Emirates Drug Establishment (EDE)

The Emirates Drug Establishment (EDE) is the United Arab Emirates' federal authority for medical and pharmaceutical products, including medical devices. Established in 2023, EDE now administers federal medical device marketing authorization and related services that older materials may attribute to the Ministry of Health and Prevention (MOHAP). Companies entering the United Arab Emirates should use current EDE portals and guidance.

Is EDE the same as MOHAP?

No. MOHAP remains the federal health ministry, while EDE is a separate federal regulatory establishment with responsibility for medical and pharmaceutical products. Because responsibilities transitioned from MOHAP, legacy certificates, articles, and search results may still say “MOHAP medical device registration.” Applicants should verify the current EDE service and any transition instructions rather than filing from an old checklist.

What does EDE do for medical devices?

EDE classifies products, issues medical device marketing authorizations, registers relevant companies and manufacturing sites, regulates imports and circulation, and oversees safety, quality, vigilance, and enforcement. Local health authorities and other government bodies can also affect business licensing and distribution, so federal product authorization is only one part of market readiness.

How are medical devices classified in the UAE?

The UAE applies risk-based medical device classification. EDE offers a product-classification service that can confirm whether a product is a medical device and identify the applicable category. Classification should be resolved before marketing-authorization filing, especially for combination products, software, diagnostics, and borderline wellness products.

Does a foreign manufacturer need a local applicant?

The EDE marketing-authorization service requires the marketing authorization holder, company, and manufacturing site to meet applicable registration or licensing prerequisites. An overseas manufacturer typically works with a locally licensed medical warehouse or marketing office. The agreement should allocate regulatory data access, change management, vigilance, recalls, and control of the authorization.

What are EDE's stated timeline, fee, and validity?

EDE's official service page currently lists an estimated completion time of 45 working days, an AED 100 application fee, an AED 5,000 registration fee, and a five-year certificate validity period. These figures are government-service details, not a guaranteed project timeline or total cost. Applicants should check the live service page because fees, processing targets, and requirements can change.

What documentation is commonly required?

The submission can include product and manufacturing-site details, free-sale or authorization evidence, quality and conformity certificates, device description, classification, labeling, and technical safety and performance evidence. The exact package depends on the device and the authority's current service conditions.

Where can I verify EDE information?

Use EDE's official medical device marketing authorization service and product classification service. EDE lists 80033784 and info@ede.gov.ae for general contact.

Related UAE regulatory topics

See our UAE medical device registration overview for the broader market-access pathway.