Nigeria medical device registration timeline

Source-linked clocks

National Agency for Food and Drug Administration and Control (NAFDAC) review clocks and end-to-end planning ranges, using the 4-class (A, B, C, D) — EU-aligned classification system.

4 pathways4 of 4 clocks verifiedvalidity 5 yearsMDSAP not acceptedreviewed 2026-08-25

Class / pathway	Review clock	Planning total	With prior approval	Provenance
Class A(NAFDAC registration) Guideline: 120 working days; RDRT-038-00 (effective 1 May 2025) standardised clocks across device classes	120 working days	7-10 months	—	Verified
Class B(NAFDAC registration) Guideline: 240 working days; RDRT-038-00 (effective 1 May 2025) revised the earlier 120-working-day clock to 240 for Class B-D	240 working days	1.1-1.5 years	—	Verified
Class C(NAFDAC registration) Guideline: 240 working days; RDRT-038-00 (effective 1 May 2025) revised the earlier 120-working-day clock to 240 for Class B-D	240 working days	1.1-1.7 years	—	Verified
Class D(NAFDAC registration) Guideline: 240 working days; RDRT-038-00 (effective 1 May 2025) revised the earlier 120-working-day clock to 240 for Class B-D	240 working days	1.2-2 years	—	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Nigeria Medical Device Registration Process

Step-by-step NAFDAC registration process. Total estimated timeline: 7-10 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by NAFDAC. Appoint a Nigerian Authorized Representative.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to NAFDAC including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

NAFDAC reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

120 working days

In-depth technical assessment of device safety and performance. NAFDAC may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, NAFDAC issues Nigeria market authorization certificate.

Summary: The Nigeria medical device registration process through National Agency for Food and Drug Administration and Control (NAFDAC) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Prior approval recognition

CE Mark (EU MDR)Technical documentation and QMS evidence reuse1-3 months

FDA 510(k)/PMASubmission content reuse as reference evidence

Key requirements

Local Authorized Representative required for foreign manufacturers
WHO-listed authorities route: WHO prequalification recognition within 60 working days (about 90 calendar days), plus a 20-working-day notification
Nigerian content directives may add local-partner requirements

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Source-linked review clocks verified against NAFDAC publications · full review 2026-08-25 · row IDs are stable — cite as registration-timeline:nigeria:class-a