[Home](/)/[Resources](/resources)/UAE Medical Device Registration UAEGlobalRegulation guide # UAE Medical Device Registration — EDE (formerly MOHAP) Medical devices sold in the UAE need registration with the Emirates Drug Establishment (EDE) — the federal body that took over medical device and pharmaceutical regulation from the Ministry of Health and Prevention (MOHAP) on 29 December 2025. The process runs through a licensed local agent, a company-level Marketing Authorization Holder registration, and a two-stage import permit — not a single customs filing. Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Fuae-medical-device-registration) At a glance Regulator EDE (formerly MOHAP) Registration validity 5 years Local presence Licensed local agent required Import process 2-stage: pre-import + clearance ## What structures the UAE medical device route ### The EDE transfer Federal Decree-Law No. 38 of 2024 moved medical device and pharmaceutical regulatory authority from the Ministry of Health and Prevention (MOHAP) to the newly established Emirates Drug Establishment (EDE), effective 29 December 2025. The registration mechanics carry forward unchanged — only the issuing federal authority's name and branding changed. ### Local agent requirement A licensed local agent holding a valid medical store license is the operational anchor for UAE medical device registration. Foreign manufacturers cannot register directly without one — the local agent holds Marketing Authorization Holder (MAH) status and files on the manufacturer's behalf. ### Two-stage import permit Import isn't a single customs filing. There's a pre-import permit stage (before the shipment leaves origin) and a separate shipment-clearance stage on arrival, which can include customs inspection and local-market release inspection for medicated devices. ### Registration validity Device registration certificates are valid for five years. Supporting evidence for registration can include existing approvals from other markets — EC certification, FDA 510(k), or PMA — depending on the device's risk classification. ## Registration and import workflow 01 Establish or engage a UAE legal entity structure — a foreign manufacturer without a UAE presence works through a licensed local agent for every subsequent step. 02 Register the company as a Marketing Authorization Holder (MAH) with EDE — this is a company-level registration, separate from any individual device registration. 03 Confirm the local agent holds a valid medical store license — device registration cannot proceed without one. 04 Submit the device registration application with supporting technical and clinical evidence appropriate to the device's risk classification. 05 Obtain the device registration certificate (five-year validity) once EDE review is complete. 06 Obtain the pre-import permit before the shipment leaves its country of origin. 07 Ship to the UAE, then complete the shipment-clearance stage — including any required customs and local-market release inspection. 08 Release the device to the UAE market once clearance is complete. ## Frequently asked questions ### Do I need to resubmit anything because of the MOHAP-to-EDE transfer? Existing MOHAP registrations and certificates were not automatically invalidated by the transfer — the transfer moved regulatory authority to EDE, not the underlying registrations. However, new filings, renewals, and correspondence should reference EDE rather than MOHAP going forward, and any outstanding applications submitted under MOHAP should be confirmed with the local agent as to which authority is now handling them. ### Can a foreign manufacturer register a device without a UAE office? Yes, through a licensed local agent holding a valid medical store license. The local agent becomes the Marketing Authorization Holder of record and handles registration, import permits, and post-market obligations on the manufacturer's behalf — this is the standard structure, not an exception. ### What counts as acceptable supporting evidence for registration? EDE registration can draw on existing approvals from other regulators — EC certification (CE marking under the EU MDR), US FDA 510(k) clearance, or FDA PMA — as supporting evidence, with the specific evidentiary bar set by the device's risk classification. Higher-risk and implantable devices face more scrutiny than general-use equipment. ### Why is there a two-stage import permit instead of one customs filing? The pre-import permit stage confirms the shipment is authorized before it leaves origin, reducing the risk of goods arriving without valid clearance. The shipment-clearance stage then handles the physical arrival, including possible customs and local-market release inspection — particularly for medicated medical devices, which face an added layer of scrutiny. **Disclaimer:** Educational resource only. Regulatory requirements change and vary by product category. Consult an accredited test laboratory or qualified compliance engineer before making certification decisions. 🇦🇪 UAE roadmap for your product Every standard, document, and test that applies — free, no account required. See your free roadmap[ Want an expert to take your product through 🇦🇪 UAE compliance for you? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. See compliance services](/services) Learn this properly In-depth course that teaches the full process, not just this one answer. [Start the course — $199](/courses/41-uae-medical-device-registration-mohap-ede-transition)[Prefer to read? 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