Which country first? Sequencing medical device market entry.
Pick your first export markets on four things, for your own device: how far your CE marking or FDA clearance shortens registration, whether licensed distributors exist in your segment, how much the country spends on health, and what the border adds to your price. GDP and conference buzz are not on the list. Run the four filters, open two or three markets you can support, and leave the rest for year two.
Filter 1: registration route
Your clearance is worth different amounts in different places. Inside the EU, CE marking is the authorisation. Australia's TGA accepts comparable overseas evidence, Singapore's HSA has abridged routes, and Saudi Arabia's SFDA runs a reliance route on approvals from the EEA, FDA, Health Canada, TGA, PMDA and the MHRA (see the Saudi page for the source). Brazil notifies class I and II devices, but its shortened route for class III and IV relies on FDA, Health Canada, TGA and Japan decisions, not the EU. Most of these markets also need a local registration holder. Confirm the route with a regulatory specialist before you plan a date.
Filter 2: channel and licensed distributors
Our market data classes 106 of 113 markets as distributor-led for a foreign small or mid-size maker. So the useful question is how many licensed distributors work in your segment. That count depends on the register: EUDAMED and the US FDA database do not list distributors, so counts there are a minimum.
Filter 3: market size
Use World Bank health spending, total and per head, as the hard number. Treat any device market figure, ours included, as an estimate with a range. Ours is labelled as one and the method is public. A small rich market can beat a large poor one for a premium device.
Filter 4: landed cost
Separate cash from cost. Duty, import VAT and charges collected at the border are cash your distributor must fund. What stays after a VAT-registered importer reclaims VAT is the real cost. From the EU into the UK, the Market Finder shows about 20 percent collected at the border but under 1 percent real cost. Real cost hits your price. Cash hits your distributor's working capital. See the landed cost method.
Worked example: a US dental device
An example, run on the free Market Finder on 25 October 2026. A US maker of a dental device with FDA clearance, 11 to 50 people, selling only at home, no region picked.
| Rank | Market | Verdict | Why |
|---|---|---|---|
| 1 | Australia | Go now | FDA opens a shorter reliance route; health spending USD 186bn (2023); 3 independent dental distributors confirmed |
| 2 | Singapore | Go now | Reliance route; 92 dental distributors; a regional hub for Southeast Asia |
| 3 | Israel | Go now | Reliance route; 119 dental distributors; about 18 percent collected at the border, under 1 percent real |
| 4 | Saudi Arabia | Go now | Reliance route; register without device categories, so its dental count may understate the channel |
| 5 | Canada | Go next | Health Canada licenses class II devices on attestation and an MDSAP certificate; distributors and direct sales both work; 4 independent dental distributors confirmed; about 5 percent collected at the border, under 1 percent real |
| 6 | Brazil | Go next | Class I and II notified; 149 dental distributors; about 57 percent collected at the border, about 20 percent real (medium confidence) |
Australia ranks first on route and size with only three dental distributors confirmed, so the work there is finding the right one. Brazil has the deepest channel and the heaviest border cost, so it is a year-two market unless the price can carry it. Your own device class and current markets change the answer. Distributor counts: Bastion Hale Distributor Index, build of 25 October 2026.
Sequencing patterns
- Reference market first. Get the clearance other regulators rely on, then open the markets that rely on it.
- Cluster. Group markets that can share a registration holder, a master distributor or a stock point.
- Do not over-open. Each market needs training, demo stock and a monthly review. For most small teams that means two or three at a time.
What to leave for year two
Markets that need a full local registration, markets whose border cost your price cannot absorb, and markets where you cannot name three licensed distributors in your segment. They are not bad markets. They are expensive first markets. When you are ready, find the distributor and settle the sales model market by market.
Common mistakes
- Ranking by GDP or population.
- Opening five markets in year one.
- Ignoring cash at the border because the real cost is low.
- Treating a market estimate as a measured number.
- Picking the market where the first keen distributor lives.
Questions people ask
Which market should a small device company enter first?
The one where your clearance shortens registration, licensed distributors exist in your segment, health spending supports your price and the border adds little. For FDA-cleared makers, reliance markets such as Australia, Singapore and Israel often rank high. For CE-marked makers, another EU market often does.
How does CE marking or FDA clearance shorten registration elsewhere?
Some regulators rely on the evidence behind it. The TGA accepts comparable overseas evidence, Singapore's HSA has abridged routes for devices a reference agency approved, and the SFDA runs a reliance route. A local holder and a local review still apply.
How do I compare market size across countries?
Start with World Bank health spending, total and per head, because it is measured and comparable. Use any device market estimate only as a range, and check how it was built.
How many markets should I open at once?
As many as you can train, stock and review every month. For most small teams that is two or three.
Ten markets ranked for your device, partners named.
The free Market Finder gives your top 3. The Next 10 Markets report ranks ten markets for your device and names up to ten licensed distributors in each, ranked by fit, with the registration route and landed cost. Start free with your top 3 markets in the Market Finder, and follow your markets in Market Watch: new licensed distributors, once a week.
Get the Next 10 Markets report, €490No-risk guarantee: if this report is not worth €490 to you, reply within 7 days of delivery and the fee is refunded in full; you keep the report. It is also refunded if the report names fewer than 30 licensed channel partners you did not already know.
Delivered one working day after your intake.
Sources: TGA on comparable overseas regulators; HSA abridged registration route; SFDA MDS-G030; ANVISA RDC 751/2022 and Instrucao Normativa 290/2024; World Bank current health expenditure (SH.XPD.CHEX.PC.CD); Market Finder ranking, market data of 23 October 2026; Bastion Hale Distributor Index, build 2026-10-25T12:02:08Z (source notes). Market estimates are models, not measured markets. Last reviewed 25 October 2026.