Offences, Penalties and Forfeiture for Medical Devices in Nigeria under Article 48

1. Key takeaways

The device penalties in Nigeria are set out in Article 48, the most deterrent and most frequently miscited part of the Regulations:

• Article 48(1)(a): natural persons — up to 1 year imprisonment, or a fine of up to ₦800,000, or both;
• Article 48(1)(b): body corporate — a fine of up to ₦5,000,000;
• Article 48(2): liability piercing — where an offence is committed with the consent or connivance of, or is attributable to the neglect of, any director, manager, secretary, partner, trustee or other officer, both that individual and the body corporate are guilty of the offence and may be prosecuted separately.

Two companion provisions complete the picture: Article 49 (forfeiture of proceeds and instruments / devices) and Article 15 (NAFDAC’s power to seal premises). Read together, they allow the agency to pursue the company, the individual, the goods and the premises in a single enforcement sequence.

2. Legal basis

3. Expert insights

Insight one: the fine amounts are written into the body of the Regulations, not into a guideline — a marked difference from most African markets.

In most markets, device regulations only state that violations are punishable, with amounts left to a penalties statute or schedule. S.I. No. 42 of 2024 writes ₦800,000 and ₦5,000,000 directly into Article 48(1), so a company can assess its risk exposure without consulting a second statute. This is why we listed mandatory registration plus explicit penalties as the first of the three differentiating features. For budget holders, it also means the numbers are fixed in primary legislation and cannot drift with administrative guidance.

Insight two: the piercing in Article 48(2) targets individuals, not only the company.

Article 48(2) lists: directors, managers, secretaries, partners, trustees and other officers. This is a classic dual liability regime — while the company is fined up to ₦5,000,000, the individuals concerned can be prosecuted as natural persons, facing up to ₦800,000 and 1 year imprisonment. Executives of Nigerian subsidiaries and local partners therefore carry personal exposure, which changes the tone of every compliance conversation inside the company.

Insight three: the defence under Article 48(2) is lack of knowledge, consent or connivance.

The proviso in Article 48(2): a person is not guilty if they can prove that the offence occurred without their knowledge, consent or connivance. The burden of proof for this defence lies on the individual — the practical lesson is that compliance decisions and approvals must leave a documented trail, which is the only available evidence of non-connivance. A signature on a dated approval, a recorded objection, or a documented escalation all become personal protection, not merely good governance.

Insight four: forfeiture under Article 49 covers proceeds and instruments; the devices themselves can be confiscated.

Article 49: courts may order the forfeiture of proceeds and instruments. For devices imported or sold without registration, the value of the goods is a direct loss — the fine is the ceiling of one exposure, and the loss of the goods is calculated separately. When modelling worst-case scenarios, finance teams should add consignment value, channel inventory and logistics costs on top of the statutory fines.

Insight five: the trigger points are numerous; labelling and advertising are the most easily overlooked entries.

Article 48 does not apply only to unregistered sales. Several provisions of the Regulations expressly create offences, for example Article 26(1) (displaying misleading information) and Article 47 (conduct relating to unregistered devices). A single label, a single advertising claim, can fall directly under Article 48. Marketing sign-off should therefore include a regulatory check with the same rigour as the technical file review.

4. Practical recommendations

1. Include the Article 48 fine amounts in compliance training, so that local teams and management know the risk exposure.
2. Document compliance decisions and approvals throughout, as the evidence source for the Article 48(2) defence of non-connivance.
3. Screen labelling and advertising as a priority — the two easiest entries into Article 48 (Articles 26(1), 47).
4. Never touch the import or sale of unregistered devices (Article 47(1)), and be alert to the risk of goods forfeiture (Article 49).
5. Cover all pre-registration scenarios with the six permitted purposes of Article 47(2), leaving no grey zones.
6. Add compliance representations and indemnity clauses to local partner contracts, passing the Article 48(2) piercing risk to the responsible party.

5. Verification checklist

• □ The Article 48(1) fine standards (natural persons ₦800,000 / 1 year; body corporate ₦5,000,000) have been briefed to management and local teams.
• □ Compliance approval records are fully documented and can support the Article 48(2) defence.
• □ Labelling and advertising have completed a criminal risk screen (Article 26(1)).
• □ No import, sale or use of unregistered devices occurs (Article 47(1)).
• □ All pre-registration scenarios hold a corresponding Article 47(2) permit.
• □ Local partner contracts contain compliance representations and indemnity clauses.
• □ The risk of goods forfeiture (Article 49) has been assessed and budgeted.

Regulatory information verified as of 29 October 2026. All citations have been checked against the official NAFDAC Regulations text (S.I. No. 42 of 2024, Articles 15, 26(1), 47(1)–(2), 48(1)(a)(b), 48(2), 49, 50) and the two enabling statutes (NAFDAC Act, Cap. N1, LFN 2004, s. 30; Food, Drugs and Related Products (Registration, Etc.) Act, Cap. F33, LFN 2004, s. 12); the fine amounts are the maxima stated in the body of the Regulations, and outcomes in individual cases are subject to judicial or administrative decisions.

• Local resources in Nigeria: GRZAN can coordinate locally licensed importer and authorised representative resources, covering NAPAMS electronic submission, dossier screening permit coordination, import permits, sample delivery and laboratory analysis support.
• Service capabilities: classification determination, registration pathway selection, technical documentation (IMDRF ToC), CMFS and legalisation, GMP and foreign inspection readiness, advertisement permits, vigilance and PMS reporting, change management and renewal.
• Contact: hito.lin@grzan.cn; website www.grzan.cn; email info@grzanglobal.com.