Medical device market entry in Nigeria
Last verified:
Medical devices and IVDs must be registered with NAFDAC before they are imported or sold in Nigeria: devices fall into risk classes A–D, a certificate is valid for 5 years, and NAFDAC's published target is 120 working days from acceptance of the dossier (S.I. 42 of 2024; NAFDAC import guideline). A foreign maker files through a Nigerian company holding a notarised power of attorney, and WHO-prequalified IVDs and devices can use NAFDAC's WHO Collaborative Registration Procedure, with a 60-working-day decision target (CRP guideline, 2025). From 1 January 2026 the Nigeria Tax Act zero-rates medical equipment for VAT, against a standard rate of 7.5% (Mondaq summary).
How this works
Egypt is our base: we cover Egypt directly and coordinate the next markets through in-country partners. Every country requires its own registration, and foreign-made goods get no COMESA or AfCFTA tariff preference by passing through Egypt.
UltraTeb Market Access is a zero-upfront-fee route into Egypt's medical market: UltraTeb registers, imports, markets, stores and sells your product, shares the risk, and pays you when it sells.
Egypt is our base. We launch your product in Egypt first and coordinate next markets such as Nigeria through in-country partners we identify and check for your product. Nigeria needs its own NAFDAC registration, filed by a Nigerian company — an Egyptian registration does not carry over, and UltraTeb has no office or registration in Nigeria. A device made outside Egypt gets no AfCFTA or ECOWAS tariff preference by passing through Egypt: it pays Nigeria's normal duty.
What are the key facts for medical devices in Nigeria?
| Fact | Value | Source | As of |
|---|---|---|---|
| Regulator | National Agency for Food and Drug Administration and Control (NAFDAC); device dossiers are filed on the NAPAMS portal | nafdac.gov.ng | |
| Registration route | Registration required before import or sale; risk classes A (low) to D (high); one application can cover a device, group, family or system; certificate valid 5 years, renewable | nafdac.gov.ng | |
| IVDs | Same 2024 Regulations and steps, including laboratory analysis of samples; WHO-prequalified IVDs and devices can use the WHO Collaborative Registration Procedure (effective 29 April 2025) | nafdac.gov.ng | |
| Local representative | Required: a Nigerian company (incorporated with the Corporate Affairs Commission) holding the manufacturer's notarised power of attorney | nafdac.gov.ng | |
| Reliance on foreign approvals | Partial: NAFDAC may rely on WHO Listed Authorities and well-resourced regulators but keeps its own decision; CE marking or FDA clearance is not an automatic abridged route | nafdac.gov.ng | |
| Published timeline | 120 working days from acceptance to registration number (clock stops for open queries); WHO CRP route: 60 working days | nafdac.gov.ng | |
| Labelling language | English (other languages may be added); labels carry an expiry date, the manufacturer and the country of manufacture | nafdac.gov.ng | |
| Import documents | NAFDAC registration first; commercial imports use the CBN Form M and a Customs Pre-Arrival Assessment Report (PAAR), with destination inspection at the port | trade.gov | |
| Import duty (ECOWAS CET) | HS 9018 instruments 5%; HS 3822 reagents 0%; HS 4015.12 medical gloves 0%; HS 3005.90 dressings 0% | wits.worldbank.org | 2023 |
| VAT | Standard 7.5%; medical equipment and medical and pharmaceutical products zero-rated under the Nigeria Tax Act 2025 (s. 187), in force 1 January 2026 | mondaq.com | |
| Market size | Population 237.5 million | data.worldbank.org | 2025 |
| Health spending | 4.19% of GDP, about US$67 per person | data.worldbank.org | 2023 |
| Device imports (HS 9018) | US$56.2 million in 2024 (US$86.8 million in 2023); largest supplier China at US$16.5 million | comtradeapi.un.org | 2024 |
| Egypt–Nigeria trade | Egypt's exports to Nigeria US$150.8 million; Egypt's HS 9018 exports to Nigeria US$0.12 million | comtradeapi.un.org | 2024 |
| Lane from Egypt | Sea: Alexandria to Lagos (Apapa, Tincan) on Arkas Line's weekly Med Africa Service, formed October 2025; air: EgyptAir from Cairo to Lagos, Abuja and Kano | container-news.com |
Every row comes from UltraTeb's fact record for Nigeria, read at source on 2026-09-25. Trade values are UN Comtrade data; the import duty rates are Nigeria's 2023 report to UNCTAD TRAINS — check the current Nigeria Customs tariff before quoting.
Last verified:
How do you register an imported medical device with NAFDAC?
-
File the dossier
Through your Nigerian applicant on the NAPAMS portal, with the documents listed below.
-
Import samples
NAFDAC issues an import permit for the registration samples.
-
Label vetting and laboratory analysis
NAFDAC checks the labels and analyses the samples; a novel device also needs a satisfactory NAFDAC performance evaluation.
-
Approval meeting
The product is approved and receives its registration number, valid 5 years.
What goes into a NAFDAC dossier for an imported device?
- A notarised power of attorney from the manufacturer to the Nigerian applicant, valid 5 years or more, stating the authority to register the product with NAFDAC
- A Certificate of Manufacture and Free Sale, authenticated by the Nigerian mission in the country of origin
- A certificate of analysis
- The applicant's Corporate Affairs Commission incorporation
- Trademark registration in Nigeria
- The labels
- An invitation letter for NAFDAC's GMP inspection of the foreign factory
- For products from India and China: a manufacturing licence from the country of origin
Is there a faster route for WHO-prequalified products?
Yes. NAFDAC's WHO Collaborative Registration Procedure guideline, effective 29 April 2025, covers WHO-prequalified IVDs and devices, with a decision target of 60 working days (90 calendar days) of regulatory time. Outside that route, the 2024 Regulations let NAFDAC rely on WHO Listed Authorities and well-resourced regulators, but it keeps its own national decision — CE marking or FDA clearance alone does not shorten the file.
What duty and VAT apply to medical devices in Nigeria?
Nigeria applies the ECOWAS Common External Tariff: 5% on HS 9018 instruments and 0% on HS 3822 reagents, medical gloves (4015.12) and dressings (3005.90), per its 2023 tariff report. A June 2024 Executive Order announced zero tariffs, excise and VAT on imported pharmaceuticals, diagnostics and devices such as needles and syringes; whether Customs applies it to finished imported devices, and on which lines, has not been verified. On VAT, the Nigeria Tax Act 2025 zero-rates medical equipment from 1 January 2026 (EY on the start date); how the Act defines medical equipment has not been verified line by line.
Who buys medical devices in Nigeria?
There is no single national buyer. The federal Central Medical Stores and the National Product Supply Chain Management Programme coordinate federal supply, State Drug Management Agencies run pooled state procurement, federal tertiary hospitals buy directly, and donor programmes for HIV, TB and malaria procure in parallel (Results for Development). Private hospital groups, clinics and diagnostic laboratory chains buy on their own account. The US Commercial Service reports that over 98% of Nigeria's medical equipment needs are sourced abroad (trade.gov).
How do goods get from Egypt to Nigeria?
By sea from Alexandria to Lagos on Arkas Line's weekly Med Africa Service, formed in October 2025, or by transshipment through Mediterranean hubs; by air on EgyptAir from Cairo to Lagos, Abuja and Kano (Container News). No sea transit time has been verified.
How can UltraTeb help you reach Nigeria?
-
Egypt-first launch & proof of demand
We register, import, market and sell your product in Egypt first, so you approach Nigeria with real sales data.
-
Introductions to in-country distributors/registration holders
NAFDAC accepts only a Nigerian applicant. We identify and check Nigerian distributors or registration holders for your product and introduce you.
-
Tender documentation support
Where your Nigerian partner bids for federal hospitals or state Drug Management Agencies, we help prepare the tender documents.
-
Consolidated logistics from Egypt
When it costs less than shipping from your factory, we plan consolidated shipments to Nigeria from Egypt.
Why start in Egypt before Nigeria?
Nigeria is a large market with a demanding registration: foreign factory inspection, documents authenticated by a Nigerian mission, and a Nigerian company as applicant. Launching in Egypt first gives you a live product, sales data and a tested offer before you commit to that file.
“Nigeria is its own market with its own rules. We prove your product in Egypt first, then help you find the right Nigerian partner to register it.” — Mohamed Dabees, Founder, UltraTeb
Frequently asked questions
Do I need a Nigerian company to register a medical device with NAFDAC?
Yes. The applicant must be a Nigerian company incorporated with the Corporate Affairs Commission and hold the manufacturer's notarised power of attorney (NAFDAC guideline). The guideline does not say the agent must be exclusive.
How long does NAFDAC registration take?
NAFDAC's published target is 120 working days from acceptance of the submission, with the clock stopped while queries are open; queries not answered within 90 working days close the application. The WHO Collaborative Registration Procedure targets 60 working days. No measured real-world duration has been verified, and the foreign GMP inspection has to be scheduled.
Does NAFDAC accept CE marking or FDA clearance?
Only partly. The 2024 Regulations let NAFDAC rely on WHO Listed Authorities and well-resourced regulators, but it keeps its own decision. The one written fast route is the WHO Collaborative Registration Procedure for WHO-prequalified IVDs and devices.
What language must device labels be in for Nigeria?
English; other languages may be added. Labels must also show an expiry date, the manufacturer and the country of manufacture (S.I. 42 of 2024).
Is there VAT on medical devices in Nigeria?
The standard rate is 7.5%, but the Nigeria Tax Act 2025, in force from 1 January 2026, zero-rates medical equipment and medical and pharmaceutical products. Zero-rating lets suppliers recover input VAT. How the Act defines medical equipment has not been verified for every consumable line.
Is my Egyptian EDA registration valid in Nigeria?
No. An EDA registration is valid in Egypt only. Nigeria requires its own NAFDAC registration.
Can UltraTeb register my device in Nigeria?
No. NAFDAC requires a Nigerian applicant, so UltraTeb, an Egyptian company, cannot hold the registration. We launch your product in Egypt, then identify and introduce Nigerian distributors or registration holders for it.
Do goods shipped via Egypt pay less duty in Nigeria?
No. A device made outside Egypt keeps its origin when it passes through Egypt, so it gets no AfCFTA or ECOWAS preference and pays Nigeria's normal duty.
Start in Egypt. Take Nigeria next.
Zero upfront fees in Egypt: we handle registration, import, duties, warehousing and selling, and you're paid when we sell.