How to Place a Medical Device on the Saudi Market in 2026: MDMA versus Authorized Representative versus Establishment License, SFDA Classes A–D, 2025 Fees, and the May 2026 Bundling Rules

What Is in Force on the Saudi Market Today: MDMA, CE Reliance, or Both?

For international medical device manufacturers and Middle Eastern distributors structuring supply agreements for the Kingdom of Saudi Arabia (KSA), few regulatory topics generate as much commercial confusion as the relationship between European CE marking, US FDA clearance, and Saudi Food and Drug Authority (SFDA) marketing authorization. Overseas sales teams frequently present CE certificates or 510(k) letters to Saudi distributors under the assumption that Saudi Arabia operates an expedited 'mutual recognition' or 'regulatory reliance' gateway. That assumption does not match the in-force SFDA technical-file pathway ¹.

The regulatory framework governing medical device commercialization in Saudi Arabia is codified in the Medical Devices and Supplies Law, promulgated by Royal Decree No. (M/54) dated 6/7/1442 H, and its formal Implementing Regulation enacted under Board of Directors Decree No. (3-29-1443) ¹⁰. MDS-REQ 1 requires SFDA registration and an MDMA based on technical documentation and the Essential Principles of Safety and Performance; it does not describe a GHTF reference-country reliance route or treat a CE mark or 510(k) as a substitute for MDMA ¹. Consultancy pages that still cite the 2008 Medical Device Interim Regulation or GHTF reliance are describing a superseded framework, not the current filing test.

Today, placing any medical device on the Saudi market requires a full, independent Medical Devices Marketing Authorization (MDMA) issued directly by the SFDA ⁹. Applications must be submitted through the SFDA's unified electronic system, known as GHAD (the Unified Electronic System for Medical Devices and Supplies), under MDS-REQ 1. SFDA FAQs still refer to this as the Technical File Assessment (TFA) track ¹.

Marketing Authorization (MDMA): A document issued by the SFDA permitting the circulation of a medical device in the market.— SFDA MDS-G028, Annex 1 (version 1.0, 3 May 2026)

While a European CE certificate or US FDA 510(k) clearance does not grant automatic market entry, foreign approvals remain highly valuable. Under MDS-REQ 1, clinical evaluation reports, ISO 10993 biocompatibility dossiers, sterilization validation reports (ISO 11135 or ISO 11137), and risk management files (ISO 14971) prepared for European Notified Bodies or the US FDA serve as core technical documentation in the GHAD submission ¹. However, the SFDA conducts its own substantive review, verifies conformity against Saudi Essential Principles, reviews Arabic labeling and IFU requirements, and issues a standalone Saudi MDMA certificate ⁹.

MDS-REQ 1's submission architecture is a technical-file assessment against Saudi Essential Principles, not a reliance file that lists a prior CE mark, 510(k), or country-of-origin approval as a prerequisite ¹. A device that holds China NMPA registration without an EU CE mark can still be filed if the manufacturer compiles the documentation MDS-REQ 1 requires. Existing CE or 510(k) evidence still belongs in that file as supporting technical documentation after it has been verified; it does not replace the MDMA ⁹. For the Great Britain analogue of this country-entry decision, see placing the same device on the Great Britain market.

How Do MDMA, the Authorized Representative License, and the Importer/Distributor Establishment License Differ?

One of the most frequent structural errors made by international procurement teams is treating the Saudi regulatory process as a single commercial agreement. Commercial teams often ask: 'Does our Saudi distributor hold the registration, or do we?' In Saudi law, market access is partitioned into three distinct legal pillars that must never be conflated ⁶:

• 1. Medical Devices Marketing Authorization (MDMA): The product-specific marketing license issued by the SFDA. The MDMA is granted in the name of the legal manufacturer (with the Authorized Representative listed as the local administrative liaison). The MDMA establishes that the specific device design, packaging, sterilization, and labeling meet Saudi statutory standards ¹.
• 2. Authorized Representative (AR) License: The legal representation license required for any overseas manufacturer that does not maintain a direct corporate entity within the Kingdom. The AR must be a Saudi legal entity formally appointed by the manufacturer through an authenticated mandate contract and licensed by the SFDA under Article 6 of Law M/54 ⁶.
• 3. Establishment License for Importers and Distributors: The commercial establishment license required under MDS-REQ 9 and Article 6 of Law M/54 for any commercial entity that physically imports, warehouses, transports, or sells medical devices within Saudi Arabia ⁷.

To visualize how these three instruments interact during market entry and ongoing commercial distribution, review the regulatory architecture below:

Can a single Saudi company serve as both the Authorized Representative and the commercial distributor? Yes, but this requires strict contractual discipline. When an exclusive distributor also acts as the AR, the distributor controls the GHAD portal access and the MDMA administrative certificate ⁶. If the commercial relationship sours, transferring the MDMA to a new partner requires an official AR mandate cancellation and transfer on GHAD, which can stall commercial supply if the distribution agreement did not explicitly separate AR responsibilities from sales quotas.

For this reason, many international manufacturers prefer to appoint an independent third-party regulatory entity as their licensed Saudi Authorized Representative, and then grant non-exclusive or territory-specific distribution rights to multiple commercial importers who hold their own establishment licenses under MDS-REQ 9 ⁷. To verify the Quality Management System documentation underpinning a prospective Saudi AR or distributor, teams should consult our comprehensive guide on verifying ISO 13485 QMS certificates.

How Does SFDA Classify Devices A–D, and Why Must You Not Import an EU IIa or US Class II Label as the Saudi Class?

Device classification in Saudi Arabia is governed by guidance document MDS-G008 (Guidance on Medical Devices Classification, version 2.0 dated 13 December 2022), which formally replaced the earlier MDS-G42 guidance ³. Under MDS-G008, medical devices (excluding In Vitro Diagnostics, which follow a dedicated IVD schema) are categorized into four risk classes: Class A (Low Risk), Class B (Low-Medium Risk), Class C (Medium-High Risk), and Class D (High Risk) ³.

A critical compliance principle emphasized in SFDA FAQ 73908 is that the legal manufacturer is strictly responsible for classifying the medical device using the rules set out in MDS-G008 ⁸. The manufacturer must evaluate all classification rules against the device's specific intended medical purpose and assign the device to the highest risk class triggered by any applicable rule ³. FAQ 73908 still hyperlinks the withdrawn MDS-G42 PDF; use MDS-G008 as the live guidance.

Why is it a severe regulatory mistake to copy an EU or US classification label directly into a Saudi filing? Regulatory consultancies frequently make the error of describing Saudi devices using European roman numerals (such as 'SFDA Class IIa' or 'Class IIb') or US three-tier numbering ('SFDA Class II') ³. These labels do not exist in Saudi law. When an applicant selects the wrong classification nomenclature or misinterprets the underlying rule, the GHAD system rejects the submission, resulting in forfeited review fees and substantial project delays.

Consider the crucial application of MDS-G008 Rule 6 (Surgically Invasive Devices Intended for Transient Use). Rule 6 governs medical devices that penetrate the body through the surface or via surgical incision for a transient duration (defined as continuous use for less than 60 minutes) ³:

• Default Rule 6 Classification: All surgically invasive devices intended for transient use are classified as Class B by default ³. MDS-G008's own examples of that default include single-use scalpels and hypodermic needles. A sterile single-use circumcision stapler, circumcision ring, or energy-delivery fiber is not a reusable surgical instrument under the Class A exception, but the manufacturer still has to apply every remaining rule — including Rule 9 for active therapeutic energy devices and dedicated accessories — and file the highest class.
• Rule 6 Specific Class A Exception: The only exception that permits a transient surgically invasive device to be down-classified to Class A is if the device is a reusable surgical instrument (defined as instruments used in surgery for cutting, drilling, sawing, scraping, clamping, or retracting, without being connected to an active medical device, and intended to be cleaned and sterilized between uses) ³.
• The Single-Use Consumable Pitfall: A sterile single-use circumcision stapler, circumcision ring, or puncture needle is not a reusable surgical instrument. Footnote 7 of Rule 6 states that single-use surgical instruments remain Class B under that rule. That is a rule illustration, not a filed class for a named VEMERIX SKU; the manufacturer still documents the highest applicable rule ³.

For a comparative analysis of how circumcision devices and single-use staplers are categorized across global regulatory regimes, see our dedicated guide on US, EU, and China circumcision evidence packs.

What Does the May 2025 MDMA Fee Table Actually Charge, and Which Lead Time Is Printed?

Budgeting for Saudi market access requires strict adherence to the official Elevation Fees of Medical Device Marketing Authorization (MDMA) schedule published by the SFDA in May 2025 ⁴. Many commercial proposals circulating in the Middle East continue to cite superseded 2019 fee structures or inaccurate flat-rate estimates.

The May 2025 elevation schedule establishes base application fees strictly stratified by the device's SFDA risk class (Classes A through D), alongside standardized fees for renewals and post-approval administrative variations ⁴:

A crucial nuance regarding review timelines: on the official May 2025 fee elevation sheet, 35 working days is printed exclusively in the row corresponding to Class A applications ⁴. Classes B, C, and D do not have a statutory timeline printed on the fee schedule. A December 2024 SFDA fee sheet had printed 35 working days beside Classes A–D; the later May 2025 elevation sheet dropped those B/C/D cells. Do not treat FAQ 73908 (classification) as a review-clock source. When SFDA returns a file with observations, FAQ 73938 explains that the applicant has 60 calendar days in total across three cycles to fulfil those requirements — that is an applicant-response window, not a promise of how long SFDA will take to review a complete Class B or Class C file ¹⁴.

Additionally, regulatory managers must avoid another prevalent online myth: claiming that an SFDA MDMA certificate is valid for five years. MDS-REQ 1 does not print a 3-year or 5-year statutory term. Annex 12 points fees, review time and validity to SFDA circulars; Annex 13 says the certificate itself states the period of its validity ¹. What is in the current requirement documents is the duty to renew before expiry, with a renewal request permitted from 90 days before expiry under both MDS-REQ 1 and MDS-REQ 5 ⁵. Read the term on the certificate in GHAD; do not budget from a consultancy page.

When Can Multiple Sizes, a System, or a Procedure Pack Share One MDMA under MDS-G028 (3 May 2026)?

When an international manufacturer produces a medical device line with multiple sizes (for example, a circumcision stapler available in 10 mm through 38 mm diameters, or laser fibers with radial versus bare-tip configurations), a central commercial question arises: Must we pay 19,000 SAR for every individual SKU, or can the entire portfolio share a single MDMA application?

This question is now governed authoritatively by guidance document MDS-G028 (Guidance on Bundling Criteria for Medical Devices within a Single MDMA Application, version 1.0, dated 3 May 2026) ². MDS-G028 formally replaced and superseded Annex 15 of MDS-REQ 1, introducing precise statutory criteria and strict numerical ceilings that every applicant must obey ².

Under MDS-G028, multiple medical device SKUs can be bundled into a single MDMA application only if they qualify under one of four designated bundling categories: Medical Device Family, Medical Device System, Medical Device Procedure Pack (Convenience Kit), or In Vitro Diagnostic Category ².

Beyond the family and system rules, MDS-G028 imposes three non-negotiable operational requirements that prevent common bundling rejections ²:

• The Hard Ceiling of 5 Technical Files and 50 Items: No single MDMA application may contain more than five (5) distinct technical construction files or more than fifty (50) individual item codes / SKUs. If a manufacturer produces 75 size variants or accessories, the portfolio must be split into at least two separate MDMA applications with two separate application fees ².
• The Standalone-Plus-Kit Prohibition: MDS-G028 explicitly forbids bundling a standalone commercial SKU (sold separately) with a procedural set or kit in a single MDMA. For example, if a manufacturer sells the Circumcision Anastomat as a standalone sterile device AND also sells a pre-packaged Circumcision Anastomat Procedure Kit containing drapes and gauze, the standalone device and the procedure kit require separate MDMA applications ².
• Component Manufacturer Letters of Agreement: For procedure packs containing components sourced from third-party manufacturers, MDS-G028 mandates that the pack assembler include a formal Letter of Agreement from each component manufacturer agreeing to provide full technical documentation and design master files directly to the SFDA upon request ².

For a detailed comparison of how procedure packs and convenience kits are regulated under US FDA and European MDR Article 22 frameworks, see our operational guide on sterile procedure kit regulation in the US and EU.

What Do GHAD Submission and Shipment Clearance (MDS-REQ 5) Still Check Before the First Container Is Released?

Obtaining an approved MDMA certificate is a major milestone, but it does not guarantee that a container will clear Saudi customs. Commercial importation and physical shipment release at Saudi seaports, airports, and land border crossings are governed by MDS-REQ 5 (Requirements on Importation and Shipments Clearance of Medical Devices and Supplies, version 6.0 dated 19 July 2023) ⁵.

Under MDS-REQ 5, Saudi Customs systems (FASAH) are integrated directly with the SFDA's GHAD electronic database. When a shipment arrives at the port of entry (such as King Abdulaziz Port in Dammam, Jeddah Islamic Port, or King Khalid International Airport in Riyadh), customs automated screening cross-checks four mandatory regulatory data points before releasing the physical cargo ⁵:

Pay particular attention to the footnote in MDS-REQ 5 regarding the Manufacturer's Declaration of Conformity: the note stating that naming the Authorized Representative on the circulation Declaration of Conformity is 'Not applicable for low-risk medical devices that are non-sterile and not having measuring function' ⁵. Sales representatives frequently cite this note to argue that an AR is not needed. The note is limited to low-risk devices that are non-sterile and not measuring. Sterile surgical consumables do not meet those three conditions and should name the licensed Authorized Representative on the circulation DoC ⁵.

Does a CE Certificate or 510(k) Clearance Replace the Technical File, and What Does It Still Contribute?

Because MDS-REQ 1 is a technical-file assessment rather than a CE or 510(k) reliance route, what role do existing European CE certificates or US FDA 510(k) clearances actually play in a 2026 Saudi MDMA filing? They do not replace the technical file. They can shorten assembly of the GHAD dossier when the underlying reports already map to Saudi Essential Principles ¹.

SFDA's Overview Medical page describes the sector's framework as aligned with IMDRF and GHWP practice, and MDS-REQ 1 requires evidence of conformity with the Essential Principles ⁹. A manufacturer that already maintains EU MDR technical documentation or an FDA 510(k) design-history file can usually reuse the following sections as supporting evidence — SFDA still reviews them against Saudi requirements rather than accepting a foreign certificate as automatic proof:

• Biocompatibility Evaluation (ISO 10993 Series): ISO 10993-series biological evaluation reports prepared for European or US regulators can be placed in the technical file as evidence of Essential Principles conformity; they are not a substitute for SFDA review ¹. See our guide on reviewing ISO 10993 biocompatibility files.
• Sterilization Validation & Bioburden Controls: Ethylene oxide (ISO 11135) or radiation (ISO 11137) sterilization validation dossiers, EO residual testing (ISO 10993-7), and packaging sterile-barrier integrity testing (ISO 11607-1/2) can usually be reused in the Saudi file when they still cover the marketed configuration; they do not by themselves prove SFDA acceptance. See our EO sterilization guide and sterile-barrier packaging guide.
• Clinical Evaluation Reports (CER): Clinical evaluation evidence belongs in the technical documentation; MDS-REQ 1 Annex 6 covers clinical evaluation and post-market clinical follow-up. MEDDEV 2.7/1 or MDCG 2020-6 structure can help assemble that evidence, but those EU documents are not a Saudi statutory section ¹.
• Risk Management File (ISO 14971): Risk analysis, hazard identification, and risk-benefit conclusions prepared for CE marking are typical inputs to the MDS-REQ 1 risk-management file; SFDA still assesses whether they cover the Saudi intended use and Essential Principles.

However, distributors must verify the authenticity and scope of any foreign certificate before submitting it to the SFDA. Submitting an expired, suspended, or scope-mismatched CE certificate or 510(k) printout is a foreseeable cause of questions, delay, or refusal. To verify foreign regulatory documents independently, distributors should consult our guide on verifying CE certificates and Notified Body designations and our step-by-step 510(k) verification methodology.

If the SFDA technical reviewer requests a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG) from the country of origin to verify legal commercialization, teams should follow our dedicated guide on authenticating Certificates of Free Sale and export certificates.

Arabic Labeling, Saudi-DI UDI, and Post-Market Duties That Apply After MDMA

Once the MDMA certificate is granted, the manufacturer and its Authorized Representative inherit ongoing post-market compliance obligations under Law M/54 that must be maintained throughout the product lifecycle ¹⁰:

• Dual-Language Labeling Requirements: SFDA labeling rules enforce strict language standards based on user persona. MDS-REQ 1 Essential Principles require information supplied by the manufacturer for devices for use by lay persons to be in both Arabic and English, including an Arabic trade name as pronounced in English on the label ¹. The same annex does not print a blanket 'English-only is always sufficient' permission for professional-use IFUs. Confirm GHAD artwork requirements with the Authorized Representative for each SKU rather than assuming hospital-use devices need no Arabic.
• Saudi-DI (Unique Device Identification): MDS-REQ 7 requires the manufacturer to assign UDI using an accepted issuing agency (GS1, HIBCC or ICCBBA). The UDI comprises UDI-DI and UDI-PI. The manufacturer or Authorized Representative shall submit and maintain the data in the Saudi-DI database; UDI-DI data shall be available in that database at the time the device is placed on the market ¹⁵. US GUDID or EUDAMED entries are not a substitute. For private-label UDI architecture outside KSA, see our guide on UDI for private-label medical devices.
• Post-Market Vigilance & Mandatory Incident Reporting: SFDA FAQ 59933 sets the incident clocks from the date of awareness: not later than 2 working days for a serious public health threat; not later than 10 working days for an unanticipated death or unanticipated serious injury; and not later than 30 calendar days for events, incidents and complaints not associated with high risks ¹¹. MDS-REQ 9 refers incident and shortage notifications to the National Center for Medical Devices Reporting (NCMDR). Do not cite Law M/54 Article 24 for these clocks — SFDA cites Articles 24 and 25 of the Law for advertising and promotion, not for vigilance ¹⁰.
• Field Safety Corrective Actions (FSCA) & Recalls: Field safety corrective actions that affect the Kingdom must be notified to SFDA through the Authorized Representative or importer. Do not invent a 48-hour statutory clock; use the current SFDA FSCA/NCMDR procedure and the incident clocks in FAQ 59933 where they apply ¹¹.

Worked Examples: A CE-Marked Circumcision Ring versus an NMPA-Only Laser Fiber

To demonstrate how these regulatory principles apply in practice, let us examine two real-world device configurations from the VEMERIX surgical and vascular portfolios ¹²:

Case Study 1: The CE-Marked Auto-Circumcision Ring

• Device Profile: Single-use, self-detaching biodegradable circumcision ring; adult and pediatric variants across 14 size codes; supplied factory-sterile via Ethylene Oxide blister packaging ¹².
• Existing Regulatory Status: NMPA Class II (Registration: Lu Mech Reg. 20172020238) and European CE Mark certificate ¹².
• Saudi classification method: The manufacturer applies MDS-G008 to intended use and files the highest applicable rule. Rule 6's default for transient surgically invasive devices is Class B, and the Class A reusable-instrument exception does not apply to a factory-sterile single-use ring. That is a rule-path, not a filed SFDA class for this SKU ³.
• Bundling Structure (MDS-G028): The 14 size codes can be proposed as a Medical Device Family only if they share legal manufacturer, intended use, risk class, GMDN definition when available, and common design/materials/process, and stay within five technical files and 50 items. Confirm GMDN and design-commonality on the actual IFU and technical file before paying one Class-B-or-higher fee for the whole range ².
• Fee if Class B is the highest applicable class: 19,000 SAR on the May 2025 new-application schedule — budget only after the manufacturer has documented the class ⁴.
• Filing Strategy: The existing CE technical documentation and ISO 11135 EO validation files form the core of the GHAD submission. The CE mark accelerates the review, but the manufacturer and its licensed AR still obtain a standalone Saudi MDMA before shipping to Saudi hospitals ¹.

Case Study 2: The Disposable Medical Laser Fiber

• Device Profile: Single-use medical optical laser fiber (1470 nm endovenous laser ablation) pairing with a partner-supplied diode laser source. The console is not a Medison-manufactured or Medison-registered capital system ¹³.
• Existing Regulatory Status: NMPA Class II (Registration: Lu Mech Reg. 20192010517); no European CE mark claimed by the consumable manufacturer ¹³.
• Saudi classification method: The manufacturer applies every applicable MDS-G008 rule. Rule 6 is relevant because the fiber is surgically invasive and single-use. Rule 9 is also relevant because active therapeutic devices that administer energy — and dedicated accessories that influence them — can elevate to Class C when energy is administered in a potentially hazardous way; MDS-G008's Class C examples include surgical lasers. Do not file the fiber as Class B by slogan, and do not bundle it into one system MDMA with a partner-supplied generator that has a different legal manufacturer ³.
• Is It Eligible for Saudi MDMA Without CE? Yes, as a filing pathway. MDS-REQ 1 does not list a prior CE mark or 510(k) as a submission prerequisite. The manufacturer still compiles a full technical file — NMPA bench data, ISO 10993 evaluation, optical performance, and ISO 11135 sterility — against the Essential Principles ¹. To verify the underlying China NMPA certificate, see our guide on verifying China NMPA registration certificates.
• Fee: Pay the May 2025 new-application fee for the class the manufacturer actually files, not a class copied from China NMPA 'Class II' ⁴.
• Clearance Gate: Requires an active MDMA, licensed AR mandate, and licensed Saudi distributor holding an establishment license with controlled storage facilities ⁵.

Distributor Checklist, Agreement Terms, and Red Flags Before the First KSA Shipment

Before executing a distribution agreement or issuing purchase orders for the Saudi market, procurement teams and international manufacturers should execute the operational checklist below:

Where VEMERIX Fits in Saudi Market Registration—and Where Due Diligence Still Begins

VEMERIX operates as the international brand of Weihai Medison Medical Equipment Co., Ltd., positioned as a Minimally Invasive Surgery Total Solution Platform serving urology, vascular surgery, and perioperative care ¹².

When partnering with Middle Eastern distributors, private-label buyers, and regional hospital procurement consortia targeting the Saudi market, VEMERIX structures regulatory cooperation on complete transparency:

• Technical File Assembly for GHAD: VEMERIX provides comprehensive technical construction files—including ISO 10993 biocompatibility testing, ISO 11135 EO sterilization validation data, design drawings, and clinical evaluation summaries—to support the distributor's appointed Saudi Authorized Representative during GHAD MDMA filing.
• MDS-G028 Bundling Architecture: We map product families (such as the 14-size Circumcision Device range) against MDS-G028's five-technical-file and 50-item ceiling so a distributor can see what will and will not share one MDMA before paying a class fee.
• Certified Quality Management System: All manufacturing facilities operate under certified ISO 13485 Quality Management Systems with complete traceability, supporting the Quality Management System documentation required for Saudi AR and importer filings.
• Contractual Clarity on Regulatory Ownership: We support distributors in establishing clean, separate Authorized Representative mandates and distribution agreements, ensuring that regulatory ownership, vigilance reporting, and market access rights remain unambiguous throughout the partnership.

To explore technical specifications, request sample evaluation kits, or initiate regulatory data pack reviews for Saudi Arabia market access, explore our surgical and vascular portfolios on our Circumcision Device product page, review our Disposable Medical Laser Fiber platform, inspect our quality systems at VEMERIX Quality & Compliance, or contact our international regulatory team directly through VEMERIX Partner Inquiries.

Frequently Asked Questions

Do I need an SFDA MDMA if my device already has an EU CE mark or FDA 510(k)?
Yes. Under Law M/54 and MDS-REQ 1, every medical device placed on the Saudi market must hold an independent Medical Devices Marketing Authorization (MDMA) issued by the SFDA. European CE certificates and US FDA 510(k) clearances serve as vital supporting technical documentation in the GHAD submission, but they do not bypass the requirement for a Saudi MDMA ¹.

Is a Saudi Authorized Representative (AR) the same as a commercial importer or distributor?
No. An Authorized Representative is a legal entity mandated by the foreign manufacturer to manage regulatory affairs, GHAD submissions, and vigilance before the SFDA (2,600 SAR annual contract fee). A commercial importer is a licensed entity authorized to physically import, warehouse, and sell devices under MDS-REQ 9. A single Saudi company can hold both licenses, but they represent two distinct legal responsibilities ⁶.

Can I bundle 50 circumcision stapler sizes into a single MDMA application?
Yes, provided they meet MDS-G028 family criteria: the same legal manufacturer, intended use, risk class, GMDN definition when available, and common physical design, construction material and manufacturing process, within the five-technical-file and 50-item caps. However, 50 is the absolute statutory cap; a 51st size would require a second MDMA application and an additional application fee ².

How much are SFDA MDMA application fees in 2026?
Under the official May 2025 fee schedule, new MDMA application fees are: Class A (15,000 SAR), Class B (19,000 SAR), Class C (21,000 SAR), and Class D (23,000 SAR). Standard renewals cost 5,000 SAR, and minor administrative variations (label/IFU updates only) cost 1,100 SAR ⁴.

Does an SFDA MDMA allow me to sell devices in the UAE or other GCC countries?
No. An SFDA MDMA is a national marketing authorization valid strictly within the Kingdom of Saudi Arabia under Royal Decree M/54. Placing devices in the United Arab Emirates (UAE MoHAP), Qatar (MOPH), Kuwait, Bahrain, or Oman requires separate national registration filings in each target country ¹⁰.

Is the SFDA MDMA review always completed within 35 working days?
No. The May 2025 elevation sheet prints 35 working days only in the Class A row ⁴. Classes B–D have no lead time printed on that sheet. FAQ 73938's 60 calendar days is the applicant's total window to answer SFDA observations on a returned file, not a guaranteed SFDA review duration ¹⁴.

Does a sterile single-use circumcision stapler qualify for the Class A abbreviated file?
No. MDS-REQ 1's abbreviated low-risk file already excludes sterile devices. Separately, Rule 6's Class A exception is limited to reusable surgical instruments; a factory-sterilized single-use stapler is not that exception. The manufacturer still files the highest applicable MDS-G008 rule rather than copying an EU IIa or US Class II label ¹.

Does VEMERIX already hold an SFDA MDMA for its surgical products?
No. This article does not claim that VEMERIX or Weihai Medison currently holds an SFDA MDMA for these SKUs. VEMERIX maintains ISO 13485 manufacturing and technical files — including China NMPA registrations and a European CE certificate where one is in force for that SKU, such as the Auto-Circumcision Ring — and can support a licensed Saudi Authorized Representative assembling a GHAD file. Due diligence still begins with the distributor's GHAD roles and a current MDMA check ¹².