SFDA · structured requirements

🇸🇦 Saudi Arabia IVD regulatory data

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

12 facts7 dimensions8 official sourceslatest verification 2026-10-21

Changes after registration

Common questions about changing a registered IVD in Saudi Arabia. Each question separates published rules from details still awaiting verification.

Does changing a device brand name or logo require an update? →Source-linked rules available
How do I update a manufacturer's name without changing the legal entity? →Source-linked rules available
What changes when the manufacturer's office address changes? →Source-linked rules available
Does a catalogue or reference code change affect registration or UDI? →Source-linked rules available
Can a registration transfer to a different legal entity? →Source-linked rules available
Can several changes be filed together? →Source-linked rules available

Change control

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

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Combined changes and sequencing boundaries

combined.mdma.change.boundaries

Fact-level verified

Annex 1 records multiple affected change categories and the manufacturer must classify the complete change. This supports describing all linked brand/name/address/REF changes and their cumulative risk in the relevant MDMA update. It does not establish that a true legal-person transfer, AR/establishment change, Saudi-DI update, CFS or chemical permission can all be processed as one application with one fee or clock. Significant affected-device supply must await SFDA approval; coordinate other records with the accepted manufacturer and representation route.

Conditions

For a+d, b+d and c+d map the actual REF field separately.
For a+e, b+e, c+e, d+e, a+d+e, b+d+e and c+d+e resolve the successor route and each dependent record; no universal e-first statutory order is asserted.

MDS-G11: Guidance on requirements for medical-device manufacturers, V2/250707 MDS-REQ 7: Requirements for Unique Device Identification (UDI) & Saudi-DI, v4.0, 24/05/2022 Implementing Regulation of the Law of Medical Devices (Translated Copy), SFDA Board Decision No. (3-29-1443) dated 19/02/1443 AH MDS-REQ5: importation, exportation and shipment clearance requirements (English)

Legal manufacturer and authorization identity

manufacturer.identity.and.succession

Fact-level verified

The manufacturer is responsible for obtaining MDMA, and the authorization is issued in the manufacturer’s name. Labels must identify the responsible legal manufacturer. A genuine transfer of legal-manufacturer responsibility requires assessment of the successor’s manufacturer identity, updated conformity/technical evidence, MDMA route and representation; a rename of the same company or a change of authorised representative does not by itself establish succession to another legal person’s MDMA.

Conditions

The exact amendment/new-application route for a particular foreign legal-person succession and its corporate evidence require SFDA acceptance of those facts; no automatic MDMA inheritance is established.

Implementing Regulation of the Law of Medical Devices (Translated Copy), SFDA Board Decision No. (3-29-1443) dated 19/02/1443 AH

Annex 1 and change-specific evidence

mdma.change.form.materials

Fact-level verified

Use the Medical Device Change Form (Annex 1) with the affected MDMA number, manufacturer name/address, device name/model, national listing number and risk class. Select every affected category, explain and justify the change and risk assessment, state whether it is implemented or already supplied in Saudi Arabia, classify it, and attach relevant updated technical and label documents with a signed truth/completeness declaration.

Conditions

The supporting corporate, conformity and technical evidence must match the actual change; a tick-box form does not authorize every corporate transfer.

Significant and non-significant change deadlines

mdma.change.notification.and.approval

Fact-level verified

Report significant changes within 10 days of the change, update the relevant MDMA on GHAD with Annex 1 and relevant documents, and obtain SFDA approval before trading the affected device. Notify non-significant changes within 30 days: submit Annex 1 and documents by the designated MDMA email, then update GHAD when updating or renewing; alternatively send the prescribed short description first and complete the full notification information within 90 days of the change. These are manufacturer deadlines, not an SFDA decision SLA.

Conditions

The current Arabic wording controls; the 90-day alternative concerns completing notification information, not a universal GHAD deadline.

Registered identity changes versus artwork

mdma.change.triggers

Fact-level verified

For devices including IVDs already holding an MDMA, the manufacturer must evaluate, verify and validate each change under its QMS. The significant-change examples include device name/model and manufacturer name/address; artwork, colour, font and label layout alone are non-significant examples. Rebranding that changes the registered device name must therefore be distinguished from a purely cosmetic logo change.

Conditions

Confirm the exact approved name/model and actual safety/performance effects; a marketing description alone does not determine classification.

Dossier requirements

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

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CFS and shipment documents after changes

cfs.and.shipment.change.information

Fact-level verified

Saudi CFS is a separate export service for a licensed manufacturer with MDMA: submit the Annex 6 request/declaration, manufacturer licence and MDMA verification. CFS validity is one year taking MDMA validity into account; Annex 6 requires informing SFDA within 10 calendar days of a change to submitted information. Shipment clearance instead uses Annex 8 and invoice/product/model/part/lot details. A change in a CFS field is not automatically a one-for-one replacement permission or an MDMA ownership transfer.

Conditions

CFS is conditional on Saudi manufacturing/export role and requested destination.
Chemical/IVD composition and permit-party changes require the separately held REQ5/Annex 2 and current chemical-form/list branch; no blanket exemption is inferred from conflicting English item8.

Economic-operator roles

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

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Foreign manufacturer representation at transition

authorised.representative.transition

Fact-level verified

A foreign manufacturer’s authorised-representative arrangement is a separate licensed role. On termination the manufacturer must appoint a replacement immediately, transfer relevant obligations and notify SFDA. The outgoing representative’s responsibilities continue until replacement or until the products are no longer marketed or in use, under the implementing regulation. This continuity rule does not transfer legal-manufacturer ownership of MDMA.

Conditions

Identify the affected device group, agreement, local licence and responsibilities; do not substitute an importer/account-access change for manufacturer succession.

Fees

What regulator fee applies to this class, route, event, and date?

Compare countries

MDMA change-fee categories

mdma.variation.fee.categories

Fact-level verified

The MDMA fee table’s reduced SAR 5,000 category covers renewal, adding devices or models, changing brand name, updating the technical file, a transition-period letter and minor manufacturer name/address changes. The administrative SAR 1,100 category covers only label-only, IFU-only and advertising-material-only updates. A change of legal manufacturer name/address or risk classification attracts the full risk-class fee: A SAR 15,000, B SAR 19,000, C SAR 21,000 and D SAR 23,000. Classify the actual SFDA request; a same-company description does not by itself decide whether the minor or legal-manufacturer fee category applies.

Conditions

The SAR 5,000 reduced merged cell spans Renew through Minor change in manufacturer name/address. The SAR 1,100 administrative merged cell begins at Update label(s) only and ends at Update advertising materials only.
The35–60 working-day heading is confined to new applications; this table does not publish a current universal variation-review duration.
The URL upload month is not an effective-date clause. Apply the accepted request category at filing; no single combined-case charge is established.

Label, IFU & language

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

Compare countries

Manufacturer identity on labels and import records

manufacturer.label.and.import.consistency

Fact-level verified

The responsible legal manufacturer’s name and address must remain consistent with the authorization and label evidence. Import shipment records and the shipment declaration must identify the product and manufacturer consistently with the approved information; imported labels must correspond to the labels submitted to SFDA. Evaluate a brand, name, address, REF or successor change across those linked documents before affected supply.

Conditions

Manufactured-for wording alone does not establish assumption of legal-manufacturer responsibility.
Do not infer a general right to relabel or sell through old stock.

MDS-REQ5: importation, exportation and shipment clearance requirements (English)

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 (4 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 renewal NHRA Medical Device Classification Guideline, Version 2.4 (June 2022) — important rules, classification review time NHRA 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.)."

Prior approvals and evidence for Saudi Arabia (4 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 days SFDA MDMA evaluation fees table — 35 working day lead time for every fee group, MDMA validity 3 years SFDA MDS-REQ 1 V6 — Requirements for Medical Devices Marketing Authorization SFDA 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 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

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

UDI, listing & traceability

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

Compare countries

UDI versus catalogue/REF changes

udi.brand.model.and.catalogue

Fact-level verified

A new UDI-DI is required for a change that can cause misidentification or ambiguity in traceability, including the listed brand/trade-name and version/model changes. Catalogue number, version/model and primary UDI-DI are separate Saudi-DI data fields. An orderable REF/SMN change is therefore assessed by its actual field and device effect; it is not automatically a model or UDI-DI change. For changes not requiring a new UDI-DI, update the relevant Saudi-DI record within 10 working days.

Conditions

Apply the UDI-DI packaging and identity rules in addition to MDMA change control.
No universal old-stock grace period follows from these field-update rules.

Related structured datasets

Classification systems · 1 record

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

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

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Saudi Arabia registration →

Country

Saudi Arabia

Jurisdiction Id

saudi-arabia

Country Code

Flag

🇸🇦

Regulator

Saudi Food and Drug Authority

Regulator Abbrev

SFDA

Region

middle-east

Tier

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

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

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Saudi Arabia fees →

Country

Saudi Arabia

Jurisdiction Id

saudi-arabia

Country Code

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

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

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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Need to apply Saudi Arabia's requirements to a product?

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Pricing

Changes after registration

Change control

Combined changes and sequencing boundaries

Legal manufacturer and authorization identity

Annex 1 and change-specific evidence

Significant and non-significant change deadlines

Registered identity changes versus artwork

Dossier requirements

CFS and shipment documents after changes

Economic-operator roles

Foreign manufacturer representation at transition

Fees

MDMA change-fee categories

Label, IFU & language

Manufacturer identity on labels and import records

Reliance & recognition

Saudi Arabia approvals and evidence in other markets (4 records)

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

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

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

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

Prior approvals and evidence for Saudi Arabia (4 records)

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

China NMPA approval: no recognition regime

FDA 510(k)

EU CE Mark

UDI, listing & traceability

UDI versus catalogue/REF changes

Related structured datasets

More Saudi Arabia medical device resources