United Arab Emirates medical device registration timeline

Source-linked clocks

Emirates Drug Establishment (EDE) review clocks and end-to-end planning ranges, using the Medical devices: Class I, II, III, IV; IVDs: Class A, B, C, D classification system.

4 pathways4 of 4 clocks verifiedvalidity The marketing authorisation certificate is valid for five years from the date of the registration committee approval, not from the date of application.MDSAP not acceptedreviewed 2026-08-30ede.gov.ae

Class / pathway	Review clock	Planning total	With prior approval	Provenance
Class I(Registration) EDE publishes one marketing authorisation service for medical devices with a completion duration of 45 working days, and it does not vary by class	45 working days	2-3 months	—	Verified
Class II(Registration) EDE publishes one marketing authorisation service for medical devices with a completion duration of 45 working days, and it does not vary by class	45 working days	3-6 months	—	Verified
Class III(Registration) EDE publishes one marketing authorisation service for medical devices with a completion duration of 45 working days, and it does not vary by class	45 working days	4-8 months	—	Verified
Class IV(Full Registration) EDE publishes one marketing authorisation service for medical devices with a completion duration of 45 working days, and it does not vary by class	45 working days	6-12 months	—	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Planning steps and estimates; these are not regulator deadlines.

United Arab Emirates Medical Device Registration Process

Step-by-step EDE registration process. Total estimated timeline: 2-3 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by EDE. Appoint a UAE Authorized Representative.

Step 2: Application Submission

1-2 weeks

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

Step 3: Administrative Review

2-4 weeks

EDE reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

45 working days

In-depth technical assessment of device safety and performance. EDE may issue questions.

Step 5: Registration Approval

1-2 weeks

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

Summary: The United Arab Emirates medical device registration process through Emirates Drug Establishment (EDE) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Prior approval recognition

FDA 510(k)/PMARequired, 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.None published — 45 working days is the only figure EDE publishes, and it is the same for every class

EU CE MarkAn 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.None published

Health Canada or Australia TGAA 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.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

Primary regulator sources

ede.gov.ae · UAE EDE — medical device marketing authorization (45 working days)

Reviewed 2026-08-30. End-to-end totals remain planning estimates.

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Source-linked review clocks verified against EDE publications · full review 2026-08-30 · row IDs are stable — cite as registration-timeline:uae:class-i