Federal Decree-Law No. 28/2023: The EDE’s Statutory Powers and What They Mean for Companies

1. Key takeaways

Federal Decree-Law No. 28/2023 established the Emirates Drug Establishment (EDE) and granted it powers over licensing, pricing, vigilance and traceability, and this is the organisational-law foundation that made the institutional switch of January 2, 2025 possible. Our understanding is that every EDE power corresponds to an obligation node for the company: the licensing power corresponds to the marketing authorization and the import licence; the pricing power corresponds to the pricing documents at filing and to price compliance after market entry; the vigilance power corresponds to building the system and submitting reports; and the traceability power corresponds to database registration and distribution records. Mapping the list of powers onto a list of obligations is the most effective way to build an internal compliance ledger.

• Federal Decree-Law No. 28/2023 establishes the EDE and grants it powers over licensing, pricing, vigilance and traceability.
• Each EDE power maps onto a specific obligation node for the company.
• The licensing power maps to marketing authorization and import licences; the pricing power to pricing documents and post-market price compliance.
• The vigilance power maps to system-building and reporting; the traceability power to database registration and distribution records.

2. Legal basis

The table below lists the establishment instrument, the two provisions of the later decree that give effect to traceability and pricing policy, and the current EDE service terms for medical device marketing authorization.

3. Expert insights

Insight 1: Because the EDE holds pricing powers, pricing is a “filing matter”, not a “commercial matter”. Article 36 establishes the drug policy council responsible for policies on circulation, pricing and monitoring, and the documents required on the EDE service page expressly include pricing requirements for specific devices. Our judgement is that pricing documents should be prepared in step with the registration dossier, not negotiated after approval. By reference to the precedent of Ministerial Resolution No. 130/2019, under which the prices of 410 products were reduced by 2%–77%, once a price is adjusted the company’s commercial model needs to leave room to absorb it.

Insight 2: The traceability power is moving from institution to system, and companies should prepare their data in advance. Article 66 provides the database registration obligation. Our judgement is that the path by which the EDE advances the national traceability system will first land on registration fields and coding, and then on distribution data. The most valuable action at this stage is therefore not to wait for the detailed rules, but to organise product identification, batches, UDI and distribution records into structured, importable data. The reason is simple: the preparation window left to companies after detailed rules are issued is usually short, whereas the officially published service timelines (such as 45 working days for a marketing authorization) do not change; the only compressible part is the company’s internal preparation time.

Insight 3: The vigilance power places responsibility on the rights holder, not on the agent. Article 21 provides the rights-holder obligations, of which paragraph 6 requires compliance with the EDE vigilance guidance; Article 22 requires the designation of a lead institution to carry the vigilance affairs. Our judgement is that outsourcing vigilance work in its entirety to a local agent does not transfer responsibility when an incident is pursued. The sound approach is for the rights holder to retain ownership of the system and the decision-making, to entrust execution actions to the lead institution, and to fix the reporting routes and timelines in a written agreement.

4. Practical recommendations

• Build an obligations ledger along the four lines of “licensing — pricing — vigilance — traceability”, marking for each line the corresponding provision, the responsible person and the form of evidence.
• Prepare the pricing documents in step with the registration dossier, and leave room for price adjustments in the commercial model.
• Organise product identification, batch and UDI data in advance into a structured, importable format to meet the database registration requirement.
• Keep ownership of the vigilance system with the rights holder, entrust execution actions to the lead institution by written agreement, and specify the reporting timelines and escalation routes.
• Retain acceptance numbers and receipts for every submission falling within EDE powers, forming an evidence-based compliance trail.
• For matters not yet clarified by the executive regulations, obtain written replies from the EDE by written enquiry, and do not rely on industry practice as a basis (see the relevant judgement in Article 07).

5. Verification checklist

• □ An obligations ledger covering the four lines of licensing, pricing, vigilance and traceability has been established.
• □ The person responsible for preparing the pricing documents and the submission milestone in the filing package have been confirmed.
• □ Product identification, batch and UDI data have been confirmed as exportable in a structured format.
• □ The trigger point for database registration under Article 66 and the source of the registration fields have been confirmed.
• □ Ownership of the vigilance system has been confirmed as resting with the rights holder, and the lead institution’s duties are agreed in writing.
• □ Acceptance numbers, receipts and reply documents from correspondence with the EDE have been retained.
• □ It has been confirmed that matters reserved to the executive regulations are handled by written enquiry rather than by inferring from practice.

Further reading: Article 04 “The Three-Tier Regulatory Structure for Medical Devices in the UAE: EDE, MOHAP and the Emirate-Level Health Authorities”; Article 06 “The Mandatory Nature of Marketing Approval: The Red Line of Article 5 and the Two Exemptions”; Article 47 “The Pricing Mechanism and the Drug Policy Council: Article 36 and Ministerial Resolution No. 130/2019”.

Regulatory information verified as of October 29, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the United Arab Emirates. Our team manages MOHAP registrations and free-zone (DHCC) pathways, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com