The Nigerian representative rule
A PoA to a Nigerian representative (often the distributor) files on NAPAMS — with the manufacturer inviting NAFDAC to inspect its factory abroad.
Free field guide · PDF
Nigeria NAFDAC Medical Device Registration2026 Field Guide
The Nigerian representative rule, the inspection gate, and the 120-day clock — with 2026 fee and validity numbers.
- Registration cost
- ₦30,000
- Timeline
- 120 WDs
- Certificate validity
- 5 yrs
Sourced from 2026 NAFDAC registration guidance and 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — 2026 NAFDAC registration guidance and 2026 publications.
The inspection gate and the 120-day clock
120 working days from acceptance to Registration Number — if documents are timely and correct, and compliance directives answered within 90 days.
Validity, labeling, and the SaMD note
₦30,000 registration cost, 5-year certificate, NAFDAC labeling rules, and why a foreign approval strengthens the file.
Sources & scope
- nigerianinformer.com, NAFDAC registration: how to get NAFDAC number (2026).
- firmusnigeria.com, registering software as a medical device with NAFDAC.
- proshare.co, NAFDAC product registration — frequently asked questions.
- Solid Media, NAFDAC stakeholder engagement update (Sept 2026).
This guide is market-access intelligence, not regulatory or legal advice. NAFDAC fees, timelines, and inspection practice are product-specific — professional review is required before business use.
Market Access Strategy Session
Nigeria on your roadmap? Start with the full picture.
A Market Access Strategy Session maps your NAFDAC route — representative selection, NAPAMS sequencing, and inspection readiness.
Professional review is required before business use.
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