Pathway Selection for Class A to D Devices in Nigeria

1. Key takeaways

Nigeria’s device registration offers no exemption or simplified channel — all four classes A, B, C and D go through the full registration pathway (the mandatory registration in Regulation 47(1) makes no class distinction). The difference between classes lies not in whether registration is required, but in how many gates stand on the pathway:

• Dossier Screening Clearance: VBM-R&RA-GDL-001-01 §3.1 states expressly that this is a precondition for submitting medium- and high-risk IVDs and non-IVDs on NAPAMS — that is, low-risk classes A and B may not need it, while classes C and D and medium- and high-risk IVDs do;
• Samples and laboratory (§8.0): whether samples must be sent, and which ones;
• FDRC meeting (§9.0): whether the case must go to committee;
• GMP (§5.0–§5.1): whether an on-site inspection is required;
• Processing time caps: R&R-GDL-008-02 §12.7 sets 120 working days, and VBM-R&RA-GDL-001-01 §11.7 sets 240 working days.

On fees: the official texts uniformly point to the NAFDAC Tariff section; the original fee schedule was not obtained in this cycle, so all amounts are treated as a practical estimate.

2. Legal basis

3. Expert insights

Insight 1: the true watershed is whether a dossier screening clearance is needed.

§3.1 states that the dossier screening clearance is a precondition for submission on NAPAMS for medium- and high-risk IVDs and non-IVDs. On this wording, the low-risk classes A and B (and low-risk IVDs) fall outside the mandatory scope. Whether this step applies determines whether you must first email md.vbmrr@nafdac.gov.ng to request dossier access (§3.2), wait for the link, and then build the dossier — the single most commonly missed segment of the project schedule.

Insight 2: two official turnaround figures coexist, and both must be presented.

§12.7 sets 120 working days, and §11.7 sets 240 working days. These figures belong to two different guidelines, and both are official texts. As article 13 explained: do not derive a mapping such as classes A/B at 120 and classes C/D at 240 — that correspondence appears nowhere in the official texts. The correct approach in external communication is to give both figures and explain that which one applies depends on the governing guideline and the specific product situation.

Insight 3: compliance queries stop the clock, and this is the largest source of schedule uncertainty.

§11.8/§12.8: once a compliance query (compliances) is issued, the clock stops. The published 120 / 240 working days are therefore net review time, excluding the time the company spends responding. Together with §11.6/§12.6, under which the application closes automatically after 90 days / 90 working days without a reply, the focus of project management should be on response speed, not on watching the official clock.

Insight 4: the variable cost items outnumber the fixed ones.

The official texts say only See NAFDAC Tariff section on fees. In practice, the variable cost items include: the number of application units (see the grouping strategy in article 48), whether a dossier screening clearance is needed, the number of sample test items, whether a foreign GMP inspection is required, whether an FDRC meeting is required, and whether an advertisement permit is needed. Of these, the number of application units is the only variable fully under the company’s control and with the largest impact.

Insight 5: the real constraint on class D implants lies in evidence, not in regulation.

The difficulty of class D is not a few extra documents but clinical evidence and local applicability data — the reliance mechanism of Regulation 14 and the clinical evidence requirements of Chapter 4 of VBM-R&RA-GDL-005-01 stack here. Class D projects should make the reliance claim plus verifiable evidence package the first task of the project, not an afterthought once the dossier is drafted.

4. Practical recommendations

1. Determine first whether a dossier screening clearance is required (§3.1); if yes, list the sequence of emailing for access, receiving the link and building the dossier as a standalone schedule item.
2. Present both official figures of 120 and 240 working days in external communication, without deriving a class-based mapping yourself.
3. Make response speed a project KPI: an internal deadline of 30 days, far ahead of the 90 days / 90 working days closure red line.
4. Reduce the number of application units through grouping strategy, the most controllable variable in the cost structure.
5. Start the reliance claim and evidence package at project initiation for class D and medium- and high-risk IVDs.
6. Confirm all amounts case by case as a practical estimate, and never extrapolate from other countries or historical figures.

5. Verification checklist

• □ Whether this product requires a dossier screening clearance has been determined (§3.1).
• □ If required, dossier access has been requested from md.vbmrr@nafdac.gov.ng (§3.2).
• □ The project schedule includes both official figures of 120 and 240 working days.
• □ The internal response deadline is set at 30 days (ahead of 90 days / 90 working days).
• □ The number of application units has been optimized through grouping strategy.
• □ The reliance claim and evidence package for class D / medium- and high-risk IVDs has been started.
• □ All fees have been confirmed case by case 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, Regulations 3, 4(7) and 47(1)) and the two guidelines (VBM-R&RA-GDL-001-01 §3.1, §3.2, §8.0, §9.0, §10.0, §11.6–§11.8, effective 10 April 2025; R&R-GDL-008-02 §5.0–§6.1, §9.0–§9.1, §11.0, §12.6–§12.8, effective 3 May 2024); the official texts on fees uniformly point to the NAFDAC Tariff section, the fee schedule original was not obtained in this cycle, and all amounts are therefore treated as a practical estimate and not cited as official figures.

• Local Nigeria resources: GRZAN can coordinate locally licensed import entities and authorized representative resources, covering NAPAMS online submission, dossier screening clearance interfacing, import permits, sample delivery and laboratory analysis support.
• Service capability: classification determination, registration pathway selection, technical documentation (IMDRF ToC) drafting, CMFS and notarization/legalization, GMP and foreign inspection preparation, advertisement permits, vigilance and PMS reporting, change management and renewal.
• Contact: info@grzanglobal.com; website www.grzan.cn.