The Six-Step NAFDAC Medical Device Registration Process in Nigeria

1. Key takeaways

Following the chapter order of the 2025 registration guideline (VBM-R&RA-GDL-001-01), the registration process for imported and locally manufactured devices can be broken down into six nodes. Each node produces a document or decision that the next node depends on, so the sequence should be planned as a chain rather than a list of unrelated tasks.

1. Document screening and the Dossier Screening Clearance (§3.1–§3.2) — the prerequisite gate for medium- and high-risk products;
2. Submission of the application on NAPAMS with administrative and technical documents (from §3.0) — including the application letter, notarized declaration, power of attorney or contract manufacturing agreement, CMFS, ISO 13485 certificate, technical dossier, labelling and instructions for use;
3. The import permit (2024 guideline §6.0–§6.1) — after document screening and review of supporting documents, the authority electronically issues the Permit to Import via NAPAMS, used to import registration samples;
4. GMP inspection (2024 guideline §5.0–§5.1) — manufacturing facilities for both imported and locally manufactured devices are inspected; specific requirements are published on the website under the DER Directorate section;
5. Laboratory analysis of samples (2025 guideline §8.0–§8.2) — for imported devices the applicant delivers samples to the VBM-R&RA Directorate for onward transfer to the laboratory; for locally manufactured devices the DER Directorate draws the samples;
6. The FDRC approval meeting and issuance (§9.0 / 2024 guideline §8.0–§9.1) — once document review, GMP inspection and laboratory results (where applicable) are satisfactory, the product goes to the FDRC; on approval the product registration certificate is issued electronically.

The step numbering differs between the two guidelines. The 2024 guideline labels the stages Step I (GMP) → Step II (import permit) → Step III (laboratory) → Step IV (FDRC) → Step V (issuance); the 2025 guideline labels the laboratory as Step V and FDRC as Step VI. This article splits the process into six nodes following the logic of the workflow, without adopting the numbering of either version.

2. Legal basis

3. Expert insights

Insight one: the import permit is confined to registration samples and is not a commercial import channel.

The wording of the 2024 guideline at §6.1 is that the permit is issued for the importation of registration samples for laboratory testing. Combined with the registration purpose in Regulation 47(2)(a), this is a narrow, purpose-restricted channel — it must not be used for goods intended for sale. Using it otherwise would put the consignment outside the legal basis on which the permit was granted.

Insight two: sample submission requires four accompanying documents, and none is optional.

Both the 2025 guideline (§8.1) and the 2024 guideline (§7.1) list: ① the Letter for Submission of Laboratory Samples; ② Evidence of payment; ③ the Certificate of analysis; and ④ the Evidence of submission of samples for vetting. A missing item at the point of delivery can stall the whole laboratory stage, so the set should be assembled before shipment, not afterwards.

Insight three: samples of locally manufactured devices are drawn by DER; the applicant cannot deliver them directly.

Under §8.2, registration samples of locally manufactured devices and IVDs are drawn by the DER Directorate. This ties the progress of local projects to the DER inspection and sampling calendar. The cycle time of a locally manufactured project therefore cannot be estimated on the rhythm of an imported project.

Insight four: the FDRC approval meeting is the single decision point; the preceding three stages are tickets to it.

The wording of both guidelines is consistent: the product is submitted to the FDRC only after document review, GMP inspection of the manufacturing facility and laboratory analysis of the product (where applicable) are all satisfactory. Chasing certificate issuance while laboratory results are still outstanding is therefore procedurally untenable and will not accelerate anything.

Insight five: the certificate is electronic and valid for five years.

The 2024 guideline at §9.1 provides that products approved at the meeting are issued an electronic product registration certificate; §12.2 and the 2025 guideline §11.2 provide that the registration certificate is valid for five years. Note also §11.3 and §12.3: registration does not automatically carry an advertisement permit, which must be pursued separately.

4. Practical recommendations

1. Build the Gantt chart around the six nodes, specifying the deliverable of each node (permit, payment evidence, sample submission receipt, inspection result, meeting decision).
2. Use the import permit only for registration samples; commercial importation must follow the separate import route (see article 39 of this series).
3. Assemble the four-document sample set in advance, especially the evidence of payment and the evidence of submission for vetting.
4. Agree the sampling window with DER early for locally manufactured projects, and build it into the cycle estimate.
5. Apply for the advertisement permit separately once the certificate is issued; do not assume that advertising can begin immediately.

5. Verification checklist

• □ The Dossier Screening Clearance has been obtained (medium and high risk) and the application submitted on NAPAMS.
• □ The Permit to Import has been obtained (imported products) and is used solely for registration samples.
• □ The GMP inspection route has been confirmed (DER Directorate guidance; separate arrangements for overseas facilities).
• □ Samples and the four accompanying documents have been delivered (imported) / the sampling window agreed with DER (local).
• □ All preconditions for the FDRC approval meeting have been confirmed as met.
• □ The electronic registration certificate has been obtained (5-year validity) and the advertisement permit application planned separately.

Regulatory information verified as of 29 October 2026. All citations above were checked against the registration guidelines published on the NAFDAC website (VBM-R&RA-GDL-001-01 §3.0–§9.0; R&R-GDL-008-02 §5.0–§9.1) and the regulation text (S.I. No. 42 of 2024, Regulation 4 and Regulation 47(2)(a)); 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.