2026 Outlook: Executive Regulation, Reference Authority List Updates and UDI Digital Traceability

1. Key takeaways

Federal Decree-Law No. 38/2024 contains 181 articles; it was issued on 2024-10-01, published in the Official Gazette on 2024-10-14 and came into effect on 2025-01-02, with a 1-year transition period from the effective date, extendable by a decision of the Cabinet. Three forward-looking lines of work open up from this. First, the Executive Regulation has not yet been issued in full, and Article 6(1)(h) leaves other conditions to the Executive Regulation. Second, EDE applies reliance review and is preparing to update its list of reference authorities. Third, the database registration of Article 66 reserves the interface for the national traceability system and UDI implementation. Our judgment is that the compliance cost in 2026 lies mainly not in official fees but in the documentation and data transformation workload reserved for these three changes; the earlier the transformation is started, the lower the cost.

• 181 articles; issued 2024-10-01, published 2024-10-14, effective 2025-01-02, with a 1-year transition period extendable by Cabinet decision.
• Article 6(1)(h) reserves other conditions for the Executive Regulation, which is not yet issued in full.
• EDE reliance review rests on the reference authority list, which is being updated and will rearrange the evidence base.
• Article 66 database registration is the precondition for the national traceability system and UDI to take effect.

2. Legal basis

The provisions underpinning the three forward-looking lines of work, and the decree establishing EDE itself, are set out in the table below.

3. Expert insights

Insight 1: Article 6(h) is an open clause; for everything the Executive Regulation reserves, written confirmation should replace industry practice. Our professional judgment is not to infer the UAE’s executive approach from experience in other markets. The reason is that item (h) expressly leaves other conditions to the Executive Regulation; before the Regulation is issued, any self-devised operating standard has no regulatory basis, and once the Regulation is issued it may directly overturn existing arrangements. On the trade-off, submit written enquiries to EDE and keep them on file long-term, using the replies as the basis for execution; the same question should be re-asked in different years, because lists and approaches change.

Insight 2: An update of the reference authority list directly changes how evidence is organized. The judgment is that EDE currently relies on approvals by the EMA, the US FDA, the UK MHRA, Australia’s TGA, Switzerland’s Swissmedic, Health Canada, and Japan’s MHLW / PMDA; once the list is updated, the main axis of evidence must be rearranged. The reason is that Article 6(1)(c) requires assessment of the compliance of reference country marketing authorizations, and eligibility as a reference country is the precondition for evidence to be admissible. On the trade-off, companies holding only a Chinese NMPA registration certificate should prepare reinforcement of reference country evidence in parallel, and include the list update in the annual review, rather than discovering only at application that the main axis of evidence has failed.

Insight 3: Article 66 database registration is the precondition for UDI to land. The judgment is that without a database registration obligation the national traceability system cannot close its loop, and UDI would remain nothing more than printing on a label. The reason is that Article 66 interlocks with the traceability powers conferred on EDE by Federal Decree-Law No. 28/2023; traceability depends on data, not labels. On the trade-off, before the Executive Regulation specifies the detailed UDI requirements, complete the assignment of UDI-DIs and the transformation of the label data structure first, so that later requirements land on an existing skeleton and the packaging does not have to be redesigned after the Regulation is issued.

4. Practical recommendations

• Build an Executive Regulation tracking ledger listing the matters reserved under Article 6(h) item by item; for anything without express provision, submit a written enquiry to EDE and keep it on file.
• Include the reference authority list in the annual review, using the EMA, FDA, MHRA, TGA, Swissmedic, Health Canada and PMDA as the current main axis of evidence, and rearrange the technical documentation immediately after any list update.
• Companies holding only a Chinese NMPA registration certificate should prepare a plan for reinforcing reference country evidence in parallel, and not treat a single-market certificate as a long-term evidence base.
• Complete the assignment of UDI-DIs and the transformation of the label data structure ahead of time, reserving the interface for Article 66 database registration and the national traceability system.
• Build post-market vigilance, periodic reporting and traceability data on a single data model, avoiding three systems each acting on its own.
• Plan the renewal rhythm against the Article 7 5-year validity period, so that the documentation transformation is completed before the renewal node.

5. Verification checklist

• □ An Executive Regulation tracking ledger has been built, with the matters reserved under Article 6(h) listed item by item
• □ Matters without express provision have been submitted to EDE as written enquiries and kept on file long-term
• □ The reference authority list is included in the annual review, and the main axis of evidence can be rearranged when the list is updated
• □ Companies holding only a Chinese NMPA certificate have prepared a plan for reinforcing reference country evidence
• □ The assignment of UDI-DIs and the transformation of the label data structure have started
• □ Vigilance, periodic reporting and traceability data are planned on a single data model
• □ The documentation transformation plan is aligned with the Article 7 5-year renewal node
• □ The Article 66 database registration obligation has been entered into the internal allocation of responsibilities

Further reading: Article No. 45, Change Management: Notification of Minor Changes and Re-Approval of Major Changes (Article 15); Article No. 47, The Pricing Mechanism and the Drug Policy Committee: Article 36 and Ministerial Decision No. 130/2019; Article No. 12, How to Use Reference Country Reliance: The Logic of the EDE Reference Authority List.

Regulatory information verified as of October 29, 2026.

Disclaimer: This volume was compiled by the GRZAN regulatory team from UAE official regulations and public information from the regulator available as of the verification date, for compliance reference only; it does not constitute legal advice or a business commitment. The Executive Regulation of UAE Federal Decree-Law No. 38/2024 has not yet been issued in full, and the EDE service processes and fees may be adjusted. Companies should rely on the latest service pages published by EDE (www.ede.gov.ae), the text of the UAE Official Gazette, and written replies from the competent authority.

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 adverse event reporting and recall coordination with MOHAP, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com