IVD Dossier Evidence: The Three-Part Study Format in Nigeria

1. Key takeaways

NAFDAC’s technical evidence requirements for IVDs are set out in the dossier compilation guideline VBM-R&RA-GDL-005-01 (effective 17 March 2025), and the core construct is a three-part format for every study.

Studies the manufacturer should conduct: to support the intended purpose, relevant studies must be performed, including analytical sensitivity and specificity, accuracy, repeatability, reproducibility, linearity, limit of detection and traceability (as applicable); in addition, NAFDAC requires studies on interference and on reagent and product stability claims. The studies should also take account of the intended users and the intended use environment.

The three parts to be submitted for each study:

1. Study Description — including the study identifier, product identification (such as batch number), the version of the IFU used, and start and completion dates; all data must be clearly labelled and linked to the study report;
2. Study summary — a concise overview of the objective, methods, acceptance criteria, results, discussion and conclusion, including a statement of how the study objectives were met; outliers and deviations must be reported together with the results;
3. Full study protocol and report — at minimum the study objectives, design, methods and data collected; the locations where the study was performed (such as the manufacturer’s R&D laboratory, a hospital laboratory, a clinic); the operators; the reference standard or method (as applicable); sample acceptance or selection criteria and sample characterisation; sample types and the numbers of each; summaries of the actual test results with their acceptance criteria (not just pass/fail statements); the numbers of invalid tests; photographs of all test results, wherever possible; the statistical methods and details of calculations; the study conclusions; and where the study was performed by a third party, details of that third party, its relationship with the manufacturer, and a copy of the contract defining the roles and responsibilities of both parties.

2. Legal basis

3. Expert insights

Insight one: the phrase not just pass/fail statements is the easiest requirement to overlook.

The authority requires summaries of actual test results with their acceptance criteria, and not just pass/fail statements. Beyond the statistical conclusion, a summary of the raw data must be given. Reports that close with a simple statement of conformity to a YY or ISO standard need to be reworked to add the underlying data layer before submission.

Insight two: results must be detailed enough to reveal performance differences between conditions — semi-quantitative scoring or colour charts are the named methods.

The authority requires the reporting of results to be sufficiently detailed to detect potential performance differences between the conditions studied, and gives examples: depending on the product, a semi-quantitative scoring system or a calibrated graded colour card may be needed to record line intensity. This bites hardest on lateral-flow rapid tests and similar visual-read products.

Insight three: the numbers of invalid tests and photographs of results are mandatory reporting items too.

Both the numbers of invalid tests observed and photographs of all test results, wherever possible appear on the mandatory list. Companies should capture photographs at the time the registration-batch studies are run; reconstructing them afterwards is not accepted.

Insight four: third-party studies require a copy of the contract defining roles and responsibilities.

Where a study is performed by an organisation other than the manufacturer, the submission must include details of the third party and of its relationship with the manufacturer, together with a copy of the contract clearly defining the roles and responsibilities of both parties. What this provision prevents is a study that was performed but whose accountability cannot be traced.

Insight five: the thirteen IFU content items and the analytical performance chapter corroborate each other.

Registration guideline §7.3.1–§7.3.13 lists the contents the IFU must include, among them §7.3.9 analytical performance characteristics (precision, accuracy, sensitivity, specificity), §7.3.10 clinical performance characteristics (diagnostic sensitivity, diagnostic specificity, positive and negative predictive values, likelihood ratios, expected values in normal and diseased populations), §7.3.11 reference intervals, §7.3.12 interfering substances or limitations, and §7.3.5 use stability (storage conditions and expiry after first opening, and storage conditions and stability of working solutions). Every number printed in the IFU must be traceable to a source in Chapters 3 and 4 of the dossier.

4. Practical recommendations

1. Reorganise every performance study report into the three-part format of study description, study summary and full protocol and report.
2. Add summaries of raw data and the numbers of invalid tests; a pass conclusion alone is not sufficient.
3. For rapid-test products, record results with semi-quantitative scoring or graded colour cards, and retain photographs.
4. Prepare the contract copy and the role-responsibility statement for third-party studies at the same time as the study itself.
5. Build a cross-check table between the thirteen IFU items of §7.3 and Chapters 3 and 4 of the dossier.

5. Verification checklist

• □ Analytical performance items are covered: sensitivity, specificity, accuracy, repeatability, reproducibility, linearity, limit of detection, traceability (as applicable).
• □ Studies on interference and on stability (reagents and product) have been submitted.
• □ Each study contains the three parts: study description, study summary, full protocol and report.
• □ Result reports include summaries of actual data with acceptance criteria, not only pass/fail.
• □ Numbers of invalid tests are recorded and photographs of results retained.
• □ Every figure in IFU sections §7.3.9–§7.3.12 is traceable to a dossier chapter.

Regulatory information verified as of 29 October 2026. All citations above were checked against the IVD dossier compilation guideline published on the NAFDAC website (VBM-R&RA-GDL-005-01, effective 17 March 2025) and the registration guideline (VBM-R&RA-GDL-001-01 §7.3.1–§7.3.13); this page is reviewed whenever the regulations are updated.

GRZAN support for the Nigerian market: GRZAN coordinates local licensed import entities and authorised representative resources in Nigeria, covering online submission on NAPAMS, liaison for the Dossier Screening Clearance, import permits, sample delivery and laboratory analysis support. Service capabilities include classification decisions, selection of the registration pathway, preparation of technical documentation on the IMDRF ToC, handling of the CMFS and notarisation or legalisation, GMP and overseas inspection readiness, advertisement permits, vigilance and PMS reporting, variation management and renewal. Contact: hito.lin@grzan.cn; website www.grzan.cn.