NAFDAC market access

Nigeria medical device registration resources

Research NAFDAC registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Nigeria medical device resource.

5 free resources24/25 requirements coveredAug 2026 fees reviewed

Run the classification agent

Everything we track for Nigeria

Browse by resource instead →

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Nigeria requirements.

Medical device regulation news

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

Registration timeline

Compare official and realistic NAFDAC approval times by device class and pathway.

AI medical device classifier

Describe your device and get a preliminary NAFDAC risk class with official rule references.

Government registration fees

Review current NAFDAC application, review, and renewal fees.

Structured regulatory requirements

Explore all 62 source-linked facts →

24 of 25 research dimensions currently covered · 18 official sources · latest verification 2026-09-07

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

Primary legislation: NAFDAC Act CAP N1 (LFN) 2004 is the primary legal basis; device registration obligations are stated as 'in accordance with the provisions of NAFDAC Act CAP N1 (LFN) 2004, other related Legi…
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

Open details →

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

Open details →

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

Open details →

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.
One application per device or group: A separate application is required for each medical device, IVD, related product, device group, device family or device system; a separate application form is required for each product, pro…

5 source-linked facts

Checked 2026-08-25

Open details →

D06

Reliance & recognition

Verified

Reliance on Stringent Regulatory Authorities: NAFDAC has mechanisms to rely on evaluation decisions of SRAs as per WHO definition/classification: it 'may rely on the assessment report of such SRAs but retains its Sovereignty in decisio…
WHO PQ collaborative registration decision timeline: Under the WHO Collaborative Registration Procedure for WHO prequalified medical devices (incl. IVDs), NAFDAC makes its national registration decision within 60 working days (approximately 9…

2 source-linked facts

Checked 2026-08-25

Open details →

D07

Economic-operator roles

Verified

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…
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…

3 source-linked facts

Checked 2026-08-25

Open details →

D08

Establishment, import & distribution

Verified

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…
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.

3 source-linked facts

Checked 2026-08-25

Open details →

D09

Dossier requirements

Verified

Notarized declaration for imported devices: For imported devices, a Notarized Declaration (Appendix 1 of the registration guideline) must be completed typed, signed by the declarant, and notarized by a Notary Public in Nigeria.
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

Open details →

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

Open details →

Submission & evidence

D11

Label, IFU & language

Verified

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…
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…

2 source-linked facts

Checked 2026-08-25

Open details →

D12

QMS, audit & inspection

Verified

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…
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…

2 source-linked facts

Checked 2026-08-25

Open details →

D13

Standards, testing & ancillary approvals

Unresolved

NAFDAC recognized-standards certificate and lab analysis: Electrical safety

1 maintained overlay

Checked 2026-09-07

Open details →

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

Open details →

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

Open details →

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

Open details →

Lifecycle & post-market

D17

Change control

Verified

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…
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.

2 source-linked facts

Checked 2026-08-25

Open details →

D18

UDI, listing & traceability

Verified

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…
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.

2 source-linked facts

Checked 2026-08-25

Open details →

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

Open details →

D20

Special access & derogation

Verified

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…
Permit for service medical devices: NAFDAC issues a Permit for Service Drugs (including orphan drugs)/Medical Devices per product for special need devices that are not registered or not available in Nigeria, requested for use…

3 source-linked facts

Checked 2026-08-25

Open details →

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…
Trending and periodic reporting: Manufacturers must operate a trending system monitoring frequency/severity of incidents, conducted periodically (e.g. monthly), and summarize all feedback into periodic reports to the Direc…

3 source-linked facts

Checked 2026-08-25

Open details →

D22

Vigilance & incident reporting

Verified

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…
Device user facility reporting deadlines: Device user facilities report adverse events using the end user form: Death 48 hours; Serious Injury 48 hours; Public Health Concern 10 calendar days; possible death or serious injury if re…

5 source-linked facts

Checked 2026-08-25

Open details →

D23

Recall, FSCA & market surveillance

Verified

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…
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…

2 source-linked facts

Checked 2026-08-25

Open details →

D24

Advertising, claims & promotion

Verified

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…
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…

2 source-linked facts

Checked 2026-08-25

Open details →

D25

Submission communications & appeal

Verified

Queries must be answered within 90 days: Failure to respond promptly to NAFDAC queries or enquiries on an application (within ninety (90) days) will automatically lead to closure of the application.
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.

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 line	Amount	Provenance
Registration - Medical Devices 1 and 2, local (per product)	NGN 20,000	Verified
Registration - Medical Devices 1 (all except diapers/sanitary pads), foreign	USD 750	Verified
Registration - Medical Devices 2 (diapers and sanitary pads), foreign	USD 874	Verified
Laboratory analysis - other medical devices, local	NGN 29,700	Verified

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 / pathway	Review clock	Planning total	Provenance
Class A(NAFDAC registration)	120 working days	7-10 months	Verified
Class B(NAFDAC registration)	240 working days	1.1-1.5 years	Verified
Class C(NAFDAC registration)	240 working days	1.1-1.7 years	Verified
Class D(NAFDAC registration)	240 working days	1.2-2 years	Verified