NAPAMS Dossier Screening Clearance and Submission Access in Nigeria

1. Key takeaways

Registration in Nigeria starts with two mandatory preconditions, and neither can be skipped, merged with the formal application, or completed after submission. They are the true entry gate of the process.

First, the Dossier Screening Clearance. Under registration guideline VBM-R&RA-GDL-001-01 §3.1, the Dossier Screening Clearance is a stated prerequisite for submitting registration applications for medium-risk and high-risk IVD and non-IVD medical devices on the NAPAMS platform. An application that reaches the platform without this clearance sits outside the sequence the guideline describes, and the applicant risks a formal refusal at the very first step rather than a simple administrative correction.

Second, submission access. Under §3.2, to start the registration process for an IVD or non-IVD device product, the applicant must send an email to md.vbmrr@nafdac.gov.ng requesting access to submit the product dossier. Access is therefore granted in response to an email request, not self-activated on the platform, and the request should state the application number so the dossier can advance to full review.

The platform is NAPAMS, the NAFDAC Automated Products Administration and Monitoring System. Key outputs of the process also flow through it: after document screening, the authority electronically issues the import permit via NAPAMS (2024 guideline §6.1), and ultimately electronically issues the product registration certificate (§9.1). In other words, NAPAMS is not a filing cabinet but the operational backbone of the entire pathway.

One point deserves attention: §3.1 names only medium-risk and high-risk products within the prerequisite scope, and Class A (low-risk) devices are not named in that sentence. Whether low-risk products also require a Dossier Screening Clearance is not explicit in the official text. GRZAN handles this as a practical estimate and recommends obtaining written confirmation from NAFDAC before committing to a schedule.

2. Legal basis

3. Expert insights

Insight one: this is the most substantive addition of the 2025 guideline compared with the 2024 guideline.

The 2024 guideline (R&R-GDL-008-02) contains no Dossier Screening Clearance step. The 2025 VBM guideline elevates it to a prerequisite. The same application that could go straight onto the platform under the 2024 text must first pass screening under the 2025 text. Companies that reuse their old process map will stall at step one, often without understanding why the platform will not accept them.

Insight two: the clearance attaches to the dossier, not to the company.

The provision refers to the product dossier, so the clearance is obtained per product. A licence holder with ten medium- or high-risk products must complete ten screening rounds. This has a major scheduling impact for multi-SKU portfolios: it is unsafe to assume that one clearance covers a whole product family or an entire applicant account.

Insight three: submission access is requested by email, not opened by self-service.

§3.2 requires an email to the designated mailbox requesting the permission, and the request should state the application number so the dossier can proceed to full review. This implies a manual queue on the authority side. The email must be tracked after sending; access does not take effect automatically upon submission of any form.

Insight four: the dossier is submitted through a unique link generated by the VBM-R&RA Directorate.

The dossier compilation guideline (GDL-005-01) states that the product dossier should be submitted through a unique link generated by the VBM-R&RA Directorate, that the authority is entitled to destroy dossier materials after evaluation without returning them, and that dossier information is treated as confidential. Applicants should keep a complete copy of everything submitted before handing it over.

Insight five: three consequences are written into the guideline text itself.

GDL-005-01 makes clear that failing to provide required information may lead NAFDAC to not accept the dossier, to seriously delay the evaluation, or to discontinue the evaluation process; a poorly prepared dossier is an obstacle to efficient assessment and may be rejected without review. This is the direct textual basis for treating documentation quality as a compliance matter, not merely a presentation preference.

4. Practical recommendations

1. List the Dossier Screening Clearance as a separate milestone in the schedule for medium- and high-risk products; do not merge it into the formal application timeline.
2. Apply for screening separately for each product, and queue them by SKU count when planning the portfolio.
3. Request submission access by email and track it in writing, stating the application number in the request.
4. Submit the dossier through the officially generated unique link, and keep a complete copy beforehand, since the authority does not return materials.
5. Confirm in writing with NAFDAC whether Class A devices need screening, and retain the reply in the project file.

5. Verification checklist

• □ The device risk class has been confirmed, and the need for a Dossier Screening Clearance determined.
• □ Submission access has been requested from md.vbmrr@nafdac.gov.ng and confirmation received.
• □ The product dossier has been submitted through the unique link generated by VBM-R&RA.
• □ The dossier has been filed section by section against the NAFDAC dossier checklist, except items marked if applicable.
• □ A complete copy of the dossier has been retained (the authority does not return materials).
• □ The screening requirement for Class A devices has been confirmed in writing with NAFDAC (practical estimate).

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 §3.1 and §3.2; R&R-GDL-008-02 §6.1 and §9.1) and the dossier compilation guideline (VBM-R&RA-GDL-005-01); 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.