Very little, in most places — and not because anyone rejected it. Because the lists that grant a shortcut were written around a group of jurisdictions the United Kingdom left, and being written back in requires a foreign regulator to actively amend its own rules. A few have. Most have not.
Reference lists in medical device regulation are old furniture. Most were drafted in the era of the Global Harmonization Task Force and name the same five founding jurisdictions: Australia, Canada, Japan, the United States, and the European Union — usually written as "the EU" or "EU/EFTA".
Until 2021 a British manufacturer sat inside that last entry. After 2021 it did not, and nothing in those documents changed to reflect it. Regulators do not maintain other countries' lists as a courtesy; a jurisdiction gets added when someone drafts an amendment, takes it through a legislative process and publishes it.
India did exactly that in March 2022, inserting the United Kingdom by name into the rule that allows a licence to be granted without clinical investigation where a free sale certificate exists. It was a deliberate, dated act. Most regulators have not performed it, and there is no mechanism that makes them.
Almost every confused conversation about UKCA abroad comes from collapsing three separate mechanisms into one phrase. They have different consequences and the UK sits differently in each.
| Kind of list | What it buys you | Where the UK sits |
|---|---|---|
| Reference or equivalence list Singapore, Thailand, Indonesia, the Philippines, Brazil, Malaysia | A shortened technical review, or an abridged route, because another regulator has already assessed the device | Almost never — Malaysia is the confirmed exception |
| Free-sale-authority list India, Vietnam, Egypt, Pakistan | Acceptance of your country's paperwork as evidence the product is legally sold at home | Reasonably often, as "the United Kingdom" |
| Country-of-origin requirement the UAE, Nigeria | Nothing in itself — it simply requires documents from wherever you happen to manufacture | Neutral. Being British is neither help nor hindrance |
The practical test: if a regulator's document says it will verify against or rely on another authority's approval, that is the first kind, and the UK's absence costs you time and money. If it says it wants a certificate of free sale from the country of origin, that is the third kind, and your nationality is irrelevant.
Both statements sit on the same regulatory reliance page. For devices the equivalent authorities are Health Canada, the US FDA, Japan's MHLW and PMDA, and Australia's TGA. The MHRA appears in the medicines column and not the device one.
That is the whole problem in a single screenshot. It is not hostility, and it is not a judgment about British regulatory quality — the same agency is trusted for one product class and not listed for another. It is simply what happens when lists are maintained separately and nobody has amended one of them.
| Market | Position | What it means for you |
|---|---|---|
| Malaysia | UKCA named | The device authority's verification route lists the MHRA and accepts UKCA and EC certificates |
| India | UK named | A UK free sale certificate supports a licence without clinical investigation, by rule since March 2022 |
| Pakistan | UK named | Listed among accepted countries — and listed individually, so the position never depended on EU membership |
| Vietnam | UK named | Named as a territory whose free sale certificates are accepted, alongside the EU and Switzerland |
| Egypt | UK named | Appears among reference countries in the diagnostics rulebook |
| Singapore · Thailand · Indonesia · Philippines | Absent | Reference agencies are Australia, Canada, the EU, Japan and the US. A UK approval buys no abridgement |
| Brazil | Absent for devices | Present for medicines, absent for devices, on the same page |
| Colombia · Mexico | Absent | Reference or equivalence routes name the EU, US, Canada, Japan and Australia |
| South Africa · Kenya | Absent | Reliance and benchmark documents name the EU, US, Australia, Canada, Japan, Brazil |
| Switzerland | Absent | Recognises EU CE marking only. Current reform work is aimed at the US FDA, not the UK |
| Saudi Arabia | No list at all | The current framework has no reference route. The one that existed named the EU and EFTA, and closed to new applications in 2020 |
| United Arab Emirates | Not named | The document list asks for an EC certificate, a 510(k) or a PMA. UKCA is not named, and we have found nothing published saying it is accepted |
Some of these are confirmed absent from a list that exists. Others are "we could not find a list" — a different statement, and we keep them apart below.
Manufacturers frequently tell us that the MHRA's international recognition framework will fix this. It will not, because it is pointed the other way.
The International Recognition Procedure, live since January 2024, lets the MHRA rely on assessments by Australia, Canada, Switzerland, Singapore, Japan, the United States and the EU — for medicines, entering Great Britain. The parallel device work identifies Australia, Canada, the EU and the USA as comparable regulators whose approvals can support entry to the GB market. Both are unilateral import doors. Neither contains a reciprocity mechanism, and neither obliges any foreign authority to do anything.
The MHRA has designated Australia's regulator as a UK Approved Body, able to issue UKCA certificates. No foreign regulator has done the reverse for Britain.
The formal mutual recognition agreements do not close the gap either. Only the Australian and New Zealand agreements mention medical devices at all, and both government pages state plainly that conformity assessment bodies in each country cannot currently apply to test to the other's device regulations. The agreements with Switzerland, the United States and Canada cover other sectors, or pharmaceutical manufacturing practice, but not device conformity.
The MHRA issues a Certificate of Free Sale for medical devices, ordered through its registration system by a UK manufacturer or UK Responsible Person. It costs £75 for the first ten certificates and £10 for each additional one, and the agency asks for ten working days.
It is genuinely useful — it is the document that satisfies the free-sale-authority lists and the country-of-origin regimes. But read what the MHRA says about it, because it is unusually candid:
The agency even offers a downloadable sample so you can email it to the destination regulator and ask in advance. That facility exists because acceptance is routinely in doubt, and it is the single most practical thing on this page: ask the receiving authority, in writing, before you build a plan around the answer.
It is worth knowing that this is not only an export problem. In a consultation paper published in 2026, the MHRA recorded that approximately ninety per cent of medical devices on the Great Britain market remain CE marked, and that most manufacturers delayed transitioning to UKCA while the international reliance scheme was developed. The agency is now consulting on recognising CE-marked devices in Great Britain indefinitely.
In the government's own consultation response of July 2025, respondents said that applying a UKCA marking to a device may itself be a barrier to trade and market access. The government accepted the point and agreed to remove the mandatory on-device marking, subject to conditions.
So a manufacturer that kept its CE certificate is not behind. It is with the overwhelming majority, and it holds the document that most of the world's reference lists were written around.
A UK manufacturer can hold and maintain an EU MDR certificate indefinitely through an EU-established notified body and an EU or Northern Irish authorised representative. Several UK approved bodies belong to groups that operate separate EU notified body entities, which makes the arrangement administratively familiar even though the legal persons differ.
The cost is not the mark. It is that a reference route you could have used becomes a full technical assessment, in every market whose list names the EU and not the UK. That difference is usually larger than the certificate.
India, Malaysia, Pakistan, Vietnam and Egypt name the United Kingdom. If your target is one of those, the position is better than the general picture — and worth confirming in writing, because it is precisely the kind of detail a provider quoting from memory will get wrong.
Where a market is silent on UKCA — which is common — the answer is not in a consultancy blog. It is in a written enquiry to the authority, before you spend money on legalisation, translation or licensing. The MHRA's sample certificate exists for exactly this.
Because the difference matters, and because most articles on this subject do not draw it:
A route assessment answers it in writing for your class and your markets, with the regulator's own document cited next to each answer. Two weeks, fixed fee, credited against the project if you go ahead.
Check your routeEvery position above was taken from the regulator's or government's own publication where one could be reached. Where only a secondary source existed, we say so in the text rather than presenting it as settled. This page is re-checked quarterly; regulators amend these lists without announcement, and an article of this kind is only as good as the date on it.