Medical Device Registration in Dubai, UAE
Register medical devices—from Class I diagnostic tools to Class IV implants—via MOHAP through a comprehensive registration process. Ensure legal import, sale, and compliance with UAE regulations for safety, efficacy, and international standards. Gain market access and protect your brand across the GCC.
What is Medical Device Registration
Medical device registration is a mandatory requirement regulated by the UAE Ministry of Health and Prevention (MOHAP) and the Dubai Health Authority (DHA). It applies to all types of medical devices, from basic diagnostic tools to advanced surgical implants. Each device must comply with strict safety, efficacy, and labeling standards through the MOHAP portal. Registration requires verified technical documents, clinical data, and internationally recognized certifications before a device can be imported, sold, or distributed in the UAE.
The registration process ensures patient safety, product effectiveness, and regulatory compliance with both UAE and international standards. Labels must be in Arabic, and English is allowed only if it exactly matches the Arabic content. Device classification ranging from low-risk to high-risk devices determines the specific approval pathway and submission requirements, including clinical evaluations, technical files, and quality management documentation.
Once approved, registration provides legal authorization to import, distribute, and supply medical devices across hospitals, clinics, and healthcare facilities in the UAE. It also strengthens brand credibility, reassures healthcare professionals and patients, and opens doors for regional expansion within the GCC. Registered devices are recognized for their compliance, safety, and quality, making market entry smoother and more trustworthy.
Benefits of Medical Device Registration in Dubai
Registering medical devices with UAE authorities ensures lawful market entry, builds healthcare provider trust, and provides regulatory credibility. It supports patient safety, streamlines hospital procurement, and prepares your brand for GCC regional expansion.
Legal Market Entry
Secure approval for import, manufacturing, and UAE distribution while avoiding penalties and customs delays.
Brand Credibility & Trust
Build confidence with hospitals, clinics, and distributors; gain access to government tenders.
Technical Verification
Certify devices meet international safety, efficacy, and quality standards.
Labeling Compliance Assurance
Meet bilingual and UDI (Unique Device Identification) requirements; reduce rejection risks.
Regional Export Gateway
Enable trading throughout GCC markets using Dubai as the regulatory hub.
Post-Market Monitoring
Comply with ongoing safety surveillance for high-risk devices and support long-term brand reputation.
Requirements for Medical Device Registration in UAE
01.Trade License & Company
UAE registered company with medical device import or distribution activity; valid business license.
02.MOHAP/DHA Portal
Register company on MOHAP website or smart app with authorized signatory details.
03.Product Classification
First obtain Classification Letter from MOHAP determining risk class (I, II, III, IV) in 5–10 days.
04.ISO 13485 Certificate
Manufacturing facility's Quality Management System (QMS) certification proving compliance.
05.Free Sale Certificate
Country-of-origin certificate attesting legal sale; must be legalized by UAE Embassy.
06.Technical Documentation
Complete device design, manufacturing process, intended use, risk assessment documentation.
07.Marketing Authorization
EC (European Conformity), FDA 510K, or PMA certification from country of origin.
08.Product Labeling & IFU
Bilingual Arabic-English labels, instructions for use, warnings, storage, UDI codes.
09.Post-Market Surveillance Plan
Documentation for ongoing monitoring, reporting, and risk management post-registration.
10.Authorized Representative
Local UAE agent agreement for foreign manufacturers required for all registrations.
How We Help Register Your Medical Devices
Step 1: Initial Assessment
We review device class, risk level, and the required regulatory pathway.
Step 2: Classification Support
We prepare and submit your device classification request to MOHAP.
Step 3: Documentation Preparation
We compile technical files, certifications, labels, and post-market plans.
Step 4: Portal Submission
We create your account, submit the application, and handle the 5,100 AED fee.
Step 5: Authority Communication
We respond to MOHAP queries and provide any additional required documents.
Step 6: Certificate Delivery
We obtain your 5-year registration certificate and support market launch setup.
Special Requirements for Certain Medical Devices
- Class III/IV implants require clinical safety data, risk analysis, and post-market surveillance reports.
- Surgical instruments need sterilization validation and biocompatibility testing where applicable.
- Diagnostic devices require analytical validation, accuracy, sensitivity, and specificity documentation.
- Software-based devices must comply with UAE Data Protection Law No. 2 of 2019 for patient data handling.
- Imported high-risk devices must submit clinical evaluation reports from FDA/EU or equivalent approvals.
- Pediatric devices require biocompatibility testing and pediatric safety substantiation.
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