Updated 7 October 2026. We re-verified every market in this piece against the authorities' own instruments. Several positions had changed since August, and several we had wrong. The corrections are listed at the end.
Almost every guide to international expansion says the same reassuring thing: get an FDA clearance or a CE mark, and a lot of other markets will lean on it. That is true. It is also two completely different mechanisms wearing one word, and the difference decides something more important than cost.
In some markets a foreign approval is a shortcut. You can enter without one; having one means less dossier, less review, less money.
In others it is a prerequisite. It shortens nothing. It decides whether you are allowed to file at all.
A shortcut you lack is a line item. A prerequisite you lack is a closed market. Most planning treats them identically, and the mistake only surfaces after the budget is approved.
Singapore: the shortcut, working exactly as advertised
Singapore's HSA runs an abridged evaluation route recognising the US FDA, EU notified bodies, Health Canada, Australia's TGA and Japan's MHLW/PMDA, and since March 2026 also Malaysia's MDA for devices that went through Malaysia's full conformity assessment. Hold a current authorisation from one of them and you submit a reduced-scope technical file instead of a full evaluation. For a Class B device that is SGD 2,010 and 100 working days against SGD 3,900 and 160.
Crucially, you can still enter Singapore without any of them — you just do more work. That is what a shortcut means. It lowers the price of entry; it does not control the door.
Malaysia works the same way. Its conformity assessment bodies verify a reference approval instead of performing a full review, and it recognises the five above plus Singapore, Thailand and the UK. Since 1 March 2026 an HSA registration is verified in 30 working days instead of 60, so the two markets now lean on each other in both directions.
Saudi Arabia: the route came back
The SFDA used to run a GHTF reference route that let you lean on a US, EU, Canadian, Japanese or Australian approval. It cancelled that route at the end of 2021, and the earlier version of this piece used Saudi Arabia as the example of reliance moving backwards.
On 9 September 2026 it moved forward again. SFDA guidance MDS-G30 sets up a reliance pathway: an approval from the FDA, an EU notified body, the MHRA, Health Canada, the TGA or Japan's PMDA gives a lighter dossier and a 35–60 working-day review, for every risk class, provided the device is identical. Two exclusions decide who actually qualifies. Approvals granted primarily on substantial equivalence to a predicate are excluded, so a US 510(k) on its own does not open this route while a PMA or De Novo does. Self-declared approvals are excluded too.
We had also described Saudi Arabia as a gate. We can find no SFDA instrument that requires a foreign approval before you apply, and the new guidance treats reliance as optional. Any manufacturer can file through the standard route; without a reference approval it simply faces the fuller review. That makes Saudi Arabia a shortcut market, not a gate.
Where the gate is real
Israel is built as a gate. AMAR registers a device on the strength of approval in a recognised country — the US, the EU, Canada and Australia are named in its own procedure — and there is no independent Israeli assessment route to fall back on. Its fast track then adds a second layer: up to 45 working days for a class II device on an FDA 510(k) or De Novo, or an EU class IIa approval. An FDA PMA does not qualify for the fast track.
Egypt registers imported devices on a free sale certificate from one of 37 reference countries — the EU and EEA states, Switzerland, the UK, the US, Canada, Australia, Japan and New Zealand — or an FDA Certificate to Foreign Government. Devices from anywhere else face extra testing and committee review. The UAE likewise expects foreign registration evidence before it will authorise.
A different kind of gate is easy to confuse with these. China, Taiwan and India require approval or free sale in the device's own country of origin or manufacture. That is a rule about where you make the product and whether it is approved there, not about which reference approval you hold.
The approval type matters as much as the country
"Holds an FDA approval" is not one fact. Reliance rules increasingly name the type of approval, and a US-only company with 510(k) clearances qualifies for noticeably less than the phrase suggests:
- Saudi Arabia excludes predicate-equivalence approvals — 510(k) — from its new route.
- Australia waives the mandatory application audit for Class III devices on an FDA PMA, not a 510(k) or De Novo, and on EU certificates under the MDR, not the old directives.
- Malaysia accepts 510(k) and PMA but not De Novo.
- Israel's fast track takes 510(k) and De Novo but not PMA.
- Brazil accepts US, Canadian, Australian and Japanese approvals but not CE marking.
- Kenya accepts EU certificates issued under the MDR or IVDR, not under the directives.
The practical consequence: for a 510(k)-only company, a second approval of a different type — CE through a notified body, a TGA inclusion, a Health Canada Class III or IV licence — is often worth more than the next market on the list.
Conditions that no recognition list captures
Thailand requires the reference product to be registered and marketed for more than a year. A clearance obtained last month does not qualify for the concise route, and neither does an approval for a product you have not yet sold. There is a seasoning period between earning leverage and being able to spend it.
India uses its reference countries to waive clinical work, not to permit filing. An import with a free sale certificate from Australia, Canada, Japan, an EU country, the UK or the US needs no Indian clinical investigation. Since August 2026 the EU also counts for a novel device with no Indian predicate, provided it has been approved and marketed there for two years and the manufacturer commits to a post-marketing study.
Mexico requires the filings to match, and has widened who it listens to. Its 2025 abbreviated route accepts an approval from any member of the IMDRF Management Committee — which brings in the EU, Australia, Brazil, China, Korea, Singapore and Switzerland alongside the US, Canada and Japan — checks the file for completeness and must decide within 30 business days. But the device must be the same as the one the reference authority approved, on configuration, indications and manufacturing sites. A clearance for a slightly different configuration does not carry across.
Brazil lightens the review, not the queue. Since June 2024 a Class III or IV device holding a US, Canadian, Australian or Japanese approval gets an optimised technical analysis. The application keeps its place in the chronological queue.
And reliance moves in both directions. Saudi Arabia removed a route in 2021 and opened a different one in 2026. Argentina, Brazil and Mexico have all widened theirs. The UK's planned reliance scheme now names only Australia, Canada and the US, not the EU. Reliance is a per-market fact with a date on it, not a property of your FDA clearance.
How the categories actually split
Of the 32 markets we cover, here is where each stands as at 7 October 2026:
| Reliance is a… | Markets | Which |
|---|---|---|
| A gate — you cannot file without a recognised approval | 3 | Egypt, Israel, UAE |
| A shortcut — faster or cheaper with one, and you can still file without | 16 | Argentina, Australia, Brazil, Great Britain, Hong Kong, India, Kenya, Malaysia, Mexico, Nigeria, Saudi Arabia, Singapore, Switzerland, Taiwan, Thailand, Vietnam |
| A pilot only | 1 | South Africa |
| Not offered — independent assessment only | 8 | Canada, China, Colombia, EU, Japan, Korea, Peru, US |
| Being re-verified | 4 | Costa Rica, Indonesia, New Zealand, Philippines |
The gate row shrank from eight to three. In August we had India, Nigeria, Saudi Arabia, Taiwan, New Zealand and the Philippines there as well. Three of those are shortcuts on a closer reading of their own rules, Nigeria opened a formal reliance route in 2025, and two are being checked again. For a company with no approval yet, that is good news: far more of the world will take a first application than the August version of this table suggested.
"Shortcut" also covers very different sizes of saving, from Taiwan's narrow clinical waiver for novel Class 2 devices to Vietnam's 10-working-day fast track and Switzerland's outright acceptance of the CE mark.
Which approval opens the most doors
Counting the markets where at least one route in force today accepts an approval from each authority (of some type — see above):
| Approval held | Markets where it is leverage |
|---|---|
| European Union (notified body) | 16 |
| United States (FDA) | 15 |
| Canada (Health Canada) | 13 |
| Japan (MHLW/PMDA) | 12 |
| Australia (TGA) | 11 |
| Singapore (HSA) | 6 |
| Great Britain (MHRA) | 5 |
The EU and the US are effectively tied, and Canada is close behind. A Health Canada licence carries most of the onward leverage of an FDA clearance. For a company weighing which approval to pursue first, that changes the calculation, because the two do not cost the same.
Singapore is a hub, not just a small market. An HSA registration is leverage in Malaysia, Thailand, Hong Kong, Australia, Mexico and the Philippines. An ASEAN-focused manufacturer that treats Singapore purely as a small market is missing what a Singaporean registration is worth elsewhere in the region.
And Brazil, otherwise one of the most expensive independent filings in the world, now buys leverage too: Mexico's abbreviated route accepts an ANVISA registration.
Where approvals compound
Most reliance frameworks are indifferent to how many approvals you hold — one qualifies you, the rest are wasted. A few are not.
- Hong Kong's expedited scheme requires two or more reference approvals, plus a clean worldwide safety record: no reported deaths or serious injury, and no active recalls or field safety corrective actions.
- Singapore lets a second independent approval replace three years of marketing history for immediate Class B registration. It counts the TGA and EU notified bodies as one agency, so CE plus an Australian inclusion is not two.
- Taiwan waives the clinical trial report for a novel Class 2 device only when it holds both US and EU approval.
- Kenya's expedited route for Class D devices needs two independent reference approvals.
In each of them, a second approval is not redundancy. It is the difference between filing now and filing years later.
What we checked, and what we got wrong
In August we verified the reference lists our Regulatory Atlas held and found nine markets wrong in some way. In October we went back to every market's own instruments and found more, mostly in the direction of the world being more open than we had said:
- Saudi Arabia: a new reliance route (September 2026), and no requirement for a prior foreign approval. We had it as a gate.
- Brazil: an optimised review for Class III/IV on a US, Canadian, Australian or Japanese approval has existed since June 2024. We had it as "not offered".
- Argentina: since February 2026, Class I and II devices authorised in the US or EU enter by sworn notification. We had it as "not offered".
- India: the reference countries waive clinical investigation; they are not a gate. Australia and Japan were missing from our list.
- Taiwan: we wrote that it was not a reliance market at all. US plus EU approval waives the clinical trial report for a novel Class 2 device.
- Nigeria: a formal reliance route since September 2025.
- Thailand: we said an expedited route rewarded products registered in more than one reference country. We cannot find a source for it and have removed it.
- South Africa: the reliance route is a voluntary feasibility study, not a general pathway.
- Australia: UK certifications became acceptable on 1 December 2025, not in 2026.
Kenya and Egypt, which we left out in August because we could not verify them, are now verified and in the table. Botswana and Ethiopia are still not.
The short version
- Establish which position each target market takes — a gate, a shortcut, or no reliance at all. Only a gate restricts where you can start, and there are fewer gates than most plans assume.
- Check the type of approval each route accepts, not just the country. A 510(k) and a PMA are not interchangeable leverage.
- Check the conditions: marketing history, identical configuration and sites, a clean safety record, how many independent approvals.
- Re-check before you file. Six markets in this piece changed their rules in the last twelve months.
Method, and what this is not
Every market position above was checked on 7 October 2026 against the authority's own published instrument — the regulation, guidance or official notice — and is held in Meridian's Regulatory Atlas with the instrument, the date checked and whether it has been through expert review. Where we relied on our reading of an instrument rather than its explicit words, we have said so. One exception to the instrument rule: Argentina's annex of qualifying countries could not be retrieved, and its inclusion of the US and EU is confirmed from published summaries of it.
Regulatory reliance frameworks change. Verify against the authority before making a filing decision, and treat any reliance claim without a date on it as unreliable, including ours.
This is not regulatory advice.
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