Registration Samples and Laboratory Analysis for NAFDAC Submission

1. Key takeaways

The sample stage in Nigeria runs along three separate lines, and each line has its own owner, its own documents and its own timing constraints.

Imported devices: after document screening and review of the supporting documents, the authority electronically issues the import permit (Permit to Import) via NAPAMS, used to import registration samples; once the samples have been imported, the applicant delivers them to the VBM-R&RA Directorate, which transfers them to the laboratory for analysis (2025 guideline §8.1; 2024 guideline §7.0–§7.1).

Locally manufactured devices: the registration samples are drawn by the DER Directorate (§8.2), so the applicant has no direct control over when sampling happens.

Accompanying documents (the four-item set): ① the letter for submission of laboratory samples; ② evidence of payment; ③ the Certificate of analysis; ④ the evidence of submission of samples for vetting.

Testing turnaround: the official NAFDAC website states that the Directorate of Vaccine, Biologics and Medical Devices Laboratory Services works to an analysis turnaround of 60 working days, and lists six categories of grounds on which samples may be rejected: cold-chain interruption, insufficient sample quantity, missing documentation, unclear or illegible labelling, inconsistency between product information and documents, and less than six months of remaining shelf life before the expiry date (except for special products deliberately designed with a short shelf life).

2. Legal basis

3. Expert insights

Insight one: the import permit is a dedicated import-for-registration channel and is a different matter from commercial importation.

The wording of the 2024 guideline at §6.1 is that the permit is issued for the importation of registration samples for laboratory testing. This corresponds to the registration purpose in Regulation 47(2)(a). Importing commercial goods under this permit would directly violate Regulation 47(3), which requires the conditions stated in the permit to be observed.

Insight two: the 60-working-day testing turnaround comes from the laboratory services directorate page; the registration guidelines do not repeat it.

When citing the figure, the source level must be stated: the NAFDAC website page of the laboratory services directorate gives the 60 working days and also states that sample reception is not open directly to manufacturers — samples must be forwarded by the technical directorate, under a memorandum signed by the director or an authorised person, according to the regulatory requirements for the product (registration, compliance or investigation). This means companies cannot deliver samples straight to the laboratory.

Insight three: less than six months of remaining shelf life means rejection — the hardest constraint in sample planning.

The laboratory’s rejection conditions explicitly include products with less than six (6) months of remaining shelf life from the expiry date (except special products deliberately designed with a short shelf life). When arranging the registration batch, companies must work backwards through production date → shipment → customs clearance → sample delivery and ensure that more than six months of shelf life remain at the time of delivery.

Insight four: who draws the samples determines who controls the timeline.

For imported samples the applicant controls the pace (although delivery still runs through VBM-R&RA); for local samples DER draws them, and the applicant cannot accelerate this unilaterally. Schedules for locally manufactured projects must treat the DER inspection and sampling windows as an external dependency with its own lead time.

Insight five: laboratory results and the GMP inspection together form the ticket to the FDRC meeting.

Both guidelines state that the product goes to the FDRC only after document review, GMP inspection of the manufacturing facility and laboratory analysis (where applicable) are all satisfactory. Delay in the sample stage therefore propagates backward into the entire cycle, and the clock-stop rule covers only the period of compliance instructions, not sample shipment.

4. Practical recommendations

1. Ship samples only after the import permit is in hand, and bind the permit number to the shipment details.
2. Assemble the four-item sample set in one pass: the submission letter, evidence of payment, the certificate of analysis and the evidence of submission for vetting.
3. Work the shelf life backwards: ensure more than 6 months remain at delivery, and reschedule the registration batch if necessary.
4. Agree the sampling window with DER early for locally manufactured projects, and integrate it into the master schedule.
5. Do not deliver samples directly to the laboratory — they must be forwarded through the technical directorate.

5. Verification checklist

• □ The Permit to Import has been obtained and its purpose is registration samples.
• □ The four-item sample set is complete: submission letter, evidence of payment, certificate of analysis, evidence of submission for vetting.
• □ At delivery, samples retain more than 6 months of shelf life (except special short-shelf-life products).
• □ Samples are forwarded to the laboratory through the VBM-R&RA Directorate (not delivered directly).
• □ Sampling arrangements for local manufacture have been confirmed with DER.
• □ The 60 working days testing turnaround is in the schedule, with the source level noted.

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 §8.0–§8.2; R&R-GDL-008-02 §6.0–§7.1.4), the laboratory services directorate page and the regulation text (S.I. No. 42 of 2024, Regulations 47(2)(a) and 47(3)); this page is reviewed whenever the regulations or pages 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.