The Workbench · Craft
The UAE moved device registration to a new regulator
This blog has already covered how South Africa's device registration is still being built out in phases behind an establishment licence that came first, and how an FDA Establishment Identifier survives independently of the annual registration filed under it. The United Arab Emirates offers a transition neither of those posts covers: not a register growing into itself, and not an identifier outlasting a filing, but an entire federal authority handing a live register to a successor, mid-file, on a clock written into the handover itself.
One law, one new regulator
Federal Decree-Law No. 38 of 2024, governing medical products, the pharmacy profession and pharmaceutical establishments, entered into force on January 2, 2025. It hands the bulk of the UAE's medical-product regulatory functions — device registration among them — to the Emirates Drug Establishment, a federal authority first created the year before under Federal Decree-Law No. 28 of 2023 and given this expanded mandate by the 2024 law. Before that date, the Ministry of Health and Prevention ran device registration directly. After it, MOHAP is no longer the authority a new device filing answers to; the EDE is.
The handover runs on a grace period, not a hard switch
The 2024 law doesn't take effect on every regulated party the same day it takes effect in principle. Entities and individuals it covers get a one-year grace period from the effective date to bring their arrangements into compliance with its provisions — and that period can itself be extended by a Cabinet decision, which is a different kind of clock than a fixed statutory deadline. A device file that was open with MOHAP on January 1, 2025 doesn't close and reopen with the EDE on January 2; it has a window, of a length the Cabinet can still move, to land on the new authority's side of the handover.
MOHAP didn't fully step aside
The handover also isn't total. MOHAP keeps licensing community and compounding pharmacies, and continues to perform certain administrative functions jointly with the EDE rather than ceding them outright. “Which UAE authority do we file with” stopped being a single answer the moment the 2024 law took effect — it now depends on which function the filing concerns, in a way a one-line “MOHAP” entry in a tracker can no longer capture correctly for every row.
A live file's authority depends on when it was filed, not what the device is
None of this is the device-versus-company split this blog has already traced in Canada's MDEL and MDL, or in South Africa's establishment licence running years ahead of product registration. Those are two registers, stable once built, answering two different questions about the same device. The UAE's case is one register, mid-handover, where the correct answer to “who administers this filing” depends on the filing's own timing against a transition date a Cabinet decision can still shift. A company tracking a UAE device file by device alone, with the regulator's name typed once and left alone, has recorded a fact that was only briefly true.
Where this meets the file
A UAE row in a cross-border registration tracker needs the authority of record carried as its own field, timestamped against the grace-period window rather than written once and assumed permanent, with a separate note for any function — like pharmacy licensing — that MOHAP still performs instead of or alongside the EDE. A cross-border tracker built to carry that structure, alongside the launch catalog's other registration templates, is previewed there now. If your program has tracked the MOHAP-to-EDE handover differently, the shelf takes that correction directly.
The Regulatory Toolkit launches soon — a free shelf of source-mapped templates, checklists and browser-only tools for regulatory teams. Get one email when it opens, or contribute a template.