MEDICAL DEVICE REGISTRATION AND APPROVAL IN Ghana

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 update: December 2022

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: AngolaBeninBotswanaBurkina FasoBurundiCameroonCentral African RepublicChadComorosCongoDR CongoEquatorial GuineaEritreaEthiopiaGabonGambiaGuineaGuinea – BissauIvory CoastKenyaLesothoLiberiaMadagascarMaliMozambiqueNamibiaNigerNigeriaRwandaSenegalSierra LeoneSomaliaSouth AfricaSouth SudanSwazilandTanzaniaTogoZanzibar

Last Update October 2022

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