Pure Global AI
EDE · structured requirements

🇦🇪 United Arab Emirates medical device regulatory data

Explore the medical device requirements currently available for United Arab Emirates, organized by topic and linked to official sources.

49 facts21 dimensions9 official sourceslatest verification 2026-09-18

Advertising, claims & promotion

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

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Advertisement pre-approval

advertising.approval-required
Fact-level verified

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, semi-controlled, hazardous or toxic products/substances it specifies; Article 44(3) allows EDE to prohibit or restrict advertising of other medical products.

Conditions
  • Requires a valid marketing authorization and a licensed pharmaceutical or healthcare establishment as applicant
  • Material must be truthful, non-misleading, evidence-based and must clearly disclose risks or side effects
  • Controlled/semi-controlled products, hazardous or toxic substances and chemical precursors may not be advertised

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Advertising evidence and risk disclosure

advertising.evidence-and-risk-disclosure
Fact-level verified

To obtain advertising approval, the applicant must be a licensed pharmaceutical or healthcare establishment. Advertising must be truthful, not misleading, supported by evidence reflecting the product information and approved uses, and clearly disclose associated risks or side effects. A valid marketing approval is required unless the product is exempt under Article 5(3); additional audience-specific controls also apply.

Official English expression; Arabic original prevails. R217 independent review.

Advertisement approval validity

advertising.validity
Fact-level verified

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.

Conditions
  • Approval cannot be transferred to another party (Art. 47(2))

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Approval validity & renewal

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

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Conditional approval term and renewal

authorization.conditional-term-and-renewal
Fact-level verified

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 after expiry until renewal. EDE may grant a shorter term. If the reasons cease and the holder wishes to continue circulation, an ordinary marketing-approval application is required.

Conditions
  • Conditional approvals only; distinct from the ordinary five-year term.

Official English expression; Arabic original prevails. R217 independent review.

Expiry or lapse consequence

authorization.lapse
Fact-level verified

The Marketing Rights holder may not continue the activity permitted by the marketing approval after expiry until renewal, unless EDE allows continued activities for some medical products where necessary.

Conditions
  • EDE may authorize continued activity for specific products if necessary

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Renewal or maintenance

authorization.renewal
Fact-level verified

Renewal grants a further five years (renewed certificate valid five years from the committee's approval date); the renewal request must be submitted 90 days before expiry; the EDE device-renewal service completes in 15 working days.

Conditions
  • Renewal applicant must be an EDE-licensed medical warehouse

90-day filing window: Art. 7(2) - 'The request to renew the Marketing Approval shall be submitted ninety (90) days before its expiration date.'

Authority & regime

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

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Competent authority

authority.competent-authority
Fact-level verified

The 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 Ministry and competent health authorities within their respective jurisdictions.

Conditions
  • Federal level; local health authorities retain health-facility and profession licensing within their jurisdictions

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Local health authorities' role

authority.local-health-entities
Fact-level verified

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 oversight responsibilities alongside EDE, including the licensing of pharmacy practice.

Conditions
  • Product-level regulation (registration, import, vigilance, recalls) is federal under EDE

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Change control

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

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Change-control outcomes

change.available-outcomes
Fact-level verified
Outcomes
  • Prior Approval Amendment Or Variation
  • New Registration Or New Application
Description

Minor changes (e.g. leaflet, manufacturing location, Marketing Rights holder change) are handled by a minor-change/amendment request without a new application; EDE's amendment service accepts minor variation requests only while the marketing authorization is valid or an active renewal application exists.

Conditions
  • Amendment service: AED 1,000 fee, 22 working days
  • Variation evidence must be approved by the competent authorities of the country of origin where applicable

Continues: '...unless there is an active application for its renewal.' The service refers to the 'Minor Change Guidelines for Medical Products Registered in the United Arab Emirates' for what qualifies as minor.

New-application triggers

change.new-application-triggers
Fact-level verified
  • 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 classification or route of administration not covered by the current approval
  • significant manufacturing-process changes affecting quality, safety or effectiveness
  • voluntary market withdrawal for later re-introduction with significant changes
  • pharmacovigilance findings requiring withdrawal or re-assessment and significant changes to the product
Conditions
  • Applies where the relevant trigger is met for the product type; Article 15(8) allows additional cases in the Executive Regulations.

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Authorization ownership transfer

change.ownership-transfer
Fact-level verified

Ownership of a marketing approval may be transferred to another party with EDE approval; import/export permit ownership is not transferable - when the importing or exporting establishment changes, a new permit must be applied for.

Conditions
  • Transfer terms and conditions are set by the Executive Regulations

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Clinical investigation & performance

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

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Clinical trial preconditions

clinical.trial-preconditions
Fact-level verified

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 Executive Regulation controls. Clinical research follows the terms, controls and procedures issued by the Cabinet.

Conditions
  • Compassionate use is excepted per Executive Regulations (Art. 25(2))
  • Non-clinical research on humans is prohibited (Art. 25(1))

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Device definition & scope

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

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Device definition

definition.medical-equipment
Fact-level verified

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 software; it expressly includes wearable devices and AI-based products, achieves its intended purpose without a pharmaceutical, immune or metabolic effect, and is used for diagnosis/treatment/prevention of disease, injury or disability, detection/modification/replacement of anatomical position, or birth control.

Conditions
  • Covers human and animal use, accessories, operating software, wearables and AI-based products

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Dossier requirements

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

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Class III/IV safety and efficacy data

dossier.class-iii-iv-safety-efficacy
Fact-level verified

Safety and efficacy data must be submitted for devices classified as Class III or IV.

Conditions
  • Special requirement: certificate of conformity for equipment manufactured from animal products

This is the only class-differentiated evidence delta stated on the device MA service card.

Class-linked conformity evidence

dossier.evidence-by-class
Fact-level verified

Device registration requires quality-conformity / marketing-authorization evidence matched to the device class: EC certificate, FDA 510(k) clearance, or PMA approval.

Conditions
  • Certificate type follows the classification of the equipment, i.e. Class I, II, III, IV

An EC Declaration of Conformity per the Medical Equipment Manual is also required: 'Acknowledgment of the company that equipment conforms to the specifications as per the Medical Equipment Manual (EC-Declaration of Conformity)'.

Free-sale certificate legalization

dossier.free-sale-legalization
Fact-level verified

Device registration requires a valid free-sale or registration certificate from the competent authority of the country of origin, certified by the UAE Embassy.

Conditions
  • Applies to medical-device marketing-authorization applications

Application form must be signed and stamped by the company; a product agency contract between company and agent is also required.

Economic-operator roles

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

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Local market-entry role

market-entry.local-role
Fact-level verified
Archetype

Marketing Authorization Holder Or Registrant

Name

Licensed marketing office, medical products manufacturer, contracted manufacturing company, or medical warehouse designated by the Marketing Rights holder

Required For Foreign

yes

Registration Relation

Local Eligible Applicant Holds Or Manages Authorization

Importer Relation

import by at least two EDE-licensed appointed importers, subject to Cabinet exemptions under Art. 22(4)

Distributor Relation

one or more licensed distributors; can be a separate channel

Combination

Allowed Subject To Licences

Conditions
  • Applicant must hold a valid EDE licence
  • All appointed importers must import during the calendar year

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Representative or holder change

market-entry.representative-change
Fact-level verified
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 a change in the Marketing Rights holder or manufacturing location (Art. 16(3))
  • EDE-approved transfer of marketing-approval ownership (Art. 17(2))
  • new import permit application for the new importing establishment (Art. 33(2))
Notes

Import/export permit ownership is never transferable; when the importing or exporting establishment changes, a new permit must be applied for.

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Minimum importer appointment

market-entry.two-importer-rule
Fact-level verified

For imported medical products, the Marketing Rights holder must appoint at least two EDE-licensed pharmaceutical establishments as importers and one or more licensed distributors. A main establishment handles product licensing, pharmacovigilance and lifecycle management; all designated importing establishments must import during the calendar year. Locally manufactured products instead follow the storage/distribution arrangements in Article 22(2). The Cabinet may grant exemptions under Article 22(4).

Conditions
  • The Cabinet may exempt the Marketing Rights holder from this requirement on the Chairman's proposal
  • Local products may instead use dedicated establishments at the licensed local factory

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Establishment, import & distribution

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

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Device-only warehouse technical manager

establishment.device-warehouse-manager
Fact-level verified

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 dedicated to working in it, as an exception to the full-time pharmacist requirement.

Conditions
  • Applies only where warehouse/store activity is limited to medical equipment
  • Warehouse licence also requires a valid Good Storage and Distribution Practice certificate from EDE (Art. 98(2)(a))

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Prior approval or permit for import, export and re-export

import.per-shipment-permit
Fact-level verified

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 Article 31(2).

Conditions
  • Applicant must be a licensed establishment (e.g. medical warehouse, factory, research entity)
  • The product must hold a valid marketing approval or emergency-use approval unless exempt under Art. 5 (Art. 32(1))
  • EDE confirms conditions incl. shipping conditions by inspecting shipments (Art. 32(2))

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Import permit validity

import.permit-validity-two-months
Fact-level verified

An import permit for medical materials and products is valid for two months from the date of issuance.

Conditions
  • Multiple initial import requests may be consolidated under one shipment-clearance request on the same bill of lading

Initial import requests complete in 3 working days; shipment-clearance requests in 2 working days (service completion duration).

Label, IFU & language

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

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Product information must match the approval

label.approved-product-information
Fact-level verified

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 product exempt from marketing approval. EDE determines the required label and leaflet data.

Official English expression; Arabic original prevails. R217 independent review.

Leaflet languages

label.leaflet-languages
Fact-level verified

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.

Conditions
  • Applies to all medical products including devices

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Manufacturer PMS

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

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MAH performance monitoring

pms.mah-monitoring
Fact-level verified

The Marketing Rights holder (or its representative) must monitor the performance of the marketed product, receive effectiveness/safety/quality reports from health establishments, comply with EDE pharmacovigilance guides, and follow up product-withdrawal procedures.

Conditions
  • Applicant for marketing rights must also implement a quality-assurance and traceability system, a pharmacovigilance system and post-marketing follow-up (Art. 6(1)(b))
  • One or more qualified persons residing in the State must be appointed (Art. 21(1))

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Pharmacovigilance practice guideline

pms.pv-guideline-2026
Fact-level verified

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.

Conditions
  • Applies to medical products; the guideline covers safety governance, adverse-event monitoring and reporting, local PV responsibilities and qualified PV personnel

Effective from 2026-07-27

EDE also operates a PV-plan evaluation/approval service requiring appointment of a Qualified Person for Pharmacovigilance (QPPV).

Official forms & portals

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

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Submission portal and login

forms.ede-portal-uaepass
Fact-level verified

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.

Conditions
  • Service channel listed as Website: www.ede.gov.ae
  • Payment via e-payment

Same channel and process shown on the device MA service card ('Website: www.ede.gov.ae', 'E-Payment').

QMS, audit & inspection

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

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ISO 13485 for device manufacturing sites

qms.iso13485-site-registration
Fact-level verified

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.

Conditions
  • Applies to medical-device manufacturing sites seeking EDE registration
  • Site must have a marketing-authorization holder (legal manufacturer) registered with EDE

Legal basis: Art. 127 of Decree-Law 38/2024 - manufacturers 'shall comply with the quality management standards and good manufacturing practices controls issued and approved by the EDE'; GMP certificate is a factory-licence condition (Art. 126(2)(a)).

Recall, FSCA & market surveillance

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

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Batch withdrawal complaint deadline

recall.batch-complaint-15-days
Fact-level verified

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.

Conditions
  • Duty applies to the same reporting categories as adverse events (Art. 68(3))

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Withdrawal decision after suspension

recall.withdrawal-30-days
Fact-level verified

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 of suspension.

Conditions
  • The withdrawal duty applies to the cases listed in Article 70(1)(a)-(h), following investigation and verification under Article 70(2).

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Registration pathways

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

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Conditional marketing approval eligibility

registration.conditional-marketing-approval
Fact-level verified

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 available authorised equivalent, and unavailable products without an equivalent alternative. The conditions and controls in Article 9 must also be met; eligibility does not confer automatic approval.

Conditions
  • Only medical products meeting the statutory category and approval conditions are eligible.

Official English expression; Arabic original prevails. R217 independent review.

Market-access route or official registration surface

registration.market-access-route
Fact-level verified

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 company and product manufacturing sites must be registered with EDE beforehand.

Conditions
  • Marketing approval of any type from EDE is required before import, distribution, possession, sale, display, re-marketing, use or manufacture for circulation (Art. 5(1))

Art. 6(1)(a): 'The Applicant shall be a Pharmaceutical Establishment licensed as a Marketing Office, a Medical Products Manufacturer, a contracted Medical Products manufacturing company, or a Medical Warehouse'. Art. 5(1): 'it is not permitted to import, distribute, possess, sell, display, re-market, use, or manufacture any Medical Product in the State for circulation therein, except after obtaining Marketing Approval'.

Prerequisite company and site registration

registration.prerequisite-site-registration
Fact-level verified

Marketing Authorization Holder companies and product manufacturing sites must be registered with EDE before their products can be registered.

Conditions
  • Applies to device marketing-authorization applications

Manufacturer registration runs as a separate EDE service (AED 10,000, five-year renewal).

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.

United Arab Emirates approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for United Arab Emirates (5 records)

United Arab EmiratesAustralia TGA · Health Canada

Prior approval / evidence record

Health Canada or Australia TGA

Authority

Health Canada or Australia TGA

Accepted

Yes

Benefit

A Canadian or Australian registration can serve as the free sale or registration certificate from the country of origin, but EDE names EC, 510(k) and PMA as the conformity certificate types.

Timeline Savings

None published

UAE EDE — medical device marketing authorization (45 working days)

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

United Arab EmiratesUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority

FDA 510(k)/PMA

Accepted

Yes

Benefit

Required, not optional. EDE lists a certificate of quality conformity or marketing authorisation such as EC, 510(k) or PMA, matched to the device class, among the documents that must accompany the application, alongside a free sale or registration certificate from the country of origin attested by the UAE Embassy. There is no separate recognition route and no second, shorter service.

Timeline Savings

None published — 45 working days is the only figure EDE publishes, and it is the same for every class

UAE EDE — medical device marketing authorization (45 working days)

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

United Arab EmiratesNMPA

Prior approval / evidence record

NMPA evidence requires product-specific EDE eligibility assessment

reliance.china-nmpa-origin-evidence
Pending verification
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 NMPA, automatically accept an NMPA certificate or Class I filing record, or create an NMPA-specific abridged route. Any Chinese origin-country evidence must meet the applicable EDE documentary requirements and remains subject to EDE assessment.

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

uae

China Classes In Scope

No NMPA class or filing record is expressly accepted by the cited provision; product-specific EDE requirements must be met.

Edge Type

Eligibility Unresolved

Market Access Strength

undetermined

Regulatory Layer

Product Marketing

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • This general evidentiary route is not confirmation that any particular NMPA document is sufficient.

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

United Arab EmiratesEU conformity assessment

Prior approval / evidence record

EU CE Mark

Authority

EU CE Mark

Accepted

Yes

Benefit

An EC certificate is one of the accepted conformity certificates for the same mandatory document slot, with an EC declaration of conformity acknowledgement required in addition.

Timeline Savings

None published

UAE EDE — medical device marketing authorization (45 working days)

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

United Arab EmiratesSource authority not specified

Prior approval / evidence record

EDE assessment of reference approvals or research evidence

reliance.reliance-edge-country-origin-evidence-to-uae-evidence-country-of-origin-or-uae-reference-marketing-status-united-arab-emirates
Fact-level verified
Target

geo:are

Source Approval

Reference-country marketing approval assessed by EDE, or research information proving effectiveness, safety and quality (Article 6(1)(c))

Edge Type

Eligibility Gate

Market Access Strength

Eligibility Only

Regulatory Layer

Filing Prerequisite

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • EDE assesses compliance with approvals issued by reference countries as a marketing-approval condition (Art. 6(1)(c))
  • certificate type must match device class (EC / 510(K) / PMA)
  • does not itself authorize UAE sale

Effective from 2025-01-02

Article 6(1)(c) expressly provides alternative evidence; a foreign approval alone does not grant UAE market access. Official English expression; Arabic prevails.

Special access & derogation

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

Compare countries

Emergency use approval

special.emergency-use-approval
Fact-level verified

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 conditions; validity lasts for the declared emergency period unless EDE specifies otherwise and may be extended or renewed.

Conditions
  • Evidence of effectiveness, favourable benefit-risk, no adequate approved alternatives, and a use-monitoring/risk-management plan are required (Art. 12)
  • Conditional Marketing Approval (one year, renewable) is separately available for orphan, life-threatening-shortage and unavailable products (Arts. 8-10)

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Submission communications & appeal

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

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Grievance against decisions

appeal.grievance
Fact-level verified

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 health authority) within 15 days of becoming aware of the decision; the Committee must decide within 30 days by reasoned decision; silence is deemed rejection; the grievance decision is final.

Conditions
  • Subject to the specific disciplinary-appeal rules in Article 162.

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

UDI, listing & traceability

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

Compare countries

National tracking and coding system

udi.national-tracking-system
Fact-level verified

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 reporting by health authorities, establishments, health professionals, customs and the public.

Conditions
  • Operating mechanism and data controls are set by Cabinet resolution

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Registered-product database

udi.product-database
Fact-level verified

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 procedures to a decision of the Board of Directors.

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Vigilance & incident reporting

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

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National electronic reporting system

vigilance.national-reporting-system
Fact-level verified

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 public.

Conditions
  • EDE must educate reporting categories on the reporting mechanism and system use

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Non-serious event deadline

vigilance.non-serious-90-days
Fact-level verified

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.

Conditions
  • Applies during circulation or through local and international clinical research

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Serious event deadlines

vigilance.serious-deadlines
Fact-level verified

Serious side effects, serious adverse events and serious adverse reactions (expected or unexpected) must be reported to EDE as soon as possible and no later than 5 days from knowledge, with follow-up reports within a maximum of 15 days.

Conditions
  • Applies to pharmaceutical establishments, biobanks, health establishments, the Ministry, local health authorities, their employees and health professionals
  • Adverse events from local and international clinical research are included

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Immediate reporting of suspected counterfeit or illegal trade

vigilance.suspected-counterfeit-immediate
Fact-level verified

The establishments, authorities and health professionals listed in Article 68(3) must inform EDE immediately upon learning of suspected fraud or counterfeiting of a medical product or suspected illegal trade in medical products by third parties.

Official English expression; Arabic original prevails. R217 independent review.

Related structured datasets

Classification systems · 2 records
Open United Arab Emirates IVD risk classification →
Id

uae:ivd

Jurisdiction Id

uae

Domains
  • ivd
Name

United Arab Emirates IVD risk classification

Classes
  • Id

    a

    Label

    IVD Class A

    Normalized Risk Level

    low

  • Id

    b

    Label

    IVD Class B

    Normalized Risk Level

    medium

  • Id

    c

    Label

    IVD Class C

    Normalized Risk Level

    high

  • Id

    d

    Label

    IVD Class D

    Normalized Risk Level

    highest

Regulator

EDE

Official Domains
  • ede.gov.ae
  • uaelegislation.gov.ae
Source Status

official-source-verified

Source Title

UAE government product-classification guidelines

Source Url

https://mohap.gov.ae/documents/20117/1212145/Classification+of+a+Product-+Guidelines-277.pdf/dfa0c036-89f5-b5da-18f5-88f8ce3a88be

Verified On

2026-08-13

Source Supports
  • ivd-class-axis
Open Medical-device classes I through IV. →
Id

uae:medical-device

Jurisdiction Id

uae

Domains
  • medical-device
Name

Medical-device classes I through IV.

Classes
  • Id

    i

    Label

    Class I

    Normalized Risk Level

    low

  • Id

    ii

    Label

    Class II

    Normalized Risk Level

    medium

  • Id

    iii

    Label

    Class III

    Normalized Risk Level

    high

  • Id

    iv

    Label

    Class IV

    Normalized Risk Level

    highest

Regulator

EDE

Official Domains
  • ede.gov.ae
  • uaelegislation.gov.ae
  • mohap.gov.ae
Source Status

official-source-verified

Source Title

EDE — Classification of a Product service (marketing authorization for medical devices)

Source Url

https://www.ede.gov.ae/en/w/classification-of-a-product

Verified On

2026-08-25

Source Supports
  • class-axis
  • classification-rules
Notes
  • Device class framework Class I-IV with class-linked origin evidence: EC certificate, FDA 510(k) or PMA per the classification of the equipment.
  • Class is established via the EDE 'Classification of a Product' letter service (open to all company types and individuals); the letter determines the regulatory category of the product and whether EDE marketing authorization/registration is required.
Registration pathways, prior approvals and planning · 1 record
Open United Arab Emirates registration →
Country

United Arab Emirates

Jurisdiction Id

uae

Country Code

AE

Flag

🇦🇪

Regulator

Emirates Drug Establishment

Regulator Abbrev

EDE

Region

middle-east

Tier

2

Risk Classification

Medical devices: Class I, II, III, IV; IVDs: Class A, B, C, D

Classes
  • Id

    class-i

    Class Name

    Class I

    Risk Level

    low

    Pathway

    Registration

    Official Timeline
    Min

    45

    Max

    45

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    UAE EDE — medical device marketing authorization (45 working days)

    Url

    https://www.ede.gov.ae/en/w/issuance-of-marketing-authorization-for-a-medical-device

    Accessed Date

    2026-08-25

    Realistic Timeline
    Min

    2

    Max

    3

    Unit

    months

    Notes
    • EDE publishes one marketing authorisation service for medical devices with a completion duration of 45 working days, and it does not vary by class
    • A certificate of quality conformity or marketing authorisation — EC, 510(k) or PMA as appropriate to the class — is a required document, so a foreign approval is the price of entry rather than a shortcut
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    class-ii

    Class Name

    Class II

    Risk Level

    medium

    Pathway

    Registration

    Official Timeline
    Min

    45

    Max

    45

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    UAE EDE — medical device marketing authorization (45 working days)

    Url

    https://www.ede.gov.ae/en/w/issuance-of-marketing-authorization-for-a-medical-device

    Accessed Date

    2026-08-25

    Realistic Timeline
    Min

    3

    Max

    6

    Unit

    months

    Notes
    • EDE publishes one marketing authorisation service for medical devices with a completion duration of 45 working days, and it does not vary by class
    • A certificate of quality conformity or marketing authorisation — EC, 510(k) or PMA as appropriate to the class — is a required document, so a foreign approval is the price of entry rather than a shortcut
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    class-iii

    Class Name

    Class III

    Risk Level

    high

    Pathway

    Registration

    Official Timeline
    Min

    45

    Max

    45

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    UAE EDE — medical device marketing authorization (45 working days)

    Url

    https://www.ede.gov.ae/en/w/issuance-of-marketing-authorization-for-a-medical-device

    Accessed Date

    2026-08-25

    Realistic Timeline
    Min

    4

    Max

    8

    Unit

    months

    Notes
    • EDE publishes one marketing authorisation service for medical devices with a completion duration of 45 working days, and it does not vary by class
    • Safety and efficacy data are a required document at Class III and IV
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    class-iv

    Class Name

    Class IV

    Risk Level

    highest

    Pathway

    Full Registration

    Official Timeline
    Min

    45

    Max

    45

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    UAE EDE — medical device marketing authorization (45 working days)

    Url

    https://www.ede.gov.ae/en/w/issuance-of-marketing-authorization-for-a-medical-device

    Accessed Date

    2026-08-25

    Realistic Timeline
    Min

    6

    Max

    12

    Unit

    months

    Notes
    • EDE publishes one marketing authorisation service for medical devices with a completion duration of 45 working days, and it does not vary by class
    • Safety and efficacy data are a required document at Class III and IV
    Clinical Trial Required

    Yes

    Local Testing Required

    No

    Gmp Required

    Yes

Prior Approvals
  • Authority

    FDA 510(k)/PMA

    Accepted

    Yes

    Benefit

    Required, not optional. EDE lists a certificate of quality conformity or marketing authorisation such as EC, 510(k) or PMA, matched to the device class, among the documents that must accompany the application, alongside a free sale or registration certificate from the country of origin attested by the UAE Embassy. There is no separate recognition route and no second, shorter service.

    Timeline Savings

    None published — 45 working days is the only figure EDE publishes, and it is the same for every class

  • Authority

    EU CE Mark

    Accepted

    Yes

    Benefit

    An EC certificate is one of the accepted conformity certificates for the same mandatory document slot, with an EC declaration of conformity acknowledgement required in addition.

    Timeline Savings

    None published

  • Authority

    Health Canada or Australia TGA

    Accepted

    Yes

    Benefit

    A Canadian or Australian registration can serve as the free sale or registration certificate from the country of origin, but EDE names EC, 510(k) and PMA as the conformity certificate types.

    Timeline Savings

    None published

Key Requirements
  • UAE Authorized Representative
  • Arabic/English labeling
  • ISO 13485 certification
  • Free Sale Certificate
  • GCC conformity assessment
  • Related EDE clocks: MA renewal 15 working days; classification letter 10 working days; minor-variation certificate 22 working days
  • Import permits: initial import requests 3 working days, shipment clearance 2 working days; advertisement licence 3 working days; manufacturer (site) registration 2-4 weeks
Local Rep Required

Yes

Local Rep Name

UAE Authorized Representative

Mdsap Accepted

No

Mdsap Benefit

Not recognised. EDE names EC, 510(k) and PMA as the conformity certificate types, and requires ISO 13485 separately.

Registration Validity

The marketing authorisation certificate is valid for five years from the date of the registration committee approval, not from the date of application.

Verification Status

official-verified

Official Sources
  • Title

    UAE EDE — medical device marketing authorization (45 working days)

    Url

    https://www.ede.gov.ae/en/w/issuance-of-marketing-authorization-for-a-medical-device

    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 EDE. Appoint a UAE Authorized Representative.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

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

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    EDE 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. EDE may issue questions.

    Duration

    45 working days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, EDE issues United Arab Emirates market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record
Open United Arab Emirates fees →
Country

United Arab Emirates

Jurisdiction Id

uae

Country Code

AE

Authority

EDE

Low Risk Local
Min

5100

Max

5100

Currency

AED

Per Product

Yes

High Risk Local
Min

5100

Max

5100

Currency

AED

Per Product

Yes

Details
  • Id

    application-fee

    Item

    Marketing-authorization application fee

    Currency

    AED

    Amount Local

    100

    Amount Local Formatted

    AED 100

    Frequency

    Per application

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.ede.gov.ae/en/w/issuance-of-marketing-authorization-for-a-medical-device

    Source Title

    EDE marketing authorization for a medical device

    Verified On

    2026-08-25

  • Id

    device-registration

    Item

    Device Registration

    Currency

    AED

    Amount Local

    5000

    Amount Local Formatted

    AED 5,000

    Frequency

    Per device

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.ede.gov.ae/en/w/issuance-of-marketing-authorization-for-a-medical-device

    Source Title

    EDE marketing authorization for a medical device

    Verified On

    2026-08-25

  • Id

    renewal-application-fee

    Item

    Marketing-authorization renewal application fee

    Currency

    AED

    Amount Local

    100

    Amount Local Formatted

    AED 100

    Frequency

    Per renewal application

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.ede.gov.ae/en/w/renewal-of-marketing-authorization-for-a-medical-device

    Source Title

    EDE renewal of marketing authorization for a medical device

    Verified On

    2026-08-25

  • Id

    renewal-registration-fee

    Item

    Marketing-authorization renewal fee

    Currency

    AED

    Amount Local

    2500

    Amount Local Formatted

    AED 2,500

    Frequency

    Per renewal

    Notes

    The renewal service card prints the fee line as "Renewal of the registration of pharmaceutical product for general sale: AED 2500" — label wording appears generic, amount as published.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.ede.gov.ae/en/w/renewal-of-marketing-authorization-for-a-medical-device

    Source Title

    EDE renewal of marketing authorization for a medical device

    Verified On

    2026-08-25

  • Id

    classification-letter

    Item

    Classification-of-a-product letter

    Currency

    AED

    Amount Local

    500

    Amount Local Formatted

    AED 500

    Frequency

    Per letter

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.ede.gov.ae/en/w/classification-of-a-product

    Source Title

    EDE classification of a product letter

    Verified On

    2026-08-25

  • Id

    import-permit-application

    Item

    Import permit - application fee

    Currency

    AED

    Amount Local

    100

    Amount Local Formatted

    AED 100

    Frequency

    Per application

    Notes

    Chemical-precursor import permits are 1% of invoice value, minimum AED 200 per permit.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.ede.gov.ae/en/w/import-permit-for-medical-materials-and-products

    Source Title

    EDE import permit for medical materials and products

    Verified On

    2026-08-25

  • Id

    manufacturer-registration-application

    Item

    Manufacturer (site) registration - application fee

    Currency

    AED

    Amount Local

    100

    Amount Local Formatted

    AED 100

    Frequency

    Per application

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.ede.gov.ae/en/w/registration-of-a-manufacturer-of-medical-products

    Source Title

    EDE registration of a manufacturer of medical products

    Verified On

    2026-08-25

  • Id

    manufacturer-registration

    Item

    Registration of a medical-products manufacturer

    Currency

    AED

    Amount Local

    10000

    Amount Local Formatted

    AED 10,000

    Frequency

    Per registration, renewed every 5 years

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.ede.gov.ae/en/w/registration-of-a-manufacturer-of-medical-products

    Source Title

    EDE registration of a manufacturer of medical products

    Verified On

    2026-08-25

  • Id

    facility-plans-approval

    Item

    Domestic manufacturing-facility licence - approval of architectural plans and drawings

    Currency

    AED

    Amount Local

    2000

    Amount Local Formatted

    AED 2,000

    Frequency

    Per approval

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.ede.gov.ae/en/w/issuance-of-a-license-for-a-medical-products-factory-and-contractual-companies-for-research-and-development

    Source Title

    EDE licensing of a medical-products factory: plans approval and final licensing

    Verified On

    2026-08-25

  • Id

    facility-final-licensing

    Item

    Domestic manufacturing-facility licence - final licensing of pharmaceutical and medical facilities

    Currency

    AED

    Amount Local

    50000

    Amount Local Formatted

    AED 50,000

    Frequency

    Per licence

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.ede.gov.ae/en/w/issuance-of-a-license-for-a-medical-products-factory-and-contractual-companies-for-research-and-development

    Source Title

    EDE licensing of a medical-products factory: plans approval and final licensing

    Verified On

    2026-08-25

  • Id

    advertisement-licence-application

    Item

    Advertisement licence - application fee

    Currency

    AED

    Amount Local

    100

    Amount Local Formatted

    AED 100

    Frequency

    Per application

    Notes

    The licence fee varies by advertising-facility category (clinic, healthcare centre, hospital) and advertisement type (print, audio, audiovisual).

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.ede.gov.ae/en/w/licensing-an-advertisement-for-a-medical-product

    Source Title

    EDE licensing an advertisement for a medical product

    Verified On

    2026-08-25

  • Id

    minor-variation-certificate

    Item

    Minor-variation (amendment) certificate for registered MA data

    Currency

    AED

    Amount Local

    1000

    Amount Local Formatted

    AED 1,000

    Frequency

    Per certificate

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.ede.gov.ae/en/w/issuance-of-a-certificate-of-amendment-to-the-registered-marketing-authorization-data-for-a-medical-product

    Source Title

    EDE certificate of amendment to registered marketing-authorization data

    Verified On

    2026-08-25

Notes
  • The official service supports AED 100 application plus AED 5,000 registration for device marketing authorization.
  • Manufacturer, facility, advertisement, variation, classification, and import-permit fees are separate EDE services with their own published amounts.
Last Updated

2026-08-25

Verification Status

official-verified

Official Sources
  • Title

    EDE marketing authorization for a medical device

    Url

    https://www.ede.gov.ae/en/w/issuance-of-marketing-authorization-for-a-medical-device

    Accessed Date

    2026-08-25

  • Title

    EDE renewal of marketing authorization for a medical device

    Url

    https://www.ede.gov.ae/en/w/renewal-of-marketing-authorization-for-a-medical-device

    Accessed Date

    2026-08-25

  • Title

    EDE classification of a product letter

    Url

    https://www.ede.gov.ae/en/w/classification-of-a-product

    Accessed Date

    2026-08-25

  • Title

    EDE import permit for medical materials and products

    Url

    https://www.ede.gov.ae/en/w/import-permit-for-medical-materials-and-products

    Accessed Date

    2026-08-25

  • Title

    EDE registration of a manufacturer of medical products

    Url

    https://www.ede.gov.ae/en/w/registration-of-a-manufacturer-of-medical-products

    Accessed Date

    2026-08-25

  • Title

    EDE licensing of a medical-products factory: plans approval and final licensing

    Url

    https://www.ede.gov.ae/en/w/issuance-of-a-license-for-a-medical-products-factory-and-contractual-companies-for-research-and-development

    Accessed Date

    2026-08-25

  • Title

    EDE licensing an advertisement for a medical product

    Url

    https://www.ede.gov.ae/en/w/licensing-an-advertisement-for-a-medical-product

    Accessed Date

    2026-08-25

  • Title

    EDE certificate of amendment to registered marketing-authorization data

    Url

    https://www.ede.gov.ae/en/w/issuance-of-a-certificate-of-amendment-to-the-registered-marketing-authorization-data-for-a-medical-product

    Accessed Date

    2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record
Open United Arab Emirates certifications →
Slug

uae

Market

United Arab Emirates

Confidence

low

Schemes
  • Id

    mohap-electrical-emc-evidence

    Name

    MOHAP electrical/EMC evidence

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    EDE routes: manufacturer-site registration requires a valid legalized ISO 13485 certificate from the competent authority of the country of origin; device marketing authorization requires an EC Declaration of Conformity acknowledging conformity with the Medical Equipment Manual specifications, and animal-origin devices additionally need a certificate of conformity; import permits accept valid FDA registration, ISO 13485/EC quality certificates, a Free Sale Certificate or GMP.

    Source Binding

    unresolved

  • Id

    tdra-equipment-registration-level-1-2-3

    Name

    TDRA equipment registration Level 1/2/3

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Covered Telecommunications Equipment

    Source Urls
    • https://tdra.gov.ae/en/services/equipment-registration
    Source Binding

    candidate

  • Id

    moiat-ecas

    Name

    MOIAT ECAS

    Category

    General Electrical Components

    Status

    Mandatory If Feature

    Object

    Regulated Product Or Component

    Source Urls
    • https://moiat.gov.ae/en/services/issue-conformity-certificates-for-regulated-products
    Source Binding

    candidate

  • Id

    fanr-radiation-authorization

    Name

    FANR radiation authorization

    Category

    Ionizing Radiation

    Status

    Mandatory If Feature

    Object

    Radiation Product Import Or Use Site

    Source Binding

    unresolved

  • Id

    halal-certification-mark

    Name

    Halal certification/mark

    Category

    Halal And Material Origin

    Status

    Voluntary Or Procurement

    Object

    Eligible Product Or Claim

    Source Binding

    unresolved

Official Sources
  • Authority

    TDRA

    Topic

    telecommunications equipment registration

    Url

    https://tdra.gov.ae/en/services/equipment-registration

  • Authority

    MOIAT

    Topic

    ECAS conformity certificate for regulated products

    Url

    https://moiat.gov.ae/en/services/issue-conformity-certificates-for-regulated-products

  • Authority

    EDE

    Topic

    manufacturer registration legalized ISO 13485 certificate

    Url

    https://www.ede.gov.ae/en/w/registration-of-a-manufacturer-of-medical-products

  • Authority

    EDE

    Topic

    marketing authorization EC declaration of conformity and animal-origin certificate

    Url

    https://www.ede.gov.ae/en/w/issuance-of-marketing-authorization-for-a-medical-device

  • Authority

    EDE

    Topic

    import permit accepted FDA ISO 13485 EC and free sale evidence

    Url

    https://www.ede.gov.ae/en/w/import-permit-for-medical-materials-and-products

Keep researching this market

More United Arab Emirates medical device resources

View the United Arab Emirates resource hub →
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