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: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Central African Republic, Chad, Comoros, Congo, DR Congo, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, Ghana, Guinea, Guinea – Bissau, Ivory Coast, Kenya, Lesotho, Liberia, Madagascar, Mali, Mozambique, Namibia, Niger, Rwanda, Senegal, Sierra Leone, Somalia, South Africa, South Sudan, Swaziland, Tanzania, Togo, Zanzibar

Last Update January 2023