Explore the medical device requirements currently available for United Arab Emirates, organized by topic and linked to official sources.
What expires, what is retained periodically, and when must renewal start?
Fixed Term
5 years
Device MA service card: certificate 'valid for five years from the date of the committee's approval'.
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 a valid marketing approval.
Import condition: Art. 32(1)(a) requires a valid marketing approval or emergency-use approval for the imported product.
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.
90-day filing window: Art. 7(2) - 'The request to renew the Marketing Approval shall be submitted ninety (90) days before its expiration date.'
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
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.
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.
Correction vs baseline: the device-specific trigger is now verbatim in law ('Fundamental changes in medical device design'), replacing the generic 'major changes outside the amendment service' wording.
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.
Art. 33(2): 'The Ownership of the approval or import, export or re-export permit issued by the EDE may not be transferred to another party.'
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Marketing Authorization Holder Or Registrant
UAE-licensed medical warehouse / marketing office appointed by the Marketing Rights holder
yes
Local Eligible Applicant Holds Or Manages Authorization
import by at least two EDE-licensed appointed importers unless the Cabinet exempts (Art. 22(1))
one or more licensed distributors; can be a separate channel
Allowed Subject To Licences
Correction vs baseline: Art. 22(1) additionally requires appointment of at least two EDE-licensed importers plus one or more distributors, with one main establishment handling licensing, pharmacovigilance and lifecycle; the Cabinet may exempt. Device MA service: 'The applicant must be a medical warehouse or marketing office licensed by EDE and must hold a valid license.'
Minor Change Request And Or Ownership Transfer Approval
Not Required For Marketing Rights Holder Change
Import/export permit ownership is never transferable; when the importing or exporting establishment changes, a new permit must be applied for.
Art. 17(2): 'With the approval of the EDE, Ownership of the Marketing Approval or conditional Marketing Approval for a Medical Product may be transferred to other parties'. Art. 33(2): 'The Ownership of the approval or import, export or re-export permit issued by the EDE may not be transferred to another party.' This closes the baseline validation gap.
The Marketing Rights holder must appoint at least two EDE-licensed pharmaceutical establishments as importers of the product, and one or more licensed distributors; one main establishment is designated to handle all licensing work, pharmacovigilance and lifecycle management, and all appointed importers must import during the calendar year.
One application for marketing approval is submitted by the designated main establishment regardless of the number of appointed establishments.
Which current law, regulation, guidance, and transition provisions apply?
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 force on 2 January 2025.
Official English translation consulted on the UAE legislation portal; Arabic text is authoritative.
Federal Law No. (8) of 2019 is repealed; its implementing regulations and resolutions remain in force, without contradiction with Decree-Law 38/2024, until replaced.
Art. 180(2): 'The regulations and resolutions applying the aforementioned Federal Law No. (8) of 2019 shall remain in force without contradiction to the provisions of this Law, until regulations and resolutions have been issued to replace them.' Art. 175 gives existing operators one year to regularize.
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 38/2024.
Federal Decree-Law No. (28) of 2023 'On the Establishment of the UAE Drug Corporation' is listed on the EDE Legislations page (uaelegislation.gov.ae/en/legislations/2122); its full text could not be opened (HTTP 403).
Is the product a device, IVD, accessory, software, or borderline product locally?
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.
Scope of the law includes Medical Equipment (Art. 2). IVDs are not defined as a separate category; borderline products are resolved through the EDE classification-letter service.
Which registration, notification, listing, reliance, or conformity route applies?
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.
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'.
Marketing Authorization Holder companies and product manufacturing sites must be registered with EDE before their products can be registered.
Manufacturer registration runs as a separate EDE service (AED 10,000, five-year renewal).
Which foreign decisions or evidence can be reused, with what effect and conditions?
geo:are
Reference-country marketing approvals / conformity certificates (EC, 510(K), PMA per class; CPP, Free Sale, ISO or CE certificates accepted at classification)
Eligibility Gate
Eligibility Only
Filing Prerequisite
Yes
Yes
Device MA service documents: 'Certificate of quality conformity/ marketing authorization, such as EC, 510 (K), PMA as per the classification of the equipment'. Classification service accepts CPP / Free Sale / ISO / CE certificates from the country of origin plus certificates from countries where the product is registered.
Which establishment licences, importer permissions, and distribution controls apply?
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.
Import-permit service additionally requires import through the authorized local agent and, for devices, catalogue/leaflet/photos and distribution-authorization letters.
An import permit for medical materials and products is valid for two months from the date of issuance.
Initial import requests complete in 3 working days; shipment-clearance requests in 2 working days (service completion duration).
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 professions instead of a full-time pharmacist.
Import activity additionally requires an EDE import licence (Art. 98(2)(d)).
Which evidence, local deltas, formats, and signatures are required?
Device registration requires a valid free-sale or registration certificate from the competent authority of the country of origin, certified by the UAE Embassy.
Application form must be signed and stamped by the company; a product agency contract between company and agent is also required.
Device registration requires quality-conformity / marketing-authorization evidence matched to the device class: EC certificate, FDA 510(k) clearance, or PMA approval.
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)'.
Safety and efficacy data must be submitted for devices classified as Class III or IV.
This is the only class-differentiated evidence delta stated on the device MA service card.
Which current form, portal, account, and submission package must be used?
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.
Same channel and process shown on the device MA service card ('Website: www.ede.gov.ae', 'E-Payment').
Which label and IFU elements, languages, symbols, and translation controls apply?
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.
The classification service likewise requires 'Leaflet/product information in English/ Arabic' and an inner-pack label artwork with clear product name and information.
Which QMS, audit, inspection, and certificate scope is accepted or required?
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.
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)).
Which UDI, device listing, database, and traceability duties apply?
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.
System objectives include detecting grey-market, counterfeit, expired or illegal products (Art. 65(1)(b)).
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 Devices for Humans' with status and registration date.
Public register: EDE Drug Directory (services.ede.gov.ae/drugdirectory) lists device entries with columns 'Product name | Classification | Strength | Form | Manufacturer | Country of origin | Status | Registered On'.
Which clinical or IVD performance evidence or study is required and accepted?
Clinical trials are prohibited before non-clinical studies have initially confirmed safety and effectiveness of the intended intervention; clinical research is conducted under terms, controls and procedures issued by the Cabinet.
Class III/IV device registrations additionally require safety and efficacy data (device MA service card).
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
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.
Personal-use import of medical products (incl. shipment by courier) is regulated through Executive Regulations under Art. 35; EDE operates a personal-medicines import-permit service (controlled/narcotic products).
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
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.
Establishments must operate reporting systems and issue periodic safety reports to EDE per EDE good-vigilance-practice controls (Art. 68(1)-(2)).
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.
EDE also operates a PV-plan evaluation/approval service requiring appointment of a Qualified Person for Pharmacovigilance (QPPV).
What is reportable, by whom, where, in what format, and by what deadline?
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.
Art. 1 defines the reportable event for devices: an undesirable medical event 'is also called an adverse effect if the Medical Product is a medical device'. Suspicion of counterfeit or illegal trade must be reported immediately (Art. 68(3)(d)); quality defects within 15 days (Art. 68(3)(e)).
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.
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.
EDE investigates reports, may inspect and take samples, and may suspend or withdraw the product based on results (Art. 68(7)).
Which recall, FSCA, notice, and authority-coordination duties apply?
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.
EDE published recall-related circulars (Nos. 1, 4, 5 of 2026) on its Legislations page.
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.
EDE also supervises and inspects shipments and logistics centres at ports and outlets, including free zones (Art. 159(2)).
Which claims, audiences, channels, approvals, and restrictions apply?
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 completes in 3 working days with an AED 100 application fee, and the licence number must be printed on the approved designs.
Service card: 'The applicant prints or writes the licence number on the advertisement design based on the approval and the licence expiry date.'
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.
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
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.
Continues: 'Failure to respond to the grievance within that period shall be considered a rejection of it.' Licence applications are decided within 30 days with reasoned rejection (Art. 72(2)).
