Device Classification A to D under Regulation 3 and the First Schedule

1. Key takeaways

Device classification in Nigeria is set out in regulation 3 of S.I. No. 42 of 2024:

Regulation 3(1) — devices and related products are classified according to the First Schedule by risk class:

• (a) Class A: low risk;
• (b) Class B: low to moderate risk;
• (c) Class C: moderate to high risk;
• (d) Class D: high risk;
• (e) any other class as the Agency may deem fit.

Regulation 3(2) — where a device or related product falls into more than one class, the class representing the higher risk applies.

Regulation 4(1)(b) further requires that a registration application state the class of the device, together with identification information where the product is a system, test kit, device group, device family or device group family.

Together, these provisions mean that classification is not a labelling exercise. The class stated in the application drives the review pathway: whether the application must be preceded by a dossier screening permit, whether GMP inspection and laboratory analysis will be requested, and how the file moves toward the FDRC approval meeting. Getting the class wrong therefore does not merely delay the file — it puts the whole procedural chain on the wrong track, and correcting the class after submission is far more costly than a careful self-assessment before filing.

2. Legal basis

3. Expert insights

Insight 1: the four class definitions are interval-based, not top-class-based.

Class A is low, B is low to moderate, C is moderate to high, and D is high. Note that the definitions of B and C overlap in the moderate band (B includes moderate, and C includes moderate). This means that when a device’s risk sits near the moderate band, the classification outcome depends on the wording of the specific rules in the First Schedule, not on the names of the four classes. Self-assessment must return to the individual rules of the First Schedule, and a device with a moderate risk profile cannot be assigned to Class B or Class C by intuition — only the applicable Schedule rule decides.

Insight 2: regulation 3(1)(e) gives the Agency a catch-all class power.

The phrase “any other class as the Agency may deem fit” allows the Agency to set additional classes on its own initiative. In practice, this means the final decision on classification rests with NAFDAC, and a company’s self-assessment is only the starting point. Before filing, GRZAN seeks classification consensus through formal communication with the Agency rather than gambling on the outcome of a self-assessment.

Insight 3: the highest-class principle matches Tanzania (GN. No. 315, regulation 5(2)), but the downstream consequences differ.

Both systems apply the highest class when multiple rules apply, but Nigeria’s consequence chain runs: class → whether a dossier screening permit is required (yes for moderate to high risk) → whether GMP inspection and laboratory analysis apply → whether the application proceeds to the FDRC approval meeting. The difference between Class A and Class C is therefore not merely the volume of paperwork, but the number of procedural gates.

Insight 4: IVDs and non-IVDs are classified on different dimensions, and cannot share one table.

Regulation 3 and the First Schedule deal with devices and related products; IVDs are classified on the dual axes of individual risk and public health risk (guideline §2.2), as detailed in the dedicated IVD classification article. Applying non-IVD rules to an IVD is one of the most common elementary errors seen in Nigerian filings.

Insight 5: the 2025 draft retains the classification clause, but the overall framework will be rearranged.

In the 2025 draft, §32 Classification still sits under Part 4 (registration), corresponding to current regulation 3. The draft also adds provisions on novel devices (§39) and obligations of the certificate holder (§43). The draft has not yet been gazetted and must not be cited as a current obligation.

4. Practical recommendations

1. Consult the specific rules of the First Schedule first in self-assessment, then assign A/B/C/D — do not classify from experience alone.
2. Document the highest-class determination internally: list every potentially applicable rule and its individual conclusion, take the highest, and state the reasoning.
3. Initiate the dossier screening permit early for moderate to high risk (Classes C and D) (guideline §3.1); it is the front gate of the registration process.
4. Where classification is disputed, seek written confirmation from NAFDAC and retain the correspondence; regulation 3(1)(e) gives the Agency the catch-all power.
5. Classify IVDs and non-IVDs on their respective dimensions, without cross-application.

5. Verification checklist

• □ Classification self-assessment completed against the specific rules of the First Schedule, not from experience alone.
• □ The highest-class principle of regulation 3(2) applied, with the determination process recorded.
• □ The device class stated in the application materials (regulation 4(1)(b)(iii)).
• □ For systems, test kits, groups or families, identification information provided under regulation 4(1)(b)(v).
• □ Dossier screening permit initiated for Classes C and D.
• □ IVDs classified separately on the dual axes of individual risk and public health risk.

Regulatory information verified as of 29 October 2026. The provisions cited were checked against the regulation text published on the NAFDAC website (S.I. No. 42 of 2024, regulations 3 and 4, and the First Schedule) and the registration guideline (VBM-R&RA-GDL-001-01 §2.1, §3.1). The 2025 draft regulations had not been gazetted as of the verification date.

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.