REGULATORY AUTHORITY:
Food and Drug Authority (FDA) Ghana
CLASSIFICATION SYSTEM:
Medical Devices & IVDs: I/II/III/IV.
TIMEFRAME:
Approximately six (6) months according to our experience.
LICENSE VALIDITY:
Both manufacturing and product licenses are valid for 1 year and shall be renewed annually.
LOCAL FEES (New Application):
Medical Devices:
Class I: USD 60
Class II: USD 100
Class III: USD 160
Class IV: USD 200
SaMD: USD 100
IVDs (the fees depend on the number of reagents to register):
Class I: USD 16-35
Class II: USD 25-60
Class III/IV: USD 40-95
LOCAL FEES (Manufacturer):
A verification of compliance to the current Good Manufacturing Practices (cGMP) and Quality Management System (QMS) is required for a medical device manufacturer. This process might include an on-site inspection of a foreign manufacturing facility.
Inspection fee for a facility inside of Africa region: USD 4,000
Inspection fee for a facility outside of Africa region: USD 7,500
LICENSE TRANSFER:
Transferring the license from one to another holder is possible. The Current Local Agent (AR) is responsible to submit all the necessary documents to the FDA for the license transfer process.
AUTHORIZED REPRESENTATIVE:
Foreign manufacturers are required to appoint a local authorized representative (AR).
ADDITIONAL INFORMATION:
Local clinical trials and testing are not required except for condoms where any consignment of imported condoms is subject to sampling and analysis.
For class II-IV devices, GMP verification and/or on-site inspection to the foreign manufacturing facility is required.
The application for medical device registration and GMP verification can be submitted in parallel.
The foreign manufacturer can sell their products as soon as the registration certificate is issued without waiting for the GMP verification process completed.
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, Guinea, Guinea – Bissau, Ivory Coast, Kenya, Lesotho, Liberia, Madagascar, Mali, Mozambique, Namibia, Niger, Nigeria, Rwanda, Senegal, Sierra Leone, Somalia, South Africa, South Sudan, Swaziland, Tanzania, Togo, Zanzibar
