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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 January 9th, 2023.
Medical Device Regulations and Classification in Ghana
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.
SPECIAL REQUIREMENT:
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.
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:
Both manufacturing and product licenses are valid for 1 year and shall be renewed annually.
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).
ADDITIONAL INFORMATION:
- 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
For detailed device-specific compliance information for each market, including Ghana, to expedite the preparation of your medical device or IVD registration application.
Any Questions?
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* Note: If you use your general ISP e-mail address, such as gmail, yahoo etc. your LinkedIn profile address is required to process your request.