A small firm with a narrow brief
We do one thing: take UK health technology, diagnostics and pharmaceutical products into six regulated markets. We are not a global network, we do not have offices in those countries, and the list of what we decline to do is published alongside the list of what we do.
Everything is read before it is written
There is a version of this business that resells what everyone else has already published. It is faster, cheaper to run, and it is how a client ends up quoting a fee schedule that a regulator withdrew two years ago.
Our rule is that a figure appears on this site only when we have opened the document it comes from. We record the document's name, its number, its version and the date we read it, and we put all four on the page. Where an authority publishes nothing, we publish the gap instead of filling it.
What that produces
- Twelve market pages, each with a sources section and a "what we could not confirm" list
- Fees in the regulator's own currency, at the regulator's own figure
- Two conflicting review periods shown as two, where a regulator's own documents disagree
- Findings that cost us work — a closed market, a product that should not be filed
What it rules out
- Quoting a timeline from a guidance version that has been superseded
- Presenting a law firm's description of practice as a regulator's rule
- Treating "we could not find it" as "it does not exist"
- Any number we cannot show you the source for
Deliberately small, and structured to stay that way
Six markets, and why these six
They are the markets where a UK company's existing approvals matter most and are understood least. Each is large enough to be worth entering, regulated enough that entry is a project rather than a shipment, and poorly enough documented in English that the published advice is routinely out of date.
| Market | Authority | Why it is on this list |
|---|---|---|
| Saudi Arabia | SFDA | The largest Gulf market, and the one where no foreign approval shortens anything for a device — while an MHRA authorisation moves a medicine from 405 working days to 280. |
| United Arab Emirates | EDE | A regulator created in 2023 with a decree-law in force since 2025, requiring at least two importers by statute. The rules are new enough that most published advice predates them. |
| Egypt | EDA | The only market that writes the UK mark into its own reference list, with a dedicated instrument for Great Britain, and that waives the factory inspection for a UK site. |
| Türkiye | TİTCK | Simultaneously the most open of the six for a device and the most closed for a medicine. The same country gives a company two opposite answers. |
| Nigeria | NAFDAC | The only country that has promised in writing to accept UKCA. It has not done it, and half of what an applicant must actually do sits outside the gazetted law. |
| South Africa | SAHPRA | Names the MHRA on its own line for medicines, does not recognise the UK for devices, and has not commenced device registration at all. |
Registered details
On the registered office. It is a registered address, not a place to visit. Like most companies of our size the work happens elsewhere, and we would rather say so than imply an office we do not keep. All of the above is on the public register at Companies House and you are welcome to check it before you write.
Two lines is enough to start
What you make, and which markets you are thinking about. If we need more we will ask, and if we do not need anything at all we will just answer the question.
mail@bcabusiness.co.uk · +44 7342 901002 · 128 City Road, London EC1V 2NX