IVD Classification in Nigeria: Two Risk Axes under Guideline Section 2.2

1. Key takeaways

Nigeria gives in vitro diagnostic devices (IVDs) a separate classification formulation, set out in the registration guideline VBM-R&RA-GDL-001-01 §2.2:

• (a) Class A: low individual risk and low public health risk;
• (b) Class B: low to moderate individual risk and/or low public health risk;
• (c) Class C: high individual risk and/or moderate public health risk;
• (d) Class D: high individual risk and high public health risk.

IVD classification has 4 classes (A/B/C/D), determined by the intersection of two axes (individual risk and public health risk). The connectors are used in two ways: Classes A and D use and, while Classes B and C use and/or.

As with general device classification, the final sentence of guideline §2.1 provides that where a device or related product falls into more than one class, the class representing the higher risk applies.

2. Legal basis

3. Expert insights

Insight 1: the connector between the two axes is and/or for B and C, but and for A and D.

Read the connectors for the four classes separately: Class A uses and (low individual risk and low public health risk), and Class D uses and (high individual risk and high public health risk), while Classes B and C use and/or. This means Classes A and D are conjunctive conditions — both elements must be satisfied — whereas B and C are disjunctive, with either element sufficient to bring the device into the class. Class A must not be misread as requiring only one of the two risks to be low.

Insight 2: the boundary between Classes B and C lies on the individual risk axis.

For Class B, the individual risk band is low to moderate; for Class C it is high. An IVD whose individual risk is high therefore falls into Class C even if its public health risk is only moderate; Class D is reached only when both individual risk and public health risk are high. This line separates the self-testing category, the blood-glucose monitoring category, and the blood-donor screening category.

Insight 3: the IVD class determines the depth of the technical dossier, not merely the fee.

Guideline §3.1 requires that moderate to high risk IVDs and non-IVD devices obtain a dossier screening permit before submission in NAPAMS. The dossier compilation guideline (GDL-005-01) requires Chapter 3 analytical performance evidence (precision, accuracy, sensitivity, specificity, limit of detection, linearity, traceability and related items) and Chapter 4 clinical evidence. The higher the class, the heavier the evidentiary demands under these two chapters.

Insight 4: Nigeria splits IVD and non-IVD dossier compilation into two guideline systems.

Guideline §1.4 requires the guideline to be read together with four GHTF/IMDRF documents, which explicitly distinguish:

• IVD MA ToC (IMDRF/RPS WG/N13, Edition 2, 2019);
• nIVD MA ToC (IMDRF/RPS WG/N9, Edition 3, 2019).

NAFDAC has issued a dedicated dossier compilation guideline for IVDs (GDL-005-01). The table-of-contents structure for non-IVDs cannot be applied to an IVD.

Insight 5: IVDs are within the registration obligation for related products, and the class does not waive registration.

Whether Class A or Class D, IVDs are subject to the mandatory registration requirement of regulation 47(1) — classification affects the pathway and the documentation, but does not exempt from registration. This is the point most often misjudged for self-testing IVDs.

4. Practical recommendations

1. Assess individual risk and public health risk separately when classifying an IVD, then apply the connectors for A/B/C/D — do not collapse the two axes into a single impression.
2. Apply and/or for Classes B and C, and and for Classes A and D, and record the connector relied upon in the determination record.
3. Initiate the dossier screening permit early for moderate to high risk IVDs, and prepare the full evidence required under Chapters 3 and 4 of GDL-005-01.
4. Organize the IVD dossier according to the IVD MA ToC, managed separately from the nIVD MA ToC.
5. Never treat classification as a registration exemption — Class A IVDs also require registration.

5. Verification checklist

• □ The individual risk and public health risk assessment results recorded separately.
• □ Class assigned according to the connectors: A (and), B/C (and/or), D (and).
• □ The highest-class principle applied where the product falls into more than one class.
• □ Dossier screening permit initiated for moderate to high risk IVDs.
• □ Dossier organized per the IVD MA ToC structure, including Chapter 3 analytical performance and Chapter 4 clinical evidence.
• □ Confirmed that Class A IVDs remain subject to mandatory registration and were not misjudged as exempt.

Regulatory information verified as of 29 October 2026. The content cited was checked against the registration guidelines published on the NAFDAC website (VBM-R&RA-GDL-001-01 §2.1, §2.2, §3.1; VBM-R&RA-GDL-005-01) and the regulation text (S.I. No. 42 of 2024, regulation 3). Updates are re-checked whenever the regulations change.

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.