iAssets · SFDA Compliance
SFDA preventive maintenance requirements for medical devices
The Saudi Food and Drug Authority sets out how planned preventive maintenance of medical devices must be performed and, crucially, how it must be recorded. Its guidance is unusually specific about the system of record: PPM details are to be entered in the device record within a computerized maintenance management system, and the data retained for at least five years.
That turns a CMMS from a productivity tool into a compliance instrument. This page sets out what SFDA asks for and how iAssets — deployed across the Saudi MOH Tabuk Health Cluster — satisfies each element.
What SFDA requires
SFDA guidance requires that preventive maintenance follow the manufacturer's specifications and be carried out only by trained personnel, with performance and functional testing plus calibration after maintenance. Safety inspection is treated as a core part of PPM rather than a separate activity.
The documentation requirements are equally explicit. PPM details — including the date and the tool kits used — must be recorded in the device record within a computerized maintenance management system, and devices must be labelled with the last maintenance date and the next scheduled date.
- PPM aligned to manufacturer specifications
- Performed only by trained personnel
- Performance testing, functional testing and calibration after maintenance
- Safety inspection as a core component of PPM
- PPM details recorded in the device record within a CMMS
- Device labelling showing last and next maintenance dates
- Records retained for a minimum of five years
The five-year retention requirement is the hard part
A five-year retention window is longer than most spreadsheets survive intact. Over that period technicians leave, devices move between departments, and files get reorganised — and the record must still be retrievable and attributable to the device and the person who did the work.
This is the single strongest argument for a system of record over local files, and it is why SFDA names the system category explicitly rather than simply requiring "documentation".
- Records survive staff turnover and departmental reorganisation
- History follows the device when it moves location or ownership
- Technician attribution is retained, as required for signed PPM reports
- Retrieval is by device, so an inspection question has a direct answer
How iAssets satisfies each element
iAssets was built for exactly this pattern of work: scheduled PPM against a device register, closed by an identified technician, with calibration and test results attached to the device rather than filed separately.
It runs today across 12 hospitals and 84 primary healthcare centres in the Saudi MOH Tabuk Health Cluster, tracking more than 25,000 medical assets through their lifecycle.
- PPM schedules derived from manufacturer intervals and device risk class
- Work orders closed by the assigned, identified technician
- Calibration and functional-test results stored on the device record
- Full history retained for the device lifetime, well beyond five years
- QR and RFID labelling carrying last and next service dates
- Arabic and English records and reports
FAQ
Does SFDA require a computerized maintenance management system?
SFDA guidance on preventive maintenance of medical devices requires PPM details — including date and tool kits used — to be recorded in the device record within a computerized maintenance management system ("في سجل الجهاز/المنتج الطبي ضمن نظام إدارة الصيانة الحاسوبي"). It is one of the few places where a regulator names the software category rather than only the outcome.
How long must PPM records be kept under SFDA rules?
At least five years. SFDA states the data must be retained "لمدة خمس سنوات على الأقل" — a minimum of five years. In practice this means the record has to outlive the technician who created it, any departmental reorganisation, and often the device's move between locations, which is difficult to guarantee with spreadsheets or local files.
Who is allowed to perform preventive maintenance on medical devices?
SFDA requires PPM to be carried out only by trained personnel, following the manufacturer's specifications, with performance and functional testing plus calibration afterwards. Because reports carry end-user and technician signatures, the maintenance record needs to identify who performed the work — which is why technician attribution on every closed work order matters for compliance and not just for management.
What has to be on the device label?
SFDA requires device labelling that shows the last maintenance date and the next scheduled date. In iAssets this is generated from the live PM schedule and carried on a QR or RFID tag, so the label reflects the current schedule rather than whatever was printed the last time someone updated it manually.
Is safety inspection separate from preventive maintenance?
No — SFDA treats safety inspection as a core component of PPM rather than a separate exercise. Practically, that means the PPM checklist should include the safety checks and the completion record should evidence them, instead of maintaining a parallel safety file that has to be reconciled with the maintenance history at audit time.
Does iAssets support Arabic for SFDA documentation?
Yes. Arabic and English are both first-class languages in iAssets, including generated reports. Since SFDA guidance is issued in Arabic and biomedical teams frequently work in Arabic while equipment documentation arrives in English, keeping both in one record avoids the translation step that otherwise sits between the work and the evidence.
Can iAssets be deployed on-premise for Saudi health data?
Yes — cloud or fully on-premise. Hosting location is often a procurement condition for Saudi health data rather than a preference, and most global CMMS products are cloud-only and hosted outside the region. iAssets is deployed inside the Saudi Ministry of Health Tabuk Health Cluster today.
Bring your equipment records to audit standard
Talk to the Intrazero team about deploying iAssets — the CMMS running the Saudi MOH Tabuk Health Cluster — with Arabic and English interfaces and cloud or on-premise hosting.
Talk to the Intrazero team about deploying iAssets — the CMMS running the Saudi MOH Tabuk Health Cluster — with Arabic and English interfaces and cloud or on-premise hosting.
Plattform-Demo planen
Erleben Sie das Ökosystem. Füllen Sie das Formular aus, um Ihre Demo mit den richtigen Produktspezialisten abzustimmen.