Nigeria Regulatory Reliance: Regulation 14 of S.I. No. 42 of 2024

1. Key takeaways

Nigeria is one of the few African markets that has written the concept of regulatory reliance directly into the body of its medical device regulations. The anchor provision is Regulation 14 of S.I. No. 42 of 2024, and it sets out three trigger conditions:

1. the quality, safety and performance of the device have been established;
2. the performance evaluation stage has been initiated or approved in a well-resourced jurisdiction;
3. the relevant regulatory authority is a WHO Listed Authority (WLA) or a harmonized regional body operating at Maturity Level 3 (ML3).

The operational detail is supplied by two NAFDAC directives: NAFDAC-RDRR-005-03 (effective 30 July 2025) and NAFDAC-RDRR-005-04 (effective 11 October 2025, with a review date of 10 October 2030). Two updates within a single year show that this pathway is being refined quickly.

2. Legal basis

3. Expert insights

Insight 1: reliance is a power to adopt, not an obligation to accept — this is the single most important reading of Regulation 14.

Regulation 14 is structured so as to give NAFDAC the authority and the conditions under which it may adopt reliance, while Regulation 14(2) and 14(3) expressly preserve the national decision right and the right to require verifiable evidence. An applicant may argue for reliance, but it cannot demand that NAFDAC must accept it. Any submission strategy built on the assumption that reliance guarantees acceptance misreads the provision.

Insight 2: of the three trigger conditions, the second is the most useful one for Chinese companies.

Among the three conditions in Regulation 14, the condition that performance evaluation has been initiated or approved in a well-resourced jurisdiction maps most closely to the real position of Chinese manufacturers — the performance evaluations and clinical data you have completed in the EU, the United States or China are exactly what this limb contemplates. But note the wording: the criterion is a well-resourced jurisdiction, and NAFDAC holds the power to judge whether a jurisdiction qualifies.

Insight 3: WHO status is not the only entry point; the nine source categories are the complete map.

Section 2.1 of NAFDAC-RDRR-005-04 lists nine categories of acceptable reliance sources: WLA/VICH/ICH observers, ML3 and ML4 regulatory authorities, the United States EPA, WHO/WOAH, the WAHO and ECOWAS regional health mechanisms, WHO PQ or ISO/IEC 17025 accredited laboratories, AMRH, the WHO Collaborative Registration Procedure (CRP), and formal members of the WHO network of National Control Laboratories. Many applicants fixate on WHO PQ, yet ISO/IEC 17025 laboratory reports under item 2.1.6 are equally listed.

Insight 4: the scope of reliance extends well beyond registration review.

Section 2.2 makes clear that reliance may apply to: market authorization (MA), pharmacovigilance (PV), clinical trials and investigations, post-market surveillance, market surveillance, lot release, laboratory testing, and inspections. This means reliance is a pathway that runs across the whole product life cycle, not a one-time device used only at first registration. Vigilance submissions, PMS reviews and inspection planning can all be argued on the same basis.

Insight 5: two directive versions in one year reflect a system that is converging.

NAFDAC-RDRR-005-03 (30 July 2025) was superseded by -005-04 (11 October 2025) after an interval of roughly two and a half months. For applicants the practical implication is straightforward: whenever you cite a reliance provision, verify the directive number and effective date of the current version, because clause numbering in the earlier version may not match the newer one.

4. Practical recommendations

1. Raise the reliance claim proactively in the submission and map it in the dossier to one specific category under §2.1; do not write vaguely that the product holds international certifications.
2. Prepare the verifiable evidence required by Regulation 14(3): approval documents, review reports, GCP/GLP attestations, laboratory accreditation certificates.
3. When citing reliance provisions, confirm the number and effective date of the current directive (-005-04, effective 11 October 2025).
4. Use reliance across the whole life cycle, not only for first registration: vigilance, PMS and inspections can all be claimed.
5. Do not substitute reliance for local obligations — the authorized representative, PMS, vigilance and advertisement permits must still be established locally.
6. The figure of about 60 working days for the WHO CRP is a practical estimate; it was not retrieved from official texts in this cycle, so flag it as such and confirm case by case.

5. Verification checklist

• □ The reliance claim has been stated expressly in the dossier and mapped to a specific category under §2.1.
• □ A complete verifiable evidence package has been assembled (approvals, review reports, accreditation certificates).
• □ The citation references the current directive NAFDAC-RDRR-005-04 (effective 11 October 2025).
• □ Extended application of reliance to PV, PMS and inspections has been assessed (§2.2).
• □ Local obligations (authorized representative, PMS, vigilance, advertisement permit) have been established independently and are not left to default because of reliance.
• □ Any cited turnaround figure has been flagged as a practical estimate.

Regulatory information verified as of 29 October 2026. All content cited in this document has been checked against the official NAFDAC regulation text (S.I. No. 42 of 2024, Regulation 14(1)–(3)) and the two reliance directives (NAFDAC-RDRR-005-03, effective 30 July 2025; NAFDAC-RDRR-005-04, effective 11 October 2025, review 10 October 2030). The WHO CRP turnaround figure was not retrieved from official texts and is treated as a practical estimate.

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