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. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Ghana, to expedite the preparation of your medical device or IVD registration application.
Medical Device Regulations and Classification in Ghana
REGULATORY AUTHORITY: Medical devices are regulated by Ghana’s FDA (Food and Drug Authority).
CLASSIFICATION SYSTEM: Devices are classified according to the EU model of risk-based classification into Classes I, IIa, IIb, III, and IV.
TIMEFRAME: The approval process takes around 3-6 months for devices for all classes.
LICENSE VALIDITY: Licenses issued in Ghana are valid for three years.
AUTHORIZED REPRESENTATIVE: An authorized representative is required.
Last updated on January 22, 2015.
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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