VAT and Payment Channels for SFDA Fees

Updated: 2026-11-12 · GRZAN Regulatory Team · Verification date 2026-10-20

1. Key takeaways

All official Saudi registration fees carry an additional 15% VAT on top of the listed price, are paid through SADAD, and the amount actually due is governed by invoices issued through the GHAD portal or the SFDA billing system. Taking a Class D new application as an example, the listed price of SAR 23,000 becomes SAR 26,450 with VAT; Class A at SAR 15,000 becomes SAR 17,250. Payment happens after submission and before review proceeds; while the invoice is unpaid, the process does not move forward, and this sequence means the budget must be calculated by timing as well as by total. The AR (Authorized Representative) licence is billed at SAR 2,600 per contract per year (practical estimate) and is the only periodic outlay. GRZAN’s advice: build the budget table on three columns, event, amount and timing, rather than spreading an annual total evenly.

  • Every official fee carries 15% VAT; Class D SAR 23,000 becomes SAR 26,450, Class A SAR 15,000 becomes SAR 17,250.
  • Payment runs through SADAD, with the GHAD invoice as the binding amount.
  • Payment falls after submission and before review; unpaid invoices stall the process.
  • The AR licence of SAR 2,600 per contract per year (practical estimate) is the only recurring expense.
  • Budget by event, amount and timing, and keep an auditable fee ledger of invoices and applications.

2. Legal basis

The table below lists the instruments cited for VAT and payment channels. Items marked as a practical estimate are pending verification against official invoices and announcements.

RegulationReferencePublication dateProvisionKey point
SFDA fee invoicing and VAT treatmentNo official fee announcement reference [practical estimate]No official publication date [practical estimate]No provision number [practical estimate]All official fees carry an additional 15% VAT; verification: invoice amounts issued by the GHAD portal or SFDA billing system and current SFDA announcements prevail
Payment channel SADADNo SFDA official statement reference [practical estimate]No official publication date [practical estimate]No provision number [practical estimate]Official fees are paid via SADAD; verification: confirm the payment method and bill numbering rules in the GHAD billing system
Law of Medical Devices and SuppliesRoyal Decree No. M/54, Hijri 1442/7/62021-02-18Article 1 (definition of License)A License is a document issued by the SFDA for any activity governed by the Law
MDS-REQ 1 Requirements for Medical Devices Marketing AuthorizationV6.0, reference MDS-REQ-001-V6/2112192021-12-19Article 4MDMA application, renewal and change procedures; verification: download the current version and check the filing provisions related to payment
MDS-REQ 9 Requirements for Licensing of Medical Devices EstablishmentsV1.0, reference MDS-REQ-009-V1/2207312022-07-31Specific article numbers not compiled item by item [practical estimate]Procedural basis for the AR licence and the MDEL; verification: download the current version and check the provisions

3. Expert insights

1. 15% is not small change; it is the most persistent deviation in the budget table. Under the practical estimate, all official fees carry 15% VAT. On common combinations: a Class C new application of SAR 21,000 becomes SAR 24,150 with VAT; renewal of SAR 5,000 becomes SAR 5,750; a label update of SAR 1,100 becomes SAR 1,265; and the AR licence of SAR 2,600 becomes SAR 2,990. Each item looks small, but across a project with several models, multiple years and several changes, ignoring this line produces a persistent underestimate. GRZAN makes the VAT-inclusive column the only externally quoted figure in its budget templates, so the internal price and the amount actually paid never diverge.

2. The payment sequence drives the process; timing causes more trouble than amounts. Official fees are paid after submission and before review, and while the invoice is unsettled the process usually does not advance. This makes the timing dimension of the budget more critical than the total: if the company’s payment approval cycle is longer than the invoice validity, or cross-border transfer time is not accounted for, an application can be filed yet sit idle outside review. This is especially visible on the reliance pathway (MDS-G030 V1.0), whose review timeline is 35 to 60 working days across all four risk classes; if that window is burned by payment delays, the time advantage reliance brings is cancelled out. The recommendation is to write the four actions, invoice issued, internal approval, SADAD payment, receipt archived, with owners and day counts into the project plan at initiation.

3. Tax burden and voucher management for overseas entities need early arrangement. Chinese manufacturers usually pay through cooperation between the overseas manufacturer entity and the local Saudi AR. Who bears the VAT, whether it can be credited or refunded, and how payment vouchers are booked are fiscal arrangements rather than regulatory requirements, but they directly affect project cost and internal approval speed (the specific treatment is a practical estimate, to be judged by the company’s tax advisers against Saudi tax rules and its own situation). The executable action is to download the formal invoice from the GHAD billing system and keep the original, map invoice numbers to application numbers and device models, and build an auditable fee ledger. In the archive GRZAN delivers at project close, the fee ledger sits beside the certificates as a key document; later changes and renewals all cite historical payment records.

4. Interaction between payment and change strategy. Since every change is billed separately and carries 15% VAT, the economics of combining several small changes need case-by-case judgement: label updates, IFU updates and advertising material updates are each SAR 1,100, so filing separately means three payments of SAR 1,265; but combining does not guarantee a single charge, depending on the current consolidation rules GHAD applies to change types (practical estimate, the billing statement prevails). Conversely, spacing changes such as adding models or brand name changes, each SAR 5,000, away from renewal at SAR 5,000 may be more controllable than bundling everything at once. The recommended approach: confirm the billing treatment of each change type with the billing system first, then decide whether to combine or split, rather than estimating from experience.

For the full fee landscape and rates, see https://www.grzan.cn/regulations/saudi/sfda-mdma-fee-structure-sar-38 ; for MDMA validity and renewal rhythm, see https://www.grzan.cn/regulations/saudi/mdma-validity-and-renewal-20 .

4. Practical recommendations

  • Standardize on VAT-inclusive figures: state all external budgets including 15% VAT, and stop using ex-VAT prices internally.
  • Build a conversion table: pre-convert fee types at the 1.15 factor (for example SAR 15,000 to 17,250 and SAR 23,000 to 26,450) to reduce ad hoc calculation errors.
  • Schedule payment timing: write the four steps of invoice issued, approval, SADAD payment and receipt archived into the project plan, with owners and day counts.
  • Pay via SADAD and keep vouchers: rely on the amount and bill number displayed by the GHAD billing system, archiving receipts under application number and device model.
  • Maintain a fee ledger: invoice number, application number, device model, amount and date mapped one to one, as the reference for later changes and renewals.
  • List annual outlays separately: the AR licence at SAR 2,600 per contract per year (practical estimate, SAR 2,990 with VAT) goes into fixed annual expenditure.
  • Ask the billing system before change strategy: confirm the billing treatment before combining or splitting changes, then decide the filing approach.
  • Arrange tax matters early: have tax advisers confirm VAT bearing, voucher booking and cross-border payment routes; for regulatory questions use call centre 19999 and md.rs@sfda.gov.sa.

5. Verification checklist

  • □ Budget table restructured into three columns: event, amount and timing
  • □ All fees converted at the 1.15 factor, including 15% VAT
  • □ Payment via SADAD and bill numbering rules confirmed in the GHAD billing system (practical estimate)
  • □ Owners and day counts for the four payment steps written into the project plan
  • □ Original invoices downloaded and mapped by application number and device model
  • □ VAT bearing and booking method for the overseas entity confirmed by tax advisers
  • □ AR licence annual fee of SAR 2,600 (SAR 2,990 with VAT) in the annual budget (practical estimate)
  • □ Billing treatment confirmed with the billing system for the change combination or split plan
  • □ Amounts actually due rechecked against GHAD portal or SFDA billing system invoices
  • □ Payment receipts archived, able to support later change and renewal references

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

Disclaimer

Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.

About GRZAN

GRZAN (Global Regulatory Zone Access Navigator) — the global market-access navigator for medical devices and IVDs.

GRZAN is a specialist consultancy for medical device and IVD market access, providing end-to-end regulatory solutions across the product lifecycle and making international market entry simpler and faster.

Key figures. More than 25 wholly owned subsidiaries worldwide covering 50+ countries and regions; chosen by 100+ listed and leading Chinese device manufacturers, with 4,000+ successful cases; 12+ years in the sector and 200+ regulatory training sessions and seminars delivered.

What we do. Global market access: multi-country registration programmes, technical documentation, regulatory advice. Clinical evidence: clinical evaluation reports (CER), usability studies, overseas clinical investigations. Quality systems: ISO 13485, MDSAP, FDA QMSR and BGMP implementation and audit readiness. Authorised representative and licence-holder services across Southeast Asia, Latin America, the Middle East, Africa, Europe and North America.

Why GRZAN. A real operating entity, with the certificate held by the manufacturer: our direct overseas subsidiaries act as the compliant local holder, so the regulatory relationship stays clear and you keep control rather than being tied to a distributor. Direct access to the team: no time-zone gap, no language barrier, no cultural gap. Review points anticipated: we know what FDA 510(k), EU MDR, Southeast Asian, Latin American and Middle Eastern reviewers look for, which shortens timelines and reduces deficiency letters. Pathway planning: pre-decision analysis and risk assessment before you commit.

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