The Middle East is the most international region we cover, and by a wide margin. In Saudi Arabia the overwhelming majority of registered manufacturers also hold a US or EU registration, and very few appear nowhere else. That single fact tells you most of what you need to know about competing here — the field is companies like you, and the barrier is commercial rather than regulatory.
Request a demo →It is tempting to conclude that the world is converging on "get FDA or CE, then everything else is administrative". It is not, and the region's largest market shows why.
Saudi Arabia historically ran a route that let manufacturers use a CE or US approval more or less directly. That route was retired in January 2022 in favour of the authority's own technical file assessment. In September 2026 the SFDA opened a new reliance route: an approval from the FDA, an EU notified body, the UK, Canada, Australia or Japan now buys a lighter dossier and a 35–60 working-day review, provided the device is identical. Approvals granted on equivalence to a predicate are excluded, so a US 510(k) on its own does not qualify. A manufacturer without a reference approval can still apply through the standard route, with a fuller review.
The lesson generalises: whether a market will genuinely shorten your timeline on the strength of an existing approval, and which kind of approval it accepts, is a per-market fact that changes. It is worth checking as of the quarter you are planning in, not the year you last looked.
These are not large registers by global standards, and the number of manufacturers in each is smaller still. That cuts both ways. A small field means a well-differentiated product can take a meaningful position quickly, without the multi-year grind a crowded market demands.
It also means the top of each category is more concentrated than the headline numbers suggest, and that a distributor already carrying a competing line has little reason to take yours. Knowing who holds what before you approach anyone is worth more here than in a market where every distributor has room for one more product.
The region is small by record count and unusually reliance-friendly: several of these authorities will shorten or largely substitute their review on the strength of an approval you already hold. That makes it one of the cheapest places to convert existing regulatory work into new market access.
The constraint is rarely the review. It is the local holder — who must be established in-market, and who in several of these markets ends up named on the licence.
Tell us your products and the markets you are weighing, and we will set up an account around your portfolio rather than give you a generic tour. Onboarding is free, and quarterly training and support come with every plan.
Most companies come to us with one of these four questions. Each one is a conversation, not a form.