Most market evaluations start in the wrong place. Someone asks "can we register there?", a consultant answers yes with a timeline and a fee, and the decision gets made on that basis. Eighteen months later the registration is granted and nothing sells.
Registration is permission. It is not demand, it is not a price, and it is not a route to a buyer. Here are the questions worth answering first — in the order that stops you spending money on the wrong market.
1. Who is allowed to hold the registration?
In the US and the EU, you hold your own market authorisation. Across most of Asia, Latin America and the Middle East, you cannot: it is granted to a locally domiciled entity — an importer, a distributor, or your own subsidiary if you have one — and that entity's name sits on the certificate.
That single structural fact reshapes the whole decision. Your market access becomes legally attached to your partner. Changing partners can mean re-registering, and re-registering can mean months with nothing to sell. Across the markets where we can classify the relationship, roughly three registrants in four exist to hold somebody else's product rather than their own.
So partner selection is not a commercial step that follows the regulatory one. It is the regulatory step, and it belongs in the evaluation rather than after it.
2. What class is your device there?
Not at home — there. Classification drives the pathway, the dossier, the timeline and the fee, and it is not portable. A device that is Class II in the US can land higher elsewhere, at which point the fast route you budgeted for may not be available to you and the dossier is substantially larger than planned.
It is also the input to every reliance pathway: markets that will shorten their review because a trusted authority already did one generally key that off your classification in their system. Get the class wrong and the shortcut evaporates. We published the divergence by device type because it is the most common way a regional budget goes wrong before anyone has filed anything.
3. Who is already there, and are they like you?
Two markets can hold the same number of registrations in your category and be completely different places to compete. What matters is how concentrated the field is, and whether the companies in it are international or local.
The spread is dramatic. In Hong Kong, 4.4% of registered manufacturers appear in no other market — the field is companies you already know. In China it is 88%, and a competitor analysis built from familiar names describes about a tenth of the market. We wrote up the method for answering this properly, because it is answerable and most companies never try.
4. Will your existing approvals do any work?
A meaningful number of markets will shorten their own review on the strength of an approval you already hold. The formal name is reliance, and the direction of travel is mostly toward more of it — IMDRF published a dedicated playbook in February 2026.
This makes order a lever rather than an afterthought. Enter the reliance-friendly markets first and each subsequent filing starts from a stronger position; the cost per market falls as you go. Markets running a wholly independent assessment are their own projects and should be budgeted as such.
Do not assume it is a one-way ratchet. Saudi Arabia retired the route that let manufacturers use a CE or US approval more or less directly in January 2022, in favour of its own technical file assessment. Whether a market will shorten your timeline is a per-market fact that changes — check it for the quarter you are planning in, not the year you last looked.
5. How does anyone actually get paid?
This is the question first-time expanders underweight most, and the one that decides whether the approval turns into revenue.
There are broadly three routes and most markets use a combination. Reimbursement listing: a national payer maintains a list of what it will pay for and at what amount, and if your device is not on it, nobody pays. Public tender: hospital purchasing runs through published procurement, which is unusually good news because it means the real purchase cadence, the specification language buyers use, and often the winning price are matters of record. Private and direct purchasing: less visible, and in several emerging markets the majority of addressable volume.
A market with a fast, reliance-friendly registration pathway and no payment route for your category is a slower path to revenue than a harder market with a clear one. That comparison should happen before you file, not after.
6. What does the failure look like?
Worth asking explicitly. For most markets on most shortlists the downside is not a regulatory rejection — it is a granted registration held by a distributor who never really pushed the product, in a market where switching means starting over.
If that is the realistic failure mode, then the diligence that matters is on the partner and the competitive field, not on the submission. Most evaluation effort goes the other way round.
The short version
- Establish who can legally hold your registration; if it is not you, partner selection is part of the evaluation.
- Check your classification in the target market, not at home.
- Look at who is already registered in your category — including the local manufacturers you have never heard of.
- Find out whether your existing approvals shorten anything, and sequence so they compound.
- Identify the payment route before you commit. Approval without one is an expensive certificate.
- Ask what failure looks like, and put the diligence there.
None of this requires a consultant to answer at the shortlist stage. It requires knowing what is already true in each market, which is exactly what our regional assessments set out.