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The short answer
Medical devices and in vitro diagnostics cannot be imported or sold in Nigeria unless registered with NAFDAC under its guideline VBM-R&RA-GDL-001-01 (effective 10 April 2025). A Nigerian applicant applies through the NAPAMS portal with a power of attorney from the UK manufacturer, a certificate of manufacture and free sale authenticated by the Nigerian mission, and quality and conformity evidence. NAFDAC gives a maximum of 120 workdays for Class A and 240 for Classes B to D, and a certificate lasts five years.
Nigeria is a large market for diagnostic kits, hospital equipment and consumables, and UK makers are often approached by Nigerian distributors. Before the first unit is shipped, the product needs NAFDAC registration. The work is shared: the Nigerian applicant files, but much of the evidence has to come from you as the manufacturer.
The rule
NAFDAC's Guidelines for Registration of Medical Devices Including In Vitro Diagnostics (IVDs) and Related Products, effective 10 April 2025, say devices may be manufactured, imported, exported, advertised, sold, distributed or used in Nigeria only if registered. NAFDAC will not accept new applications for products on the Federal Government import prohibition list or its own ceiling list.
Risk classes
| Class | Risk | Maximum processing time |
|---|---|---|
| A | Low | 120 workdays |
| B | Above A | 240 workdays |
| C | Above B (full dossier) | 240 workdays |
| D | High (full dossier) | 240 workdays |
IVDs are classed A to D by individual and public health risk. Where a product could fit two classes, the higher applies. The clock stops while a NAFDAC query is open, and an applicant who does not reply within 90 days has the application closed.
What the UK manufacturer must provide
- Power of attorney to the Nigerian applicant, signed by a senior officer, containing the words "Authority to register product with NAFDAC", stating brand ownership, notarised in the country of manufacture and valid for at least five years.
- Certificate of Manufacture and Free Sale from a health or regulatory body in the country of manufacture, authenticated by the Nigerian mission. For UK-made devices, ask the MHRA how it issues such certificates, then have it authenticated through the Nigeria High Commission in London.
- Certificate of analysis on the testing laboratory's letterhead, with batch and dates.
- Quality management system certificate and a declaration of conformity with recognised standards.
- Labels and instructions for use, and evidence of trademark registration.
- GMP inspection invitation letter naming the local agent; NAFDAC may inspect the manufacturing site.
The Nigerian side adds a declaration notarised in Nigeria, CAC incorporation evidence, and, for moderate and high-risk devices, dossier screening clearance.
The process
- Applicant requests dossier submission access and uploads documents to NAPAMS.
- NAFDAC issues an electronic import permit for samples.
- GMP inspection of the manufacturer, where required.
- Labelling and instructions-for-use review.
- Samples submitted for laboratory analysis with proof of fee payment.
- Review by NAFDAC's Food and Drug Registration Committee, then the certificate.
Fees are set by NAFDAC's tariff; the guideline gives no amounts. Registration does not cover advertising, which needs a separate approval, and paying the fee does not itself confer registration.
Labelling
Labels must show at least the device name, manufacturer name and address, device identifier, batch or lot number, and manufacturing and expiry dates (month and year), plus sterile and single-use statements where they apply, directions for use and storage conditions.
Planning the timeline
Registration is the long pole. At the guideline maximum of 240 workdays, a Class C device could take about a year from accepted application to certificate, before shipping and clearance. Practical points:
- Start the power of attorney and free sale certificate early; notarisation and mission authentication each take time.
- Make sure the Nigerian applicant is incorporated with the CAC and able to receive the GMP inspection correspondence.
- Agree who pays NAFDAC fees, sample costs and inspection travel in your distribution contract.
- Diary the five-year renewal; NAFDAC publishes a separate renewal guideline.
- Reply to every NAFDAC query well inside the 90 days, or the application closes.
Other checks
- SON's SONCAP fee notice exempts "medical items other than equipment", which suggests medical equipment may also need SONCAP; confirm with an accredited firm. See SONCAP certificates.
- Your buyer files Form M; see why your buyer needs a Form M.
- Some devices and their technology can fall under UK export controls; see do UK goods need an export licence?
Where Pryme fits
Registration can take months, so distributors often pay in stages. A Pryme Business Account can receive GBP, USD or EUR, and invoicing keeps each stage linked to its payment. Outside Nigeria, Pryme's activities are carried out through regulated partners.
Questions people ask
Do medical devices need NAFDAC registration?
Yes. NAFDAC's 2025 guideline says devices and IVDs may be imported, sold or used in Nigeria only if registered.
How long does NAFDAC medical device registration take?
The guideline sets a maximum of 120 workdays for Class A and 240 workdays for Classes B, C and D, with the clock stopped during queries.
Who applies for NAFDAC registration, the UK maker or the Nigerian importer?
A Nigerian applicant applies through NAPAMS, with a power of attorney and other documents from the manufacturer.
How long is a NAFDAC device certificate valid?
Five years, according to the 2025 guideline, though NAFDAC may revoke, suspend or vary it.
Sources
- NAFDAC: Guidelines for registration of medical devices including IVDs and related products, VBM-R&RA-GDL-001-01, effective 10 Apr 2025 (PDF) · accessed Oct 2026
- NAFDAC: Regulatory resources, guidelines · accessed Oct 2026
- Standards Organisation of Nigeria: SONCAP approved fees, effective 1 Aug 2022 (PDF) · accessed Oct 2026
This article is general information, not financial, legal or tax advice. Products described are provided under the terms on this site and are subject to regulation and eligibility.