Nigeria Device Labelling Duties under Part III of the 2024 Regulations

1. Key takeaways

In Nigeria, labelling obligations sit at the level of a statutory instrument: they are set out in Part III of S.I. No. 42 of 2024 (Regulations 16–27), comprising 12 regulations. Each regulation addresses one element of the label, so a compliant label is best built by working through the list systematically rather than by adapting an existing export artwork and hoping nothing is missing.

In parallel, the registration guideline (R&R-GDL-008-02 §10.2) sets out a minimum information list for the labelling of imported and locally manufactured devices, which corresponds to the statutory provisions above: the device name; the manufacturer’s name and address; device identification (including identification of a device that is part of a system, test kit, device group, device family or group of families); the family or group of families, where applicable; the batch or lot number; a statement of quantity where the contents are not obvious (size, net weight, length, volume or number of units); the word Sterile where the device is intended to be marketed in a sterile state; the words for single use only where the device is intended for single use; the production date and expiry date expressed in month and year; the medical conditions, purposes and uses for which the device is intended (including, where necessary for proper use, performance specifications); instructions for use (unless the device can be used safely and effectively without them); any special storage conditions; and, where the package is too small to bear all of this, instructions for use should accompany the device but need not be printed on the outer packaging or be visible under normal conditions of sale.

The two layers work together: the Regulations define the duty, and the guideline tells an applicant exactly what the reviewer will look for in the submitted label artwork.

2. Legal basis

3. Expert insights

Insight one: labelling violations carry two independent legal consequences in Nigeria. First, Regulation 4(10)(d) lists a product label that contravenes the Regulations as a ground for rejection of a registration application; second, Regulation 47(4) prohibits any person from manufacturing, importing, exporting, distributing, selling, advertising, displaying for sale or using devices that are not labelled as required by the Regulations. In other words, a labelling problem blocks the entry gate and also governs the end market. A label that passed artwork review years ago can still ground enforcement action if it drifts out of conformity during production, so label control is a lifecycle duty.

Insight two: dates must be month and year, and batch numbers and date marking must not be pre-printed. Guideline §10.2 requires the production date and expiry date to be expressed in month and year. The accompanying labelling rules (on product identification and date marking) go further: batch numbers and date marking shall not be pre-printed on the label. The design consequence is concrete: variable fields must be applied at packaging time, which means the packaging line needs an online coding capability and the batch record needs a coding verification step.

Insight three: the composition rules contain a 1 percent rule and an allergen rule. The labelling rules on composition or components require devices, IVDs and related products to declare a complete list of composition or components on both the primary and secondary labels in descending order of amount; where there is no secondary packaging, on the primary label; components present at less than 1 percent may be listed in any order after those at 1 percent or above; where pharmacologically active components are present, the active ingredients must be declared in accordance with the official drug labelling regulations; components known to cause allergy must be declared on the label; and multi-packs have four permitted treatments (listing components separately or combined; where the outer packaging cannot bear the list, using accompanying inserts, labels, tags, tape or cards with abbreviated information or special symbols on the outer packaging directing the user to them; no additional attachment where each single container already carries the list; and no additional marking where the pack is transparent and the list is clearly visible). Artwork teams should build these branches into their label templates rather than resolving them case by case.

Insight four: the accompany-don’t-print rule for small packages is a statutory exception, not a workaround. Guideline §10.2 mirrors the labelling rules: where the package is too small to bear all items (a)–(k), the instructions for use should accompany the device, but need not be printed on the outer packaging or be visible under normal conditions of sale. Companies may rely on this provision directly when designing small-package configurations, without applying for any derogation. The insert content must be complete; only its placement changes, never its substance.

Insight five: misleading display information is itself an offence. The labelling rules state that any information on a label that misleads or deceives the consumer in any way constitutes an offence under the Regulations, and that no person may remove, add to, alter, deface or render illegible any statement on a label. Distributors and hospitals therefore fall within the scope of the duty, which is why contractual clauses on label integrity are advisable.

4. Practical recommendations

1. Build a twelve-item check sheet against Regulations 16–27, cross-verified against the §10.2 minimum information list of the guideline.
2. Standardise dates in month–year format, and ensure batch numbers and date marking are not pre-printed.
3. Order the component list by descending amount, place sub-1-percent components afterwards, and declare allergenic components separately.
4. Use the statutory accompanied-instructions route for small packages rather than printing everything on the outer box.
5. Bring label changes into change management (Regulation 6 of the Regulations) and keep the evidence in the label master record.

A label built this way survives two very different tests: the desk review at registration, and the market surveillance check that Regulation 47(4) empowers after the product is on sale. Both use the same source documents, which is exactly why a single consolidated check sheet pays for itself.

5. Verification checklist

• □ The label has been checked item by item against Regulations 16–27.
• □ The §10.2 minimum information list has been checked (including Sterile and for single use only).
• □ The production date and expiry date are expressed in month and year.
• □ Batch numbers and date marking are not pre-printed on the label.
• □ The component list is in descending order and allergenic components are declared.
• □ Small packages use the statutory accompanied instructions for use route.

Regulatory information verified as of 29 October 2026. All provisions cited above were checked against the Regulations (S.I. No. 42 of 2024, Part III Regulations 16–27, Regulations 4(10)(d) and 47(4)) and the registration guideline (R&R-GDL-008-02 §10.1–§10.2) as published on the NAFDAC website; this review is refreshed whenever the regulations are updated.

GRZAN supports manufacturers entering the Nigerian market with registration documentation and conformity files, including classification determination, registration pathway selection, technical documentation to the IMDRF ToC, GMP and foreign inspection readiness, advertisement permits, vigilance and PMS reporting, change management and renewal. Local resources in Nigeria cover licensed import entities and authorised representative services, NAPAMS online submission, dossier screening permit liaison, import permits, sample delivery and laboratory analysis support. Contact: hito.lin@grzan.cn; website www.grzan.cn.