Three things live here. A weekly digest of UK pharmaceutical and medical device news, read for one question only — what it changes for a company selling abroad. Foundations, for the parts of this subject that are worth understanding once and properly. And a dated log of what the regulators in our six markets have actually changed.
Digest No. 1 publishedThis is what we recorded while verifying our own market pages. It is not a complete record of every regulatory event in these countries — it is the set of changes that alter what a manufacturer has to do, and each one is traced to the authority's own publication.
Applications through the reliance route based on the five GHTF founding jurisdictions stopped being accepted.Still the most consequential item on this page. A route that closed six years ago is still being sold as a fast track.
Revised requirements for licensing medical device establishments.Sets the current representative duties, the exclusivity confirmation and the fee and validity table.
New guidance mapping ISO 13485 requirements to the authority's own.Useful if your quality system was certified against the standard alone.
Manufacturing paths guidance revised.The legal manufacturer files the authorisation, including in contract manufacturing arrangements.
First guidance covering digital health products.Software as a medical device, mobile health, digital therapeutics, wearables and AI-enabled devices brought into scope.
New risk communication guidance, and a new version of the advertising requirements.Advertising now reaches social media content. Relevant before your distributor starts posting.
The marketing authorisation fee schedule has not moved since December 2024.Worth knowing when someone quotes you a higher number.
New federal law governing medical products in force, replacing the 2019 regime.Covers devices, biologics and supplements, and applies expressly to establishments in free zones.
Device registration, renewals and import permits transferred from the health ministry to the new federal authority.If your last submission went through the old portal, the process you remember is not the current one.
The multiple-importer mechanism activated and announced publicly.At least two licensed importers per product. A single exclusive distributor arrangement no longer fits.
New pharmacovigilance practice guideline adopted by resolution.Reporting timelines under the previous guideline should not be assumed to carry over.
The executive regulations of the 2025 law have not been issued.Agent appointment mechanics, transfers of authorisation and the fast-track routes all depend on them.
India added the United Kingdom by name to the rule allowing a licence without clinical investigation where a free sale certificate exists.A deliberate post-Brexit amendment. Most regulators have not made the equivalent one.
Malaysia's device authority published a second edition naming the MHRA and accepting UKCA certificates.The only market we have confirmed at primary level that names the mark itself.
The UK government's consultation response recorded that applying a UKCA mark may itself be a barrier to trade, and agreed to remove the mandatory on-device marking.Useful if you are being told the mark is an asset abroad.
The MHRA recorded that roughly 90% of devices on the Great Britain market remain CE marked, and opened a consultation on recognising CE marking indefinitely.If you kept your CE certificate, you are with the overwhelming majority.
Where a change is in force we say what it does. Where it is announced but the implementing rules are unwritten, we say that instead — the pending line above is not a footnote, it is the single largest source of uncertainty in that market today.
One page a week on UK pharmaceutical and medical device regulation, written for exporters. Every item carries a date, a source and a line saying what it changes for a company selling abroad. Nothing is included to fill a section — a thin week produces a short digest, and says so.
Export certificates for medicines up 27% and device post-market fees up 70% in an open MHRA consultation; CPTPP completing with Canada; enabling powers for a future device licensing regime; and Saudi Arabia putting AI label checks on the border.
Read issue 01 →Free, by email, one page. Reply once to stop and you are removed the same day. We do not share the list and it is not used for anything else.
Email to subscribeWhat is in every issue. The items that matter, each with what it changes for an exporter. A note on our six markets, including the ones where nothing happened and the ones we could not check — we do not report silence as calm. A list of the things that did not move, because in this field an unchanged rule is regularly mistaken for a new one. And one trap: a source, a stale page or a circulating claim that would mislead a careful person.
The parts of this subject that come up in almost every first conversation, written out at length so we can send a link instead of repeating ourselves. Each one takes a week of primary-source checking, and both of the first two produced a correction to something we had already published.
Which regulators name the UK, which name the mark, and which do neither — with the distinction between an equivalence list and a free-sale list, where most of the confusion lives.
Read →What happens when the authorisation sits in your distributor's name, which markets allow a transfer and which do not, and how to structure the appointment so the question never arises.
In preparationMost providers treat their sourcing as the product. We think the opposite: if you can verify what we publish, you can also tell when someone else has not. Every market page names its documents and versions, and these are the places those documents come from.
| Market | Authority | What to look for |
|---|---|---|
| Saudi Arabia | Saudi Food and Drug Authority | The MDS-REQ requirement series and MDS-G guidance series, each with a version number and date; the circulars index; the published fee sheets |
| United Arab Emirates | Emirates Drug Establishment | The service pages for device authorisation and establishment licensing; the legislation register; the federal legislation portal for the governing decree-law |
| Egypt | Egyptian Drug Authority | The regulatory rules for devices and for in vitro diagnostics, including the reference country list |
| Türkiye | Turkish Medicines and Medical Devices Agency | The product tracking system rules and the transposed EU-aligned regulations |
| Nigeria | NAFDAC | The device registration guidelines and the published tariff |
| South Africa | SAHPRA | The medical devices section, licensing requirements and the reliance pathway |
| United Kingdom | MHRA | Guidance on regulating medical devices; the approved bodies list; certificates of free sale guidance; the current fee schedule |
Two traps we have walked into, so you do not have to. Superseded guidance often stays published — one of our regulators still hosts documents describing a framework that was replaced, and consultancies still quote them as current. And service pages frequently carry no publication date, which means a fee shown there may have been migrated from a predecessor authority. Where a page is undated we confirm the figure with the authority rather than printing it.
The digest goes out every Thursday. Clients on maintenance also get a quarterly note covering their own markets in more depth, with the source for each item. If nothing material changed, both say so — that is useful information in markets where things move without announcement.
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Or ask about a market whose page is not up yet — the assessment covers all six regardless of what is published here.
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