United Arab
Emirates
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.
The regulator changed, and so did who may apply
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.
Two layers, then the product
- 01
Establish who will hold the file
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 partner - 02
Register the manufacturing site
Your 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 us - 03
Settle the classification
Where 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.
Us - 04
Legalise the free sale certificate
A 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 us - 05
Submit the marketing authorisation
Filed 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 us - 06
Appoint the second importer, and the rest
Statute 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
Published fees and review periods
| 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.
Here your existing approval is not optional
EDE asks for a quality conformity certificate: EC, 510(k) or PMA.
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.
Two importers is now the law, not a negotiating position
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.
What we do here, and what we do not
We do
- Design the structure: who holds the authorisation, who imports, who distributes, and how they are contracted
- Identify and vet the licensed establishments, including the second importer the law requires
- Run the manufacturing site registration and the product submission through EDE
- Track the embassy legalisation of the free sale certificate, which is where UAE files usually stall
- Hold the calendar afterwards: renewals, variations, import permits, vigilance obligations
We do not
- Act as your importer, distributor or agent — those must be UAE-licensed establishments
- Sell your product or take margin on it
- Assert that a UKCA certificate is accepted where the regulator has not said so
- Promise an approval date. Forty-five working days assumes a file with no questions
- Quote you a fee schedule without re-confirming it, on pages the regulator does not date
What we will ask you for
- Device description, intended purpose and variants
- Risk class and your rationale
- EC certificate, 510(k) or PMA — whichever you hold
- ISO 13485 certificate
- GMP certificate from the country of origin
- Certificate of free sale, and its legalisation status
- Technical documentation
- Post-market surveillance documentation
- Internal and external packaging, leaflets and IFU
- Any existing agency or distribution agreement for the UAE
- Whether you sell into Abu Dhabi, which adds its own reporting duties
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.
What changed, and what is still unwritten
- Jan 2025New federal law governing medical products in force, replacing the 2019 regime and covering devices, biologics, supplements and free-zone establishments
- 2025–26Device registration, renewals and import permits transferred from the Ministry of Health portal to EDE
- Feb 2026EDE activates the multiple-importer mechanism and announces it publicly
- Jul 2026New pharmacovigilance practice guideline for medical products adopted by EDE resolution
- PendingThe executive regulations of the 2025 law have still not been issued. Agent appointment mechanics, transfers of authorisation and the fast-track routes all depend on them
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.
Entering the Gulf as one project
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
federal legislation register · 27 August 2026
Sources
- Federal Decree-Law No. 38 of 2024 governing medical products, pharmacists and pharmaceutical establishments — in force 2 January 2025. Articles cited: applicant eligibility, five-year validity, two-importer requirement, leaflet language, national tracking system
- Emirates Drug Establishment — service pages for issuance and renewal of a medical device marketing authorisation, manufacturer registration, medical warehouse licensing and product classification
- Ministry of Health and Prevention — notice of transfer of medical product services to EDE
- EDE announcement of the multiple-agent mechanism, 24 February 2026
- EDE resolution adopting the pharmacovigilance practice guideline for medical products, July 2026
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.