UDI and the Saudi-DI Database

1. Key takeaways

The core basis for Saudi UDI is MDS-REQ 7 V4.0 (2022-05-24, reference MDS-REQ-007-V4/220524). The UDI consists of the UDI-DI (device identifier) and the UDI-PI (production identifier); lot number, serial number, software identification or expiry date on the label go into the UDI-PI. Three issuing agencies are recognized: GS1, HIBCC and ICCBBA. The UDI must appear on the device label and all higher-level packaging, in both human-readable form (HRI) and automatic identification and data capture (AIDC), with barcodes verified against the applicable ISO/IEC standards. The Saudi-DI database (Ramz) launched on 1 October 2020 with voluntary registration for all device types; data is submitted and maintained by the manufacturer or the AR; model names and GMDN codes in GHAD and Saudi-DI must be accurate, and non-proprietary data will be made public. Mandatory dates differ between versions; the practical estimate is 1 September 2023 and 1 September 2024, per current SFDA announcements and MDS-REQ 7.

• UDI-DI plus UDI-PI; issuing agencies limited to GS1, HIBCC and ICCBBA.
• UDI on the device label and all higher-level packaging, in HRI and AIDC, verified against ISO/IEC standards.
• Saudi-DI (Ramz) open since 1 October 2020; data maintained by the manufacturer or the AR.
• Data before market: new UDI-DI data must be in the database at market placement.
• Mandatory dates vary by source; verify current batches on the Saudi-DI or GHAD portal.

2. Legal basis

The table below lists the instruments cited for UDI and Saudi-DI. Items marked as a practical estimate are pending verification against SFDA announcements.

3. Expert insights

1. The coding rules are not the hard part; the hard part is when the DI changes. The first blocker in a UDI project is not whether the barcode scans, but the UDI-DI change triggers: changes to model names, packaging levels or key specifications can trigger a new DI, and once the DI changes, labels, packaging, the database and GHAD records must follow. MDS-REQ 7 V4.0 requires the UDI on the device label and all higher-level packaging, so one DI change cascades into multiple updates along the hierarchy. GRZAN recommends a UDI impact assessment in design change management: any change affecting the model name, packaging configuration or label content first determines whether the DI changes, avoiding new packaging with old data. Model names and GMDN codes in GHAD and Saudi-DI must be accurate; once inconsistent, changes and clearance repeatedly run into verification requests.

2. Dual presentation and barcode quality are the two items most easily failed on site. MDS-REQ 7 V4.0 requires the UDI in both human-readable form (HRI) and automatic identification and data capture (AIDC), with barcodes verified against applicable ISO/IEC standards and meeting the agencies’ grading criteria. Common failures: barcodes printed without HRI, HRI squeezed into illegibility, or print precision below grading grade so scanners cannot read the code. Correctness adds no points, but errors mean outright rejection. Two boundary rules matter: constrained reusable devices must bear direct marking (DM) on the body, permanently readable through normal use and expected lifetime; transport containers may be exempt where other tracking means exist. The first hits orthopaedic, endoscopic and surgical instruments hardest; the second saves logistics work.

3. Data maintenance is a continuing duty, and the data is public. Saudi-DI data responsibility rests with the manufacturer or the AR: data must be submitted and maintained in the database, new UDI-DI data must already be there when the device is placed on the market, and all designated (non-proprietary) data will be made public. Together these form one hard constraint: data first, market second. UDI data submission should be an independent pre-market milestone, not patched in after shipment. The data’s public nature means fields such as model name and GMDN code are externally visible, and their quality shapes the company’s standing in the Saudi market. GRZAN recommends synchronizing Saudi-DI field maintenance with GHAD in one ledger, mapping fields one to one.

4. The mandatory phasing differs between versions and must be verified on the spot. The SFDA phases in mandatory UDI labelling and Saudi-DI submission by risk class; public sources show batch deadlines differ between versions: the practical estimate is 1 September 2023 and 1 September 2024 for the higher and lower risk classes respectively, with current SFDA announcements and MDS-REQ 7 prevailing. An earlier set (Class B/C 2022-02-01, Class A 2023-02-01) and another set (Class D 2023-06-01, B/C 2024-01-01, A 2025-06-30) also circulate. Whichever set is credited, one action is executable: check the current mandatory batches on the Saudi-DI or GHAD portal and archive a screenshot. Products approved via the reliance pathway (MDS-G030 V1.0) bear the same UDI and Saudi-DI duties; reliance compresses review timelines and does not waive data duties. Note the exclusions: devices for research and research use, and IVDs and devices custom-made for specific patients, fall outside UDI; SaMD, implantable, configurable devices, components and subsystems, the device constituent parts of combination products, and single-use devices have dedicated provisions.

For UDI data and post-market changes, see https://www.grzan.cn/regulations/saudi/pms-and-udi-data-maintenance-47 ; for UDI documents at import clearance, see https://www.grzan.cn/regulations/saudi/import-clearance-and-shipment-permit-36 .

4. Practical recommendations

• Choose the issuing agency first: select among GS1, HIBCC and ICCBBA, complete membership and prefix applications, and do not mix agencies within one product line.
• Model by layer: define the DI for the device body, inner, middle and outer packaging, forming a packaging hierarchy table.
• Dual-form check: labels and every higher-level packaging carry HRI and AIDC; barcodes verified against ISO/IEC standards, grading reports retained.
• Reusable devices: confirm whether direct marking (DM) is required on the body, and validate permanent readability over the expected lifetime.
• Data before market: schedule Saudi-DI submission as an independent pre-market milestone, with new UDI-DI data retrievable before shipment.
• Field consistency across tracks: build a GHAD and Saudi-DI field mapping table, comparing model names and GMDN codes word for word.
• Change linkage: add a UDI impact assessment to design changes; when a DI changes, update labels, packaging, the database and GHAD records in step.
• Verify mandatory batches on site: check the current batches on the Saudi-DI or GHAD portal and archive screenshots; direct questions to SFDA free channels, call centre 19999 and md.rs@sfda.gov.sa.

5. Verification checklist

• □ Current MDS-REQ 7 downloaded (V4.0, 2022-05-24) and checked for later revisions
• □ Issuing agency selected among GS1, HIBCC and ICCBBA, prefix obtained
• □ UDI-DI and UDI-PI structures defined; lot number, serial number, software identification and expiry date in the PI
• □ UDI applied on the device label and all higher-level packaging
• □ Both HRI and AIDC present, barcode grading report retained (ISO/IEC)
• □ Direct marking (DM) applied to reusable devices and validated permanently readable
• □ New UDI-DI data retrievable in Saudi-DI, completed before market placement
• □ Model names and GMDN codes identical word for word between GHAD and Saudi-DI
• □ Scope and exclusions confirmed (research-use and custom-made IVDs and devices excluded)
• □ Current mandatory batches checked on the Saudi-DI or GHAD portal, screenshots archived

Regulatory information verified as of 29 October 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 coordinates Saudi Authorized Representative arrangements, import licences, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com