UAE Medical Device Registration (EDE): Fees and Timeline | AIMEILI FAQ

Short answer: According to the EDE official service page, a UAE medical device marketing authorization requires an application fee of AED 100 and a registration fee of AED 5,000 — AED 5,100 in total, which is a calculated figure because the official page does not publish the combined amount. The published service completion duration is 45 working days, and the certificate is valid for 5 years from the date of approval by the Technical Committee. These are official government fees and service timelines only; they do not include agent fees, certification, translation or testing costs, and they are not the same as the total project timeline.

Key summary

• Since 2026, UAE medical device marketing authorizations have been handled by EDE (Emirates Drug Establishment).
• Marketing authorization: application fee AED 100; registration fee AED 5,000; combined AED 5,100 (calculated value).
• Service completion duration for marketing authorization: 45 working days.
• Certificate validity: 5 years from the date of Technical Committee approval.
• Classification service: AED 500 / 10 working days.
• Manufacturing site registration: AED 100 + AED 10,000 / 2–4 weeks, renewed every 5 years.
• Variation to a marketing authorization: AED 1,000 / 22 working days.
• Marketing authorization renewal: AED 100 + AED 2,500 / 15 working days.
• Import permit: AED 100 / 3 working days for first import; customs clearance 2 working days.

All figures above are official fees and published service timelines. They do not include agent, certification, translation or testing costs, and they do not represent the total project duration.

Applicable scenarios and core questions

People searching for “UAE medical device registration fees” generally want to know three things: who currently regulates the process, how much the government actually charges, and how long it takes. These three questions were affected by an institutional change in 2026, while much of the information available online still reflects the MOHAP era. Confirming the competent authority first is therefore essential before discussing figures.

Decision logic

The UAE does not have one single fee or one single timeline. Instead, six services are connected in sequence: product classification → manufacturing site registration → marketing authorization → import permit, followed after market entry by variations and renewal. If a quotation combines these six services into one figure, the client will find that it does not match the EDE portal when they check it.

Official figures (verifiable item by item)

Marketing authorization

The EDE service page publishes an application fee of AED 100 and a registration fee of AED 5,000. The two add up to AED 5,100 (this is a calculated value; the official page does not directly publish the combined total). The service completion duration is 45 working days, and the certificate is valid for 5 years from the date of Technical Committee approval. The applicant must be a medical warehouse or marketing office holding a valid licence issued by EDE; the MAH company and the manufacturing site must first be registered with EDE.

Product classification

AED 500, 10 working days.

Manufacturing site registration

AED 100 plus AED 10,000, 2–4 weeks, renewed every 5 years.

Variation to marketing authorization data

AED 1,000, 22 working days.

Marketing authorization renewal

AED 100 plus AED 2,500, 15 working days.

Import permit

Application fee AED 100; 3 working days for first import and 2 working days for customs clearance.

Verification date for this page: 2026-10-31; version: AE-FEE-2026-10.

Legal basis: Cabinet Resolution No. (40) of 2025

In addition to the EDE service page, the amounts above also have a regulatory source: Cabinet Resolution No. (40) of 2025 Regarding the Service Fees Provided by the Emirates Drug Establishment (issued on 2025-04-16, effective on 2025-04-29, Official Gazette Issue No. 798). Annex I, item 20, “Medical Device Marketing Authorization”, lists an application fee of AED 100, an issuance fee of AED 5,000 and a renewal fee of AED 2,500, calculated on a 5-year basis.

The significance of this provision is that the AED 2,500 renewal fee is not an “industry reference price”; it has a regulatory source and is consistent with the EDE renewal service page. Where the two sources differ (the resolution is a consolidated schedule, while the service page lists individual items), the current EDE service page prevails, and the verification date should be stated on the page.

Common errors

• Still stating that “UAE medical device registration is handled by MOHAP”.
• Stating that “both MOHAP and EDE can accept submissions”.
• Describing the 45 working days as “getting the certificate in 45 days”.
• Treating AED 5,100 as the total landed cost.
• Treating a classification letter as a registration certificate.
• Describing the AED 2,500 renewal fee as an “industry reference price” — the EDE renewal service page explicitly lists this amount as an official fee.

Company preparation checklist

Before starting, confirm four points: the product category and the basis for classification; whether foreign registration evidence already exists (CE / 510(k) / PMA); whether the Free Sales Certificate can complete UAE embassy authentication; and whether the applicant holds the required EDE licence (medical warehouse or marketing office). If any one of these four items is missing, the subsequent 45 working days cannot begin.

AIMEILI view

The most common mistake in UAE-related materials is not an incorrect figure, but describing the “official service timeline” as the “project timeline”. EDE's 45 working days cover only the marketing authorization service. Classification, site registration, embassy authentication and deficiency responses all fall outside that period. When quoting timelines to clients, listing the six services separately is more credible than giving a vague “3–6 months”, and it is more defensible when questions arise.

Common follow-up questions

How much does UAE medical device registration (EDE) cost?

The EDE official service page lists an application fee of AED 100 and a medical device registration fee of AED 5,000, totaling AED 5,100 (calculated value). In addition, the classification service is AED 500, manufacturing site registration is AED 100 plus AED 10,000, a variation is AED 1,000, renewal is AED 100 plus AED 2,500, and an import permit is AED 100. All of these are official government fees and do not include agent, notarization and authentication, translation or testing costs.

What is the official timeline for UAE medical device registration?

EDE publishes a service completion duration of 45 working days for the Issuance of Marketing Authorization for a Medical Device; classification takes 10 working days; manufacturing site registration takes 2–4 weeks; a variation takes 22 working days; renewal takes 15 working days; and an import permit takes 3 working days for first import and 2 working days for customs clearance. These are published timelines for individual services, not the total project timeline.

Is MOHAP still the competent authority for medical devices in the UAE?

No. On 5 January 2026, MOHAP announced the transfer of 44 services, including marketing authorization, to EDE. Marketing authorizations for medical devices are now handled by EDE. MOHAP still exists as an institution, but it no longer accepts this type of application; there is no official basis for the statement that “both MOHAP and EDE can accept submissions”.

How long is a UAE medical device registration certificate valid?

5 years from the date of Technical Committee approval. The starting date is the date of committee approval, not the date of certificate issuance.

Continue reading

• Related: How to choose a local agent for medical device registration in the Middle East?
• Country page: UAE Medical Device Registration and Market Access Guide.
• Recommended: UAE country page.
• Recommended: Saudi Arabia Registration Guide.
• Recommended: Saudi SFDA Medical Device Registration Document Checklist.
• Return to: FAQ Centre.
• Contact: AIMEILI.

Content review and scope of application

Content author: AIMEILI Regulatory Editorial Team. Professional review: AIMEILI Medical Device International Registration Project Team. Source principle: priority is given to official regulatory authority service pages and announcements; all figures on this page are accompanied by official direct links.

Scope of application: This article is intended for preliminary understanding and project planning and does not replace EDE's formal requirements or approval decisions.