The UAE has moved medical device regulation to a new federal authority. The Emirates Drug Establishment (EDE), created under Federal Decree-Law No. 28 of 2023 and given its full mandate under Federal Decree-Law No. 38 of 2024 (in force 2 January 2025), now regulates medical products, IVDs, and pharmaceutical establishments across the country. The handover from the Ministry of Health and Prevention (MOHAP) completed on 29 December 2025, when EDE assumed 44 core services including all device and IVD marketing authorizations, import and export permits, GMP certification, facility licensing, and pharmacovigilance. All submissions, new or ongoing, now flow through the EDE portal at ede.gov.ae; MOHAP no longer accepts device applications.

The underlying requirements have not fundamentally changed, the authority, the portal, and several process details have. A foreign manufacturer still cannot register directly: it must appoint a UAE-based Local Authorized Representative, which must itself be a licensed establishment registered with EDE before a product application can begin. 

For companies holding existing registrations, MOHAP certificates remain valid through their stated expiry dates; at renewal, EDE issues the new certificate and the registration must be aligned with EDE requirements, sometimes with documentation resubmitted where portal formatting differs. The manufacturers most exposed are those who assume nothing changed, applications sent to the old system, LARs whose EDE establishment status is unconfirmed, or renewals left until expiry.

🔗 For the detailed version, please visit our LinkedIn article: https://www.linkedin.com/pulse/mohap-ede-what-changed-medical-device-registration-uae-consulting-dedtf/

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