The United Arab Emirates has officially completed a significant regulatory restructuring: all medical device related services previously overseen by the Ministry of Health and Prevention (MOHAP) have been transferred to the Emirates Drug Establishment (EDE). EDE now serves as the sole federal authority governing medical device classification, market authorization, import permits, manufacturer licensing, advertising approvals, and post-market vigilance.
This centralization is designed to streamline processes, remove jurisdictional overlap, reduce administrative complexity, and enhance regulatory oversight. For companies marketing, importing, or manufacturing medical devices in the UAE, this shift requires immediate operational alignment.
All submissions, new or ongoing, must now flow through EDE rather than MOHAP.
Regulatory Context
This transition is part of a broader multi-year initiative by the UAE to modernize and consolidate healthcare product regulation. Historically, regulatory responsibilities were distributed across multiple governmental bodies.
MOHAP was tasked with device classification, marketing authorization, and advertising approvals, while additional functions related to pharmaceuticals and controlled substances were spread across other federal entities. The creation of the Emirates Drug Establishment in 2023 marked the first phase of regulatory unification.
Originally intended to serve as a centralized regulatory, supervisory, and enforcement authority for medicines and medical products, EDE has progressively absorbed responsibilities from MOHAP. As of late 2025, the transition is complete.
The rationale for unifying medical device governance under EDE includes:
- Regulatory Harmonization: Consolidating oversight allows the UAE to align more closely with international frameworks such as EU MDR, TGA, and SFDA systems.
- Digital Transformation: EDE operates as a digital-first regulator, offering a centralized portal for all applications and submissions.
- Lifecycle Management: With a single authority overseeing classification through post-market vigilance, regulators can better detect trends, track safety signals, and enforce compliance.
- Market Predictability: Companies benefit from clearer processes, centralized communications, and faster turnaround times.
This restructuring positions the UAE to better support its rapidly expanding healthcare and medtech markets while establishing a regulatory foundation capable of scaling with future innovation.
Transferred Medical Device Services
Nine core regulatory services have transitioned from MOHAP to EDE. These services encompass the full medical device lifecycle and significantly impact how manufacturers, importers, and authorized representatives interact with the UAE regulatory system.
1. Classification of a Medical Product
Device classification, whether a product is considered a medical device, IVD, accessory, or non-regulated product, is now exclusively determined by EDE. This step is essential because classification impacts the pathway, documentation requirements, testing expectations, and clinical evidence thresholds for approval.
2. Issuance of Marketing Authorization for a Medical Device
All new device approvals now go through EDE. Applicants must submit documentation through EDE’s digital portal, including technical files, safety data, performance testing, clinical evaluation reports, and CE/FDA certificates where applicable.
3. Renewal of Marketing Authorization for a Medical Device
Renewals previously filed with MOHAP must now align with EDE’s requirements. Companies should verify whether their renewal timelines remain unchanged and ensure their EDE accounts are active for future submissions.
4. Permit to Import Medical Items and Products
Import permits (required for devices, components, and sometimes even demonstration units) are now issued by EDE. Importers and distributors must ensure their UAE PASS and EDE portal credentials are updated and validated to avoid shipment delays.
5. Licensing an Advertisement for a Medical Product
All promotional content, whether digital, print, or event-based, now requires EDE approval. This includes product brochures, websites, social media posts, claims, and labeling tied to device performance.
6. Renewal of Advertisement License for a Medical Product
Ongoing promotional campaigns or previously approved materials must now be renewed through EDE. Companies should cross-check previously issued approvals to confirm whether re-submission or migration into the EDE system is required.
7. Reporting Side Effects of Medicines and Medical Products
Pharmacovigilance and post-market reporting obligations have also moved to EDE. All adverse events, field safety corrective actions (FSCAs), recalls, and trend reports must be submitted through EDE systems.
8. Registration of a Manufacturer of Medical Products
Manufacturer registration (required for all facilities producing devices marketed in the UAE) must now be done through EDE. This includes initial registration of new manufacturing sites or principal addresses.
9. Renewal of Registration of a Manufacturer of Medical Products
Annual or periodic renewals for manufacturer listings now fall under EDE authority. Companies should review the renewal cycle to avoid unintentional lapses that could impact product availability.
Operational Impact on Industry Stakeholders
The centralization of regulatory services under EDE affects all industry stakeholders, including manufacturers, authorized representatives, distributors, and importers. The most immediate operational impacts include:
EDE Is Now the Exclusive Regulatory Authority
All new submissions must be filed through EDE. MOHAP no longer accepts applications for:
- Classification
- Market authorization (new or renewal)
- Import permits
- Advertising approvals
- Manufacturer registration/renewal
- Vigilance reporting
Pending Applications May Require Action
Organizations with in-progress submissions under MOHAP should verify whether:
- Applications have automatically migrated to EDE, or
- Resubmission is required.
In some cases, companies may need to upload documentation again, especially if formatting or portal-specific requirements differ.
Digital Access Is Now Mandatory
EDE’s online platform requires:
- A UAE PASS login for identity verification
- A registered account for organizations
- Authorized representative credentials to act on behalf of manufacturers
Ensuring uninterrupted access is essential for renewals, vigilance, and import permit processing.
Supply Chain and Logistics Implications
Importers must confirm that new import permit workflows are understood internally, as delays in approvals could affect shipment release, customs clearance, or product availability.
Compliance Considerations and Immediate Next Steps
With the regulatory shift now fully in effect, medical device companies should take proactive steps to ensure compliance and avoid disruptions in market access.
1. Audit All Existing Regulatory Assets
Review:
- Active marketing authorizations
- Manufacturer registrations
- Advertising licenses
- Outstanding renewals
Identify any assets previously managed under MOHAP and determine whether they require migration or verification within EDE.
2. Update Internal SOPs and Documentation
Internal regulatory processes should be revised to reflect:
- EDE as the responsible authority
- Updated submission pathways
- Changes to approval timelines, documentation templates, and fees
Training regulatory, quality, and commercial teams is essential.
3. Confirm EDE Portal Access and Permissions
Ensure the following:
- UAE PASS accounts are active
- Your organization profile is created or migrated
- Users have appropriate access levels (admin, representative, etc.)
4. Review Vigilance Procedures Under EDE
Update reporting workflows to:
- Ensure timely submission of AEs, FSCA notices, and trend reports
- Align with EDE’s definitions and reporting timelines
- Document EDE-specific escalation requirements
5. Verify Compliance for Advertising and Promotional Materials
All device-related promotional content must be validated under EDE rules. Companies should:
- Audit existing approvals
- Confirm whether re-approval is needed
- Review claims and labeling for compliance with EDE guidance
Conclusion
The transfer of medical device regulatory services from MOHAP to the Emirates Drug Establishment marks one of the most significant regulatory restructuring efforts in UAE healthcare oversight. By centralizing classification, market authorization, import controls, manufacturer registration, advertising regulation, and vigilance under a single authority, the UAE has created a unified, digital-first regulatory environment that enhances clarity, efficiency, and accountability.
For manufacturers, authorized representatives, and distributors, this transition requires immediate alignment with EDE systems, processes, and compliance expectations. While the change introduces short-term operational adjustments, it ultimately strengthens the UAE’s position as a modernized, globally aligned regulatory market for medical technologies.
