term mandatory review nodes are configured for all three tiers
• □ The testing feasibility statement template is ready
• □ Follow-up Report trigger reminders for investigations exceeding 30 days are live
• □ The Final Report template contains the corrective or preventive action type and CAPA reference fields
• □ A list of usable laboratories in Saudi Arabia has been established
• □ The export and re-import clearance path for devices has been confirmed
• □ The archiving of investigation records meets the retrieval requirements of MDS-REQ 10

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