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.


Submit Inquiry

* 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.

Request a personal demo of


*Same day demos are not available 

Website Pop-Up - European Regulatory Representative Services