MEDICAL DEVICE REGISTRATION AND APPROVAL IN Nigeria

MEDICAL DEVICE REGISTRATION AND APPROVAL IN Nigeria

General country-specific regulatory information is provided on this page for medical device registration and approval in Nigeria
Last update: January 2023

Medical Device Regulations and Classification in Nigeria

REGULATORY AUTHORITY:

National Agency for Food & Drug Administration & Control (NAFDAC)

CLASSIFICATION SYSTEM

Medical Devices/IVDs:

Category 1: other devices

Category 2: diapers and sanitary pads

TIMEFRAME

Official timeline for new product registration is 120 working days.

SPECIAL REQUIREMENT

NAFDAC will notify the applicant if a local laboratory analysis is required. In such a case, the applicant must provide the sample.

Local clinical study is not required.

LOCAL FEES (New Application)

New registration (category 1): USD 750*

New registration (category 2): USD 874*

*Excluding other fees such as processing fee, laboratory testing, variant fee, etc.

LOCAL FEES (Manufacturer)

Local laboratory analysis: USD 250 (Diaper); USD 150 (other devices)

GMP inspection: USD 10,989.01/per site

LICENSE VALIDITY

The registration certificate is valid for 5 years.

LICENSE TRANSFER

License transfer is possible, but no clear procedure (regulation) is currently available.

AUTHORIZED REPRESENTATIVE

A foreign manufacturer must appoint a local company or a person to become their authorized representative.

ADDITIONAL INFORMATION

Not applicable.

Other Sub-Saharan African Countries: AngolaBeninBotswanaBurkina FasoBurundiCameroonCentral African RepublicChadComorosCongoDR CongoEquatorial GuineaEritreaEthiopiaGabonGambiaGhanaGuineaGuinea – BissauIvory CoastKenyaLesothoLiberiaMadagascarMaliMozambiqueNamibiaNigerRwandaSenegalSierra LeoneSomaliaSouth AfricaSouth SudanSwazilandTanzaniaTogoZanzibar

Last Update January 2023

JUST SAY WHEN!

Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?

And, in less than a minute, you can start your device-specific registration application and a complete country-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform. You can start your product registration right now!

Ready to Get Started?