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What AI agents can do in bookkeeping, close, collections and compliance today, where a person must stay in charge, and how to judge a product.
The short answer
Under NAFDAC's medical device guideline effective 10 April 2025, no medical device or in vitro diagnostic may be imported or sold in Nigeria unless registered. A Nigerian applicant registers it with a notarised power of attorney from the US manufacturer and a certificate of manufacture and free sale authenticated by a Nigerian mission; NAFDAC allows up to 120 working days for Class A and 240 for Classes B to D, and certificates last five years.
Nigerian hospitals, laboratories and distributors buy a wide range of US-made equipment, from diagnostic kits to monitors and imaging consumables. The first question a serious Nigerian distributor will ask is not price but whether the product is NAFDAC-registered. If it is not, the registration has to be done before any commercial shipment, and much of the file comes from you.
The rule and its scope
NAFDAC's Guidelines for Registration of Medical Devices Including In Vitro Diagnostics (IVDs) and Related Products, effective 10 April 2025, say devices may not be manufactured, imported, sold or distributed in Nigeria unless registered. NAFDAC will not take new applications for products on the Federal Government's import prohibition list or on its own ceiling list.
Devices are grouped into four risk classes, A (lowest) to D (highest). Where a device could fit two classes, the higher one applies.
| Class | Maximum processing time (guideline) |
|---|---|
| A | 120 working days |
| B | 240 working days |
| C | 240 working days |
| D | 240 working days |
The clock stops while a NAFDAC query is open. An applicant who does not respond within 90 days has the application closed.
What the US manufacturer supplies
- Power of attorney to the Nigerian applicant, notarised in the country of manufacture, valid for at least five years and stating authority to register the product with NAFDAC.
- Certificate of manufacture and free sale, authenticated by the Nigerian mission. For a US manufacturer that means the Embassy of Nigeria in Washington DC or a Nigerian consulate such as Atlanta or New York; ask the mission which it handles for your state.
- Certificate of analysis and evidence of a quality management system with a declaration of conformity.
- Labels and instructions for use, and trademark evidence.
- An invitation letter for a GMP inspection naming the local agent, because NAFDAC may inspect the factory.
The Nigerian applicant adds a declaration notarised in Nigeria and evidence of CAC incorporation, uploads the file to NAFDAC's NAPAMS portal, and obtains an import permit for samples. Samples go for laboratory analysis and the file goes to NAFDAC's Food and Drug Registration Committee. Fees follow NAFDAC's tariff; the guideline gives no amounts.
Who should hold the registration
Because the registration sits with the Nigerian applicant under your power of attorney, choosing that applicant is a commercial decision as much as a regulatory one. If you later change distributors, you need a clear way to move or revoke the authority. Put that in the distribution contract before signing the power of attorney; see distributor agreements for US brands.
SONCAP and the other export steps
SON's SONCAP exemptions cover "medical items other than equipment". On a plain reading, consumables may be exempt while equipment needs SONCAP, so ask an accredited inspection firm how your product is treated. Your buyer still opens Form M through their bank, and you file EEI in AES where a Schedule B line exceeds $2,500 (15 CFR 30.37).
Some diagnostic and laboratory equipment can be controlled under the Export Administration Regulations. Check the classification with the manufacturer or BIS before quoting; see EAR99 and export licences.
Why files stall
Most delays come from documents rather than from NAFDAC's review itself. The points that catch US manufacturers most often are:
- A power of attorney valid for less than five years, or signed by someone other than a senior officer, which has to be redone and re-notarised.
- A free sale certificate that has not been authenticated by a Nigerian mission, or that names a different legal entity from the one on the labels.
- A Nigerian applicant that is not yet incorporated with the CAC, so the file cannot be opened on NAPAMS.
- Samples shipped before NAFDAC has issued the import permit for samples, which can leave them held at the airport.
- A query left unanswered, which closes the application after 90 days and sends you back to the start.
Keep one person on each side responsible for the file, and agree in writing who pays NAFDAC fees, laboratory costs and inspection travel.
Timeline planning
- Month 0: choose the applicant, sign the distribution agreement.
- Months 0 to 2: notarise the power of attorney, obtain and authenticate the free sale certificate.
- Then: NAPAMS submission, sample permit, inspection, laboratory analysis.
- Up to 240 working days for Classes B to D, plus query time.
- After registration: SONCAP (where it applies), Form M, shipment.
At the guideline maximum, a Class C device can take around a year from accepted file to certificate. Diary the five-year renewal from the day the certificate issues.
Where Pryme fits
Distributors frequently pay registration costs and first orders in stages. A Pryme Business Account receives USD and NGN with local details, and verifiable statements made with VerifyDoc.ai give a buyer's bank a record it can check. Outside Nigeria, Pryme's activities are carried out through regulated partners.
Questions people ask
Do medical devices need NAFDAC registration before export to Nigeria?
Yes. NAFDAC's 2025 guideline says devices and IVDs may not be imported or sold unless registered.
How long does NAFDAC registration for a medical device take?
Up to 120 working days for Class A and 240 for Classes B, C and D, with the clock paused during queries.
Can a US company register directly with NAFDAC?
The applicant is a Nigerian company incorporated with the CAC, acting under a notarised power of attorney from the manufacturer.
Does medical equipment need SONCAP?
SON exempts medical items other than equipment, which suggests equipment is covered. Confirm with an accredited inspection firm.
Sources
- NAFDAC: Guidelines for registration of medical devices including IVDs and related products, effective 10 Apr 2025 (PDF) · accessed Oct 2026
- SON: SONCAP approved fees, effective 1 Aug 2022 (PDF) · accessed Oct 2026
- Standards Organisation of Nigeria: SONCAP service · accessed Oct 2026
- eCFR: 15 CFR 30.37, exemptions from the requirements for filing EEI · accessed Oct 2026
- US Census Bureau, Global Reach blog: The importance of Export Control Classification Numbers (revised 8 Oct 2021) · 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.