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EDE · Middle East & Africa

United Arab Emirates medical device regulatory resources

Every United Arab Emirates dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

9 free resources24/25 topics with records10 regulations trackedAug 2026 fees reviewed
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Medical device registration database

Search official EDE medical device registration records.

Medical device regulations

Browse official EDE regulations and guidance documents.

Registration timeline

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

Government registration fees

Review current EDE application, review, and renewal fees.

AI registration cost and timeline planner

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

Medical device regulation news

Follow recent EDE policy, guidance, and compliance updates.

AI medical device classifier

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Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other United Arab Emirates requirements.

Regulatory requirements data

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

Structured regulatory requirements

Explore all 49 source-linked facts →

24 of 25 research dimensions currently covered · 13 official sources · latest verification 2026-09-18

Market entry

D01

Authority & regime

Verified
Competent authority
The Emirates Drug Establishment (EDE) grants marketing approvals for medical products, including Medical Equipment, under Federal Decree Law 38/2024. The law also assigns functions to the M…
Local health authorities' role
The law defines a Competent Health Entity as a local government body concerned with health affairs within its jurisdiction. The Ministry and competent health authorities have licensing and…
2 source-linked facts
Checked 2026-09-18
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D02

Legal basis & guidance

Verified
Authority-establishing law
EDE was established on 29 September 2023 under Federal Decree Law No. (28) of 2023 establishing the UAE drug establishment/corporation, and regulates medical products under Decree Law 38/20…
Primary law
Federal Decree Law No. (38) of 2024 Governing Medical Products, Pharmacists and Pharmaceutical Establishments is the primary law for medical devices ('Medical Equipment'); it entered into f…
3 source-linked facts
Checked 2026-09-18
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D03

Device definition & scope

Verified
Device definition
A device is regulated as 'Medical Equipment': a Medical Product that contains a substance, device, instrument, engine, implant, detector or system, including accessories and its operating s…
1 source-linked fact
Checked 2026-09-18
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D05

Registration pathways

Verified
Conditional marketing approval eligibility
EDE may grant conditional marketing approval for the categories listed in Article 8, including products for life threatening or serious diseases with significant therapeutic benefit and no…
Market-access route or official registration surface
A licensed local pharmaceutical establishment (medical warehouse or marketing office designated by the Marketing Rights holder) submits the device marketing authorization to EDE; the MAH co…
3 source-linked facts
Checked 2026-09-18
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D06

Reliance & recognition

Verified
NMPA evidence requires product-specific EDE eligibility assessment
statement: Article 6(1)(c) provides for EDE assessment of reference country marketing approvals or research information demonstrating effectiveness, safety and quality. It does not name NMP…
EDE assessment of reference approvals or research evidence
target: geo:are · sourceApproval: Reference country marketing approval assessed by EDE, or research information proving effectiveness, safety and quality (Article 6(1)(c)) · edgeType: eligi…
2 source-linked facts
Checked 2026-09-18
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D07

Economic-operator roles

Verified
Local market-entry role
archetype: marketing authorization holder or registrant · name: Licensed marketing office, medical products manufacturer, contracted manufacturing company, or medical warehouse designated b…
Representative or holder change
path code: minor change request and or ownership transfer approval · fresh registration: not required for marketing rights holder change · minimum handover: minor change request to EDE for…
3 source-linked facts
Checked 2026-09-18
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D08

Establishment, import & distribution

Verified
Device-only warehouse technical manager
A medical warehouse or medical store limited to medical equipment may entrust technical management to a medical equipment engineer or a specialist in a health profession who is licensed and…
Prior approval or permit for import, export and re-export
Import, export or re export of a medical product or raw materials used in its manufacture requires prior EDE approval or a permit, except for cases exempted by a Cabinet resolution under Ar…
3 source-linked facts
Checked 2026-09-18
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D09

Dossier requirements

Verified
Class III/IV safety and efficacy data
Safety and efficacy data must be submitted for devices classified as Class III or IV.
Class-linked conformity evidence
Device registration requires quality conformity / marketing authorization evidence matched to the device class: EC certificate, FDA 510(k) clearance, or PMA approval.
3 source-linked facts
Checked 2026-08-25
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D10

Official forms & portals

Verified
Submission portal and login
Device services (classification, marketing authorization, variations, advertisement approval) are submitted through the EDE website (www.ede.gov.ae) with UAE PASS login and e payment.
1 source-linked fact
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
Product information must match the approval
The internal and external label and printed or electronic leaflet must match the package information in the marketing approval annex, or the details approved in the country of origin for a…
Leaflet languages
The internal (package) leaflet, printed or electronic, must use at least Arabic and English, unless a decision is issued by the Chairman or his delegate.
2 source-linked facts
Checked 2026-09-18
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D12

QMS, audit & inspection

Verified
Applicant quality, traceability and vigilance systems
An applicant for marketing approval must implement a quality assurance and product traceability system, a pharmacovigilance system and post marketing follow up.
ISO 13485 for device manufacturing sites
Registration of a medical device manufacturing site with EDE requires a valid legalized ISO 13485 certificate issued by the competent authority of the country of origin.
2 source-linked facts
Checked 2026-09-18
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D13

Standards, testing & ancillary approvals

Unresolved
MOHAP electrical/EMC evidence
Electrical safety
TDRA equipment registration Level 1/2/3
Wireless / radio
MOIAT ECAS
Adapters / components
5 maintained overlays
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D15

Review clocks

Verified
Class I · Registration
45 working days
Class II · Registration
45 working days
Class III · Registration
45 working days
4 maintained pathways
Checked 2026-08-30
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D16

Approval validity & renewal

Verified
Conditional approval term and renewal
Conditional marketing approval normally lasts one year, renewable for similar periods while its reasons continue. Renewal must be requested 90 days before expiry; activity cannot continue a…
Authorization duration
type: fixed term · description: 5 years
4 source-linked facts
Checked 2026-09-18
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Lifecycle & post-market

D17

Change control

Verified
Change-control outcomes
outcomes: prior approval amendment or variation; new registration or new application · description: Minor changes (e.g. leaflet, manufacturing location, Marketing Rights holder change) are…
New-application triggers
fundamental changes in medical device design (Art. 15(5)); substantial changes in composition or formulation; significant changes in dosage form or concentration; changes in product classif…
3 source-linked facts
Checked 2026-09-18
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D18

UDI, listing & traceability

Verified
National tracking and coding system
EDE must establish, in coordination with local health authorities, a national system for circulation, tracking and coding of medical products from the factory to the end user, used for repo…
Registered-product database
EDE records medical products granted marketing approval in the national Medical Products database established under Article 66. Article 66(2) leaves data sources, access and exchange proced…
2 source-linked facts
Checked 2026-09-18
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D19

Clinical investigation & performance

Verified
Clinical trial preconditions
Clinical trials require prior non clinical studies to initially confirm the safety and effectiveness of the intended intervention. Article 25(2) excepts compassionate use subject to Executi…
1 source-linked fact
Checked 2026-09-18
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D20

Special access & derogation

Verified
Emergency use approval
EDE may issue Emergency Use approval for medical products required by the State during a declared health emergency, epidemic or pandemic, as an exception to normal marketing approval condit…
1 source-linked fact
Checked 2026-09-18
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D21

Manufacturer PMS

Verified
MAH performance monitoring
The Marketing Rights holder (or its representative) must monitor the performance of the marketed product, receive effectiveness/safety/quality reports from health establishments, comply wit…
Pharmacovigilance practice guideline
EDE approved a Pharmacovigilance Practice guideline for medical products by Resolution of the Chairman of the Board No. (27) of 2026, published 27 July 2026.
2 source-linked facts
Checked 2026-09-18
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D22

Vigilance & incident reporting

Verified
National electronic reporting system
EDE establishes and manages a national electronic system to receive and document adverse event and related reports from establishments, authorities, health professionals, patients and the p…
Non-serious event deadline
Non serious side effects, adverse events or adverse reactions must be reported to EDE within 90 days of receiving the related reports, in the form of complete reports.
5 source-linked facts
Checked 2026-09-18
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D23

Recall, FSCA & market surveillance

Verified
Batch withdrawal complaint deadline
Any complaint or report to withdraw a batch or the entire medical product, inside or outside the State, must be reported to EDE within no more than 15 days from the date of knowledge.
Withdrawal decision after suspension
EDE may suspend circulation of a medical product where quality, safety or effectiveness is in doubt and must decide on withdrawal of the product or its batches within 30 days from the date…
2 source-linked facts
Checked 2026-09-18
Open details →
D24

Advertising, claims & promotion

Verified
Advertisement pre-approval
Advertising, publicizing or promoting medical products by visual, written, audio or social media means requires EDE approval. Article 44(2) prohibits public advertising of the controlled, s…
Advertising evidence and risk disclosure
To obtain advertising approval, the applicant must be a licensed pharmaceutical or healthcare establishment. Advertising must be truthful, not misleading, supported by evidence reflecting t…
3 source-linked facts
Checked 2026-09-18
Open details →
D25

Submission communications & appeal

Verified
Grievance against decisions
A person affected by any decision issued under Decree Law 38/2024 may file a grievance before the Grievance Committee (formed by decision of the Chairman, Minister or head of the local heal…
1 source-linked fact
Checked 2026-09-18
Open details →

Government fees

Full fee schedule (12 lines) →

EDE registration fees in AED · reviewed 2026-08-25

Fee lineAmountProvenance
Marketing-authorization application feeAED 100Verified
Device RegistrationAED 5,000Verified
Marketing-authorization renewal application feeAED 100Verified
Marketing-authorization renewal feeAED 2,500Verified
8 more fee lines on the full schedule · 12 of 12 rows source-verified

Registration timeline

Full registration timeline →

Emirates Drug Establishment (EDE) review clocks and planning ranges · Medical devices: Class I, II, III, IV; IVDs: Class A, B, C, D classification

Class / pathwayReview clockPlanning totalProvenance
Class I(Registration)45 working days2-3 monthsVerified
Class II(Registration)45 working days3-6 monthsVerified
Class III(Registration)45 working days4-8 monthsVerified
Class IV(Full Registration)45 working days6-12 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(45 working days)
  5. 5Registration Approval(1-2 weeks)

Latest regulation news

All United Arab Emirates regulation news →

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

Jun 24EDEmirates Drug EstablishmentEmirates Drug Establishment discusses enhancements to medical devices marketing approval services with stakeholdersUnited Arab Emirates

Key regulations

All 10 United Arab Emirates regulations →

Official EDE rules and guidance · 10 of 10 documents linked to official sources

Device ClassificationClassification of a Product
ClassificationVerified
Classification GuidelinesClassification of a Product - Guidelines
ClassificationVerified
Federal Decree-Law No. 38 of 2024Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments
GeneralVerified
Medical Equipment RegistrationRegistration of Medical Equipment
RegistrationVerified
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