Mandatory Registration Redline: Regulation 47 of S.I. No. 42 of 2024

1. Key takeaways

The mandatory registration redline in Nigeria is set out in regulation 47 of S.I. No. 42 of 2024, structured as one prohibition with six permitted purposes:

Regulation 47(1) — the prohibition. Medical devices and related products shall not be manufactured, imported, exported, distributed, advertised, sold or used in Nigeria unless registered in accordance with these Regulations.

Regulation 47(2) — six purposes for which a permit may be issued. Notwithstanding subsection (1), the Agency may issue an import or manufacturing permit for the following purposes:

• (a) registration;
• (b) service medical devices;
• (c) performance evaluation studies;
• (d) research;
• (e) use in emergency situation;
• (f) donation for humanitarian interventions.

Regulation 47(3) requires that any import or manufacture under such a permit be carried out strictly in accordance with the conditions stated in the permit. Regulations 47(4) and 47(5) further provide that devices not labelled as required shall not be manufactured, imported, exported, distributed, sold, advertised, displayed for sale or used, and that advertisements not in compliance shall not be displayed or broadcast. Regulation 47(6) prohibits the holder of a registration certificate from lending, renting, selling, transferring or otherwise disposing of the certificate without the approval of the Agency.

2. Legal basis

3. Expert insights

Insight 1: the prohibition list in regulation 47(1) includes use and export.

In most markets, the mandatory registration clause only captures placing on the market for sale. Nigeria has written export and use into the prohibition as well. This means that hospital-side use of unregistered devices, and the re-export of unregistered devices out of the country, both fall within the scope of the prohibition. GRZAN highlights this point specifically in client training: compliance obligations in Nigeria extend well beyond the importer.

Insight 2: registration itself is a permitted purpose — this is the lawful channel for importing samples.

Regulation 47(2)(a) lists registration as a permitted purpose, and this connects with the Permit to Import stage of the registration guidelines: once document screening is passed, the Agency issues the import permit electronically through NAPAMS, used to import samples for registration purposes. Importing samples before registration is therefore not a grey area in Nigeria but a lawful channel with an express textual basis, on condition that the permit is obtained.

Insight 3: the six exceptions are a list of purposes, not a list of entities.

The provision authorizes by purpose (registration, service, performance evaluation, research, emergency, donation), not by type of applicant. Whether a permit can be sought therefore depends on the intended use of the consignment, not on the identity of the applicant. Any change of purpose takes the goods outside the permit’s scope and triggers the requirement in regulation 47(3) to act strictly in accordance with the permit conditions.

Insight 4: registration certificates may not be privately transferred — a point often overlooked in corporate reorganizations.

Regulation 47(6) prohibits the holder from lending, renting, selling, transferring or otherwise disposing of the registration certificate without the approval of the Agency. Changes of entity within a corporate group, transfers of brand ownership, and adjustments of the certificate holder after mergers and acquisitions all require prior approval from the Agency — signing an internal agreement is not sufficient.

Insight 5: the consequences of breaching regulation 47 are criminal-grade, and liability reaches individuals.

Regulation 48(1): natural persons face imprisonment for a term not exceeding 1 year, or a fine not exceeding ₦800,000, or both; body corporate face up to ₦5,000,000. Regulation 48(2) extends liability to directors, managers, secretaries, partners, trustees and persons actually in charge of the business — the only path to exoneration is proving that the offence occurred without the person’s knowledge, consent or connivance.

4. Practical recommendations

1. Include the prohibited acts of regulation 47(1) in client compliance notices, making clear that use and export are also covered.
2. Route sample imports through the permit channel of regulation 47(2)(a), and ship only after obtaining the electronic import permit in NAPAMS.
3. State the purpose in permit application materials; any change of purpose requires a fresh application, and the original permit cannot be reused.
4. Obtain NAFDAC approval before any change of ownership of a registration certificate (regulation 47(6)), to avoid leaving compliance gaps during group reorganizations.
5. Cross-check both the import prohibition list and the NAFDAC cap list (guideline §1.3): products on the lists are not accepted for new applications.

5. Verification checklist

• □ Confirmed whether the product falls within medical devices or related products, and thus within the scope of regulation 47(1).
• □ Confirmed whether a valid registration certificate is held (or a permit under regulation 47(2) has been obtained).
• □ Sample imports supported by a NAPAMS electronic import permit, with the use consistent with the permit.
• □ Checked whether the product appears on the Federal Government import prohibition list or the NAFDAC cap list.
• □ No unapproved lending, transfer or disposal of the registration certificate has occurred.
• □ Clients have been notified in writing of the criminal-grade consequences under regulation 48 and the extension of liability to management personnel.

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 15, 47 and 48) and the registration guideline (VBM-R&RA-GDL-001-01 §1.2, §1.3). 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.