In February 2024 Nigeria and the United Kingdom signed a partnership in which Nigeria said it would recognise the UKCA mark for medical devices. Article 7 of the same document says it creates no legally binding rights or obligations — and no Nigerian instrument has implemented it since. This page is about the gap between those two facts.
The Enhanced Trade and Investment Partnership signed on 13 February 2024 says, under health and life sciences, that "Nigeria will recognise the UK conformity assessed (UKCA) mark for medical devices in so far as all the medical devices to be exported from the United Kingdom to Nigeria will comply with the SONCAP and NAFDAC Licenses."
Two things about that sentence. First, Article 7(a) of the same arrangement states that it "does not create legally binding rights or obligations under domestic or international law". Second, read it again: the recognition is conditional on complying with SONCAP and NAFDAC licensing anyway — so even taken at face value it removes no step from the route.
We then looked for the Nigerian instrument that would give it effect, and there is none. NAFDAC's gazetted Medical Devices Regulations of 2024 and its three device guidelines of November 2024 name no foreign regulator and no foreign mark at all — not UKCA, not the MHRA, not CE, not the US FDA, not Health Canada, not the TGA. The only reliance provision, regulation 14, is anchored to World Health Organization listed-authority status and expressly preserves NAFDAC's right to its own national decision.
The ministerial dialogue of March 2026 did not report the commitment as delivered. It covered standards cooperation between BSI and the Standards Organisation of Nigeria, accreditation, health technology assessment and pharmaceutical reliance — medical devices are not addressed as a category and the MHRA is not mentioned.
What this is worth to you anyway. Not nothing. A UK manufacturer needs a Certificate of Free Sale from its own authority, and the MHRA issues one for devices registered on its system bearing UKCA, CE or CE UKNI marking. That certificate is a mandatory part of the Nigerian file. So the mark gets you the document you need — it just does not shorten the assessment, because nothing does.
This is the finding that surprised us most, and it changes how you should read any Nigerian advice you are given. The gazetted statutory instrument is short on applicant requirements. Almost every obligation a foreign manufacturer actually meets sits in NAFDAC's guidelines instead — enforceable as practice, but resting on softer footing than a gazetted regulation.
Nothing in the gazetted instrument says the applicant must be Nigerian. The requirement arrives sideways: the guidelines want a power of attorney running from you to somebody else and evidence of that somebody's Nigerian incorporation, and the import mechanics want a Nigerian company with a tax identification number and an authorised dealer bank. The effect is the same. The legal basis is not.
Why we are telling you this rather than smoothing it over. Because it predicts the failure mode. A requirement that lives in a guideline can be revised without a gazette, and the guideline in force was issued in November 2024 with a review date of November 2029. Draft replacement regulations for 2025 and for 2026 sit in NAFDAC's own folders, apparently folding in-vitro diagnostics into the same instrument. We could not open either and we will not describe their contents — but a market whose rules are being rewritten is one where the date on your advice matters.
NAFDAC wants evidence that the brand is registered with the trademark registry at the Ministry of Industry, Trade and Investment, in the name of the trademark owner. This is a separate proceeding with its own queue, it is not NAFDAC's, and it is the step most often discovered late. Start it first.
You, with Nigerian counselIncorporated in Nigeria, holding a notarised power of attorney from you that runs at least five years and states who owns the brand. Read the structure section below before you sign this, because the certificate and the agent are harder to separate here than anywhere else on this site.
Us, with youThe MHRA issues it for devices on its register carrying UKCA, CE or CE UKNI. Nigeria is not a party to the Hague Apostille Convention, so an apostille will not do: the certificate must be authenticated by the Nigerian High Commission — or, where there is no Nigerian mission, by any Commonwealth or ECOWAS country's.
You, tracked by usThe application and dossier go in electronically. On successful screening NAFDAC issues a permit to import registration samples, which then go for laboratory analysis. The file also has to carry an invitation letter for inspection of your manufacturing site.
Agent, managed by usSamples are analysed, the product is presented to the registration committee, and an electronic certificate of registration issues with five years' validity. The published timeline is 120 working days from acceptance of the submission, and the clock stops whenever a compliance query is raised.
UsEach shipment needs a Form M on the national trade platform and a clearance report from Customs. If your device is equipment or a machine, it also needs SONCAP — see the next section, because this is where most people are caught out.
Shared — we run the calendarThe Standards Organisation of Nigeria exempts food, medicines and medical items from its offshore conformity scheme — but the exemption expressly carves out equipment and machines. Read literally, a medical device that is a machine sits inside SONCAP scope and needs a SONCAP certificate as a customs clearance document, in addition to its NAFDAC registration. SON adds that exemption from the offshore scheme does not mean a product is unregulated by SON.
We could find no document from either agency that reconciles the two regimes or draws the line between a medical "medical" and a medical "machine". That boundary is worth establishing in writing before you build a landed-cost model, because a SONCAP certificate is what permits the Form M to be opened in the first place.
And since July 2026 there is a third document for tenders. Federal procurement now requires an attestation certificate against the relevant Nigerian Industrial Standard as a mandatory bid document, where such a standard applies, under a policy prioritising goods made in Nigeria. Separately, the Public Procurement Act allows a margin of preference for domestic bidders in international competitive bidding — discretionary, and set by regulation rather than fixed in the Act.
The gazetted regulation says a certificate of registration may not be lent, hired, sold, transferred or otherwise disposed of to another person without the Agency's approval. So transfer is possible. What does not exist is a published procedure for it.
We searched the gazetted regulations, both registration guidelines and NAFDAC's application forms page. There is no change-of-agent form, no transfer-of-certificate form, no fee line and no timeline. The only description of how it works in practice comes from a Nigerian law firm, which describes writing to NAFDAC to revoke the previous power of attorney and introduce the new agent, supported by notarised instruments — and which cites no NAFDAC authority for that procedure. We are reporting it as what it is: unpublished practice.
The same source states that for a foreign manufacturer the registration certificate is issued in the local agent's name. We could not confirm that from any NAFDAC document, and we are not going to assert it. But if it is right, it matters more than anything else on this page, because it means the asset you are paying to create is registered to somebody else and can only be moved with a regulator's discretionary consent.
How we would handle it. Establish in writing, with NAFDAC, whose name goes on the certificate and what a change of agent actually requires — before the power of attorney is signed, not after the relationship sours. That question is the first item in an assessment for this market, and it is the reason we would not let a client sign a five-year power of attorney on a distributor's template.
A post-market surveillance and reporting guideline for devices and in-vitro diagnostics took effect on 19 August 2025. It puts duties on manufacturers, marketing authorisation holders, importers and distributors, which makes it a contract question with your Nigerian partner rather than purely a regulatory one.
Calendar days, from the post-market surveillance guideline effective 19 August 2025. Field safety corrective actions are reportable immediately upon identification. Bars are proportional to the deadline — the two shortest are barely visible, which is the point.
There is no unique device identification requirement in Nigeria. The gazetted regulation asks only for a batch number, lot number, serial number and a barcode on the packaging, and neither the vigilance guideline nor the two conformity assessment guidelines mention UDI. That is a confirmed absence, not a gap in our reading — and it is one of the few places where Nigeria asks less than the markets around it.
NAFDAC prices imported product registration in United States dollars, payable at the naira equivalent on the day. Given what the naira has done since, that is a deliberate and rather sensible piece of drafting — and it means the figure below has not been eroded the way a naira figure would have been.
| Item | Fee |
|---|---|
| Registration, imported medical device | US$750 |
| Registration, imported diapers and sanitary pads | US$874 |
| Registration, locally manufactured device | ₦20,000 |
| Renewal | 80% of the registration fee |
| Change in variants | 50% of the registration fee |
| Permit to import, per product | ₦11,000 |
| Laboratory analysis, imported device | ₦67,500 |
| Port inspection, medical devices | ₦27,000 |
| Certificate of free sale issued by NAFDAC | ₦25,000 |
From the NAFDAC tariff stated to take effect in January 2020, which is the only tariff document we were able to open — the tariff index page did not respond on repeated attempts, so we cannot tell you whether a newer edition exists, and we re-confirm the figures with NAFDAC before they enter a quote. All amounts are exclusive of value added tax. Two structural notes: the tariff still uses the old "medical devices 1 and 2" split and carries no fees by risk class, because it predates the four-class regime; and there is no fee line at all for registering an agent.
The registration guideline effective 4 November 2024 states 120 working days from acceptance of the submission to issuance of the registration number, with the clock stopping whenever a compliance query is raised. NAFDAC's service charter promises registration within 90 days. Those do not reconcile — 120 working days is roughly twenty-four weeks. The charter carries no date or version; the guideline does. We quote the guideline and we tell you about the charter, rather than quoting whichever number suits the conversation.
Nigeria's foreign exchange picture is materially different from the one most UK boards still carry in their heads, and the UK government's own risk page has not been updated since July 2023 — it still describes the shortages and delayed payments of that era.
On official sources: the naira was floated in June 2023 and the market segments were consolidated into a single willing-buyer, willing-seller market. In October 2023 the central bank lifted the restriction on foreign exchange access for the forty-three previously restricted import categories. The verified backlog of foreign exchange obligations, of the order of seven billion dollars, is stated as cleared. An electronic matching system followed in November 2024 and a foreign exchange code in January 2025. The International Monetary Fund classifies the regime as floating.
What remains, on the Fund's own account, is a set of unenumerated legacy exchange restrictions that it recommends eliminating, and capital flow measures that touch foreign securities, card payments abroad and oil company proceeds — none of which restricts an ordinary trade payment for imported goods. No medical device appears on the current import prohibition list, which covers certain medicaments and waste pharmaceuticals but no devices.
How we would put it to a board. The risk here has changed shape rather than disappeared. It is no longer rationing — it is regime and residual-restriction risk, plus the ordinary volatility of a floating currency. That is a smaller and more manageable exposure than the one your last briefing note probably describes, and it is worth re-checking rather than assuming.
The January 2020 tariff is the only one we could open. NAFDAC's tariff index page did not respond. We cannot say whether a newer edition exists, so we treat every figure as requiring confirmation.
A Nigerian law firm states it is issued to the local agent. No NAFDAC document we read says so. This is the most commercially important unresolved question on the page.
The regulation makes transfer conditional on NAFDAC approval and publishes no procedure, form, fee or timeline for obtaining it.
The invitation letter is a mandatory dossier item, but the device guidelines state neither the trigger criteria nor who bears the cost.
No document from either agency draws the line between a medical item and medical equipment or machinery.
Drafts dated 2025 and 2026 sit in NAFDAC's own folders and we could not open either. We are not describing their contents and neither should anyone else.
One further note on method. NAFDAC's website refused automated access for roughly three requests in four during our checks, so several documents we know exist — including a guideline on registration under the World Health Organization collaborative procedure — are named here as unread rather than summarised. Everything stated as fact above was read from the document itself.
The last two questions are not routine. An existing registration held by a former partner, and a five-year power of attorney you have forgotten about, are the two ways this market goes wrong before it starts.
The other half of this market
The medicines answer is harder and more urgent. Nigeria publishes two lists — 36 actives and 29 products — and for anything on them NAFDAC states it will not entertain a new application or a renewal for an imported product. Before a Nigerian pharmaceutical project is worth planning, the molecule has to clear both lists.
The medicines page for Nigeria, with a molecule check →
Everything expensive about Nigeria is decided in those two documents, and both are signed before NAFDAC sees anything. Send us the device and we will tell you what to sign and in whose name.
Or reach us directly — mail@bcabusiness.co.uk · +44 7342 901002 · WhatsApp
Re-checked quarterly, and specifically whenever a new NAFDAC tariff or a replacement set of device regulations appears. Two items on this page are on a watch list: the draft regulations for 2025 and 2026, and whether any Nigerian instrument gives effect to the UKCA commitment. If either moves, this page moves within the week and the change is dated.