NAFDAC · structured requirements

🇳🇬 Nigeria IVD regulatory data

Explore the IVD requirements currently available for Nigeria, organized by topic and linked to official sources.

5 facts2 dimensions4 official sourceslatest verification 2026-09-15

Changes after registration in Nigeria

Source-linked rules for common changes to a registered IVD. Read the scope and conditions with each rule; unverified details are listed separately.

Does changing a device brand name or logo require an update?

A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.

A source-verified answer for this specific scenario is not yet published.

How do I update a manufacturer's name without changing the legal entity?

The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.

A source-verified answer for this specific scenario is not yet published.

What changes when the manufacturer's office address changes?

An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.

A source-verified answer for this specific scenario is not yet published.

Does a catalogue or reference code change affect registration or UDI?

Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.

A source-verified answer for this specific scenario is not yet published.

Can a registration transfer to a different legal entity?

A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.

A source-verified answer for this specific scenario is not yet published.

Can several changes be filed together?

Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.

A source-verified answer for this specific scenario is not yet published.

Classification rules

What local class follows from which rules and decisive product facts?

Compare countries

Classification detail 2

classification.detail-2

Fact-level verified

IVD classification: Class A low individual and low public health risk; Class B low-moderate individual and/or low public health risk; Class C high individual and/or moderate public health risk; Class D high individual and high public health risk (s.2.2).

Classification detail 3

classification.detail-3

Fact-level verified

Classification follows GHTF/SG1/N077:2012 Principles of Medical Devices Classification as acknowledged in the conformity assessment guideline (non-IVD), with class-based conformity assessment tables for Classes A-D.

Classification scheme (full axis)

classification.scheme-classes

Fact-level verified

Axis

Risk classes A through D for devices and IVDs (NAFDAC registration guidelines 2025).

Classes

Id
a
Label
Class A
Normalized Risk Level
low
Id
b
Label
Class B
Normalized Risk Level
medium
Id
c
Label
Class C
Normalized Risk Level
high
Id
d
Label
Class D
Normalized Risk Level
highest

Regulator

NAFDAC

Notes

Section 2.1: Class A low risk, B low-to-moderate, C moderate-to-high, D high risk, or any other class the Agency deems fit; where a device belongs to more than one class the higher-risk class applies.
Section 2.2 IVDs: Class A low individual/low public health risk; B low-moderate individual and/or low public; C high individual and/or moderate public; D high individual and high public.
Non-IVD classification follows GHTF/SG1/N077:2012 Principles of Medical Devices Classification as acknowledged in the NAFDAC conformity assessment guideline for non-IVD devices (class-based conformity assessment tables for Classes A-D).

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Nigeria approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Nigeria (5 records)

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Usable as supporting technical evidence, with no published reduction outside the WHO-listed-authority route.
Timeline Savings: None published

NAFDAC Guidelines for Registration of Medical Devices 2025 — Class A 120, B/C/D 240 workdays

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Prior approval / evidence record

WHO prequalification / WHO-listed authority

Authority: WHO prequalification / WHO-listed authority
Accepted: Yes
Benefit: The one genuine reliance route NAFDAC publishes: recognition within 60 working days, roughly 90 calendar days, against 120 working days for Class A and 240 for Classes B, C and D
Timeline Savings: 60 working days instead of 120 or 240

NAFDAC Guidelines for Registration of Medical Devices 2025 — Class A 120, B/C/D 240 workdays

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Prior approval / evidence record

China NMPA approval: origin evidence only

reliance.china-nmpa-origin-evidence

Pending verification

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 and Free Sale issued by the relevant health/regulatory body in the country of manufacture and authenticated by the Nigerian Embassy, and the notarised declaration lists a 'Manufacturing license / Certificate for companies from India and China' authenticated by the Nigerian Mission. An NMPA registration certificate / export certificate therefore serves as country-of-origin evidence for China-made devices, but NAFDAC still performs full documentation review, GMP inspection of the factory abroad, laboratory testing and FDRC approval (120 working days).
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: nigeria
China Classes In Scope: NMPA Class I filing or Class II/III certificate and Chinese manufacturing licence as documentary evidence; target all imported devices
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Free Sale Certificate must name the manufacturer and the products and be embassy-authenticated (3.5.1-3.5.3).
Chinese and Indian manufacturers must additionally provide an authenticated manufacturing licence/certificate (Appendix I, item 2.c).
Letter of invitation for GMP inspection of the foreign factory (3.10); registration samples for laboratory analysis (7.0).
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2024-11-04

Source passage: 3.5 Certificate of Manufacture and Free Sale (for imported medical devices). The manufacturer must show evidence that the company is licensed to manufacture medical devices and that the sale of the product does not constitute a contravention of the laws of that country, i.e., Free Sale Certificate (Certificate of Manufacture and Free Sale). The Free Sale Certificate should: 3.5.1 Be issued by a relevant Health/Regulatory body in the country of manufacture. [...] c. Manufacturing license / Certificate for companies from India and China and the authentication thereof by the Nigerian Mission in the country of origin

NigeriaEU conformity assessment

Prior approval / evidence record

CE Mark (EU MDR)

Authority: CE Mark (EU MDR)
Accepted: Yes
Benefit: Usable as supporting technical evidence. The NAFDAC 2025 guidelines publish no reduced period for CE-marked devices; the only shortened route is the WHO-listed-authority one.
Timeline Savings: None published

NAFDAC Guidelines for Registration of Medical Devices 2025 — Class A 120, B/C/D 240 workdays

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Regulatory reference

China NMPA approval: not reference

reliance.china-nmpa-not-reference

Pending verification

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 Regulatory Authority 'as per WHO definition/classification' or by an authority with which NAFDAC has a reliance agreement (WAHO, AMRH, Swissmedic MAGHP). The guideline's SRA definition is closed: ICH members before 23 October 2015 (US FDA, European Commission, Japan MHLW/PMDA), ICH observers before that date (EFTA/Swissmedic, Health Canada) and MRA-associated authorities (Australia, Iceland, Liechtenstein, Norway). China NMPA is not an SRA, is not a WHO Listed Authority and has no reliance agreement with NAFDAC, so an NMPA certificate cannot open the reliance pathway.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: nigeria
China Classes In Scope: NMPA Class II/III certificates; target all NAFDAC-registered devices incl. IVDs (reliance procedure)
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Product must have been registered by the SRA for more than six months and be identical in use, dosage and precautions (Step 5.1-5.2).
NAFDAC retains sovereign decision-making; reliance activated case-by-case or on applicant request.
WHO Listed Authorities are named only for reliance on quality-control laboratory reports (7.2.4), not for product assessment.
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2025-09-25

Source passage: Stringent Regulatory Authority (SRA): is defined as a well-resourced authority as defined by the WHO that is: a. a member of ICH prior to 23 October 2015, namely: the US Food and Drug Administration, the European Commission, and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency; or b. an ICH observer prior to 23 October 2015, namely: the European Free Trade Association, as represented by Swissmedic and Health Canada; or c. a regulatory authority associated with an ICH member through a legally binding, mutual recognition agreement prior to 23 October 2015, namely: Australia, Iceland, Liechtenstein and Norway.

Related structured datasets

Classification systems · 1 record

Open Risk classes A through D for devices and IVDs (NAFDAC registration guidelines 2025). →

Id

nigeria:medical-device

Jurisdiction Id

nigeria

Domains

medical-device
ivd

Name

Risk classes A through D for devices and IVDs (NAFDAC registration guidelines 2025).

Classes

Id
a
Label
Class A
Normalized Risk Level
low
Id
b
Label
Class B
Normalized Risk Level
medium
Id
c
Label
Class C
Normalized Risk Level
high
Id
d
Label
Class D
Normalized Risk Level
highest

Regulator

NAFDAC

Official Domains

nafdac.gov.ng

Notes

Section 2.1: Class A low risk, B low-to-moderate, C moderate-to-high, D high risk, or any other class the Agency deems fit; where a device belongs to more than one class the higher-risk class applies.
Section 2.2 IVDs: Class A low individual/low public health risk; B low-moderate individual and/or low public; C high individual and/or moderate public; D high individual and high public.
Non-IVD classification follows GHTF/SG1/N077:2012 Principles of Medical Devices Classification as acknowledged in the NAFDAC conformity assessment guideline for non-IVD devices (class-based conformity assessment tables for Classes A-D).

Source Status

official-source-verified

Source Title

NAFDAC — Guidelines for Registration of Medical Devices 2025, Sections 2.1-2.2

Source Url

https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Guidelines/VBM_R&R/2025-2030/Guidelines-for-Registration-of-Medical-Devices-Including-In-Vitro-Diagnostics-IVDs-and-Related-Products.pdf

Verified On

2026-08-25

Source Supports

class-axis
ivd-class-axis

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Nigeria registration →

Country

Nigeria

Jurisdiction Id

nigeria

Country Code

NG

Flag

🇳🇬

Regulator

National Agency for Food and Drug Administration and Control

Regulator Abbrev

NAFDAC

Region

africa

Tier

3

Risk Classification

4-class (A, B, C, D) — EU-aligned

Classes

Id
class-a
Class Name
Class A
Risk Level
low
Pathway
NAFDAC registration
Official Timeline
Min
120
Max
120
Unit
working-days
Realistic Timeline
Min
7
Max
10
Unit
months
Notes
Guideline: 120 working days; RDRT-038-00 (effective 1 May 2025) standardised clocks across device classes
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Verification Status
official-verified
Official Source
Title
NAFDAC Guidelines for Registration of Medical Devices 2025 — Class A 120, B/C/D 240 workdays
Url
https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Guidelines/VBM_R&R/2025-2030/Guidelines-for-Registration-of-Medical-Devices-Including-In-Vitro-Diagnostics-IVDs-and-Related-Products.pdf
Accessed Date
2026-08-25
Id
class-b
Class Name
Class B
Risk Level
medium
Pathway
NAFDAC registration
Official Timeline
Min
240
Max
240
Unit
working-days
Realistic Timeline
Min
13
Max
18
Unit
months
Notes
Guideline: 240 working days; RDRT-038-00 (effective 1 May 2025) revised the earlier 120-working-day clock to 240 for Class B-D
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Verification Status
official-verified
Official Source
Title
NAFDAC Guidelines for Registration of Medical Devices 2025 — Class A 120, B/C/D 240 workdays
Url
https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Guidelines/VBM_R&R/2025-2030/Guidelines-for-Registration-of-Medical-Devices-Including-In-Vitro-Diagnostics-IVDs-and-Related-Products.pdf
Accessed Date
2026-08-25
Id
class-c
Class Name
Class C
Risk Level
high
Pathway
NAFDAC registration
Official Timeline
Min
240
Max
240
Unit
working-days
Realistic Timeline
Min
13
Max
20
Unit
months
Notes
Guideline: 240 working days; RDRT-038-00 (effective 1 May 2025) revised the earlier 120-working-day clock to 240 for Class B-D
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Verification Status
official-verified
Official Source
Title
NAFDAC Guidelines for Registration of Medical Devices 2025 — Class A 120, B/C/D 240 workdays
Url
https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Guidelines/VBM_R&R/2025-2030/Guidelines-for-Registration-of-Medical-Devices-Including-In-Vitro-Diagnostics-IVDs-and-Related-Products.pdf
Accessed Date
2026-08-25
Id
class-d
Class Name
Class D
Risk Level
highest
Pathway
NAFDAC registration
Official Timeline
Min
240
Max
240
Unit
working-days
Realistic Timeline
Min
14
Max
24
Unit
months
Notes
Guideline: 240 working days; RDRT-038-00 (effective 1 May 2025) revised the earlier 120-working-day clock to 240 for Class B-D
Clinical Trial Required
Yes
Local Testing Required
No
Gmp Required
Yes
Verification Status
official-verified
Official Source
Title
NAFDAC Guidelines for Registration of Medical Devices 2025 — Class A 120, B/C/D 240 workdays
Url
https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Guidelines/VBM_R&R/2025-2030/Guidelines-for-Registration-of-Medical-Devices-Including-In-Vitro-Diagnostics-IVDs-and-Related-Products.pdf
Accessed Date
2026-08-25

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

Prior Approvals

Authority
CE Mark (EU MDR)
Accepted
Yes
Benefit
Usable as supporting technical evidence. The NAFDAC 2025 guidelines publish no reduced period for CE-marked devices; the only shortened route is the WHO-listed-authority one.
Timeline Savings
None published
Authority
FDA 510(k)/PMA
Accepted
Yes
Benefit
Usable as supporting technical evidence, with no published reduction outside the WHO-listed-authority route.
Timeline Savings
None published
Authority
WHO prequalification / WHO-listed authority
Accepted
Yes
Benefit
The one genuine reliance route NAFDAC publishes: recognition within 60 working days, roughly 90 calendar days, against 120 working days for Class A and 240 for Classes B, C and D
Timeline Savings
60 working days instead of 120 or 240

Local Rep Required

Yes

Local Rep Name

Nigerian Authorized Representative

Mdsap Accepted

No

Mdsap Benefit

Not accepted

Registration Validity

5 years

Verification Status

official-verified

Official Sources

Title
NAFDAC Guidelines for Registration of Medical Devices 2025 — Class A 120, B/C/D 240 workdays
Url
https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Guidelines/VBM_R&R/2025-2030/Guidelines-for-Registration-of-Medical-Devices-Including-In-Vitro-Diagnostics-IVDs-and-Related-Products.pdf
Accessed Date
2026-08-25

Reviewed On

2026-08-30

Last Updated

2026-08-30

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by NAFDAC. Appoint a Nigerian Authorized Representative.
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to NAFDAC including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
NAFDAC reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. NAFDAC may issue questions.
Duration
120 working days
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, NAFDAC issues Nigeria market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Nigeria fees →

Jurisdiction Id

nigeria

Country

Nigeria

Country Code

NG

Authority

NAFDAC

Low Risk Local

Min: 20000
Max: 20000
Currency: NGN
Per Product: Yes

High Risk Local

Min: 20000
Max: 20000
Currency: NGN
Per Product: Yes

Details

Id
registration-local
Item
Registration - Medical Devices 1 and 2, local (per product)
Currency
NGN
Amount Local
20000
Amount Local Formatted
NGN 20,000
Frequency
Per product
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://nafdac.gov.ng/wp-content/uploads/Publications/Others/Press_Release_PDF/NAFDAC-2019-Tariff_Final_Combined.pdf
Source Title
NAFDAC tariff (effective 31 January 2020)
Source Effective Date
2020-01-31
Verified On
2026-08-25
Id
registration-foreign-md1
Item
Registration - Medical Devices 1 (all except diapers/sanitary pads), foreign
Currency
USD
Amount Local
750
Amount Local Formatted
USD 750
Frequency
Per product
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://nafdac.gov.ng/wp-content/uploads/Publications/Others/Press_Release_PDF/NAFDAC-2019-Tariff_Final_Combined.pdf
Source Title
NAFDAC tariff (effective 31 January 2020)
Source Effective Date
2020-01-31
Verified On
2026-08-25
Id
registration-foreign-md2
Item
Registration - Medical Devices 2 (diapers and sanitary pads), foreign
Currency
USD
Amount Local
874
Amount Local Formatted
USD 874
Frequency
Per product
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://nafdac.gov.ng/wp-content/uploads/Publications/Others/Press_Release_PDF/NAFDAC-2019-Tariff_Final_Combined.pdf
Source Title
NAFDAC tariff (effective 31 January 2020)
Source Effective Date
2020-01-31
Verified On
2026-08-25
Id
laboratory-analysis-local
Item
Laboratory analysis - other medical devices, local
Currency
NGN
Amount Local
29700
Amount Local Formatted
NGN 29,700
Frequency
Per sample
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://nafdac.gov.ng/wp-content/uploads/Publications/Others/Press_Release_PDF/NAFDAC-2019-Tariff_Final_Combined.pdf
Source Title
NAFDAC tariff (effective 31 January 2020)
Source Effective Date
2020-01-31
Verified On
2026-08-25
Id
laboratory-analysis-foreign-devices
Item
Laboratory analysis - other medical devices, foreign
Currency
NGN
Amount Local
67500
Amount Local Formatted
NGN 67,500
Frequency
Per sample
Notes
Diapers: NGN 29,700 local / NGN 101,250 foreign.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://nafdac.gov.ng/wp-content/uploads/Publications/Others/Press_Release_PDF/NAFDAC-2019-Tariff_Final_Combined.pdf
Source Title
NAFDAC tariff (effective 31 January 2020)
Source Effective Date
2020-01-31
Verified On
2026-08-25
Id
port-inspection
Item
Port inspection of imported products - medical devices
Currency
NGN
Amount Local
27000
Amount Local Formatted
NGN 27,000
Frequency
Per 20ft container
Notes
Donated drugs/medical devices/food/cosmetics: NGN 37,500.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://nafdac.gov.ng/wp-content/uploads/Publications/Others/Press_Release_PDF/NAFDAC-2019-Tariff_Final_Combined.pdf
Source Title
NAFDAC tariff (effective 31 January 2020)
Source Effective Date
2020-01-31
Verified On
2026-08-25
Id
service-permit
Item
Permit for service drugs (incl. orphan drugs)/medical devices
Currency
NGN
Amount Local
11000
Amount Local Formatted
NGN 11,000
Frequency
Per product
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://nafdac.gov.ng/wp-content/uploads/Publications/Others/Press_Release_PDF/NAFDAC-2019-Tariff_Final_Combined.pdf
Source Title
NAFDAC tariff (effective 31 January 2020)
Source Effective Date
2020-01-31
Verified On
2026-08-25
Id
advertisement-single-product
Item
Advertisement - single product
Currency
NGN
Amount Local
15000
Amount Local Formatted
NGN 15,000
Frequency
Per advertisement
Notes
Variants: NGN 5,000 per medium/concept/version/language; consumer promotion NGN 15,000; fast-track approval is double the standard cost.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://nafdac.gov.ng/wp-content/uploads/Publications/Others/Press_Release_PDF/NAFDAC-2019-Tariff_Final_Combined.pdf
Source Title
NAFDAC tariff (effective 31 January 2020)
Source Effective Date
2020-01-31
Verified On
2026-08-25
Id
brand-name-change
Item
Change in brand name at company instance
Currency
NGN
Amount Local
27500
Amount Local Formatted
NGN 27,500 (USD 206.25 foreign)
Frequency
Per change
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://nafdac.gov.ng/wp-content/uploads/Publications/Others/Press_Release_PDF/NAFDAC-2019-Tariff_Final_Combined.pdf
Source Title
NAFDAC tariff (effective 31 January 2020)
Source Effective Date
2020-01-31
Verified On
2026-08-25
Id
package-label-change
Item
Change of package label/design/pack-size extension
Currency
NGN
Amount Local
21000
Amount Local Formatted
NGN 21,000 (USD 206.25 foreign)
Frequency
Per change
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://nafdac.gov.ng/wp-content/uploads/Publications/Others/Press_Release_PDF/NAFDAC-2019-Tariff_Final_Combined.pdf
Source Title
NAFDAC tariff (effective 31 January 2020)
Source Effective Date
2020-01-31
Verified On
2026-08-25

Notes

Renewal of registration equals 80% of the new-registration cost (tariff row G 7.1); late-renewal enforcement amounts are NGN 156,250 local / NGN 537,500 foreign.
Pharmacovigilance/post-marketing annual fee equals 10% of the registration fee; change of agencyship equals 50% of the registration cost.
Amounts follow the NAFDAC tariff effective 31 January 2020, the latest consolidated published schedule.

Last Updated

2026-08-25

Verification Status

official-verified

Official Sources

Title
NAFDAC tariff (effective 31 January 2020)
Url
https://nafdac.gov.ng/wp-content/uploads/Publications/Others/Press_Release_PDF/NAFDAC-2019-Tariff_Final_Combined.pdf
Effective Date
2020-01-31
Accessed Date
2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Nigeria certifications →

Slug

nigeria

Market

Nigeria

Confidence

low

Schemes

Id
nafdac-recognized-standards-and-lab-analysis
Name
NAFDAC recognized-standards certificate and lab analysis
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Finished Device
Note
Use of standards is in general voluntary: manufacturers may select alternative solutions to demonstrate conformity with the GHTF harmonized Essential Principles (GHTF/SG1/N41:2005), and NAFDAC maintains a recognized-standards mechanism (recognition, revision, status changes, transition periods); a Certificate of Compliance with Recognized Standards is submitted where available (§4.14.6); registration samples undergo NAFDAC laboratory analysis before approval (§8.0); the SaMD guideline references IEC 62304:2006 and ISO/IEC/IEEE 14764:2022.
Source Urls
https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Guidelines/VBM_R&R/Guidelines-on-the-Role-of-Standards-in-the-Assessment-of-Medical-Devices.pdf
Source Binding
candidate

Official Sources

Authority
NAFDAC
Topic
role of standards in the assessment of medical devices — voluntary use and recognized standards
Url
https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Guidelines/VBM_R&R/Guidelines-on-the-Role-of-Standards-in-the-Assessment-of-Medical-Devices.pdf
Authority
NAFDAC
Topic
registration guidelines 2025 — certificate of compliance §4.14.6 and laboratory analysis §8.0
Url
https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Guidelines/VBM_R&R/2025-2030/Guidelines-for-Registration-of-Medical-Devices-Including-In-Vitro-Diagnostics-IVDs-and-Related-Products.pdf
Authority
NAFDAC
Topic
SaMD guidelines — IEC 62304 and ISO/IEC/IEEE 14764 references
Url
https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Guidelines/DR_And_R_Guidelines/Guidelines-for-Registration-of-Software-as-a-Medical-Device-SaMD-in-Nigeria.pdf

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