Intermediate2h 26m # UAE Medical Device Registration Course (EDE) Register medical devices in the UAE: classification, the local authorized representative, the technical file, EDE submissions, Arabic labeling and import. A device manufacturer emails MOHAP for a status update and gets an auto-reply: this inbox no longer exists. Every UAE medical device function — classification, marketing authorization, import permits, advertising approval, pharmacovigilance — now sits with the Emirates Drug Establishment, EDE, following a transition that completed in late 2025. Manufacturers still citing Federal Law No. 8 of 2019 or MOHAP as current authority are already behind, and the substance of what's required, while largely unchanged, now runs through a genuinely different regulator with its own portal, its own procedural quirks, and a handful of real new requirements. This course teaches UAE medical device registration from first principles to complete practical compliance, built entirely around the current legal framework: Federal Decree-Law No. 38 of 2024, in force since January 2, 2025, and EDE's own published guidance. You'll learn exactly what counts as a medical device and an IVD in UAE scope, how to classify any product across the four device classes and four IVD classes using the real duration, invasiveness, and active-status variables, and how to select and structure a relationship with the Local Authorized Representative who will legally hold your registration — including the post-February-2026 shift away from the old single-agent monopoly model. You'll build a genuine GHTF Essential Principles technical file, the ISO 13485 quality backbone behind it, and the clinical or performance evidence a reviewer will actually accept. From there, the course covers the registration process end to end through the EDE portal and UAE PASS, realistic fees and timelines, and exactly how to handle a deficiency letter — the normal outcome for a meaningful share of first-time submissions, not a sign of failure. A dedicated module covers the UAE's mandatory bilingual Arabic labeling requirement with genuine equal prominence, not just Arabic's existence. Import permits and customs, advertising and promotional approval, and the post-market obligations that begin the moment your certificate issues — pharmacovigilance, PSURs, adverse event reporting, Field Safety Corrective Actions, and recalls — round out the practical picture. A full walkthrough follows one composite manufacturer, Farasan Diagnostics, registering a connected glucose monitor start to finish, before the closing module covers common mistakes, honest multi-market Gulf strategy, and your own thirty, sixty, ninety-day action plan. Built on Krono's regulatory database and current 2026 guidance, covering Federal Decree-Law No. 38 of 2024, the completed MOHAP-to-EDE transition, and EDE's service catalog, fee schedule, and representation-model reforms as they stood at the time of this course's production. This course contains the use of artificial intelligence for asthetic purposes. * Includes the ebook edition, free * 8 downloadable resources included ## What you'll learn * Build a genuine GHTF Essential Principles technical file with the ISO 13485 quality system evidence behind it * Leverage FDA, CE MDR, TGA, Health Canada, and MHRA reference-country approvals to strengthen a UAE submission honestly * Run the registration process end to end through the EDE portal, and handle a deficiency letter effectively * Meet the UAE's mandatory bilingual Arabic labeling requirement with genuine equal prominence, not just Arabic's existence * Operate the post-approval obligations that follow every registration — import, advertising, pharmacovigilance, PSURs, adverse event reporting, and renewals ## Requirements * ·No prior UAE regulatory, legal, or engineering background required — the course builds every concept from first principles * ·A working knowledge of your own product's intended use and evidence base is helpful but not required * ·Manufacturers, importers, distributors, regulatory affairs teams, and medtech founders entering the UAE will all benefit $199.00 One-time purchase · Lifetime access · No subscription Less than one hour with a compliance consultant. [First lesson free to preview: UAE Medical Device Registration](#lesson-3851722e-bff6-43cb-802d-f79ed4ef7492) * Determine exactly what counts as a medical device or IVD under UAE scope, including software and borderline cases * Classify any device across Class I-IV, or any IVD across Class A-D, using the real duration, invasiveness, and active-status variables * Select, structure, and negotiate a Local Authorized Representative relationship built for the post-2026 multi-representative environment Includes the ebook edition, free — read it in your [library](/platform/books) after purchase. Enroll — $199.00 Secure checkout via Paddle Not what you expected? Contact us within 14 days. Built from a regulatory graph already at work 1,600 users this week 658 guides 323 product types 9 markets ## Course content 21 modules·146 min total The Big Picture Preview7 min The Regulatory Framework 9 min Scope: What Counts as a Medical Device in the UAE 8 min Risk Classification: Class I-IV Devices, Class A-D IVDs 8 min The Local Authorized Representative & Establishment Licensing 7 min Building the Technical File 9 min Quality Management & ISO 13485 7 min Clinical Evidence & Performance Data 7 min Reference-Country Recognition 7 min The EDE Portal & UAE PASS 5 min The Registration Process End to End 8 min Fees, Timelines & the Deficiency Letter Process 6 min Arabic Labeling & IFU Requirements 6 min Import Permits, Customs & the Supply Chain 7 min Advertising, Promotion & Market Communication Rules 7 min Post-Market Surveillance & Pharmacovigilance 7 min Adverse Events, Field Safety Corrective Actions & Recalls 7 min Renewals, Variations & Lifecycle Management 7 min Full Walkthrough: Registering a Class II Device 8 min Common Mistakes, Multi-Market Strategy & Your Compliance Action Plan 8 min What's Next 0 min Enroll — $199.00 Need more than one? The **All-Access Krono Vault** unlocks every course and book for one payment, or put your whole team on it with **Krono Team Vault**. [See pricing](/pricing) Short on time? ### Rather hand it over than learn it? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. [See services](/services)