Clinical Evidence and Clinical Investigations for Devices in Nigeria

1. Key takeaways

The currently effective S.I. No. 42 of 2024 contains no dedicated chapter on clinical investigations — across its six parts and 52 regulations, the clinical touchpoints are Regulation 5 (novel devices conditional on a performance evaluation study), Regulation 14 (the reliance mechanism) and Regulation 47(2)(c)(d) (import permits for research purposes). The actual requirements for clinical evidence therefore sit in the IVD dossier guideline VBM-R&RA-GDL-005-01, Chapter 4 (Clinical Evidence).

The change is happening at the draft layer: the 2025 draft published on 23 July 2025 builds a complete clinical investigation system in Part 2, 14 regulations (§3–§16) — GCP, ethics committees, sponsor obligations, investigators, safety reporting, dormant status, data safety monitoring boards (DSMB), expert advisory committees, insurance and indemnification, GCP inspections, clinical investigations conducted outside the country, registration of investigations and withdrawal.

The conclusion is clear: for now, proceed on the basis of performance evaluation studies plus reliance, but treat Part 2 of the 2025 draft as a compliance preparation list for the next one to two years. Companies that wait for gazettal before building GCP documentation will start a year behind those who prepared early, because the underlying evidence — ethics approvals, GCP certificates, verifiable raw data — takes months to assemble even when no new study is needed.

2. Legal basis

3. Expert insights

Insight one: under the current framework, clinical evidence exists as a dossier chapter, not as a clinical trial approval step. VBM-R&RA-GDL-005-01 organises the dossier into six chapters under the IMDRF ToC, with Chapter 4 as Clinical Evidence and Chapter 3 covering analytical performance and other evidence. Nigeria currently does not follow the serial structure of approve the study, conduct the study, then register; clinical evidence is submitted as one chapter of the registration dossier. This differs from the clinical trial approval plus registration structures familiar in the European Union and in China, and companies from those systems stumble here most often. Planning a Nigerian submission on an EU-style timeline wastes months waiting for an approval step that does not exist.

Insight two: the reliance mechanism of Regulation 14 is the main entry point for foreign clinical data. One of the three trigger situations in Regulation 14 is having commenced or approved the performance evaluation stage in a jurisdiction with adequate resources, and reliance may be placed on a WHO Listed Authority (WLA) or a regional harmonisation body at maturity level ML3. NAFDAC-RDRR-005-04 §2.1 further lists nine categories of reliance sources. Importantly, §3.1.4: reliance is not mutual — relying on NAFDAC does not mean NAFDAC recognises your regulator; and §3.1.5: NAFDAC retains national decision-making authority and may still require verifiable evidence. The practical reading is that a foreign approval opens the door but never replaces the evidence inside it.

Insight three: the 14 regulations of draft §3–§16 complete the serial structure. Draft Part 2 covers GCP, ethics committees, sponsor obligations, investigator duties, safety reporting, dormant status, DSMB, expert advisory committees, insurance and indemnification, GCP inspections, clinical investigations outside the country, registration and withdrawal. This architecture belongs to the same design generation as Articles 62–82 of the EU MDR and the Chinese quality management practice for medical device clinical trials. Once gazetted, Nigeria’s clinical evidence requirements will upgrade from a dossier chapter to an independent approval step. Budget owners should treat that upgrade as a planning scenario with real probability, not a remote possibility.

Insight four: the draft’s provisions on clinical investigations conducted abroad are a double-edged sword for foreign manufacturers. On one hand, defining an acceptable route for such investigations means clinical trials already completed in other jurisdictions have a channel for adoption; on the other, such provisions typically carry requirements on GCP conformity, ethics review and verifiability, and NAFDAC retains national decision authority. Preparing GCP certificates, ethics approvals and verifiable raw data in advance is the key to turning the double-edged sword into an advantage. Sponsors who can produce a complete, auditable data package on short notice will move fastest once the provisions take effect.

Insight five: watch the time window. The 2025 draft was published on 23 July 2025, with a comment period of 60 calendar days from publication (until 20 September 2025). The comment period has closed, and the next step is gazettal. As emphasised throughout this series: a draft is not current law, but a draft is a production-planning signal. We recommend making 2025 draft gazettal tracking a fixed item in the 2026 compliance calendar, reviewed monthly against the official gazette.

4. Practical recommendations

1. Prepare clinical evidence as a dossier chapter under current rules (VBM-R&RA-GDL-005-01 Chapter 4); do not schedule around a study-approval step.
2. Route foreign clinical data through the Regulation 14 reliance pathway, while preparing verifiable evidence and accepting NAFDAC’s retained decision authority.
3. Obtain study import permits under Regulation 47(2)(c) or (d), matching the purpose category to the study objective exactly.
4. Assemble GCP certificates, ethics approvals and raw-data verifiability files early, in preparation for the foreign-investigation provisions once gazetted.
5. Enter 2025 draft gazettal in the 2026 compliance calendar and track the official gazette monthly.
6. Establish a consistency check between clinical evidence and IFU claims, so performance statements never exceed the evidence (see article 27).

The common thread is anticipation: every recommendation either satisfies a current rule or pre-builds a file for a probable future rule. Because the future rules concern evidence that already exists in most companies’ archives, preparation is an indexing exercise more than a study exercise.

5. Verification checklist

• □ Clinical evidence has been submitted as a chapter per VBM-R&RA-GDL-005-01 Chapter 4.
• □ Foreign data reliance sources are mapped to one of the nine categories in NAFDAC-RDRR-005-04 §2.1.
• □ Verifiable evidence is ready for NAFDAC’s national decision authority (§3.1.5).
• □ Study samples were imported under permits per Regulation 47(2)(c) or (d).
• □ GCP certificates and ethics approvals are archived and verifiable.
• □ A gazettal tracking mechanism for draft §3–§16 has been established.
• □ Clinical evidence and IFU claims have been checked for consistency.

Regulatory information verified as of 29 October 2026. All content cited above was checked against the official Regulations (S.I. No. 42 of 2024, Regulations 5, 14, 47), VBM-R&RA-GDL-005-01 (Chapters 3 and 4) and NAFDAC-RDRR-005-04 (§2.1, §2.2, §3.1.4–§3.1.5, §3.2); Part 2 of the 2025 draft (§3–§16) was published on 23 July 2025 with a comment period ending 20 September 2025, has not been gazetted, carries no current legal force, and is referenced here only as a signal of regulatory direction.

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.