REGULATORY AUTHORITY:
Medical devices are regulated by the Liberia Medicines & Health Products Regulatory Authority (LMHRA).
CLASSIFICATION SYSTEM:
Devices are classified according to risk into Classes A, B, C, and D.
- Medical devices: Class A (low risk), Class B (low-moderate), Class C (moderate-high), and Class D (high risk).
- IVDs: Class A, B, C, and D following the same risk-based approach.
TIMEFRAME:
The registration process takes approximately:
- Medical devices: 6 months.
- IVDs: Fast track – 6 months; Regular – 9 months.
- License amendment:
- Major variation – 40 working days.
- Minor variation requiring approval – 20 working days.
- Minor variation requiring notification – 10 working days (if concerns arise).
- License renewal: 3 months before expiry.
LICENSE VALIDITY:
Licenses issued in Liberia expire after:
- Medical devices: 3 years.
- IVDs: 5 years.
LOCAL FEES:
- New Application: USD 200–300.
- License amendment:
- Major variation: USD 150.
- Minor variation requiring approval: USD 100.
- Minor variation requiring notification: No fee.
- Annual retention fee: USD 50.
LICENSE TRANSFER:
License transfer is possible under Minor Variations Requiring Notification (e.g., change in license holder name or address).
AUTHORIZED REPRESENTATIVE:
A local Authorized Representative (AR) or importer must be appointed to register medical devices in Liberia. The AR applies on behalf of the manufacturer and may also act as the importer.
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, Madagascar, Mali, Mozambique, Namibia, Niger, Nigeria, Rwanda, Senegal, Sierra Leone, Somalia, South Africa, South Sudan, Swaziland, Tanzania, Togo, Zanzibar
