The UAE medical device market is projected to grow from USD 3.18 billion in 2025 to USD 4.71 billion by 2032, driven by government investment in healthcare infrastructure, a growing expatriate population, and the UAE’s strategic ambition to rank among the world’s top 15 healthcare systems by 2031.
For any manufacturer, distributor, or importer wanting to participate in this market, one rule is absolute: no medical device may be imported, sold, distributed, or marketed in the UAE without prior MOHAP registration. This guide explains the entire process — from classification through to your 5-year registration certificate.
UAE Medical Device Regulatory Framework
The Ministry of Health and Prevention (MOHAP) regulates all medical devices in the UAE through its Drug Control Department. The UAE framework is aligned with the Global Harmonization Task Force (GHTF) — the same foundational principles used in the EU Medical Device Regulation (MDR) and FDA regulatory models.
Under this framework, MOHAP requires all medical devices sold in the UAE to undergo formal registration before market entry. The classification system determines the level of scrutiny each device receives — higher-risk devices require more extensive documentation and longer review times.
GHTF Risk-Based Classification System
MOHAP classifies medical devices into four classes based on risk level, intended use, duration of use, and degree of contact with the human body:
Class | Risk Level | Examples | Review Level |
I | Low | Bandages, tongue depressors, examination gloves, reading glasses | Standard |
IIa | Medium-Low | Hearing aids, X-ray film, short-term implants, diagnostic imaging | Moderate |
IIb | Medium-High | Infusion pumps, lung ventilators, orthopaedic implants | Enhanced |
III | High | Pacemakers, cochlear implants, absorbable sutures, heart valves |
Who Can Register Medical Devices with MOHAP?
Only a UAE-licensed entity holding a valid MOHAP Drug Store or Medical Warehouse licence can register medical devices. Foreign manufacturers cannot register directly with MOHAP. The following parties can hold a medical device registration in the UAE:
- UAE-licensed authorised agent or distributor holding a valid Drug Store licence
- Local UAE manufacturer with an active trade licence and MOHAP facility registration
- UAE subsidiary of a foreign company, provided it holds all required MOHAP licences
Important for Foreign Manufacturers: Your manufacturing site must be registered in MOHAP before any product application can be submitted. This is a separate step that requires your GMP certificate, facility address, production capabilities, and ISO 13485 certification where applicable.
Step-by-Step Medical Device Registration Process
- Step 1: Obtain MOHAP Classification Letter — Before registration, classify your device. Log into the MOHAP e-services portal via UAE PASS, submit your device’s intended use, composition, and technical specifications. MOHAP issues a Classification Letter within 5–10 working days confirming the risk class. This letter is required for the registration application.
- Step 2: Register the Manufacturing Site — Submit facility registration for the manufacturer. Required: GMP certificate, ISO 13485 (for most Class II and III devices), facility address and description, and a UAE Embassy-attested Certificate of Free Sale from the country of origin.
- Step 3: Register the Authorised Representative (MAH) — The UAE-licensed entity (Marketing Authorization Holder) that will hold the registration must be registered in the MOHAP system separately. This requires trade licence, Drug Store licence, and company registration documents.
- Step 4: Prepare the Technical Dossier — Compile your complete product dossier based on device class. Class I requires basic documentation. Classes IIa, IIb, and III require increasingly comprehensive technical files including clinical evaluation data, biocompatibility testing, software validation (if applicable), and post-market surveillance plans.
- Step 5: Submit via MOHAP e-Portal — Log into the MOHAP portal using UAE PASS, create a new medical device registration application, upload all documents, and pay the applicable registration fee via e-Dirham.
- Step 6: Technical Committee Review — MOHAP’s technical team evaluates the dossier. Information Requests (IRs) may be issued. All IRs must be responded to promptly — unanswered IRs automatically pause the review clock.
- Step 7: Ministerial Committee Final Decision — After technical clearance, the file goes before the Ministerial Committee. Upon approval, MOHAP issues the Medical Device Registration Certificate, valid for 5 years from the date of committee approval.
Technical Dossier Requirements by Device Class
Document / Requirement | Class I | Class IIa | Class IIb | Class III |
Classification Letter from MOHAP | ✅ | ✅ | ✅ | ✅ |
GMP Certificate (attested) | ✅ | ✅ | ✅ | ✅ |
ISO 13485 Certificate | Optional | ✅ | ✅ | ✅ |
Certificate of Free Sale / CPP | ✅ | ✅ | ✅ | ✅ |
Technical Description & Specs | ✅ | ✅ | ✅ | ✅ |
Biocompatibility Test Reports | Optional | ✅ | ✅ | ✅ |
Clinical Evaluation Report | ❌ | ✅ | ✅ | ✅ |
Software Validation (if applicable) | ❌ | Partial | ✅ | ✅ |
Post-Market Surveillance Plan | ❌ | Optional | ✅ | ✅ |
Bilateral Arabic/English Labels | ✅ | ✅ | ✅ | ✅ |
Post-Registration Obligations
Registration is not the end of your compliance journey — it is the beginning. After your Medical Device Registration Certificate is issued, you must:
- Maintain pharmacovigilance — report adverse events, device defects, and field safety corrective actions (FSCAs) to MOHAP within required timeframes
- Comply with Tatmeen — the UAE’s national medical device track-and-trace system. All Class II and III devices must be traceable in the Tatmeen system
- Notify MOHAP before any changes to device design, manufacturing site, intended use, or labelling
- Apply for renewal at least 6 months before the 5-year registration expiry
- Maintain GMP compliance and be prepared for MOHAP facility inspections at any time
MOHAP Medical Device Registration Costs
Approximate government fee ranges in AED — 2026
Fees
Note: Professional service fees for dossier preparation, site registration & regulatory support are additional and vary by product complexity and classification.
Frequently Asked Questions — Medical Device Registration UAE
Q1: Does my Class I medical device really need MOHAP registration?
Yes. All medical devices — regardless of class — require MOHAP registration before they can be sold or distributed in the UAE. Class I devices have a lighter documentation requirement, but the registration step itself is mandatory for every class.
Q2: What is an Information Request (IR) and how do I handle it?
An IR is a formal request from MOHAP’s technical committee asking for clarification, additional data, or corrections to your dossier. IRs are common and do not mean rejection. You must respond to each IR within the timeframe specified by MOHAP. Nextmove prepares IR responses quickly and accurately to minimise timeline impact.
Q3: Can a medical device with a CE mark be registered in UAE more easily?
CE marking demonstrates compliance with EU MDR, which is closely aligned with MOHAP requirements. A CE-marked device often has much of the required technical documentation already prepared. However, CE marking does not automatically grant UAE market access — MOHAP registration is still required. CE documentation significantly speeds up dossier preparation.
Q4: What is Tatmeen and does it apply to my device?
Tatmeen is the UAE’s national track-and-trace system for medical devices and pharmaceutical products. It assigns unique identifiers to each registered product and allows authorities to monitor the full supply chain. Compliance is mandatory for all Class II and Class III medical devices, and is being progressively extended to other categories.
Q5: How does Nextmove help with medical device registration?
Nextmove manages the entire MOHAP medical device registration process: from obtaining the Classification Letter, preparing and auditing the Technical Dossier, registering the manufacturing site and MAH, submitting the application via the MOHAP portal, responding to Information Requests, and tracking the application through Technical and Ministerial Committee review to certificate delivery.
