National Agency for Food & Drug Administration & Control (NAFDAC)
Category 1: other devices
Category 2: diapers and sanitary pads
Official timeline for new product registration is 120 working days.
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
The registration certificate is valid for 5 years.
License transfer is possible, but no clear procedure (regulation) is currently available.
A foreign manufacturer must appoint a local company or a person to become their authorized representative.
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