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NAFDAC · Middle East & Africa

Nigeria medical device regulatory resources

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5 free resources24/25 topics with recordsAug 2026 fees reviewed
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Medical device regulation news

Follow recent National Agency for Food and Drug Administration and Control (NAFDAC) policy, guidance, safety, and compliance updates.

Registration timeline

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AI medical device classifier

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Government registration fees

Review current NAFDAC application, review, and renewal fees.

Structured regulatory requirements

Explore all 64 source-linked facts →

24 of 25 research dimensions currently covered · 19 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified
Competent authority and marketing control mandate
NAFDAC (National Agency for Food and Drug Administration and Control) controls medical devices, IVDs and related products: no device may be manufactured, imported, exported, advertised, sol…
1 source-linked fact
Checked 2026-08-25
Open details →
D02

Legal basis & guidance

Verified
Draft Medical Devices Regulations 2026
NAFDAC published the draft 'NAFDAC Medical Devices, including In vitro Diagnostics and Related Products Regulations, 2026' for comment on 6th February 2026; the comment period is closed. It…
IMDRF/GHTF documents incorporated
The device registration guidelines must be read in conjunction with IMDRF/GHTF documents, including GHTF/SG1/N71:2012 (definitions), IMDRF IVD MA ToC N13 and nIVD MA ToC N9 (2019 dossier fo…
4 source-linked facts
Checked 2026-08-25
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D03

Device definition & scope

Verified
Device and IVD definitions adopted from IMDRF
Nigeria applies the IMDRF/GHTF definitions: the guidelines are built on GHTF/SG1/N71:2012 'Definition of the Terms Medical Device and In Vitro Diagnostic Medical Device'; separate classific…
Software as a Medical Device in scope
SaMD is regulated as a medical device: 'software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device'; SaMD incl…
2 source-linked facts
Checked 2026-08-25
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D04

Classification rules

Verified
Risk classes A through D for devices and IVDs (NAFDAC registration guidelines 2025).
Class A, Class B, Class C, Class D
1 maintained scheme · 3 related facts
Checked 2026-08-25
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D05

Registration pathways

Verified
Dossier Screening Clearance prerequisite
A Dossier Screening Clearance is a prerequisite for submitting registration applications for moderate and high risk (Class B, C, D) IVD and non IVD medical devices on NAPAMS.
Product Approval Meeting decision step
After satisfactory documentation review, GMP inspection of the production facility and laboratory analysis (where applicable), products are presented to the Food and Drug Registration Commi…
5 source-linked facts
Checked 2026-08-25
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D06

Reliance & recognition

Verified
China NMPA approval: not reference
statement: NAFDAC's Reliance Procedure applies to drugs, vaccines and medical devices including IVDs whose quality, safety and efficacy/performance have been confirmed by a Stringent Regula…
China NMPA approval: origin evidence only
statement: NAFDAC's Guidelines for Registration of Medical Devices in Nigeria (VBM R&RA GDL 001 00, effective 4 November 2024) require, for imported devices, a Certificate of Manufacture an…
4 source-linked facts
Checked 2026-09-15
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D07

Economic-operator roles

Verified
Applicant must be incorporated in Nigeria
Registration documents must include evidence of business incorporation by the Nigerian Corporate Affairs Commission (CAC), so the applicant/local agent is a Nigerian incorporated company; b…
Local applicant holds manufacturer Power of Attorney
An applicant filing on behalf of an overseas manufacturer must file a Power of Attorney issued by the manufacturer, signed by a senior officer, stating brand name ownership, notarized by a…
3 source-linked facts
Checked 2026-08-25
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D08

Establishment, import & distribution

Verified
CRIA required for China and India consignments
An original Clean Report of Inspection and Analysis (CRIA) is required for products coming from China and India, where applicable, as part of the port clearance package.
Port import clearance on PIDCARMS
Imported medical devices are cleared at ports via https://ports.nafdac.gov.ng (PIDCARMS) with uploaded documents including SGD form, commercial invoice, PAAR, Form M, Bill of Lading/Airway…
3 source-linked facts
Checked 2026-08-25
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D09

Dossier requirements

Verified
Comprehensive Certificate of Analysis
A comprehensive Certificate of Analysis on the QC laboratory's letterhead must accompany the application, stating brand name, batch number, manufacturing and expiry dates, and analyst name,…
Free Sale Certificate with embassy authentication
For imported devices, a Certificate of Manufacture and Free Sale issued by the relevant health/regulatory body in the country of manufacture must be authenticated by the Nigerian Embassy or…
6 source-linked facts
Checked 2026-08-25
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D10

Official forms & portals

Verified
Official submission portal
Device registration applications are submitted and processed on the NAPAMS portal at https://registration.nafdac.gov.ng; to initiate an IVD/non IVD dossier submission the applicant emails m…
Renewal application form purchased online
The online application form for product registration renewal is purchased on the NAFDAC registration portal (http://registration.nafdac.gov.ng) and completed for each device, IVD and relate…
2 source-linked facts
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
IFU minimum content
The Instructions for Use must minimally include: description of intended use (what is measured/detected, function, disorder/condition of interest, automation, reported result type, specimen…
Minimum label information
All imported and locally manufactured devices must bear minimum label information: device name; manufacturer name and address; device identifier; group/family where applicable; batch or lot…
2 source-linked facts
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
Class A QMS may omit design controls
For Class A devices the manufacturer may establish either a full QMS or a QMS without design and development controls; regulatory oversight increases from Class A to D as evidence and confo…
GMP inspection basis ISO 13485:2016
Premises for the manufacture of devices, IVDs and related products are inspected in accordance with the applicable regulations, the NAFDAC GMP guidelines, the current ISO 13485:2016 and oth…
2 source-linked facts
Checked 2026-08-25
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D13

Standards, testing & ancillary approvals

Unresolved
NAFDAC recognized-standards certificate and lab analysis
Electrical safety
1 maintained overlay
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D14

Fees

Verified
Registration - Medical Devices 1 and 2, local (per product)
NGN 20,000
Registration - Medical Devices 1 (all except diapers/sanitary pads), foreign
USD 750
10 maintained fee lines
Checked 2026-08-25
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D15

Review clocks

Verified
Class A · NAFDAC registration
120 working days
Class B · NAFDAC registration
240 working days
Class C · NAFDAC registration
240 working days
4 maintained pathways · 1 related fact
Checked 2026-08-30
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D16

Approval validity & renewal

Verified
Certificate of Registration valid 5 years
A successful device registration is issued a Certificate of Registration with a validity period of five (5) years; the certificate should be renewed upon expiration, and product licenses ar…
Renewal application 6 months before expiry
A renewal application can be initiated six (6) months before the current registration certificate expires; each device, IVD and related product requires its own renewal application.
3 source-linked facts
Checked 2026-08-25
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Lifecycle & post-market

D17

Change control

Verified
NAFDAC may re-categorize a submitted change
Where the category of change selected by the applicant is inappropriate, NAFDAC will advise the market authorization holder to amend the category as deemed appropriate.
Variation categories: critical, major, minor
Changes to registered devices fall into three categories: (1) Critical changes affect safety, quality and performance and require NEW registration; (2) Major changes require NAFDAC evaluati…
2 source-linked facts
Checked 2026-08-25
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D18

UDI, listing & traceability

Verified
GMDN code in Declaration of Conformity
The Declaration of Conformity must contain a Global Medical Devices (including IVDs) code and term for the device(s), where available.
Importers/distributors keep distribution records
Importers and distributors must communicate Field Safety Notices and maintain distribution records as their post market responsibility, supporting device traceability through the supply cha…
2 source-linked facts
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
Clinical evidence framework (GHTF SG5)
NAFDAC's conformity assessment framework incorporates GHTF SG5 clinical evidence documents: N1R8:2007 Clinical Evidence Key Definitions, N2R8:2007 Clinical Evaluation, N3:2010 Clinical Inve…
1 source-linked fact
Checked 2026-08-25
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D20

Special access & derogation

Verified
Donated devices require processing and import permit
No donated medical product (drugs, devices incl. IVDs) may be imported into Nigeria unless it has undergone due processing with NAFDAC under the donated products guideline and a Permit to I…
Emergency Use Authorization
NAFDAC's EUA is a special procedure granting time limited listing authorization for unlicensed vaccines, therapeutics and medical devices (incl. IVDs) during a declared public health emerge…
3 source-linked facts
Checked 2026-08-25
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D21

Manufacturer PMS

Verified
PMS plan required with registration
A post market surveillance plan must be developed in accordance with the NAFDAC Guidelines for Detecting and Reporting Adverse Reactions for Pharmaceutical Products and Medical Devices incl…
Post-Market Performance Follow-up guideline
NAFDAC publishes a dedicated 'Guidelines for Post Market Performance Follow up (PMPF) for Medical Devices including IVDs' (guidance document, PV category) in its official guidelines catalog.
3 source-linked facts
Checked 2026-08-25
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D22

Vigilance & incident reporting

Verified
Follow-up final report within 30 days
Dealers (distributors/suppliers/agents) of medical devices must follow up an initial reportable adverse event with a final report within 30 days of the initial report; if more than one deal…
Manufacturer adverse event reporting deadlines
Manufacturers must report device adverse events to NAFDAC: Death 48 hours of becoming aware; Serious Injury within Nigeria 48 hours; Serious Injury outside Nigeria 15 calendar days; Public…
5 source-linked facts
Checked 2026-08-25
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D23

Recall, FSCA & market surveillance

Verified
FSCA triggers, actions and FSN
An FSCA is triggered by incidents with distributed devices posing an unacceptable increase in risk (malfunction/deterioration, inadequate information, undesirable side effects); FSCA action…
Incident investigation report deadlines
Manufacturers (or MAHs) must send NAFDAC an investigation report: Serious Public Health Threat immediate, not later than 48 hours; Death or Serious Deterioration in Health as soon as possib…
2 source-linked facts
Checked 2026-08-25
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D24

Advertising, claims & promotion

Verified
Advert approval valid one year
NAFDAC advertisement approvals are valid for one (1) year, extendable to two (2) years upon payment of double the relevant fee if the concept is retained; advertisement fees are charged per…
Registration does not confer advertising permit
Registration of a device does not automatically confer an Advertisement Permit; a separate application and NAFDAC approval is required before a product may be advertised, per the NAFDAC Gui…
2 source-linked facts
Checked 2026-08-25
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D25

Submission communications & appeal

Verified
Compliance Directive response within 7 working days
Clients must comply with a NAFDAC Compliance Directive (CD) within 7 working days of issuance; failure to comply with any CD may result in cancellation of the application.
Client-caused delays excluded from clock
Delays caused by the client are not counted within the registration processing timelines.
3 source-linked facts
Checked 2026-08-25
Open details →

Government fees

Full fee schedule (10 lines) →

NAFDAC registration fees in NGN · reviewed 2026-08-25

Fee lineAmountProvenance
Registration - Medical Devices 1 and 2, local (per product)NGN 20,000Verified
Registration - Medical Devices 1 (all except diapers/sanitary pads), foreignUSD 750Verified
Registration - Medical Devices 2 (diapers and sanitary pads), foreignUSD 874Verified
Laboratory analysis - other medical devices, localNGN 29,700Verified
6 more fee lines on the full schedule · 10 of 10 rows source-verified

Registration timeline

Full registration timeline →

National Agency for Food and Drug Administration and Control (NAFDAC) review clocks and planning ranges · 4-class (A, B, C, D) — EU-aligned classification

Class / pathwayReview clockPlanning totalProvenance
Class A(NAFDAC registration)120 working days7-10 monthsVerified
Class B(NAFDAC registration)240 working days1.1-1.5 yearsVerified
Class C(NAFDAC registration)240 working days1.1-1.7 yearsVerified
Class D(NAFDAC registration)240 working days1.2-2 yearsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(120 working days)
  5. 5Registration Approval(1-2 weeks)

Latest regulation news

All Nigeria regulation news →

Newest official NAFDAC headlines from the daily-refreshed feed — every row links directly to the authority publication.

Aug 13NANational Agency for Food and Drug Administration and Control (NAFDAC)NAFDAC Regulatory Clarification on Deleject Disposable Needle AlertNigeriaJul 29NANational Agency for Food and Drug Administration and Control (NAFDAC)Handling Manufacturer Investigation Reports for Medical Devices and IVDsNigeria
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