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SFDA · structured requirements

🇸🇦 Saudi Arabia medical device regulatory data

Explore the medical device requirements currently available for Saudi Arabia, organized by topic and linked to official sources.

42 facts22 dimensions9 official sourceslatest verification 2026-09-15

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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Advertising approval requirement and tracks

advertising.approval-required
Fact-level verified

Medical devices may be advertised or promoted only after SFDA approval. Two submission tracks: 1st Track - advertising material submitted by the manufacturer/AR as part of the technical documentation within the MDMA application; 2nd Track - a separate advertising-approval application through the electronic portal. Track 1 approval validity is aligned with the MDMA validity; Track 2 approval is valid 1 year.

Conditions
  • The device must hold a Marketing Authorization Certificate; content must not mislead or exceed the manufacturer's claims.

Law M/54 Art. 24 as quoted in MDS-REQ8: 'Medical devices and supplies may not be advertised nor promoted without the SFDA's approval.' Awareness/charity campaigns also need prior SFDA approval (Art. 25).

Advertising language rules

advertising.language-rules
Fact-level verified

The advertisement language must be Arabic if directed at lay persons and English if directed at healthcare practitioners; other languages may be used in conformity with the advertisement's language. The same rule applies to awareness/charity campaign materials (English for professionals, Arabic plus English for lay users).

MDS-REQ8 adds procedural rules (e.g., lectures/seminars applications at least 14 working days prior; Mawthooq licensing for content creators; creator material sent 12 hours before publication).

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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Authorization duration

authorization.duration
Fact-level verified

The MDMA certificate is valid for a term of up to three (3) years from its date of issue.

Conditions
  • The 2016 fee circular adds: class I non-sterile/non-measuring MDMA validity will be 3 years; for all other classes MDMA will be valid for the remaining validity of the original license or 3 years for undefined license validity (GHTF-era nomenclature).

Expiry, lapse consequence and renewal window

authorization.lapse
Fact-level verified

The MDMA certificate must be renewed before its expiration date, with updated documents submitted through the electronic system; a renewal request can be submitted from 90 days before the expiry date. An expired MDMA cannot support ordinary placement on the market or import clearance.

Legal basis: Implementing Regulation Art. 10.7 ('shall renew the Marketing Authorization Certificate before the Certificate expires').

Authority & regime

Which authority and binding regime govern this product, task, and date?

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Competent authority

authority.competent-authority
Fact-level verified

The Saudi Food and Drug Authority (SFDA) is the competent authority for medical devices: no device may be traded in the Kingdom without SFDA registration and Marketing Authorization (MDMA). Manufacturers, Authorized Representatives and healthcare providers must report adverse events to SFDA's National Center for Medical Device Reporting (NCMDR).

Conditions
  • Applies to all device classes and to medical supplies.

Art. 28: 'The Manufacturer, Authorized Representative and healthcare provider shall report any adverse-event relating to their medical devices to the NCMDR.' Baseline fact cited MDS-G024; updated source/locator supplied.

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Change-control outcomes

change.available-outcomes
Fact-level verified

Two change tracks: significant/material changes must be notified to SFDA within 10 days and require SFDA approval (with the MDMA application updated in GHAD and the change form submitted); non-significant/non-material changes are notified within 30 days without prior approval (by email to MDMA.IT@sfda.gov.sa, followed by GHAD update within 90 days). A device subject to a significant change may not be traded before SFDA approval.

Detailed procedure: MDS-G012 v1.0 (26/09/2023); MDS-REQ1 restates the 10/30-day rule. This confirms and sharpens the baseline three-outcome structure: notification-based update vs prior-approval variation; a new application is not required for changes to an existing MDMA.

Significant changes require SFDA approval

change.significant-change-prior-approval
Fact-level verified

For significant (جوهرية) changes, SFDA must be notified within 10 days of the change and its approval is required; the MDMA application(s) must be updated in the GHAD system with the 'Medical Devices Change Form' (Annex 1 of MDS-G012) and related documents, and the changed device may not be traded before approval. Non-significant changes are notified within 30 days without approval.

Non-significant path: email to MDMA.IT@sfda.gov.sa with the MDMA certificate number in the subject, then GHAD update within 90 days or at renewal. Arabic text (translated): significant changes - notify SFDA (SFDA approval required) within 10 days of the change; non-significant changes - inform SFDA (no approval required) within 30 days.

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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Clinical evidence and local trial requirements

clinical.evidence-and-trial-approval
Fact-level verified

The MDMA technical documentation must include the clinical evaluation report, its updates and the clinical evaluation plan per Annex 6 (with PMCF plan/evaluation report where applicable). Local clinical trials or IVD performance studies require prior SFDA approval based on an approved Clinical Investigation Plan and IRB/Ethics Committee approval, appointment of a full-time Saudi national responsible for clinical trials (bachelor's degree and 3+ years experience), and an SFDA import permit for trial devices; completion, major deviations and safety/rights occurrences must be notified within 5 days.

Conditions
  • Trials must comply with the Saudi Law on Ethics of Research on Living Creatures; clinical investigators follow SFDA.MD/ISO 14155 (devices) and SFDA.MD/ISO 20916 (IVDs).

IVD performance evaluation follows Annex 7 of MDS-REQ1.

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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Medical device definition and scope

device-definition.core
Fact-level verified

Broad MDR-style definition covering instruments, apparatus, applied and implant devices, IVD reagents/calibrators, software and materials for operating medical devices, for diagnosis, prevention, monitoring, treatment or alleviation of disease etc., not achieving primary intended action by pharmacological/immunological/metabolic means. 'Medical Supplies' (including medical gases) and accessories are also within the Law's scope.

Medical Supplies: 'Medical materials and products used in diagnosis, treatment... including medical gases.' Accessories: 'Any material or product made to be used with a medical device to enable it to achieve the purpose for which it was manufactured.'

Software and digital health in scope

device-definition.software-digital-health
Fact-level verified

Software falls within the medical device definition; SFDA's digital-health guidance applies it to SaMD and digital-health categories (mHealth, digital therapeutics, health IT, telemedicine, wearables, VR/AR, AI/ML, general wellness). Software subject to the Law is classified by the intended purpose of the device it influences, or on a standalone basis by the classification rules.

Classification rule for software: Implementing Regulation Art. 21.3.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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Technical documents language

dossier.technical-documents-language
Fact-level verified

Technical documents must be submitted to SFDA in English unless SFDA has previously agreed to accept another language; if another language is used, an English translation of the relevant parts must be provided. Documents may alternatively be kept available for inspection on the same language terms.

The MDMA certificate itself is issued in both Arabic and English (MDS-REQ1 Annex 13).

MDMA technical dossier content

dossier.technical-requirements
Fact-level verified

The MDMA dossier includes administrative details (manufacturer, AR license and national registry number, authorized contact, undertaking), and technical requirements: conformity with the essential principles, technical documentation (device description, design and manufacturing information, risk management file, verification and validation including clinical trials, PMS plan, PSUR/PMS reports), labelling copy, environmental/usage information for the Kingdom, classification, QMS proof per Art. 22.1, and a Declaration of Conformity.

Conditions
  • SFDA may request further technical documents before deciding on the application (Art. 10.3).

Different devices may be bundled into one MDMA application per Art. 10.4 and MDS-REQ1 Annex 15 criteria.

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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Authorized Representative obligations

market-entry.ar-obligations
Fact-level verified

The AR must represent the manufacturer before SFDA, cooperate in post-market surveillance, inform SFDA of incidents occurring outside the Kingdom that affect devices circulated in KSA (with circumstances and corrective actions), and inform SFDA of all corrective actions from manufacturer investigations. MDS-REQ9 adds: notify NCMDR of delays/unavailability of devices posing high potential risk to medical services, and ensure after-sales service including approved spare parts through the device lifecycle.

REQ9 obligation 9: 'Notify the national center for medical devices reporting (NCMDR) of any cases of delay or unavailability of medical devices that pose high potential risks for medical services.'

Local market-entry role (Authorized Representative)

market-entry.local-role
Fact-level verified

Foreign manufacturers must appoint an Authorized Representative (AR): located in the Kingdom, holding a separate SFDA AR license for each manufacturer represented, implementing a QMS per Art. 22.1, and documenting operations for SFDA inspection. Only one AR may be appointed per class or general group of devices; a different AR is allowed per category/group.

Conditions
  • Required for manufacturers located outside the Kingdom; subject to the Commercial Agencies Law.

MDS-REQ9 adds: subsidiary manufacturers must be fully owned by the main manufacturer for a single AR license to cover them; AR confirms accuracy of submitted information annually.

Representative change

market-entry.representative-change
Fact-level verified

On termination or non-renewal of the AR agreement, the manufacturer must immediately appoint a new AR, transfer all previous obligations to them, and notify SFDA of the change. The outgoing AR's responsibility does not end on its own request to terminate unless a replacement is appointed or the devices are no longer on the market or in active use.

MDMA/AR updates are processed through the GHAD electronic system (MDS-G012 requires MDMA application updates in GHAD for relevant changes).

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Establishment license requirement and validity

establishment.license-required-and-validity
Fact-level verified

An establishment may practice an activity subject to the Law only after registration and licensing by SFDA (establishment, branches and warehouses); manufacturers additionally need an industrial license from the competent authority. SFDA issues the establishment license valid for one year or similar renewable periods. Under the Implementing Regulation the AR license is renewable for up to a maximum of five years.

Conditions
  • MDS-REQ9 covers 10 establishment categories: manufacturers, ARs, importers/distributors, warehouses, clinical trials verification, testing laboratories, conformity assessment/QMS, radiation quality assurance, technical consultation, maintenance.

Implementing Regulation Art. 15.5.3: 'Issue a License to the Authorized Representative, renewable for up to a maximum of five years'; Art. 6: 'an establishment may only practice any of the activities subject to the Law after they have registered and obtained a License'.

Import clearance and per-shipment documents

import.clearance-and-documents
Fact-level verified

Imported devices may be cleared only with SFDA approval: an MDMA, or an import permit for devices exempted from MDMA. Devices containing chemicals, restricted gases or radioactive medical materials require both an MDMA and an import permit. Licensed importers/distributors must submit with each device: the Marketing Authorization Certificate, a manufacturer-signed Declaration of Conformity, the UDI with machine-readable code, labelling information, and manufacturer/AR contact details.

Conditions
  • Importers/distributors need documented tracking and storage/transport procedures, QMS proof per Art. 22.1, and an authorized person for SFDA dealings (Art. 10.11-10.12).

Art. 11.1: 'Imported medical devices may be cleared only after obtaining a Marketing Authorization from the SFDA, or an Import Permit if they are excluded from obtaining Marketing Authorization'.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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IFU exemption and electronic IFU conditions

label.ifu-exemption-and-eifu
Fact-level verified

Instructions for use are not required (or may be abbreviated) in duly justified exceptional cases where the device can be used safely and as intended without them. For professional-use devices, IFU may be provided electronically subject to the e-IFU requirements: a documented risk assessment covering at least 9 elements, and retention of the e-IFU for at least 2 years after the expiry date of the last produced device (expiry-dated, non-implantable) or 15 years after the last device manufactured (no expiry date and implantables).

Conditions
  • e-IFU not permitted for near-patient testing devices (Annex 1 EP 23.1(f)).

Website hosting requirements for e-IFU (free software readability, no account/password, Saudi-market version identifiable) are in Annex 10 item 9.

Lay-person labelling bilingual requirement

label.lay-person-bilingual
Fact-level verified

Information supplied by the manufacturer for devices used by lay persons must be in both Arabic and English. English-only labelling is accepted where the user is professionally qualified. Labelling must not include the SFDA logo but may include the Medical Device National Listing Number; symbols must conform to SFDA.MD/ISO 15223-1.

Conditions
  • Lay-person devices: Arabic + English; professional-use devices: English accepted.

Implementing Regulation Art. 10.18.2 states the same rule; EP 23.1(i): 'Labelling shall not include the SFDA logo, but may include the Medical Device National Listing Number.' Home-use devices must be labelled in both Arabic and English (Art. 13.5).

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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PMS report types by class

pms.report-types
Fact-level verified

Non-IVD devices: class A manufacturers prepare a post-market surveillance report (updated as necessary, available to SFDA on request); class B, C and D manufacturers prepare a periodic safety update report (PSUR). IVDs: class A and B manufacturers prepare a post-market surveillance report; class C and D manufacturers prepare a PSUR.

PMS plan and PSUR/PMS report are part of the MDMA dossier (Implementing Regulation Art. 10.3.2.E-F).

Official forms & portals

Which current form, portal, account, and submission package must be used?

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Submission portal and form

portal.ghad-mdma-application
Fact-level verified

MDMA applications are submitted electronically via the GHAD System - Marketing Authorization Services using the 'Application Form for Medical Devices Marketing Authorization'; establishment licenses (manufacturer and AR) are likewise obtained through GHAD System - Licensing Services.

Implementing Regulation Art. 10.2 requires application via the electronic system.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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QMS certificate from SFDA-designated CAB and pre-market inspection

qms.cab-certificate
Fact-level verified

Manufacturers, importers, distributors and ARs must obtain a QMS certificate to Saudi Standard SFDA.MD/GSO ISO 13485:2017 (or latest published version) from SFDA-designated Conformity Assessment Bodies (CAB). SFDA inspects the manufacturer's QMS at the pre-marketing stage, and the SFDA or recognized-CAB inspection report is one of the documents required for the Marketing Authorization Certificate.

Conditions
  • ISO 13485 evidence is required market-access evidence, not a substitute for MDMA.

Art. 33.1: 'The SFDA shall inspect the Manufacturer's Quality Management System at the pre-marketing stage.' MDS-REQ9 allows an SFDA inspection report as an alternative to the CAB certificate. Baseline fact cited MDS-G024; updated source/locator supplied.

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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SFDA recall and precautionary powers

recall.authority-powers
Fact-level verified

Devices may not be traded if SFDA decides to recall them or ban their trading. On harm, misleading claims or safety impact, SFDA may seize devices, temporarily close an establishment, suspend licenses, take samples for testing at the establishment's expense, issue and publish safety alerts, ban circulation, stop production lines, and order destruction at the violating establishment's expense.

Conditions
  • Precautionary decisions must be implemented by the manufacturer, AR and establishment until safety and efficacy are ascertained (Art. 39.3).

FSCA reporting and implementation deadlines

recall.fsca-deadlines
Fact-level verified

For FSCAs affecting KSA, the manufacturer or AR must report to NCMDR within 2 days of the FSCA letter issue date (attaching the letter); respond to SFDA/NCMDR inquiries within 5 days; notify affected users (importers, distributors, healthcare providers, users) within 5 days; submit the implementation plan within 5 days; and submit periodic reports to SFDA if implementation exceeds 90 days.

For violating devices, a corrective plan must be submitted to SFDA within 5 days.

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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Abbreviated dossier for low-risk devices

registration.low-risk-abbreviated-dossier
Fact-level verified

For low-risk devices, only 6 items are submitted instead of the full Annex 3 technical documentation: (1) device description and specification, (2) information to be provided by the manufacturer, (3) essential principles checklist, (4) evidence of compliance, (5) risk management file, (6) PMS plan and report. SFDA may request the full technical documentation even after MDMA is granted; it must be provided within 10 days of the request.

Conditions
  • Excluded: IVDs, sterile devices, devices with measuring function, reusable surgical instruments, and novel devices.

Market-access route

registration.market-access-route
Fact-level verified

Route is SFDA Marketing Authorization (MDMA): a device may be made available in the KSA only if registered at SFDA with an MDMA. After authorization the device is listed in the National Registry, which constitutes registration. Application may be filed by a local manufacturer, an overseas manufacturer, or the overseas manufacturer's Authorized Representative.

Conditions
  • Applicant (manufacturer or AR) must hold the relevant GHAD establishment license first.

Legal force from Implementing Regulation Art. 8 and 8.2 ('the medical devices shall be listed in the National Registry, and the same shall be deemed a registration thereof'). Baseline fact cited MDS-G024; updated source/locator supplied.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Saudi Arabia approvals and evidence in other markets (5 records)

BahrainSaudi Arabia · US FDA · Australia TGA · Japan MHLW / PMDA · UK MHRA · Ireland · Swissmedic · France · Germany

Prior approval / evidence record

Registration certificate from SFDA (Saudi Arabia), US FDA, TGA (Australia), PMDA (Japan), MHRA (United Kingdom), HPRA (Ireland), Swissmedic (Switzerland), ANSM (France) or BfArM (Germany)

Authority

Registration certificate from SFDA (Saudi Arabia), US FDA, TGA (Australia), PMDA (Japan), MHRA (United Kingdom), HPRA (Ireland), Swissmedic (Switzerland), ANSM (France) or BfArM (Germany)

Accepted

Yes

Benefit

Article (7) bis of Resolution No. (48) of 2020, inserted by Resolution No. (69) of 2024, provides by way of exception to the ordinary Article (7) prohibition that medical devices and products registered in one of the nine listed reference countries 'shall also be registered in the Kingdom of Bahrain' on the basis of that country's registration certificate, on payment of the applicable fee. This is a documentary registration route rather than a full de novo technical assessment, but the application is still filed by a licensed Bahraini Authorized Representative and NHRA retains the decision.

NHRA Medical Devices Registration Guideline, Version 9.1 (September 2024) — general rules, process of submission, variation and renewalNHRA Medical Device Classification Guideline, Version 2.4 (June 2022) — important rules, classification review timeNHRA Medical Device Registration SLA 2025 — service completion time

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

BahrainUS FDA · Japan MHLW / PMDA · Saudi Arabia · Australia TGA · UK MHRA · Ireland · Swissmedic · France · Germany

Prior approval / evidence record

Registration certificate from a listed reference country is an alternative basis for Bahraini registration (Art. 7 bis)

reliance.reference-country-registration-certificate-route
Fact-level verified
Statement

Article (7) bis of Resolution No. (48) of 2020, inserted by Resolution No. (69) of 2024, provides that by way of exception to the ordinary Article (7) prohibition, medical devices and products registered in one of nine listed reference countries 'shall also be registered in the Kingdom of Bahrain' on the basis of the registration certificate issued by that country, following payment of the applicable fee. The listed reference authorities are SFDA (Saudi Arabia), FDA (United States), TGA (Australia), PMDA (Japan), MHRA (United Kingdom), HPRA (Ireland), Swissmedic (Switzerland), ANSM (France) and BfArM (Germany). A holder of a US FDA or Japan PMDA registration therefore has a documentary registration route in Bahrain rather than a full de novo technical assessment.

Source Approval

US FDA registration/clearance; Japan PMDA approval; Saudi SFDA registration; Australia TGA registration; UK MHRA registration; Ireland HPRA registration; Swissmedic (Switzerland) registration; France ANSM registration; Germany BfArM registration

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Product Marketing

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Only the nine authorities named in Article (7) bis are listed; Korea MFDS, Health Canada and China NMPA are not among them
  • The EU CE mark as such is not listed; the Union route appears only through three named national authorities (HPRA, ANSM, BfArM)
  • The application is still made by a Bahraini licensed Authorized Representative and the applicable fee must be paid
  • In force from the day following publication in the Official Gazette (No. 3781, 21 November 2024)
  • Resolution No. (69) of 2024 replaced Article (10) of Resolution No. (48) of 2020 so that marketing authorisation runs for three years

Effective from 2024-11-22

Verbatim source passage: "By way of exception to Article (7) of this Resolution, medical devices and products registered in one of the following reference countries shall also be registered in the Kingdom of Bahrain: 1. Kingdom of Saudi Arabia - Represented by the Saudi Food and Drug Authority (SFDA). 2. United States of America - Represented by the Food and Drug Administration (FDA). 3. Australia - Represented by the Therapeutic Goods Administration (TGA). 4. Japan - Represented by the Pharmaceuticals and Medical Devices Agency (PMDA). 5. United Kingdom - Represented by the Medicines and Healthcare products Regulatory Agency (MHRA). 6. Ireland - Represented by the Health Products Regulatory Authority (HPRA). 7. Switzerland - Represented by Swissmedic(Swissmedic). 8. France - Represented by the French National Agency for Medicines and Health Products Safety (ANSM). 9. Germany - Represented by the Federal Institute for Drugs and Medical Devices (BfArM). Based on the registration certificate issued by one of these countries, following the payment of the applicable fee."

BahrainSaudi Arabia · US FDA · UK MHRA · Australia TGA · Health Canada · Japan MHLW / PMDA · Swissmedic · Ireland · Denmark · New Zealand · France · Netherlands · Belgium

Prior approval / evidence record

Free Sale Certificate may be issued by the country of origin or by a reference country

reliance.free-sale-certificate-origin-or-reference-country
Fact-level verified
Statement

At renewal, Bahrain requires a Free Sale Certificate (FSC) or Certificate to Foreign Government issued by the regulatory authority of the country of origin or of a reference country (Registration Guideline 9.1, section 10 item 4). The guideline's glossary (item 14) defines reference countries as Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland and Belgium, so a certificate from one of those authorities substitutes for an origin-country free-sale certificate. A Free Sale Certificate is also required on manufacturer acquisition (section 12).

Source Approval

Free Sale Certificate or Certificate to Foreign Government from the country of origin or from a reference country (Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium)

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The classification guideline separately accepts a Free Sale Certificate OR Registration Certificate from one of the reference countries as a classification requirement
  • The reference-country list in the registration guideline glossary includes Canada, Denmark, the Netherlands ('Holland') and New Zealand, which are not in the Article (7) bis list of Resolution No. (69) of 2024, and omits Germany
  • Free Sale Certificate is also required on manufacturer acquisition (Section 12)

Verbatim source passages: "Free Sale Certificate (FSC) or Certificate to foreign government issued by the regulatory authority of the country of origin or a reference country." and "Reference countries: Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium."

BahrainSaudi Arabia · US FDA · UK MHRA · Australia TGA · Health Canada · Japan MHLW / PMDA · Swissmedic · Ireland · Denmark · New Zealand · France · Netherlands · Belgium

Prior approval / evidence record

Classification of a product as a medical device may be evidenced by a registration certificate from a reference country

reliance.reference-country-certificate-for-classification
Fact-level verified
Statement

To obtain an NHRA classification letter, the applicant must supply a Free Sale Certificate or Registration Certificate issued by the competent authority of the country of origin or by one of the reference countries listed in the classification guideline (SFDA, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium), together with a recognised quality assurance certificate such as ISO 13485, CE mark or FDA.

Source Approval

Registration certificate or Free Sale Certificate from SFDA (Saudi Arabia), US FDA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland or Belgium

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

classification

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • A classification letter is a separate, fee-bearing NHRA service that precedes importation and registration
  • The reference-country list here is broader than the Article (7) bis list in Resolution No. (69) of 2024 and omits Germany and includes Canada, Denmark, the Netherlands and New Zealand
  • For class I products without CE marking a manufacturer's Declaration of Conformity may be provided

Verbatim source passage: "1. Free Sale Certificate OR Registration Certificate issued from competent authority in country of origin classifies the product as a medical device. 2. Free Sale Certificate OR Registration Certificate issued from one of the following reference countries: (SFDA, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, Newzland, France, and Holland, Belgium.)."

KenyaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · Swissmedic · Ireland · Saudi Arabia

Regulatory reference

Recognized reference regulatory agencies

reliance.reference-agencies
Fact-level verified

The medical device registration guideline recognizes marketing clearances from eight listed reference regulatory agencies: Australia TGA, Health Canada, EU Notified Bodies (MDD/AIMDD/IVD Directive certificates), Japan MHLW, US FDA (510(k) or PMA), Ireland HPRA, Saudi Arabia SFDA and Swissmedic. US FDA 510(k)-exempt products do not qualify for the abridged route. Approvals from EU and TGA count as independent reference approvals only if the devices were reviewed and approved by those agencies themselves and not registered on the basis of a Mutual Recognition Agreement (MRA).

Conditions
  • Used to qualify devices for abridged, expedited (EBR/ECR/EDR) and immediate (IBR) routes.
  • Applies at the time of application.

Prior approvals and evidence for Saudi Arabia (5 records)

Saudi ArabiaNMPA

Prior approval / evidence record

SFDA-NMPA regulatory cooperation MoU (2024): no recognition effect

reliance.china-nmpa-bilateral-programme
Pending verification
Statement

SFDA and China's NMPA signed a Memorandum of Understanding on regulatory cooperation in medicines, medical devices and cosmetics at NMPA headquarters in Beijing on 1 November 2024 (SFDA CEO Hisham Aljadhey and NMPA Commissioner Li Li). SFDA describes its scope as exchange of regulatory information on laws and regulations and sharing of regulatory experience and best practices; the Saudi Council of Ministers approved the MoU on 12 May 2025. No implementing measure giving NMPA certificates any reliance or recognition effect in the MDMA process has been published by SFDA as of the check date, so the MoU is a cooperation framework, not a recognition route.

Source Jurisdiction Id

china

Source Authority Id

nmpa

Source Approval

China NMPA medical device registration certificate (Class II/III) or Class I filing record

Target Jurisdiction Id

saudi-arabia

China Classes In Scope

Not class-specific; regulator-to-regulator cooperation covering drugs, medical devices and cosmetics

Edge Type

Cooperation Mou

Market Access Strength

none

Regulatory Layer

Product Marketing

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Scope per SFDA: exchange of regulatory information on laws and regulations; sharing of regulatory experiences and best practices (medicines, medical devices, cosmetics)
  • Council of Ministers approval (14/11/1446 AH = 12 May 2025) on the Saudi side
  • No SFDA reliance, abridged-review or inspection-recognition mechanism for NMPA-approved devices found on sfda.gov.sa (EN/AR searches through 2026-09-15)
  • Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2024-11-01

Source passage: وقّعت الهيئة العامة للغذاء والدواء مذكرة تفاهم لتبادل الخبرات والمعلومات التنظيمية مع الإدارة الوطنية للمنتجات الطبية (NMPA) في جمهورية الصين الشعبية، وذلك في مقر الأخيرة بالعاصمة بكين. || Areas of cooperation outlined in the MoU regarding medicines, medical devices, and cosmetics include exchanging regulatory information pertaining to laws and regulations, as well as sharing regulatory experiences and best practices.

Saudi ArabiaNMPA

Regulatory reference

China NMPA approval: no recognition regime

reliance.china-nmpa-no-recognition-route
Pending verification
Statement

Under the Medical Devices Law (Royal Decree M/54) framework, the SFDA Medical Devices Marketing Authorization (MDMA) is a standalone technical-file assessment: MDS-REQ 1 v6.0 requires conformity with the Essential Principles (Annexes 1-2), technical documentation (Annexes 3-4) and an ISO 13485:2016 QMS, and neither lists reference regulators nor accepts any foreign marketing approval as a basis for authorization. The GHTF-founding-member basis (Australia, Canada, Japan, USA, EU/EFTA) of the pre-2021 Interim Regulation guidance MDS-G5 no longer appears in the current requirement. A China NMPA registration certificate therefore confers no abridged, verification or recognition route, and China was never a listed reference jurisdiction.

Source Jurisdiction Id

china

Source Authority Id

nmpa

Source Approval

China NMPA medical device registration certificate (Class II/III) or Class I filing record

Target Jurisdiction Id

saudi-arabia

China Classes In Scope

All NMPA classes (Class I filing, Class II, Class III); SFDA MDMA covers Saudi Classes A-D and IVDs

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Product Marketing

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Applies to the MDMA route for all device classes (A, B, C, D) and IVDs
  • Applicant must be a licensed local manufacturer or licensed Authorized Representative of the overseas manufacturer
  • Technical documentation per Annex 3/4 and ISO 13485:2016 QMS required; SFDA may request full technical documentation
  • The SFDA 'Verification and Abridged' pathway (reliance on reference agencies) is a Drug Sector process for medicines only, not medical devices
  • Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2021-12-19

Source passage: Medical device may be made available in return for payment or free of charge, with a view to distribution and/or use within the KSA only if it is registered at SFDA and obtaining medical devices marketing authorization (MDMA). 1 General Medical device shall comply with the "Essential Principles of Safety and Performance" specified in Annex (1) and Annex (2). 2 Medical device manufacture shall: - Prepare, hold and update the "Medical Device Technical Documentation" and/or "IVD Technical Documentation" that confirm to "Essential Principles of Safety and Performance" specified in Annex (3) and Annex (4) - Establish, document and maintain an effective quality management system (QMS) according to the international ISO standard (ISO 13485:2016) or any identical adopted standard for the same issue/version.

Saudi ArabiaUS FDA

Prior approval / evidence record

FDA 510(k)

Authority

FDA 510(k)

Accepted

No

Benefit

GHTF route canceled Jan 2022 - data helps but no expedited path

Timeline Savings

None

SFDA FAQ — MDMA issued within 35 business daysSFDA MDMA evaluation fees table — 35 working day lead time for every fee group, MDMA validity 3 yearsSFDA MDS-REQ 1 V6 — Requirements for Medical Devices Marketing AuthorizationSFDA MDS-ExcE — clinical trial approval no later than 60 days (Art. 7.5(1))

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Saudi ArabiaGHTF

Regulatory reference

No foreign approval prerequisite for MDMA

reliance.no-foreign-approval-prerequisite
Fact-level verified

The MDMA under the current Law is a standalone Saudi authorization: every device must be scientifically assessed by SFDA, and the current MDMA requirements (MDS-REQ1 v6.0, 2021) contain no requirement to hold a foreign/reference-country approval as a condition of application.

Conditions
  • Verified for the MDMA route under the Law M/54 system; the still-published 2016 fee circular retains GHTF-era fee group labels (see fees findings), but no foreign-approval prerequisite appears in the Law, Implementing Regulation or MDS-REQ1 v6.0.

MDS-REQ1 v6.0 (109 pages) contains no reference-country or foreign-approval submission route; conformity with essential principles and ISO standards is the evidence base.

Saudi ArabiaEU conformity assessment

Prior approval / evidence record

EU CE Mark

Authority

EU CE Mark

Accepted

No

Benefit

GHTF route canceled Jan 2022

Timeline Savings

None

SFDA FAQ — MDMA issued within 35 business daysSFDA MDMA evaluation fees table — 35 working day lead time for every fee group, MDMA validity 3 yearsSFDA MDS-REQ 1 V6 — Requirements for Medical Devices Marketing AuthorizationSFDA MDS-ExcE — clinical trial approval no later than 60 days (Art. 7.5(1))

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Review clocks

What review, validation, and applicant stop-clock rules apply?

Compare countries

Applicant response window for returned MDMA applications

review.applicant-response-60-days
Fact-level verified

The total time for all 3 inquiry cycles of a returned MDMA application is 60 calendar days to fulfill all requirements; requests to extend beyond 60 days for valid justification must be emailed to mdma.it@sfda.gov.sa. Failure to meet the deadline results in deletion of the MDMA application.

Conditions
  • Per announcement (8) 8/2019 as officially interpreted in the SFDA FAQ (updated 20/02/2024).

Separately, establishments and ARs must provide SFDA-requested documents within 10 working days (Implementing Regulation Art. 27.1).

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

Compare countries

Exemptions from Marketing Authorization

derogation.exemption-categories
Fact-level verified

SFDA may exempt devices from MDMA for humanitarian and research purposes in these cases: (A) public emergencies (natural disasters, wars, epidemics); (B) personal use per Art. 13.2 (medical report, limited quantities, no business purpose, prior SFDA approval); (C) research or educational uses; (D) approved pre-marketing clinical trials; (E) custom-made devices for a specific patient at the treatment team's request; (F) exhibition/festival/workshop samples. An SFDA import permit is required for all these exempted devices.

Conditions
  • SFDA must be satisfied as to safety; import permit required even for exempted devices.

Art. 13: 'The SFDA may allow the entry of medical devices for personal use, based on a medical report and in limited quantities, provided that they are not used for any business purpose.'

Innovative device relief

derogation.innovative-device
Fact-level verified

SFDA may exempt an innovative medical device from some conditions and procedures required for Marketing Authorization where this does not affect safety and performance. A device is innovative if it has innovative technology/use/performance characteristics with no similar technology in the local and international market, and a clinical/medical benefit exceeding available alternatives; eligibility is claimed via the Innovative Medical Device Summary Form (MDS-REQ1 Annex 11), with relief from some Annex 3/4 documentation requirements.

Conditions
  • SFDA may request further information before deciding innovative status.

MDS-REQ1: 'Innovative medical devices are exempted from some of the requirements specified in Annex (3) and Annex (4)...' A dedicated guidance (MDS-G002) also exists.

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

Compare countries

Appeals Committee and Administrative Court

appeal.penalties-committee
Fact-level verified

Appeals against SFDA penalty decisions (Art. 42.1 of the Law) are heard by a Board-formed Committee of at least 3 members including at least one legal advisor; the Committee's decisions may be appealed before the Administrative Court. Violations under Art. 42.2 are referred to the Public Prosecution and the competent court. Persons affected by violations may claim compensation before the competent court.

Penalties under Art. 42 of the Law include fines up to SAR 5 million, closure up to 180 days, MA suspension up to 1 year and revocation; adulteration is punishable by imprisonment up to 10 years and/or fines up to SAR 10 million.

Objection to MDMA refusal

appeal.refusal-objection
Fact-level verified

SFDA must notify the applicant of the reasons for refusal of an MDMA application, and the applicant may object to the refusal in accordance with the applicable legal procedures.

For advertising decisions, MDS-REQ8 items 24-26 grant appeal within 30 days of rejection/suspension/void decisions, a second appeal within 30 days, after which the decision is FINAL.

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

Compare countries

UDI scope and Saudi-DI database

udi.scope-and-saudi-di
Fact-level verified

UDI requirements apply to all medical devices, medical supplies and accessories placed on the Saudi market and not exempt from marketing authorization, and to manufacturers and Authorized Representatives. The national UDI database (Saudi-DI) has been launched and effective since 1 October 2020; required data must be submitted to Saudi-DI and UDI must be on the device before the applicable compliance date (phased by device class).

Conditions
  • Issued under Art. 10/17 of the Implementing Regulation; SFDA determines excluded devices.

Effective from 2020-10-01

UDI comprises UDI-DI and UDI-PI; the UDI-DI must be globally unique and provides access to the Saudi-DI record.

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

Compare countries

Investigation final report deadlines

vigilance.final-report-deadlines
Fact-level verified

Investigation procedures must be concluded and the final report submitted to NCMDR within: 15 days for events not requiring testing or technical evaluation; 30 days where testing inside KSA is required; 60 days where testing outside KSA is required. NCMDR follow-up inquiries must be answered within 5 days.

Extensions require justification to NCMDR by email.

Incident reporting deadlines

vigilance.incident-deadline-days
Fact-level verified

Adverse events or complaints must be reported to NCMDR: within 2 days from occurrence or awareness if they represent a serious public health threat; within 10 days if they may cause or contribute to death or serious injury; within 30 days for any effect other than the above.

Legal basis: Law Articles 14, 16, 20, 28, 30, 31; Implementing Regulation Arts. 28, 29-31.

Reporting channels

vigilance.reporting-channels
Fact-level verified

Adverse event/complaint information and documents are submitted through: the National Center for Medical Device Reporting (NCMDR), the Saudi Vigilance system, or the SFDA Call Center (19999); FSCA-related correspondence also goes to NCMDR email ncmdr.md@sfda.gov.sa.

Same channels apply for reporting violating medical devices.

Related structured datasets

Classification systems · 1 record
Open Risk classes A through D, with device-type-specific handling. →
Id

saudi-arabia:medical-device

Jurisdiction Id

saudi-arabia

Domains
  • medical-device
  • ivd
Name

Risk classes A through D, with device-type-specific handling.

Classes
  • Id

    a

    Label

    Class A

    Normalized Risk Level

    low

  • Id

    b

    Label

    Class B

    Normalized Risk Level

    medium

  • Id

    c

    Label

    Class C

    Normalized Risk Level

    high

  • Id

    d

    Label

    Class D

    Normalized Risk Level

    highest

Regulator

SFDA

Official Domains
  • sfda.gov.sa
Source Status

official-source-verified

Source Title

SFDA Medical Device System (MDSysExcE), Art. 21

Source Url

https://www.sfda.gov.sa/sites/default/files/2023-10/MDSysExcE.pdf

Verified On

2026-08-25

Source Supports
  • class-axis
  • classification-rules
Notes
  • Art. 21.1: Class A low, B low-to-medium, C medium-to-high, D high; Art. 21.5: the manufacturer classifies per SFDA-published rules and SFDA may refuse an unjustified classification claim.
  • 22 MDR-harmonized classification rules in MDS-REQ1 Annex (5) (non-invasive, invasive, active, special): Rule 1 defaults non-invasive devices to class A; Rule 6 classifies surgically invasive transient-use devices as class B subject to exceptions.
  • IVDs are classified under 7 separate rules in Annex (5); the default/catch-all is class B (Rule 6) and controls without assigned value are class B (Rule 7); Annex 5 Table 1 lists 6 categories of products without a medical purpose treated as devices.
  • Mechanics (Art. 21.2-21.3): highest class when multiple rules apply; devices and accessories classified separately; software classified by the intended purpose of the device it influences or standalone by the rules; procedure packs take the highest classification of their components.
Registration pathways, prior approvals and planning · 1 record
Open Saudi Arabia registration →
Country

Saudi Arabia

Jurisdiction Id

saudi-arabia

Country Code

SA

Flag

🇸🇦

Regulator

Saudi Food and Drug Authority

Regulator Abbrev

SFDA

Region

middle-east

Tier

2

Risk Classification

4-class (A, B, C, D)

Classes
  • Id

    class-a

    Class Name

    Class A

    Risk Level

    low

    Pathway

    MDMA Registration (Technical File Assessment)

    Official Timeline
    Min

    35

    Max

    35

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    SFDA FAQ — MDMA issued within 35 business days

    Url

    https://www.sfda.gov.sa/en/faq/what-are-fees-marketing-authorization-application-and-how-long-does-it-take-issue

    Accessed Date

    2026-08-30

    Realistic Timeline
    Min

    1.5

    Max

    3

    Unit

    months

    Notes
    • SFDA publishes one lead time for every fee group in its MDMA evaluation fees table: 35 working days, from the lowest group (all Class I and general IVDs) to the highest. The FAQ repeats the same 35-business-day maximum without distinguishing risk class
    • There is no separate low-risk listing route any more. The Medical Device National Registry, which let non-sterile non-measuring Class A devices be listed without a technical file or an Authorized Representative, was cancelled in September 2022
    • What Class A still gets is a lighter dossier, not a lighter process: MDS-REQ 1 item 4 cuts the submission for low-risk devices that are not IVDs, sterile, measuring, reusable surgical instruments or novel down to six elements — device description and specification, information provided by the manufacturer, essential principles checklist, evidence of compliance, risk management file, and post-market surveillance plan and report
    • The abbreviated dossier is conditional: SFDA may demand the full technical documentation at any point, including after the MDMA has been granted, and it must be supplied within 10 days
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    class-b

    Class Name

    Class B

    Risk Level

    medium

    Pathway

    MDMA Registration

    Official Timeline
    Min

    35

    Max

    35

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    SFDA FAQ — MDMA issued within 35 business days

    Url

    https://www.sfda.gov.sa/en/faq/what-are-fees-marketing-authorization-application-and-how-long-does-it-take-issue

    Accessed Date

    2026-08-30

    Realistic Timeline
    Min

    1.5

    Max

    3

    Unit

    months

    Notes
    • SFDA FAQ: the marketing authorization (MDMA) is issued within 35 business days as a maximum if all requirements are fulfilled
    • Full technical file required since Jan 2022
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    class-c

    Class Name

    Class C

    Risk Level

    high

    Pathway

    MDMA Registration

    Official Timeline
    Min

    35

    Max

    35

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    SFDA FAQ — MDMA issued within 35 business days

    Url

    https://www.sfda.gov.sa/en/faq/what-are-fees-marketing-authorization-application-and-how-long-does-it-take-issue

    Accessed Date

    2026-08-30

    Realistic Timeline
    Min

    3

    Max

    5

    Unit

    months

    Notes
    • SFDA FAQ: the marketing authorization (MDMA) is issued within 35 business days as a maximum if all requirements are fulfilled
    • Clinical data may be required
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    class-d

    Class Name

    Class D

    Risk Level

    highest

    Pathway

    MDMA Registration

    Official Timeline
    Min

    35

    Max

    35

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    SFDA FAQ — MDMA issued within 35 business days

    Url

    https://www.sfda.gov.sa/en/faq/what-are-fees-marketing-authorization-application-and-how-long-does-it-take-issue

    Accessed Date

    2026-08-30

    Realistic Timeline
    Min

    4

    Max

    6

    Unit

    months

    Notes
    • SFDA FAQ: the marketing authorization (MDMA) is issued within 35 business days as a maximum if all requirements are fulfilled
    • Extensive clinical data required
    Clinical Trial Required

    Yes

    Local Testing Required

    No

    Gmp Required

    Yes

Prior Approvals
  • Authority

    FDA 510(k)

    Accepted

    No

    Benefit

    GHTF route canceled Jan 2022 - data helps but no expedited path

    Timeline Savings

    None

  • Authority

    EU CE Mark

    Accepted

    No

    Benefit

    GHTF route canceled Jan 2022

    Timeline Savings

    None

Key Requirements
  • Saudi Authorized Representative
  • Complete Technical File (since Jan 2022)
  • Arabic labeling
  • ISO 13485 certification
  • One route for everything: MDMA-2, the Technical File Assessment, has been the only live pathway since January 2022, after the GHTF reliance route closed at the end of 2021 and the low-risk national registry closed in September 2022
  • Filed through the GHAD unified electronic system by a licensed local manufacturer or by the Authorized Representative, who must hold their own GHAD licence before the MDMA application can be lodged (MDS-REQ 1 item 4)
  • Clinical trial approval granted no later than 60 days when requirements are met (MDS-ExcE Art. 7.5(1))
  • Advertising review: 1st Track (within the MDMA application) 35 days; 2nd Track (separate) 10 days; missing documents must be provided within 90 days of the incompleteness notification or the application is VOID
  • Post-approval reporting clocks: significant changes must reach SFDA through the electronic system within 10 days, non-significant changes within 30 days (MDS-REQ 1 item 5)
  • Renewal is filed before expiry and the request can be submitted from 90 days before the expiry date (MDS-REQ 1 item 6)
Local Rep Required

Yes

Local Rep Name

Saudi Authorized Representative

Mdsap Accepted

No

Mdsap Benefit

Not accepted - GHTF route was canceled January 2022

Registration Validity

3 years for Class A non-sterile non-measuring devices; for all other classes the MDMA runs to the remaining validity of the underlying reference-market certificate, or 3 years where that certificate has no defined validity

Verification Status

official-verified

Official Sources
  • Title

    SFDA FAQ — MDMA issued within 35 business days

    Url

    https://www.sfda.gov.sa/en/faq/what-are-fees-marketing-authorization-application-and-how-long-does-it-take-issue

    Accessed Date

    2026-08-30

  • Title

    SFDA MDMA evaluation fees table — 35 working day lead time for every fee group, MDMA validity 3 years

    Url

    https://www.sfda.gov.sa/sites/default/files/2019-10/Fees-Rev-Times-Mark-Aut-App-ar%2Cen_9.pdf

    Accessed Date

    2026-08-30

  • Title

    SFDA MDS-REQ 1 V6 — Requirements for Medical Devices Marketing Authorization

    Url

    https://www.sfda.gov.sa/sites/default/files/2021-12/REQ1En_0.pdf

    Accessed Date

    2026-08-30

  • Title

    SFDA MDS-ExcE — clinical trial approval no later than 60 days (Art. 7.5(1))

    Url

    https://www.sfda.gov.sa/sites/default/files/2023-10/MDSysExcE.pdf

    Accessed Date

    2026-08-25

Reviewed On

2026-08-30

Last Updated

2026-08-30

Process
Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps
  • Step

    1

    Title

    Pre-Submission Preparation

    Description

    Gather technical documentation, quality management system (QMS) records, and clinical data required by SFDA. Appoint a Saudi Authorized Representative.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to SFDA including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    SFDA reviews application for completeness. May request additional documents or clarifications.

    Duration

    2-4 weeks

    Icon

    🔍

  • Step

    4

    Title

    Technical Evaluation

    Description

    In-depth technical assessment of device safety and performance. SFDA may issue questions.

    Duration

    35 working days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, SFDA issues Saudi Arabia market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record
Open Saudi Arabia fees →
Country

Saudi Arabia

Jurisdiction Id

saudi-arabia

Country Code

SA

Authority

SFDA

Low Risk Local
Min

15000

Max

15000

Currency

SAR

Per Product

Yes

High Risk Local
Min

19000

Max

23000

Currency

SAR

Per Product

Yes

Details
  • Id

    application-assessment-class-a

    Item

    Application Assessment - Class A

    Currency

    SAR

    Amount Local

    15000

    Amount Local Formatted

    SAR 15,000

    Frequency

    Per application

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sfda.gov.sa/sites/default/files/2024-12/RISK%20CLASSES_0.pdf

    Source Title

    SFDA medical-device marketing-authorization evaluation fees by risk class

    Verified On

    2026-08-25

  • Id

    application-assessment-class-b

    Item

    Application Assessment - Class B

    Currency

    SAR

    Amount Local

    19000

    Amount Local Formatted

    SAR 19,000

    Frequency

    Per application

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sfda.gov.sa/sites/default/files/2024-12/RISK%20CLASSES_0.pdf

    Source Title

    SFDA medical-device marketing-authorization evaluation fees by risk class

    Verified On

    2026-08-25

  • Id

    application-assessment-class-c

    Item

    Application Assessment - Class C

    Currency

    SAR

    Amount Local

    21000

    Amount Local Formatted

    SAR 21,000

    Frequency

    Per application

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sfda.gov.sa/sites/default/files/2024-12/RISK%20CLASSES_0.pdf

    Source Title

    SFDA medical-device marketing-authorization evaluation fees by risk class

    Verified On

    2026-08-25

  • Id

    application-assessment-class-d

    Item

    Application Assessment - Class D

    Currency

    SAR

    Amount Local

    23000

    Amount Local Formatted

    SAR 23,000

    Frequency

    Per application

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sfda.gov.sa/sites/default/files/2024-12/RISK%20CLASSES_0.pdf

    Source Title

    SFDA medical-device marketing-authorization evaluation fees by risk class

    Verified On

    2026-08-25

  • Id

    establishment-licence-manufacturer

    Item

    Establishment licence - medical-device manufacturer

    Currency

    SAR

    Amount Local

    5000

    Amount Local Formatted

    SAR 5,000

    Frequency

    Per 5-year licence

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sfda.gov.sa/sites/default/files/2025-03/MDS-REQ%209_En_V2.pdf

    Source Title

    SFDA MDS-REQ9 v2.0 Annex 2: establishment licence periods and fees

    Verified On

    2026-08-25

  • Id

    establishment-licence-authorised-representative

    Item

    Establishment licence - authorised representative

    Currency

    SAR

    Amount Local

    2600

    Amount Local Formatted

    SAR 2,600

    Frequency

    Per year (1–10 years, per contract)

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sfda.gov.sa/sites/default/files/2025-03/MDS-REQ%209_En_V2.pdf

    Source Title

    SFDA MDS-REQ9 v2.0 Annex 2: establishment licence periods and fees

    Verified On

    2026-08-25

  • Id

    establishment-licence-distributor-class-a

    Item

    Establishment licence - distributor/importer Class A

    Currency

    SAR

    Amount Local

    25000

    Amount Local Formatted

    SAR 25,000

    Frequency

    Per year

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sfda.gov.sa/sites/default/files/2025-03/MDS-REQ%209_En_V2.pdf

    Source Title

    SFDA MDS-REQ9 v2.0 Annex 2: establishment licence periods and fees

    Verified On

    2026-08-25

  • Id

    establishment-licence-distributor-class-b

    Item

    Establishment licence - distributor/importer Class B

    Currency

    SAR

    Amount Local

    15000

    Amount Local Formatted

    SAR 15,000

    Frequency

    Per year

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sfda.gov.sa/sites/default/files/2025-03/MDS-REQ%209_En_V2.pdf

    Source Title

    SFDA MDS-REQ9 v2.0 Annex 2: establishment licence periods and fees

    Verified On

    2026-08-25

  • Id

    establishment-licence-distributor-class-c

    Item

    Establishment licence - distributor/importer Class C

    Currency

    SAR

    Amount Local

    8000

    Amount Local Formatted

    SAR 8,000

    Frequency

    Per year

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sfda.gov.sa/sites/default/files/2025-03/MDS-REQ%209_En_V2.pdf

    Source Title

    SFDA MDS-REQ9 v2.0 Annex 2: establishment licence periods and fees

    Verified On

    2026-08-25

  • Id

    establishment-licence-distributor-class-d

    Item

    Establishment licence - distributor/importer Class D

    Currency

    SAR

    Amount Local

    5000

    Amount Local Formatted

    SAR 5,000

    Frequency

    Per year

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sfda.gov.sa/sites/default/files/2025-03/MDS-REQ%209_En_V2.pdf

    Source Title

    SFDA MDS-REQ9 v2.0 Annex 2: establishment licence periods and fees

    Verified On

    2026-08-25

  • Id

    establishment-licence-warehouse

    Item

    Establishment licence - warehouse

    Currency

    SAR

    Amount Local

    800

    Amount Local Formatted

    SAR 800

    Frequency

    Per year (1–5 years; SAR 800 each additional year)

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sfda.gov.sa/sites/default/files/2025-03/MDS-REQ%209_En_V2.pdf

    Source Title

    SFDA MDS-REQ9 v2.0 Annex 2: establishment licence periods and fees

    Verified On

    2026-08-25

  • Id

    advertising-approval-lay-persons

    Item

    Advertising approval - directed to lay persons

    Currency

    SAR

    Amount Local

    3000

    Amount Local Formatted

    SAR 3,000

    Frequency

    Per approval

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sfda.gov.sa/sites/default/files/2026-07/MDS-REQ%208_En_V4.pdf

    Source Title

    SFDA MDS-REQ8 v4.0: advertising approval fees

    Source Effective Date

    2026-07-20

    Verified On

    2026-08-25

  • Id

    advertising-approval-practitioners

    Item

    Advertising approval - directed to health practitioners

    Currency

    SAR

    Amount Local

    6000

    Amount Local Formatted

    SAR 6,000

    Frequency

    Per approval

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sfda.gov.sa/sites/default/files/2026-07/MDS-REQ%208_En_V4.pdf

    Source Title

    SFDA MDS-REQ8 v4.0: advertising approval fees

    Source Effective Date

    2026-07-20

    Verified On

    2026-08-25

Notes
  • SFDA marketing-authorization assessment fee by risk class (fee circular effective 28 February 2016, still linked by the current SFDA FAQ).
  • Establishment-licence periods and fees follow MDS-REQ9 v2.0 Annex 2; upgrading to a higher class costs the fee difference.
  • Advertising approvals follow MDS-REQ8 v4.0 (20 July 2026).
  • UDI, testing, and commercial service costs are excluded.
Last Updated

2026-08-25

Verification Status

official-verified

Official Sources
  • Title

    SFDA medical-device marketing-authorization evaluation fees by risk class

    Url

    https://www.sfda.gov.sa/sites/default/files/2024-12/RISK%20CLASSES_0.pdf

    Accessed Date

    2026-08-25

  • Title

    SFDA MDS-REQ9 v2.0 Annex 2: establishment licence periods and fees

    Url

    https://www.sfda.gov.sa/sites/default/files/2025-03/MDS-REQ%209_En_V2.pdf

    Accessed Date

    2026-08-25

  • Title

    SFDA MDS-REQ8 v4.0: advertising approval fees

    Url

    https://www.sfda.gov.sa/sites/default/files/2026-07/MDS-REQ%208_En_V4.pdf

    Effective Date

    2026-07-20

    Accessed Date

    2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record
Open Saudi Arabia certifications →
Slug

saudi-arabia

Market

Saudi Arabia

Confidence

low

Schemes
  • Id

    sfda-electrical-emc-evidence

    Name

    SFDA electrical/EMC evidence

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    MDMA prerequisite: QMS per ISO 13485:2016 or an identical adopted standard of the same issue (REQ1); risk management per SFDA.MD/ISO 14971 (Essential Principle 3(b)); labelling symbols per SFDA.MD/ISO 15223-1 with unrecognised symbols explained in the IFU; establishment QMS certificates per Saudi Standard SFDA.MD/GSO ISO 13485:2017 from SFDA-designated Conformity Assessment Bodies (Implementing Regulation Arts. 21-23) or an SFDA inspection report; licensed clinical-trial establishments comply with SFDA.MD/ISO 14155 and SFDA.MD/ISO 20916.

    Source Urls
    • https://www.sfda.gov.sa/sites/default/files/2021-12/REQ1En_0.pdf
    • https://www.sfda.gov.sa/sites/default/files/2023-10/MDSysExcE.pdf
    Source Binding

    candidate

  • Id

    cst-equipment-approval-licensing-and-coc

    Name

    CST equipment approval/licensing and CoC

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Covered Telecommunications Equipment

    Source Binding

    unresolved

  • Id

    saber-product-certificate-of-conformity

    Name

    SABER Product Certificate of Conformity

    Category

    Import Conformity

    Status

    Mandatory If Feature

    Object

    Regulated Product Or Component

    Source Urls
    • https://saber.sa/Home/index/
    Source Binding

    candidate

  • Id

    saber-shipment-certificate-of-conformity

    Name

    SABER Shipment Certificate of Conformity

    Category

    Import Conformity

    Status

    Mandatory At Import

    Object

    Regulated Shipment

    Source Urls
    • https://saber.sa/Home/index/
    Source Binding

    candidate

  • Id

    saso-iecee-recognition

    Name

    SASO IECEE Recognition

    Category

    General Electrical Components

    Status

    Mandatory If Feature

    Object

    Listed Electrotechnical Product

    Source Binding

    unresolved

  • Id

    halal-certification

    Name

    Halal certification

    Category

    Halal And Material Origin

    Status

    Voluntary Or Procurement

    Object

    Eligible Product Or Claim

    Source Binding

    unresolved

Official Sources
  • Authority

    CST

    Topic

    communications equipment licensing

    Url

    https://www.cst.gov.sa/services/wireless-equipment-licensing

  • Authority

    SASO

    Topic

    SABER product conformity

    Url

    https://saso.gov.sa/en/eservices/pages/maineservicesdetails.aspx?serviceid=396

  • Authority

    SABER

    Topic

    product and shipment conformity portal

    Url

    https://saber.sa/Home/index/

  • Authority

    SFDA

    Topic

    MDMA requirements ISO 13485 QMS ISO 14971 risk management and ISO 15223-1 symbols

    Url

    https://www.sfda.gov.sa/sites/default/files/2021-12/REQ1En_0.pdf

  • Authority

    SFDA

    Topic

    establishment licensing SFDA.MD/GSO ISO 13485 CAB certificates

    Url

    https://www.sfda.gov.sa/sites/default/files/2023-10/MDSysExcE.pdf

  • Authority

    SFDA

    Topic

    clinical trial verification establishments ISO 14155 and ISO 20916

    Url

    https://www.sfda.gov.sa/sites/default/files/2025-03/MDS-REQ%209_En_V2.pdf

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