SFDA Medical Equipment Maintenance Records: Saudi Buyer Checklist

Quick answer: the SFDA document Requirements for Safe Use of Medical Devices Inside Healthcare Facilities (MDS-REQ 3, version 2, 15 May 2023) asks every healthcare provider in Saudi Arabia to run a maintenance management system and an inventory management system, keep one maintenance record per medical device, and keep preventive maintenance records for at least five years. This guide lists the records the document names, shows a synthetic device record, and gives a short checklist for testing maintenance software against it.

This is a buyer guide, not legal advice. Read the official document for the full text, and check the SFDA website for later versions before you rely on it.

What does SFDA MDS-REQ 3 require for medical equipment maintenance records?

SFDA MDS-REQ 3 requires the department that looks after medical devices to keep computer-based maintenance and inventory records for every device. The scope line reads: "This document applies to healthcare providers in KSA." The maintenance rules sit in section C, "Responsibilities of the specialized department in medical devices".

• Item 19: provide a maintenance management system and an inventory management system to record, store, organise and analyse medical device information, with spare parts information and a list of spare parts suppliers authorised by the manufacturer.
• Item 21: create a record in the maintenance management system for each medical device (the fields are listed in the next section).
• Item 15(d): document the details of each periodic preventive maintenance (PPM) visit in the device log in the maintenance management system, and keep this information for at least five years.
• Item 15(e) and (f): the end user and the biomedical engineer or service provider approve the PPM report, and a tag on the device shows at least the previous PPM date, the next PPM date and who did it.
• Item 7: give each device a control number and fix it to the device, with other tags such as the warranty expiry date.
• Item 12: maintenance is done by the manufacturer, a person from the department trained by the manufacturer, or a maintenance provider licensed by SFDA.

The glossary on page 15 defines a maintenance management system as "a computer-based software system" that covers technical support, inventory, corrective maintenance, PPM and contracts management, with reports such as downtime, life cycle cost and inventory by device type, location or manufacturer.

Which fields belong in each device record?

Item 21 lists the minimum content of each device record in four groups. Use it as the field list when you check your current register or a new system.

1. General information about the device. In practice: control number, device type, manufacturer, model, serial number, department and warranty end date.
2. Periodic preventive maintenance: PPM frequency, updated procedures, calibration requirements, spare parts used, date of each PPM, test equipment and tools used, who did the maintenance and the time it took.
3. Corrective maintenance: date and description of the problem, spare parts used and time taken.
4. Field safety corrective action (FSCA): the date of the safety alert, the problem, the required action and the date the action was carried out.

The example in the image is synthetic. The field names in group 1 are our reading of "general information"; the document does not list them one by one.

How should PPM for medical equipment be scheduled and evidenced?

PPM requirements come from the manufacturer's instructions (item 14), and each visit leaves four pieces of evidence: a schedule, a completed record in the device log, an approved report and an updated tag on the device (item 15). When you review a system, ask to see all four for one device, not only the calendar.

• The schedule follows the manufacturer's frequency for that model.
• The completed visit shows spare parts, test equipment, the person who did it and the time taken.
• The report carries the approval of the end user and the biomedical engineer or service provider.
• The tag on the device matches the dates in the system.
• Records from at least the last five years can be found and exported.

Our calibration tracking guide covers due dates, certificates and test equipment in more detail.

What should a maintenance software demo prove?

A demo should prove that your team can find one device and show its full evidence trail in a few clicks. Bring a short extract of your own register (no patient data) and ask the vendor to run these steps live. Treat any step a vendor cannot show as a gap to settle before you buy, whichever vendor it is.

1. Find a device by control number or by scanning its label, and open its history.
2. Show the PPM due this month, then a completed PPM with its report.
3. Open a repair and show the problem, spare parts, time taken and who did the work.
4. Record a safety alert against every affected device and close it with the action date.
5. Export the register and five years of PPM records in a format an inspector can read.

Testing hospital maintenance software against SFDA records? See how Assetly handles equipment records, or book a demo and ask us to run the five steps above on your own equipment list. We will tell you which steps work as shown and which need configuration.

How do you move an existing spreadsheet register into a new system?

Import the spreadsheet, then reconcile it against what is physically on the floor before you trust it. Most registers contain duplicates, devices that were moved without an update, and devices that nobody has seen for months.

• Agree one control number format and fix duplicates before import.
• Keep the old register as a read-only reference until the reconciliation is signed off.
• Run a physical inventory check by department. A device that is not found is an exception to investigate, not a deletion.
• Attach past PPM reports to the device records so the five-year history is not lost.

What should you ask about language, hosting and support?

Ask each vendor to confirm these points in writing for your site. They decide whether a system works for your team, and they differ between vendors and deployments.

• Which interface languages are available today, and in which screens? Ask to see Arabic screens if your users need them.
• Where is the data hosted? Is on-premise installation available? Which subcontractors process the data?
• Who prints and fixes labels, and who supplies RFID readers if you use them?
• What support hours and response times apply in Saudi time?
• Can you export all records if you leave the vendor?

Equipment records can include staff names. Saudi personal data rules allow cross-border transfer under conditions set by SDAIA's regulations, so check hosting with your data protection officer rather than assuming one answer.

What does software not do?

Software keeps and retrieves the records. It does not perform maintenance, it does not license a maintenance provider, and it does not make a facility compliant with SFDA requirements. The engineering work, the approvals and the policies stay with the hospital and its licensed service providers.

How Assetly maps to these records

Assetly is the hospital asset management product built by Nirmitee. It keeps an equipment register with manufacturer, model, serial number, department and warranty details, imports existing registers from a spreadsheet, and supports QR and barcode labels and handheld RFID checks. Maintenance work orders carry the asset's service history, spare parts, the person who did the work, time spent and maintenance cost. Calibration records have due dates. There is an equipment recall module for safety alerts, and reports for equipment inventory, maintenance summary, PM compliance and audit trail can be exported. On-premise deployment is available.

Ask us to demonstrate each item above on your own records. Interface languages, hosting location and support hours for a Saudi site are agreed per project; ask for them in writing during the demo.

Need help connecting equipment records to other hospital systems? Explore our healthcare software product development services, or talk to our team.

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• AMC vs CMC for medical equipment

This guide is part of our hospital asset management series.