SFDA MDMA Fee Structure in SAR

1. Key takeaways

Saudi MDMA fees are tiered by risk class: the practical estimate is Class A SAR 15,000, Class B SAR 19,000, Class C SAR 21,000 and Class D SAR 23,000, with renewal at SAR 5,000; adding devices, adding models, brand name changes and minor changes of manufacturer name or address are each SAR 5,000; label updates, IFU updates and advertising material updates are each SAR 1,100; risk class changes and legal manufacturer name or address changes are charged at the full fee. The AR licence is a practical estimate of SAR 2,600 per contract per year, the MDEL SAR 5,000 to 25,000, and the classification determination application SAR 1,000. All official fees carry an additional 15% VAT, payable through SADAD; actual rates are governed by invoices issued through the GHAD portal or the SFDA billing system and by current SFDA announcements.

• Application fees by class: A SAR 15,000, B SAR 19,000, C SAR 21,000, D SAR 23,000 (practical estimate).
• Renewal SAR 5,000; most changes SAR 5,000; label, IFU and advertising updates SAR 1,100 each (practical estimate).
• Risk class changes and legal manufacturer name or address changes are charged at the full fee.
• AR licence SAR 2,600 per contract per year; MDEL SAR 5,000 to 25,000; classification determination SAR 1,000 (practical estimate).
• Add 15% VAT to every fee; payment runs through SADAD with GHAD invoices as the binding amount.

2. Legal basis

The table below lists the instruments cited for the fee structure. All figures come from third-party public sources and are marked as practical estimates, pending verification against official invoices and announcements.

3. Expert insights

1. Fees look like a four-step risk ladder, but the real budget eaters are change fees and renewal rhythm. From Class A to Class D the application fee rises from SAR 15,000 to SAR 23,000, a spread of only SAR 8,000, which makes the risk class look like a minor cost factor. Stretch the timeline, however, and another picture appears: renewal is SAR 5,000 each time, and adding devices, adding models, brand name changes and minor changes of manufacturer name or address are each SAR 5,000. A product line that makes a few model extensions, changes its brand name once and adjusts a manufacturer address quickly accumulates more than the initial application fee. When GRZAN builds budgets for clients, it models over a three-to-five-year horizon, folding in change events at reasonable frequencies, rather than quoting a single application fee figure.

2. The phrase at the full fee is the largest uncertainty in the cost model. Under the fee schedule, risk class changes and legal manufacturer name or address changes are marked as charged at the full fee, while label updates, IFU updates and advertising material updates are each SAR 1,100. Full fee means the application fee for that device’s risk class is charged again: SAR 23,000 for a Class D device, plus 15% VAT. The difference matters greatly to Chinese manufacturers: intragroup moves of the production entity, brand owners changing the legal manufacturer, and product upgrades judged as risk class increases can all trigger the full fee. Run the change classification first, before any adjustment touching the manufacturer entity or risk class, rather than changing first and filing afterwards.

3. Entity-side and transaction-side fees follow two logics and are easily left out. Beyond product-side MDMA fees there are entity-side and administrative outlays: the AR licence at SAR 2,600 per contract per year, the MDEL range of SAR 5,000 to 25,000, and the classification determination application at SAR 1,000. All three carry an additional 15% VAT, and the AR licence is the only periodic fixed outlay. Non-official costs are also easily missed: notarization and legalization, translation, local testing, site remediation, consulting and travel. GRZAN’s experience is that official fees are usually not the largest cash item in a Saudi project; relabelling artwork and UDI data clean-up, the items that look free, often are.

4. Interaction with the reliance pathway and bundling decides the size of the upfront investment. One value of the reliance pathway (MDS-G030 V1.0) is a review timeline compressed to 35 to 60 working days, but it does not lower the rates; conversely, bundling (MDS-G028 V1.0) directly decides the number of applications and therefore the multiplier on application fees. Under MDS-G028 V1.0, one application covers at most 5 technical files (TFs) and no more than 50 devices in total, so eligible product lines bundled into families, systems, procedure kits or IVD groups can merge multiple application fees into one. GRZAN’s advice: the main battlefield of cost optimization is application structure design, not haggling over rates; getting the bundling logic right saves multiples of SAR 15,000 to 23,000.

For VAT and payment rhythm in budgeting, see https://www.grzan.cn/regulations/saudi/vat-and-payment-channels-for-sfda-fees-39 ; for how bundling affects application counts, see https://www.grzan.cn/regulations/saudi/mds-g028-bundling-family-and-system-28 .

4. Practical recommendations

• Model over three to five years: fold the initial application, renewal (SAR 5,000), changes (SAR 5,000 and SAR 1,100) and the AR licence (SAR 2,600 per contract per year) into one table.
• Classify the risk class first: where classification is uncertain, file the classification determination application first (practical estimate SAR 1,000) before quoting costs.
• Classify changes before acting: for adjustments touching the risk class or legal manufacturer name and address, confirm first whether the full fee applies.
• Use bundling to control application counts: design the application structure within the MDS-G028 V1.0 limits of 5 TFs and 50 devices to reduce repeated application fees.
• Add 15% VAT to every line: multiply all official fees by 1.15 before totalling, avoiding budget shortfalls.
• Pay via SADAD and keep vouchers: treat the GHAD billing amount as binding and archive receipts under both application number and device model.
• Separate official from non-official outlays: list notarization, legalization, translation, testing and local remediation as separate lines, not mixed with official fees.
• Recheck before each payment: rely on invoices issued by the GHAD portal or SFDA billing system; direct questions to call centre 19999 or md.rs@sfda.gov.sa.

5. Verification checklist

• □ Application fee tier fixed by risk class (A SAR 15,000, B SAR 19,000, C SAR 21,000, D SAR 23,000; practical estimate)
• □ Renewal fee of SAR 5,000 included in the periodic budget (practical estimate)
• □ Change fees estimated by category: minor changes SAR 5,000, label, IFU and advertising updates SAR 1,100 (practical estimate)
• □ Situations charged at the full fee identified
• □ AR licence of SAR 2,600 per contract per year budgeted annually (practical estimate)
• □ MDEL range of SAR 5,000 to 25,000 estimated (practical estimate)
• □ Classification determination application of SAR 1,000 listed (practical estimate)
• □ All fees multiplied by 1.15 for the 15% VAT
• □ Application structure optimized under the bundling criteria, application counts minimized
• □ Actual rates rechecked against GHAD portal or SFDA billing system invoices

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