Since February 2026 the UAE requires you to appoint at least two importers for the same product. That is the opposite of what Saudi Arabia demands — and if you are entering both, you cannot use one structure for the Gulf.
Medical devices are now regulated federally by the Emirates Drug Establishment. Registration, renewals and import permits moved off the Ministry of Health's portal onto EDE's. If your last submission went through MOHAP, the process you remember is not the process that runs today.
Under the governing law, in force since January 2025, the applicant must be a UAE-licensed pharmaceutical establishment — a marketing office, a manufacturer, or a medical warehouse designated by the holder of the marketing rights. A foreign manufacturer cannot file on its own behalf, and only the agent named on the product authorisation may import.
Free zones do not sit outside this. The law states expressly that it applies to establishments operating in the State including those operating in free zones. Setting up in a healthcare free zone changes your facility licensing, not your federal product registration.
An EDE-licensed medical warehouse or marketing office must exist before anything can be submitted. Licensing runs through EDE with inspection stages, and the entity needs a qualified technical manager.
Us, with the partnerYour factory is registered with EDE separately from the product, on a five-year cycle, and the file needs a GMP certificate from the country of origin and ISO 13485.
You, assembled by usWhere the category itself is arguable — device, medicine, supplement or cosmetic — EDE issues a formal classification determination for a fee. Getting this decided in advance is cheaper than discovering it mid-review.
UsA certificate of free sale or registration from the country of origin is required, certified by the UAE Embassy. This is a diplomatic step with its own queue and it is the single most common cause of a stalled UAE file. Start it before you need it.
You, tracked by usFiled through EDE's portal with the agency contract, the quality conformity certificate, post-market surveillance documentation, packaging and leaflets, and a sample with its certificate of analysis. Safety and efficacy data are required for the higher risk classes.
Partner, managed by usStatute requires at least two licensed importers and one or more distributors, with one nominated as the main establishment responsible for licensing, pharmacovigilance and the product lifecycle. See below — this is the part that changes your commercial arrangements.
Us, with you| Item | Fee, AED | Time |
|---|---|---|
| Device marketing authorisation | 100 + 5,000 | 45 working days |
| Renewal of authorisation | 100 + 2,500 | 15 working days |
| Product classification determination | 500 | 10 working days |
| Manufacturing site registration, renewal | 100 + 10,000 | 2–4 weeks |
| Medical warehouse licence | 7,500 + inspections | 3 working days per stage |
| Import permit | 100 + 1% of CIF minimum 200 per invoice | 3 working days |
Fees as published on EDE's service pages, checked August 2026. EDE does not date-stamp these pages, so we re-confirm the schedule with the authority before quoting a project. The 45 working days assumes a complete file — a deficiency letter stops the clock. Build the full sheet for your device →
The import permit is the one that scales. Every other line above is a flat fee you pay once. This one is charged per consignment against the CIF value, which means it belongs in your landed cost model rather than in your registration budget — and it is the line most often left out of a competitor's quote entirely.
In Saudi Arabia no foreign approval shortens anything. In the UAE the document list runs the other way — a European certificate or an FDA clearance is part of what you file. That makes the Emirates faster for a manufacturer who holds one, and a genuine problem for one who does not.
Which brings us to UKCA. EDE names EC, 510(k) and PMA. It does not name UKCA. We have not found a published instrument confirming that a UKCA certificate satisfies this requirement, and we will not tell you it does on the strength of a consultancy blog. If your device carries UKCA and nothing else, treat the UAE as a market where your conformity route needs establishing in writing with EDE before you spend money on legalisation and licensing.
This is the sharpest illustration of the problem the whole UK sector inherited: a manufacturer who moved from CE to UKCA after Brexit did not simply change marks. In markets that were built to rely on the CE certificate, they removed the document the file was designed around.
The governing decree-law requires the holder of the marketing right to appoint at least two pharmaceutical establishments licensed in the UAE as importers of the product, plus one or more distributors. One of them must be notified to EDE as the main establishment, carrying the licensing work, pharmacovigilance and lifecycle management.
The obligation has been in the statute since January 2025. What changed in February 2026 is that EDE announced it was activating the mechanism, framing it publicly as breaking the monopoly on medical products in the country.
| Question | Saudi Arabia | United Arab Emirates |
|---|---|---|
| How many local partners | One representative per class or general group — exclusivity confirmed to the regulator | At least two importers, plus distributors |
| Does your existing approval help | No. Reliance route closed in 2020 | Yes — a conformity certificate is part of the file |
| Official review | 35 working days | 45 working days |
| Who may apply | Licensed authorised representative | Licensed marketing office or medical warehouse |
What this does to your distributor conversation. If a UAE distributor is offering you exclusivity, the statute now sits against that arrangement for imports. Signing an exclusive before the structure is settled is how manufacturers end up renegotiating from a weak position twelve months later. We would rather set it up correctly at the start — and it is one of the reasons we keep the licence-holding entity separate from whoever sells.
Language is statutory here. The law requires the internal leaflet to be provided in Arabic and English at minimum, printed or electronic. Budget for translation and for the review of the translated claims — not just the words, but whether the Arabic says what your regulatory file says.
That last line is not a footnote. A market whose implementing rules are unwritten is one where a provider who is not reading the regulator weekly will give you last year's answer — including on the reporting deadlines, which were revised in July 2026.
Saudi Arabia wants one exclusive representative. The UAE requires at least two importers. Send us the device and we will tell you what structure works for both, what each costs and which one to do first.
Or reach us directly — mail@bcabusiness.co.uk · +44 7342 901002 · WhatsApp
Where EDE publishes a figure without a date, we treat it as indicative and confirm it with the authority before it goes into a client quote. Where we could not find a published rule — UKCA acceptance is the live example — this page says so rather than filling the gap with a plausible sentence. Re-checked quarterly and after any EDE resolution affecting devices.