North America is where most manufacturers want to be and where the barrier is highest — not because entry is unclear, but because the field at the top is far smaller than its size suggests. Understanding how concentrated your specific category is matters more here than in any other region.
Request a demo →The most concentrated register in the world is the US high-risk premarket pathway: roughly 700 companies hold approvals under it, and ten of them hold more than half of everything. That is what a demanding, expensive route does to a market — it functions as a barrier that keeps the field small and the incumbents secure.
The lower-risk clearance route is a different world entirely, with tens of thousands of companies and a top-ten share in single digits. Which of the two you are entering changes the economics of the whole plan far more than the size of the addressable market does.
Canada sits between the two in concentration and is a materially smaller field — fewer than a third of the manufacturers the US register holds. For a company that already holds a US clearance, it is frequently the cheapest incremental market in the world; nearly two-thirds of Canada's registered manufacturers also hold a US or EU registration.
North America is not a market where the hard part is finding out what the rules are — that is well documented and freely available. The hard part is judgement: whether your device is genuinely substantially equivalent to the predicate you have in mind, how to frame an indication so it survives review, and when a pathway you would rather avoid is the one you actually need.
That is experience, not information, and it is the one place we consistently tell people to buy help rather than tooling. We work with regulatory consultants covering the US and Canada and are happy to make an introduction — no fee, no arrangement on our side, just a name we would use ourselves.
Two markets that look similar and are not. In both you own the clearance or licence yourself, but the United States still requires a foreign manufacturer to designate a US Agent for correspondence with the FDA. Canada is the genuinely unusual one: a foreign manufacturer holds its own device licence with no local holder required at all, and an agent is optional rather than mandatory. Very little of the world works that way.
The practical question is which one you file first, because the evidence you assemble for one is largely reusable for the other — and because an approval in either is the single most portable asset you can hold when you turn to Asia or Latin America, where a great many routes discount a review on the strength of it.
Tell us the markets you are weighing and we will show you your own account with your products in it. If what you actually need is a consultant who works this region, we will introduce you to one — no fee, no arrangement on our side.
Most companies come to us with one of these four questions. Each one is a conversation, not a form.