Ghana

The information on this page is valid and current as of October 2016. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer


Regulatory Authority:
Medical Device Department (MDD) of the Food and Drugs Authority (FDA) Ghana.

Classification:
I, II, III, IV

Procedure:
Medical Devices are subject to registration.
A Local Representative (Registrant) must be appointed and he will be responsible for the registration process with the competent Authority. Furthermore, device samples shall be submitted for on-site testing.
Once the registration process is complete, the importer shall obtain a permit for registered devices import.

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Applicant:
Foreign manufacturer via local representative (Registrant).

Timeframe and fees:
Registration fees: $ 900 – 2.400
Registration timeframe: 3 – 12 months

Labeling and documentation language:
Documentation and labelling should be provided in English.

Useful information:
Following registration, all devices are subject to post-market surveillance. Safety, quality and performance are continuously monitored.

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