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United Arab Emirates medical device registration resources

Research EDE registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every United Arab Emirates medical device resource.

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

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Government registration fees

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AI registration cost and timeline planner

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Medical device regulation news

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AI medical device classifier

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Additional certification and licence checker

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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 · 13 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified
Competent authority
The Emirates Drug Establishment (EDE) is the sole federal authority regulating medical products, including medical devices ('Medical Equipment'), across the UAE.
Local health authorities' role
Local government health bodies ('Competent Health Entity', e.g. emirate level health authorities) govern health affairs within their jurisdictions, including licensing of health establishme…
2 source-linked facts
Checked 2026-08-25
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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 2026-08-25
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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 2026-08-25
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D04

Classification rules

Verified
Medical-device classes I through IV.
Class I, Class II, Class III, Class IV
1 maintained scheme
Checked 2026-08-25
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D05

Registration pathways

Verified
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…
Prerequisite company and site registration
Marketing Authorization Holder companies and product manufacturing sites must be registered with EDE before their products can be registered.
2 source-linked facts
Checked 2026-08-25
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D06

Reliance & recognition

Verified
China NMPA approval: origin evidence only
statement: Federal Decree Law 38/2024 Art. 6(1)(c) makes 'assessing the medical product's compliance with the marketing approvals issued for it by the reference countries OR its compliance…
Country-of-origin or UAE-reference marketing-status evidence — eligibility gate
target: geo:are · sourceApproval: Reference country marketing approvals / conformity certificates (EC, 510(K), PMA per class; CPP, Free Sale, ISO or CE certificates accepted at classificati…
2 source-linked facts
Checked 2026-09-15
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D07

Economic-operator roles

Verified
Local market-entry role
archetype: marketing authorization holder or registrant · name: UAE licensed medical warehouse / marketing office appointed by the Marketing Rights holder · required for foreign: yes · regi…
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 2026-08-25
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D08

Establishment, import & distribution

Verified
Device-only warehouse technical manager
A medical warehouse or medical store whose activity is limited to medical equipment may be managed by a licensed medical equipment engineer or a licensed specialist in one of the health pro…
Import/export permit per shipment
Import, export and re export of any medical product (including devices) or raw materials require an EDE approval or permit for each shipment, held by a licensed establishment.
3 source-linked facts
Checked 2026-08-25
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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
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.
1 source-linked fact
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
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.
1 source-linked fact
Checked 2026-08-25
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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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D14

Fees

Verified
Marketing-authorization application fee
AED 100
Device Registration
AED 5,000
12 maintained fee lines
Checked 2026-08-25
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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
Authorization duration
type: fixed term · description: 5 years
Expiry or lapse consequence
The Marketing Rights holder may not continue the activity permitted by the marketing approval after its expiry date until renewal, unless EDE deems otherwise; import permits equally require…
3 source-linked facts
Checked 2026-08-25
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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 2026-08-25
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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
Every product granted marketing approval is recorded in the EDE national Medical Products database; registered devices are publicly searchable in the EDE Drug Directory under 'Medical Devic…
2 source-linked facts
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
Clinical trial preconditions
Clinical trials are prohibited before non clinical studies have initially confirmed safety and effectiveness of the intended intervention; clinical research is conducted under terms, contro…
1 source-linked fact
Checked 2026-08-25
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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 2026-08-25
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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 2026-08-25
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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.
3 source-linked facts
Checked 2026-08-25
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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 2026-08-25
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D24

Advertising, claims & promotion

Verified
Advertisement pre-approval
Advertising, publicizing or promoting medical products by any means (visual, written, audio, social media) is prohibited unless approved by EDE; EDE's advertisement licence service complete…
Advertisement approval validity
An advertisement approval is valid from 30 days to one year at the applicant's choice; a new approval is required for each advertised product.
2 source-linked facts
Checked 2026-08-25
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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 2026-08-25
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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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United Arab Emirates market-launch workpaper

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United Arab Emirates change notification workpaper

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United Arab Emirates regulatory change impact

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United Arab Emirates cybersecurity evidence review

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