Building the Device Dossier on the IMDRF ToC in Nigeria

1. Key takeaways

The organisation of the Nigerian technical dossier directly adopts the IMDRF Table of Contents (ToC). Registration guideline VBM-R&RA-GDL-001-01 §1.4 requires it to be read together with the following GHTF/IMDRF documents:

• GHTF/SG1/N71:2012 — definitions of the terms medical device and IVD medical device;
• IVD MA ToC (IMDRF/RPS WG/N13, Edition 2, 2019) — the IVD marketing authorisation table of contents;
• GHTF/SG1/N70:2011 — labelling and instructions for use for medical devices, including IVDs;
• nIVD MA ToC (IMDRF/RPS WG/N9, Edition 3, 2019) — the non-IVD medical device marketing authorisation table of contents.

NAFDAC has issued a dedicated dossier compilation guideline for IVDs (VBM-R&RA-GDL-005-01, effective 17 March 2025), whose six-chapter structure corresponds to the IMDRF ToC:

The guideline defines the force of its provisions through three verbs: shall = mandatory; should = recommended but not mandatory; may = a suggested compilation method, not mandatory. Understanding this gradation is the key to deciding which items of the dossier can legitimately be trimmed and which must be delivered in full.

2. Legal basis

3. Expert insights

Insight one: the distinction between shall, should and may is the sole basis for judging whether an item can be omitted.

The Introduction of the guideline defines the three verbs: shall means the manufacturer must comply; should means compliance is recommended but not required; may means a suggested compilation method, not a requirement. When trimming a dossier, companies may only exercise judgement on should and may items; every shall item must be implemented in full, and the trimming rationale should be documented on the cover of the submission.

Insight two: evidence must not be submitted twice — use cross-references.

The Layout section requires explicitly: do not repeat documents, even where the same evidence could fall under several sub-headings; the evidence should be provided once and then clearly cited in the other relevant sections, with chapter and page numbers. This directly shapes the layout of the dossier — pasting documents repeatedly slows the assessment and may even be read as poor preparation.

Insight three: a poorly prepared dossier may be rejected without review — this is the official wording.

The guideline states that applicants should make every effort to ensure the dossier is clear and well organised, and that poorly prepared dossiers are an obstacle to efficient assessment and may be rejected without review. It further states that failure to provide required information may lead to the dossier not being accepted, the evaluation being seriously delayed, or the evaluation process being discontinued. The three consequences escalate in severity, which is precisely why structure deserves as much attention as content.

Insight four: the authority reserves the right to request further information during review, and must state its reasons in writing.

The Introduction provides that in the course of registration NAFDAC may request other information not specifically described in the document in order to better understand the quality, safety and performance of the product under evaluation, and that the reason for any additional request will be clearly documented in the letter to the manufacturer. Requests for supplementation received by a company should therefore be traceable and reasoned; if they are not, that itself is worth clarifying with the authority.

Insight five: the IMDRF ToC is comprehensive but not fully used — NAFDAC has already trimmed it.

The guideline explains that Chapters 1–6 and their sub-headings, and the corresponding sections of the dossier checklist, are numbered according to the IMDRF ToC format; because of the comprehensiveness of the IMDRF ToC, not all sub-headings are required for registration purposes and some are excluded. The compilation basis is therefore this NAFDAC document together with the official dossier checklist, not a verbatim copy of the entire IMDRF framework.

4. Practical recommendations

1. Compile the dossier against the NAFDAC guideline and the official dossier checklist, using the IMDRF ToC as a structural reference rather than copying it wholesale.
2. Apply the shall / should / may gradation strictly, trimming only the latter two and recording the rationale.
3. Place each piece of evidence once and cross-reference by chapter and page number everywhere else.
4. Present each performance study in the three-part format of study description, study summary and full protocol and report (see article 19 of this series).
5. Keep the reasoned requests for supplementation on file, as the basis for later communication and query responses.

5. Verification checklist

• □ The dossier structure is aligned with Chapters 1–6 of the NAFDAC guideline and the official dossier checklist.
• □ Implementation and trimming follow the shall / should / may gradation, with the rationale recorded.
• □ Evidence is not duplicated; chapter and page cross-references are used.
• □ All sections other than those marked if applicable have been submitted.
• □ The electronic copy format meets the requirements (pagination format, hierarchical presentation, etc.).
• □ A complete copy of the dossier has been retained (the authority does not return materials).

Regulatory information verified as of 29 October 2026. All citations above were checked against the registration guideline published on the NAFDAC website (VBM-R&RA-GDL-001-01 §1.4), the dossier compilation guideline (VBM-R&RA-GDL-005-01, effective 17 March 2025) and the regulation text (S.I. No. 42 of 2024, Regulation 4(3)); 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.