Intermediate2h 26m # UAE Medical Device Registration: The MOHAP→EDE Transition The complete UAE medical device registration course for the post-MOHAP era — scope, classification, the Local Authorized Representative, technical file, EDE portal mechanics, Arabic labeling, import, advertising, and the post-market obligations that follow a marketing authorization, built from first principles to full practical compliance. 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](/profile/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 1,506 users this week 661 guides 323 product types 9 markets ## Course content 291 lessons·2134 min total The Big Picture 14 lessons · 103 min * UAE Medical Device Registration Preview7:22 * Nine Functions Moved 7:22 * MOHAP vs. EDE 7:22 * What Didn't Change 7:22 * Where Things Stand — September 2026 7:22 * Who This Course Is Built For 7:22 * How This Course Is Built 7:22 * The Digital-First Portal Experience 7:22 * What International Alignment Means in Practice 7:22 * The Nine Functions as One System 7:22 * Regulatory Consolidation Isn't Unprecedented 7:22 * The Four Pillars Ahead 7:22 * The Real Cost of Delayed Engagement 7:22 * Knowledge Check: The Transition 7:22 The Regulatory Framework 16 lessons · 141 min Scope: What Counts as a Medical Device in the UAE 14 lessons · 109 min Risk Classification: Class I-IV Devices, Class A-D IVDs 16 lessons · 135 min The Local Authorized Representative & Establishment Licensing 14 lessons · 102 min Building the Technical File 17 lessons · 152 min Quality Management & ISO 13485 13 lessons · 90 min Clinical Evidence & Performance Data 13 lessons · 87 min Reference-Country Recognition 14 lessons · 94 min The EDE Portal & UAE PASS 12 lessons · 66 min The Registration Process End to End 16 lessons · 125 min Fees, Timelines & the Deficiency Letter Process 13 lessons · 82 min Arabic Labeling & IFU Requirements 13 lessons · 78 min Import Permits, Customs & the Supply Chain 14 lessons · 95 min Advertising, Promotion & Market Communication Rules 14 lessons · 94 min Post-Market Surveillance & Pharmacovigilance 14 lessons · 91 min Adverse Events, Field Safety Corrective Actions & Recalls 15 lessons · 110 min Renewals, Variations & Lifecycle Management 14 lessons · 94 min Full Walkthrough: Registering a Class II Device 17 lessons · 140 min Common Mistakes, Multi-Market Strategy & Your Compliance Action Plan 17 lessons · 144 min What's Next 1 lessons · 0 min Enroll — $199.00