🇳🇬 Nigeria · NAFDAC · 9 minute read · Last reviewed: June 2026

Practical Guide to Medical Device Registration in Nigeria (2026)

This guide is provided for general information only. Regulatory requirements change periodically and should be independently verified before submitting an application. This guide does not constitute regulatory advice. Contact Lepaz Africa for advice tailored to your specific device and situation.

🇳🇬 Nigeria · NAFDAC · 9 minute read · Last reviewed: June 2026

At a Glance

Topic	Detail
Regulatory authority	National Agency for Food and Drug Administration and Control (NAFDAC)
Classification system	NAFDAC device categories (Category 1: general medical devices; Category 2: diapers and sanitary pads). CE Classes I–III remain relevant for documentation requirements.
Review timeline	120 working days from application acceptance
Certificate validity	5 years, renewable
Local representative	Mandatory — foreign manufacturers must appoint a NAFDAC registration agent
Submission portal	NAPAMS (NAFDAC Automated Product Administration & Monitoring System)
CE Mark / FDA clearance	Accepted in support of dossier submission
Local clinical study	Not required as standard
On-site audit	Generally not required for standard submissions, subject to product type and NAFDAC review

Step 1 — Appoint a NAFDAC Registration Agent

All foreign manufacturers seeking to register a medical device in Nigeria must first appoint a local registration agent. This agent acts as your authorised representative in Nigeria and is responsible for submitting the application and managing all NAFDAC communications on your behalf.

The agent must be a company or individual registered in Nigeria, with the appropriate business credentials. Choosing an agent with direct experience in medical device registration — rather than pharmaceuticals or food products — is important, as the documentation requirements differ.

Lepaz Africa: We have an active partner in Lagos. You deal with us and we manage the local relationship.

Step 2 — Device Classification

NAFDAC classifies medical devices into two broad categories. Category 1 covers general medical devices; Category 2 covers items such as diapers and sanitary pads. Most imported medical devices and IVDs fall under Category 1.

While NAFDAC’s published classification framework is less granular than the EU MDR’s four-class system, your CE Mark classification (Class I, IIa, IIb, or III) will inform the level of documentation required. Class I non-sterile, non-measuring devices require less supporting clinical evidence than higher-risk classes.

Step 3 — Prepare the Registration Dossier

The registration dossier must be uploaded via the NAPAMS portal. Key documents typically required include:

Completed NAFDAC application form
Application letter addressed to the Director-General of NAFDAC
Notarised and legalised (apostilled) Free Sales Certificate from the country of origin
Notarised Power of Attorney appointing the Nigerian registration agent
Valid CE Mark certificate, FDA clearance, or equivalent approval from a recognised regulatory authority
GMP certificate or equivalent quality management system evidence from the manufacturing facility
Technical dossier — including device description, intended use, specifications, and labelling
Product samples (required for laboratory analysis if requested by NAFDAC)
Guide map and letter of invitation for potential factory inspection (if requested)

Note: NAFDAC may request notarisation and embassy authentication of certain documents. This step is often underestimated by applicants and can add significant time and cost if not planned in advance. Your Nigerian registration agent should be familiar with the current authentication requirements.

Step 4 — Submit via NAPAMS

All applications are submitted electronically via the NAPAMS portal. Once the application is submitted, NAFDAC will conduct a completeness check. If accepted, the official 120 working day review clock begins. NAFDAC may issue queries during the review period — timely responses reduce the risk of delays.

A fast-track processing option is available for eligible products. Manufacturers with time-sensitive market entry plans should confirm eligibility with their registration agent.

Step 5 — Review, Queries, and Approval

During the review period, NAFDAC’s Registration and Regulatory Affairs Directorate will assess the dossier. The application is reviewed by the Food and Drug Registration Committee (FDRC). Upon approval, an electronic Certificate of Product Registration is issued to the applicant via the NAPAMS platform.

If NAFDAC requires laboratory analysis of the product, the applicant will be notified and must provide samples. For most standard device categories, local laboratory analysis is not required.

Certificate and Renewal

The NAFDAC registration certificate is valid for 5 years and must be renewed before expiry. Renewal applications should be submitted in advance — NAFDAC advises initiating renewal before the certificate lapses to avoid an interruption in market authorisation.

Practical Considerations

Documentation: NAFDAC submissions are document-heavy. Notarisation and legalisation requirements can take several weeks — build this into your timeline.
Trademark: Some agents recommend registering the brand name with Nigeria’s Trademark Registry before or alongside the NAFDAC application. Confirm with your agent whether this applies to your product.
Labelling: Labelling must comply with NAFDAC’s Medical Device Labelling Requirements. English language is sufficient.
Post-market: NAFDAC requires post-market surveillance reporting. Ensure your Nigerian agent is aware of their obligations.

Sources & References

NAFDAC Medical Device Registration Guidelines — nafdac.gov.ng
NAFDAC NAPAMS Portal — registration.nafdac.gov.ng
Medicines and Related Substances Act, Nigeria
WHO Global Benchmarking Tool — WHO Regulatory Maturity Assessments
IMDRF Medical Device Classification Guidelines

Need help with your registration in this market?

Lepaz Africa has a vetted, active partner in Nigeria ready to begin submissions on your behalf. Get in touch to discuss your device and timeline.