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.

 

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