Fees and Budgeting for NAFDAC Device Registration: What Can Be Verified

1. Key takeaways

On fees for Nigerian device registration, only three official facts can be confirmed:

1. The 2024 registration guideline (R&R-GDL-008-02), §11.0: Tariff — “See NAFDAC Tariff section”;
2. The 2025 registration guideline (VBM-R&RA-GDL-001-01), §10.0: Tariff — “See NAFDAC Tariff section”;
3. Regulation 4(1)(c): a registration application must be accompanied by evidence of payment of such fee as the Agency may from time to time prescribe.

In other words, neither official guideline states the fee levels in its text; both point to the Tariff section of the NAFDAC website. The original Tariff text was not obtained in this round of verification, and therefore:

• Any specific amount is marked as a practical estimate;
• Circulating tiered estimates (application and dossier review fees tiered by Class A/B/C/D, foreign on-site inspection fees, certificate issuance fees, annual renewal fees, and similar) are not treated as conclusions;
• For external quotations, the official Tariff values published for the current period prevail, with written verification records retained.

Two other certain money-related rules:

• Guideline §11.5 (2025) / §12.5 (2024): filing an application or paying the application fee does not itself create registration status;
• Regulation 8(3): where a product is to return to the market after suspension or cancellation under regulation 8(1)(a), the applicant must notify the Agency and pay the prescribed renewal fee (where the registration certificate has expired).

2. Legal basis

3. Expert insights

Insight 1: keeping fee levels in the Tariff rather than the guidelines is a deliberate adjustable design.

The wording of regulation 4(1)(c) refers to fees the Agency may prescribe from time to time, and the guidelines externalize the specific figures to the Tariff. This means fee levels can change, and a change does not require amendment of the guidelines. Companies building multi-year budgets must assume that the fee levels will move.

Insight 2: payment does not equal approval — stated officially in both versions of the guideline.

§11.5 / §12.5: filing an application and/or paying an application fee does not confer registration status. The practical effect of this sentence is to block the mistaken expectation that payment allows selling in the interim — measured against regulation 47(1), selling without a registration certificate falls into the penalty regime of regulation 48.

Insight 3: the real budget variable is not the application fee but the number of procedural nodes.

Under the 2025 guideline, an imported device successively triggers: dossier screening permit → NAPAMS application → import permit → samples and laboratory analysis → GMP or foreign inspection → FDRC meeting → certificate issuance. Each node can generate costs (sample delivery, arrangements for foreign inspection, possible supplementary testing). GRZAN builds budgets by estimating each node on a checklist, rather than quoting a single registration fee.

Insight 4: the officially verifiable time-cost linkage in this round is the clock-pause rule.

§11.8 / §12.8: the clock pauses when a compliance instruction (compliances) is issued. This means an inquiry not only extends the timeline, it also extends the cost of capital tied up, warehousing, and the management of sample shelf life. Budget models should build in the assumption that one round of inquiries equals one round of additional cost.

Insight 5: refusing to treat circulating market figures as conclusions is the compliance bottom line of this document.

Fee tables circulating online typically carry annotations such as 2025 Estimates and Verify current fees directly with NAFDAC, which marks them as second-hand estimates by their own terms. Under GRZAN’s verification discipline: any amount without an official source is marked as a practical estimate and must not enter conclusive statements.

4. Practical recommendations

1. Pull the current Tariff text from the NAFDAC website before quoting, rely on the official figures, and archive them.
2. Build the budget on the node checklist (dossier screening, application, import permit, laboratory, GMP, certificate issuance), not on a single registration fee.
3. Write the assumption that one round of inquiries equals one round of additional cost into the budget (the clock-pause rule).
4. Mark any amount in external documents as a practical estimate and note that the official Tariff prevails.
5. Advise clients that payment does not create registration status (§11.5), and that sale without a certificate is prohibited (regulations 47 and 48).

5. Verification checklist

• □ Current fee text obtained from the NAFDAC website Tariff section and archived.
• □ Budget compiled node by node, not as a single application fee.
• □ All amounts in external quotation documents marked as practical estimates or annotated with official sources.
• □ Additional timeline and cost from clock pauses caused by compliance instructions factored in.
• □ Clients advised in writing that payment does not equal registration status.
• □ Renewal fee obligation for re-listing scenarios confirmed (regulation 8(3)).

Regulatory information verified as of 29 October 2026. The provisions cited were checked against the registration guidelines published on the NAFDAC website (VBM-R&RA-GDL-001-01 §10.0, §11.5; R&R-GDL-008-02 §11.0, §12.5) and the regulation text (S.I. No. 42 of 2024, regulations 4(1)(c) and 8(3)). The official Tariff text was not obtained in this round, and all amounts are treated as practical estimates.

GRZAN support for the Nigerian market. GRZAN provides NAFDAC registration and compliance support for the Nigerian market, with local resources covering coordination with licensed importers and authorized representative services, NAPAMS online submission, dossier screening permit liaison, import permits, sample delivery and laboratory analysis support. Service capabilities cover classification assessment, registration pathway selection, technical documentation to the IMDRF ToC, CMFS and legalization support, GMP and foreign inspection readiness, advertisement permits, vigilance and PMS reporting, variation management and certificate renewal. Contact: info@grzanglobal.com.