S.I. No. 42 of 2024: Gazette Identity and Structure of Nigeria’s Device Regulations

1. Key takeaways

The precise identity of Nigeria’s current dedicated medical device regulation is as follows:

• Statutory name: NAFDAC Medical Devices and Related Products (Registration, Labelling and Advertisement) Regulations, 2024;
• Statutory number: S.I. No. 42 of 2024 (Statutory Instrument No. 42 of 2024);
• Gazette publication: the Official Gazette of the Federal Republic of Nigeria, No. 176, Lagos, 16 October 2024, Vol. 111, Government Notice No. 47, with the text at pages B919–B955;
• Commencement date: [16th Day of October, 2024], that is, 16 October 2024;
• Structure: six Parts (Part I–VI) and 52 regulations, plus a First Schedule (classification rules for medical devices).

The six Parts are arranged as follows: Part I, objectives and application (regulations 1–2); Part II, registration (regulations 3–15); Part III, labelling (regulations 16–27); Part IV, advertisement (regulations 28–47); Part V, offences and penalties (regulations 48–49); Part VI, miscellaneous (regulations 50–52).

One detail that must be flagged: the word “ADVETISEMENT” in the official English title of the Regulations is a spelling variant (it also appears at the arrangement of regulations). When citing, either reproduce the official spelling as printed, or standardize to Advertisement while noting the source as S.I. No. 42 of 2024.

2. Legal basis

3. Expert insights

Insight 1: this is the first time Nigeria has placed device registration, labelling and advertisement in a single statutory instrument.

Before this, device regulation relied mainly on NAFDAC’s general statutory powers and scattered registration guidelines. S.I. No. 42 of 2024 combines the three types of conduct in one instrument and sets penalty figures directly in Part V — for natural persons up to ₦800,000, and for body corporate up to ₦5,000,000. In legislative density, this is the largest difference between Nigeria and Tanzania (GN. No. 315) or Kenya (guideline-led).

Insight 2: the commencement date and the gazettal date are the same day, with no transition period.

The Commencement clause states “[16th Day of October, 2024]”, matching the gazette date. This means the Regulations apply immediately from the date of gazettal, with no phased implementation arrangement. When companies screen their legacy product portfolios for compliance, the starting point for obligations is 16 October 2024, not some assumed grace period.

Insight 3: regulation 47 casts mandatory registration as a prohibition, with six permitted purposes.

Regulation 47(1) lists the prohibited acts (manufacture, import, export, distribution, advertisement, sale, use), and regulation 47(2) sets out six purposes for which a permit may be issued (registration; service medical devices; performance evaluation studies; research; use in emergency situation; donation for humanitarian interventions). This structure fixes the compliance logic in Nigeria: first check whether the conduct falls within the prohibition, then check whether a permit can be obtained.

Insight 4: the First Schedule, not the main text, is the true basis for classification.

Regulation 3 only names the four classes (Class A low risk, B low to moderate, C moderate to high, D high) and the principle of applying the higher class. The detailed rules sit in the First Schedule: grouped by non-invasive devices (rules 1–4), invasive devices for body orifices (rule 5), and surgically invasive devices (rules 6–7), with classification driven by duration of use, site of contact and connection to a source device. Companies performing classification self-assessment must consult the Schedule and cannot rely on regulation 3 alone.

Insight 5: areas not covered by the Regulations are carried by the guidelines and the 2025 draft.

S.I. No. 42 of 2024 does not contain systematic provisions on clinical investigations, quality systems or vigilance. The current supplements are the guidelines (GMP, PMS, recalls, dossier compilation), and the future layer is the 2025 draft regulations — which, as of the verification date, have not yet been gazetted and are referred to in this document only as a draft.

4. Practical recommendations

1. Fix the full identity of the instrument in all external documents: name + S.I. No. 42 of 2024 + gazettal date 2024-10-16.
2. Consult the First Schedule when performing classification self-assessment, not only the four-class wording of regulation 3.
3. Set 16 October 2024 as the baseline date for legacy compliance screening (there is no transition period).
4. Maintain a three-column comparison table of regulation, guideline and draft: the regulation carries penalties, the guideline carries operational detail, and the draft is forward-looking only.
5. Preserve the official spelling of the title when citing, to avoid challenges over inaccurate citation.

5. Verification checklist

• □ Recorded the instrument number S.I. No. 42 of 2024 and the gazette details No. 176 Vol. 111 / GN No. 47 / B919–955.
• □ Confirmed the commencement date as 16 October 2024, with no phased transition arrangement.
• □ Captured the six-Part structure: Part I (1–2), II (3–15), III (16–27), IV (28–47), V (48–49), VI (50–52).
• □ Classification self-assessment performed against the grouped rules of the First Schedule, not only regulation 3.
• □ Distinguished current regulatory obligations from the content of the 2025 draft, without treating the draft as current law.
• □ External citations preserve the official title spelling and note the instrument number.

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, including the Arrangement of Regulations and the gazette page details). 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.