Two in the Gulf, two in North Africa and the eastern Mediterranean, two further south. We went deep on six rather than shallow on forty, because the value in this work is knowing what a regulator actually published this year — and that does not scale to a list of countries on a map.
Because it shows that the two most obvious markets to enter together demand structurally opposite arrangements — and that a European certificate is worth a great deal in one and nothing at all in the other.
| Market | Who may apply | Local partners required | Does an existing approval help | Official review | Authorisation fee |
|---|---|---|---|---|---|
| Saudi Arabia SFDA · verified Aug 2026 | A licensed authorised representative established in the Kingdom | One per class or general group — the representative confirms to the regulator that no other holds it | No. The reliance route closed in 2020 — one dossier route for everyone | 35 working days | SAR 15,000–23,000 by class |
| United Arab Emirates EDE · verified Aug 2026 | A licensed marketing office or medical warehouse | At least two importers, plus one or more distributors | Yes — a conformity certificate is part of the file: EC, 510(k) or PMA | 45 working days | AED 5,000 plus AED 100 |
| Egypt EDA · verified Sep 2026 | An Egyptian importing company, local facility or scientific office | One applicant holds it — and EDA publishes a procedure for transferring it | Yes — and it is the one market here that names UKCA in its own instrument | 20 working days 7 on the fast track | Not published no device fee schedule |
| Türkiye TİTCK · verified Sep 2026 | Any manufacturer, through an authorised representative — which may sit in Türkiye or in the EU | Representative mandatory but need not be local; the importer and the seller must be Turkish | CE only. UKCA appears nowhere in the law, and UK certificates were dropped from the system at the end of 2020 | Not published no evaluation period | ₺335 per product registration |
| Nigeria NAFDAC · verified Sep 2026 | A Nigerian-incorporated local agent holding your power of attorney — required by guideline, not by the gazetted regulation | One agent. The certificate may not be transferred without the Agency's approval, and no procedure for obtaining it is published | No. UKCA recognition was promised in a 2024 partnership that disclaims legal effect — and no Nigerian instrument names any foreign mark | 120 working days 90 in the service charter | US$750 per imported device |
| South Africa SAHPRA · verified Sep 2026 | A natural person resident in South Africa — the licence is issued in that individual's name | One representative. There is no product registration at all: the scheme in the 2016 regulations has never been called up | CE yes, UKCA no. Six recognised jurisdictions for devices, and the UK is absent — though the MHRA is on the separate medicines list | 90 working days target, for 8 files in 10 | R26,200 manufacturer licence |
All six rows are traced to the regulators' own publications and dated. Egypt's was corrected in September 2026 — we had previously reported the registration as non-transferable on the strength of secondary sources, and the regulator publishes a transfer procedure. Where a regulator publishes nothing, the cell says so rather than borrowing a number. Put your own device through the fees →
The Saudi regulator expects your representative to confirm that no other representative holds the same class of your devices. UAE statute requires the holder of the marketing right to appoint at least two licensed importers for the same product, and the regulator activated that mechanism in February 2026 under the banner of breaking the monopoly on medical products.
Both facts are ordinary once you know them. Together they mean that a single regional distributor agreement covering "the GCC" — which is what most manufacturers are offered first — cannot be right for both countries at once. It will either breach the Emirati requirement or fail the Saudi confirmation.
The second row is just as consequential in the opposite direction. If you hold a CE certificate or an FDA clearance, the UAE file is substantially assembled already, while Saudi Arabia will assess your technical documentation from first principles regardless. That single difference usually decides which market goes first — and it is the reverse of what most people assume.
Almost every manufacturer names its first market before it has the information to choose one. Answer five questions and the panel will give you an order — or tell you that the honest answer is "not yet". Nothing is sent anywhere; this runs in your browser.
All twelve pages are verified, so the panel sequences devices or medicines — the answer is different for each.
The two answers have almost nothing in common.
Everything this panel says is traced to a regulator's own publication on one of the twelve market pages. Where a regulator publishes nothing, it says so instead of guessing.
The reasoning, in full, for devices — these are the questions that actually decide the order, and none of them is about market size. For medicines the questions are different in kind: not what mark you carry, but which authority is named on which list, and what the market will be allowed to pay you. Each medicines page opens with its own.
The single strongest determinant of cost and speed.
An inbound approach changes the order, but not always in the way you would like.
It changes the evidence burden more than it changes the fee.
The registration is a precondition, not the objective.
The honest constraint, and the one most often ignored.
Four risk classes, a licensed representative with exclusivity confirmed to the regulator, 35 working days, and no shortcut for anyone regardless of what your device already carries.
Read the market page →A new federal regulator, at least two importers required by statute, a conformity certificate inside the file, and a free sale certificate that must be legalised at the embassy.
Read the market page →The only market on this site that names UKCA in its own instrument. Three permitted applicant types, a published transfer procedure, twenty working days to evaluate — and no fee schedule published at all.
Read the market page →Closed to UKCA and open in an unexpected way: three notified bodies established in Türkiye carry EU MDR numbers, so a CE certificate can be obtained there and it opens Europe at the same time.
Read the market page →The only country that has promised in writing to recognise UKCA — in a document that disclaims legal effect, and which nothing has implemented. Trademark registration and the power of attorney decide the project before NAFDAC sees it.
Read the market page →You cannot register a device here — the regulator has never started. What exists is an establishment licence, issued in the name of one named individual who must live in the country.
Read the market page →The six pages above are medical devices. Below are the same six regulators read for medicines — and for a UK company the answer comes out close to inverted: the MHRA is named in four of the six, where UKCA is named in one. The comparative article is here →
The MHRA is a stringent authority, which cuts a new-drug review from 405 working days to 280. It does not open the 30-day verification route, which names only FDA and EMA. The UK is in the pricing basket.
Read the market page →Fees and clocks published in full and recently. The reference-country list exists in statute, is used in pricing, and is published nowhere — so we say we do not know whether the MHRA counts.
Read the market page →The UK is one of twenty-four reference countries, and a site there is waived from EDA's on-site inspection entirely. Ten-year authorisations. And a pricing system being rewritten as we publish.
Read the market page →Since March 2026 the pricing euro is a formula: last year's average market rate cut to sixty-five per cent by decree. And the 210-day review clock starts at scheduling, in one of four windows a year.
Read the market page →Two published lists — 36 actives and 29 products — close the market molecule by molecule. NAFDAC says it will not entertain a new application or a renewal for an imported product on either. Check yours on the page.
Read the market page →The MHRA is named outright as a recognised authority, and Brexit never touched it. The barrier is the price: one single exit price, set once, moved only by the Minister's annual percentage — 1.47% for 2026.
Read the market page →All twelve pages are up — six markets, devices and medicines. Each one traced to the regulator's own publication and dated, and each one carrying a section listing what we could not confirm. Where a regulator publishes nothing, the page says so rather than borrowing a number from somewhere else.
What reading the regulator actually produced. Six markets, and in every one of them what we found contradicted something the industry repeats. Saudi review periods quoted at three to five times the published maximum, and a reliance route still being sold six years after it closed. An Emirati two-importer rule described as a February 2026 law when it has been in statute since January 2025. An Egyptian registration reported as non-transferable — including by us, until we read the guideline and corrected it. Turkish certificates from UK notified bodies deleted from the national system in 2020 rather than quietly ignored. A Nigerian promise to recognise UKCA in a document that disclaims legal effect. And a South African product registration scheme that, ten years after it was gazetted, has never been called up — while providers sell "SAHPRA device registration" anyway.
That is the whole argument for this website, and it is why four of the six pages carry a section listing what we could not confirm.
Every figure on a market page is traced to the regulator's own publication, with the document name and version where one exists, and the date we last checked it. Where a regulator does not publish something openly — and several do not — we say so on the page and confirm it with the authority during an assessment, rather than repeating a plausible number from a consultancy blog.
We re-check each page quarterly and after any circular or resolution affecting devices. It is a slower way to build a website. It is the only way to build one a regulatory affairs manager can quote internally without checking it first.
Twelve pages, six markets, devices and medicines. Send us the product and the markets you are weighing, and two weeks later you will have the sequence, the cost and an honest view of the order.
Or reach us directly — mail@bcabusiness.co.uk · +44 7342 901002 · WhatsApp