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SFDA · Middle East & Africa

Saudi Arabia medical device regulatory resources

Every Saudi Arabia dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

231,070 listed item records11 free resources24/25 topics with records9 regulations trackedAug 2026 fees reviewed
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Everything we track for Saudi Arabia

Medical equipment listing database

Search products in SFDA's official medical-equipment list.

Medical equipment list insights

Explore published classifications, listing status, and manufacturers in the official SFDA equipment list.

Medical device regulations

Browse official SFDA regulations and guidance documents.

Registration timeline

Compare official and realistic approval times by device class and pathway.

Government registration fees

Review current SFDA application, review, and renewal fees.

AI registration cost and timeline planner

Estimate the likely SFDA pathway, government fees, dossier preparation time, review timeline, and registration steps.

Medical device regulation news

Follow recent SFDA policy, guidance, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary SFDA risk class with an explanation and source links.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Saudi Arabia requirements.

AI similar listed product finder

Describe a device and find comparable items in SFDA's official medical-equipment list.

Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Structured regulatory requirements

Explore all 42 source-linked facts →

24 of 25 research dimensions currently covered · 16 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified
Competent authority
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).…
1 source-linked fact
Checked 2026-08-25
Open details →
D02

Legal basis & guidance

Verified
Entry into force of the Law and Regulation
The Medical Devices Law enters into force 180 days after its publication in the Official Gazette; the Implementing Regulation had to be issued by the SFDA Board within 180 days of the Law's…
Primary law and implementing regulation
Primary legislation is the Medical Devices Law issued by Royal Decree No. (M/54) dated 6/7/1442H; the Implementing Regulation was issued by SFDA Board Decision No. (3 29 1443) dated 19/2/14…
2 source-linked facts
Checked 2026-08-25
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D03

Device definition & scope

Verified
Medical device definition and scope
Broad MDR style definition covering instruments, apparatus, applied and implant devices, IVD reagents/calibrators, software and materials for operating medical devices, for diagnosis, preve…
Software and digital health in scope
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,…
2 source-linked facts
Checked 2026-08-25
Open details →
D04

Classification rules

Verified
Risk classes A through D, with device-type-specific handling.
Class A, Class B, Class C, Class D
1 maintained scheme
Checked 2026-08-25
Open details →
D05

Registration pathways

Verified
Abbreviated dossier for low-risk devices
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 manufac…
Market-access route
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 Reg…
2 source-linked facts
Checked 2026-08-25
Open details →
D06

Reliance & recognition

Verified
SFDA-NMPA regulatory cooperation MoU (2024): no recognition effect
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 202…
China NMPA approval: no recognition regime
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 req…
3 source-linked facts
Checked 2026-09-15
Open details →
D07

Economic-operator roles

Verified
Authorized Representative obligations
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…
Local market-entry role (Authorized Representative)
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 Ar…
3 source-linked facts
Checked 2026-08-25
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D08

Establishment, import & distribution

Verified
Establishment license requirement and validity
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 indus…
Import clearance and per-shipment documents
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 m…
2 source-linked facts
Checked 2026-08-25
Open details →
D09

Dossier requirements

Verified
Technical documents language
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 pa…
MDMA technical dossier content
The MDMA dossier includes administrative details (manufacturer, AR license and national registry number, authorized contact, undertaking), and technical requirements: conformity with the es…
2 source-linked facts
Checked 2026-08-25
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D10

Official forms & portals

Verified
Submission portal and form
MDMA applications are submitted electronically via the GHAD System Marketing Authorization Services using the 'Application Form for Medical Devices Marketing Authorization'; establishment l…
1 source-linked fact
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
IFU exemption and electronic IFU conditions
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 devi…
Lay-person labelling bilingual requirement
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. L…
2 source-linked facts
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
QMS certificate from SFDA-designated CAB and pre-market inspection
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 Asses…
Manufacturer QMS standard
Manufacturers must establish, document and maintain an effective QMS according to ISO 13485:2016 (or any identical adopted standard for the same issue/version) as a prerequisite for MDMA.
2 source-linked facts
Checked 2026-08-25
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D13

Standards, testing & ancillary approvals

Unresolved
SFDA electrical/EMC evidence
Electrical safety
CST equipment approval/licensing and CoC
Wireless / radio
SABER Product Certificate of Conformity
Import CoC / PVoC
6 maintained overlays
Open details →
D15

Review clocks

Verified
Class A · MDMA Registration (Technical File Assessment)
35 working days
Class B · MDMA Registration
35 working days
Class C · MDMA Registration
35 working days
4 maintained pathways · 1 related fact
Checked 2026-08-30
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D16

Approval validity & renewal

Verified
Authorization duration
The MDMA certificate is valid for a term of up to three (3) years from its date of issue.
Expiry, lapse consequence and renewal window
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 e…
2 source-linked facts
Checked 2026-08-26
Open details →

Lifecycle & post-market

D17

Change control

Verified
Change-control outcomes
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);…
Significant changes require SFDA approval
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 'Medic…
2 source-linked facts
Checked 2026-08-25
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D18

UDI, listing & traceability

Verified
Sell-off period for imported devices
Medical devices imported before the applicable UDI compliance date can be distributed for 1 year after the compliance date.
UDI scope and Saudi-DI database
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 R…
2 source-linked facts
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
Clinical evidence and local trial requirements
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). L…
1 source-linked fact
Checked 2026-08-25
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D20

Special access & derogation

Verified
Exemptions from Marketing Authorization
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…
Innovative device relief
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 innovati…
2 source-linked facts
Checked 2026-08-25
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D21

Manufacturer PMS

Verified
PMS report types by class
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 safe…
1 source-linked fact
Checked 2026-08-25
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D22

Vigilance & incident reporting

Verified
Investigation final report deadlines
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…
Incident reporting deadlines
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 cont…
3 source-linked facts
Checked 2026-08-25
Open details →
D23

Recall, FSCA & market surveillance

Verified
SFDA recall and precautionary powers
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, suspe…
FSCA reporting and implementation deadlines
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; notif…
2 source-linked facts
Checked 2026-08-25
Open details →
D24

Advertising, claims & promotion

Verified
Advertising approval requirement and tracks
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 docum…
Advertising language rules
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…
2 source-linked facts
Checked 2026-08-25
Open details →
D25

Submission communications & appeal

Verified
Appeals Committee and Administrative Court
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…
Objection to MDMA refusal
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.
2 source-linked facts
Checked 2026-08-25
Open details →

Government fees

Full fee schedule (13 lines) →

SFDA registration fees in SAR · reviewed 2026-08-25

Fee lineAmountProvenance
Application Assessment - Class ASAR 15,000Verified
Application Assessment - Class BSAR 19,000Verified
Application Assessment - Class CSAR 21,000Verified
Application Assessment - Class DSAR 23,000Verified
9 more fee lines on the full schedule · 13 of 13 rows source-verified

Registration timeline

Full registration timeline →

Saudi Food and Drug Authority (SFDA) review clocks and planning ranges · 4-class (A, B, C, D) classification

Class / pathwayReview clockPlanning totalProvenance
Class A(MDMA Registration (Technical File Assessment))35 working days1.5-3 monthsVerified
Class B(MDMA Registration)35 working days1.5-3 monthsVerified
Class C(MDMA Registration)35 working days3-5 monthsVerified
Class D(MDMA Registration)35 working days4-6 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(35 working days)
  5. 5Registration Approval(1-2 weeks)

Latest regulation news

All Saudi Arabia regulation news →

Newest official SFDA headlines from the daily-refreshed feed — every row links directly to the authority publication.

Sep 10SFSFDASFDA Grants Marketing Authorization for Two AI-Enabled Medical Software Products for Dental and Ophthalmic DiagnosisSaudi ArabiaSep 6SFSFDASFDA Detects Misleading Claims in Medical Device Advertisement and Takes Legal ActionSaudi ArabiaSep 1SFSFDASFDA Launches Smart Verification Tool for Regulated Products at LEAP 2026Saudi ArabiaAug 19, 25SFSFDAGuidance on the Operation and Use of Radiation-Emitting Medical Devices (MDS–G007)Saudi ArabiaAug 19, 25SFSFDAGuidance Manual for Operating and Using Radiation-Emitting Medical Devices (MDS–G007)Saudi Arabia

Key regulations

All 9 Saudi Arabia regulations →

Official SFDA rules and guidance · 9 of 9 documents linked to official sources

MDS-G010Guidance on Artificial Intelligence (AI) and Machine Learning (ML) Technologies Based Medical Devices
Software/SaMDVerified
MDS-G008Medical Device Classification Guidance
ClassificationVerified
OPS-G-002 V8.0Saudi FDA Products Classification Guidance
ClassificationVerified
MDS-G21Guidance on Requirements of Shipments Clearance at Ports of Entry
RegistrationVerified

Registry insights

Full registry statistics →

Computed from 231,070 official SFDA listed item records · data as of 2026-08-31

230,612
Active listed items
7,710
Manufacturers
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Saudi Arabia market-launch workpaper

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Saudi Arabia dossier reuse and delta

Compare an existing authorization and evidence set against SFDA administrative, testing, labeling, and dossier needs.

Saudi Arabia change notification workpaper

Map a product or manufacturing change to SFDA evidence, notification, timing, and implementation questions.

Saudi Arabia regulatory change impact

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Saudi Arabia cybersecurity evidence review

Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Saudi Arabia (SFDA).

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