Medical Device Registration and Approval in Ghana
General country-specific regulatory information is provided on this page for medical device registration and approval in Ghana.
Last updated on April 11th, 2022.
Medical Device Regulations and Classification in Ghana
REGULATORY AUTHORITY: Medical devices are regulated by Ghana’s FDA (Food and Drug Authority).
CLASSIFICATION SYSTEM: Medical Devices & IVDs: I/II/III/IV
TIMEFRAME: Approximately six (6) months according to our experience.
SPECIAL REQUIREMENT: Local clinical trials and testing are not required except for condoms where any consignment of imported condoms are subject to sampling and analysis.
LOCAL FEES (New Application):
Medical Devices and IVDs:
Class I: USD 60
Class II: USD 100
Class III/IV: USD 160
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 VALIDITY: Licenses issued in Ghana are valid for three years.
LICENSE TRANSFER: Transferring the license from one to another holder is possible.
AUTHORIZED REPRESENTATIVE: Foreign manufacturers are required to appoint a local authorized representative (AR).
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
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