Vigilance and Adverse Event Reporting in Nigeria: Dedicated NAFDAC Channels for Devices and IVDs

1. Key takeaways

Device vigilance obligations in Nigeria have two layers: at the Regulations layer, Article 12(3) requires manufacturers and importers to comply with the pharmacovigilance provisions; at the operational layer, NAFDAC maintains dedicated submission channels for Manufacturer Investigation Reports and Adverse Event Reports for medical devices and IVDs.

There are two key points: first, the obligation rests on both the manufacturer and the importer — it is not pushed solely onto the foreign manufacturer; second, the channels are dedicated — the general pharmacovigilance route for drugs cannot be used as a substitute for the dedicated device and IVD forms. A report submitted through the wrong channel may be treated as never having been submitted at all, which in a serious incident scenario is the difference between cooperation and non-compliance.

2. Legal basis

3. Expert insights

Insight one: the obligation holders under Article 12(3) are the manufacturer and the importer.

Note that the connecting word is and. This means the local importer is an independent obligation holder, not a message-relay office for the foreign manufacturer. When an adverse event occurs, an importer cannot use having informed the manufacturer as a defence. This is why we stressed two-directional reporting in article 34: the importer carries its own statutory duty, and the duty survives even if the manufacturer fails to act. Local partners should be trained on this before their first incident, not after.

Insight two: devices and IVDs have dedicated channels; the drug route cannot be applied.

NAFDAC maintains dedicated submission portals for medical devices and IVDs, distinguishing between the Manufacturer Investigation Report and the Adverse Event Report. These differ from the pharmacovigilance channels for drugs. In practice it is recommended that the SOP names the dedicated portal and form explicitly, so that local partners do not take the wrong route and have the report treated as never submitted. Screenshots of the current portal, kept in the SOP annex, make the instruction concrete and easy to audit.

Insight three: the definition of an adverse event differs for IVDs — an incorrect result is itself an event.

For IVDs, the most typical adverse event is not patient injury but erroneous or deviating test results leading to misdiagnosis, missed diagnosis or wrong treatment decisions. The IVD vigilance SOP must therefore cover trend monitoring of false positives and false negatives, quality control failures, and lot-to-lot variation complaints, not merely user injury. This is the same line as the analytical performance requirements in Chapter 3 of VBM-R&RA-GDL-005-01, viewed from the other end: what the dossier promises analytically is exactly what vigilance must watch operationally.

Insight four: vigilance output flows back into registration status.

Article 8(1)(c) (non-compliance with quality, performance or safety provisions) and Article 8(1)(d) (ineffective for the approved purpose) are both grounds for suspension or cancellation of registration, and vigilance data is the primary evidence source for both determinations. Vigilance is therefore never a report-and-forget exercise: it must produce trend assessments and trigger corresponding dispositions — corrective actions, recalls, labelling revisions or change applications under Article 6. The file you build today is the evidence file that will be read when the certificate is next questioned.

Insight five: the connection point with recall is whether withdrawal from circulation is needed.

When a problem identified through vigilance reaches the level of requiring market withdrawal, it enters the recall framework of PMS-GDL-020-00: graded by health hazard, communicated through recall letters and press releases, and tracked through progress monitoring. The grading determines the intensity of communication — which is the subject of article 36. Deciding early whether an event is a vigilance case, a recall case, or both, is the most consequential triage decision a local team will make.

4. Practical recommendations

1. Name the dedicated device / IVD submission portals and forms in the SOP and train local partners on them.
2. List the importer as an independent obligation holder, clarifying its reporting responsibility and response timelines in agreements.
3. Have the IVD vigilance SOP cover wrong-result events (false positive / false negative trends, quality control failures, lot-to-lot variation), not only personal injury.
4. Institute quarterly trend assessments of vigilance data, with conclusions issued and dispositions triggered.
5. Link the vigilance, change, recall and renewal registers to avoid information silos.
6. Retain evidence for all reports (submission receipts, dates, report numbers) for retrieval during renewal self-checks.

5. Verification checklist

• □ The vigilance SOP names the dedicated device / IVD submission channels and forms (Article 12(3)).
• □ Both the manufacturer and the importer are listed as obligation holders with their own execution records.
• □ The two-directional user feedback mechanism (to the manufacturer and NAFDAC) is in place (Article 12(4)).
• □ The IVD vigilance SOP covers wrong-result events.
• □ Vigilance data feeds a quarterly trend assessment that triggers dispositions.
• □ The four registers for vigilance, changes, recalls and renewal are linked.
• □ Submission evidence for reports is retained and archived.

Regulatory information verified as of 29 October 2026. All citations have been checked against the official NAFDAC Regulations text (S.I. No. 42 of 2024, Articles 8(1)(c)(d), 12(2)–(4)) and the two guidelines (PMS-GDL-016-01, effective 27 September 2024; PMS-GDL-020-00, effective 30 September 2024); the dedicated reporting portals for devices and IVDs are taken from the vigilance pages of the NAFDAC website, and the current form names and formats are subject to the official live pages. Specific items marked as pending verification should be re-checked against those pages before filing.

• Local resources in Nigeria: GRZAN can coordinate locally licensed importer and authorised representative resources, covering NAPAMS electronic submission, dossier screening permit coordination, import permits, sample delivery and laboratory analysis support.
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