The regulation and registration of medical devices and in vitro diagnostic (IVD) devices in Ghana are overseen by the Ghana Food and Drugs Authority (FDA), under the Public Health Act, 2012 (Act 851). All medical devices and IVDs intended for the Ghanaian market must be registered before they can be imported, distributed, or sold. The regulatory process classifies devices based on their level of risk, from Class A (low risk) to Class D (high risk), and requires the submission of a technical dossier that includes product information, labeling, quality certifications, and performance or clinical data depending on the device classification. This blog post provides the detailed information on the Medical Devices and IVDs Regulation and Registration Process in Ghana by Ghana Food and Drug Authority (Ghana-FDA).
For foreign manufacturers, appointing a local agent is mandatory. This agent must be a corporate body legally registered in Ghana and authorized to act on behalf of the applicant in all regulatory matters. Once submitted, the FDA reviews the application for completeness and technical compliance. Higher-risk devices may be subject to sample testing or facility inspection. If approved, the product is granted marketing authorization and added to the official register, valid for three years and renewable thereafter. All registered devices are subject to post-market surveillance, including incident reporting and compliance checks.
Country’s Profiles
Geographical Location
Ghana is a West African country located along the Gulf of Guinea and the Atlantic Ocean. It is bordered by Cote d’Ivoire to the west, Burkina Faso to the north, and Togo to the east.
Language(s)
The official language of Ghana is English. However, many local languages such as Akan, Ewe, and Ga are also widely spoken.
Population Size
As of 2025, Ghana’s estimated population is over 34 million people.
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Overview of Medical Devices and In Vitro Diagnostic Devices (IVDs) Regulation
National Regulatory Authority
The Ghana Food and Drugs Authority (Ghana-FDA) is the national regulatory authority responsible for the regulation of medical devices and IVDs among others as mandated by the Public Health Act 2012 (Act 851).
Definitions
Medical Device: Any instrument, apparatus, implement, a medical equipment, machine, contrivance, implant, in vitro reagent or any other similar or related article, including a component, part or an accessory which is- recognized in pharmacopoeia, intended for diagnosis, curing or treatment or prevention of diseases in humans or animals; intended to change structure or functions of human or animal body (Public Health Act 2012 (Act 851)).
Note: though the definition does seem to exclude some medical devices (e.g., contraceptive devices, devices used for sterilization/disinfecting/cleaning of other medical devices, software medical devices, and others), Ghana-FDA also regulates these devices.
Legal Documents and Guidelines
Key documents regulating medical devices and IVDs include (note- the list is not exhaustive):
- Public Health Act, 2012 (Act 851)
- Ghana-FDA Guidelines for Registration of Medical Devices and IVDs
- Guideline For Registration of Software as Medical Device
- Guideline for Importation of Medical Devices
Medical devices and IVDs Risk Classification System
Ghana-FDA classifies medical devices and IVDs into four risk-based classes:
- Class I: Low risk
- Class II: Low-moderate risk
- Class III: Moderate-high risk
- Class IV: High risk
The risk class assignment to each device subject to the registration application depends on the preset classification rules as provided in the guidelines of medical device registration.
Registration Process and Requirements
Appointing local agent:
A foreign applicant must appoint a local agent authorized to represent them in Ghana. The local agent must be a corporate entity legally registered in Ghana and duly mandated by the applicant to act on their behalf in all matters related to the registration of medical device(s) with the Ghana Food and Drugs Authority.
List of Required documents
Applicants must submit a complete registration dossier which includes:
- Cover letter and Application form
- Device description and intended use
- Technical documentation
- Certificate of Free Sale or Market Authorization from the country of origin
- ISO 13485 certificate or equivalent QMS documentation
- Labels, Instructions for Use (IFU), and packaging information
- Clinical evidence (if applicable)
Application Submission, Assessment Process, Fees and Timelines
Submission
Application submission is made in both hardcopy and in-person electronic versions (Text-selectable PDF format). Submission must be made in person at the Ghana FDA office or through a local authorized representative. All applications should be English language. Submission of applications is required for each medical device or a family/group of similar medical devices. However, there is no clear guidance on how to group these similar devices. For each submission, a non-refundable registration fee should be paid as per the Ghana-FDA fee schedule.
In some cases, samples of the product may also be required.
Assessment
The assessment of the submitted documents is carried out with a First-In-First-Out basis- that means all applications are sequentially assessed based on their respective submission dates with some exceptions- where some devices may be given favors based on the country’s public health priority.
Manufacturer’s Quality Management System Audit
In its medical device registration guidelines, Ghana-FDA require current Good Manufacturing Practice (cGMP). To ensure the manufacturers comply with the requirements, the Authority may conduct an onsite inspection. But, currently, the Authority conducts an onsite inspection of no or very limited number of foreign manufacturing facilities. They ensure compliance with this requirement by reviewing quality management system certificates and related documents.
Fees
Vary based on origin (local vs imported). The following table shows the registration service fees for imported products (including medical devices and IVDs).
| Assessment and Registration of- | Service Fees per product (in GH₵) |
| 1-30 products | 250 |
| 31-500 products | 200 |
| 501-1000 products | 150 |
| More than 1000 products | 100 |
Timelines
The application assessment and registration of the devices typically takes up to 6 months, depending on dossier completeness and responsiveness to queries. This is with the exception of applications that are subject to ‘expedited review’.
Validity of Registration or Marketing Authorization Certificate
- Certificates are valid for 5 years, after which renewal is required.
- The Ghana-FDA guidelines recommend Applicants to submit renewal applications for their previously registered devices three months before the certificate’s expiration date.
- Any change(s) to a registered medical device or its manufacturing facility that may potentially affect the device’s safety or performance and/or the manufacturer’s quality management system should be notified to and get approval from Ghana-FDA.
Post-registration Regulatory Controls
- Surveillance and market control inspections
- Adverse event reporting
- Random post-market testing
- Labeling and advertising compliance monitoring
Laboratory Tests
- Ghana FDA reserves the right to conduct laboratory testing on submitted product samples, particularly IVDs and Class III/IV devices.
- Local or outsourced labs may be used based on product risk level.
Links to Useful and Related Webpages
- Ghana FDA Official Website
- Medical Devices Registration Guidelines
- FDA Ghana Contact Information: Email: fda@fda.gov.gh Phone: +233 (0)3022 35100, P.O. Box: CT 2783, Accra
For more details, please visit the official website of Ghana-FDA as provided above.
If you need regulatory consultancy supports to register your medical devices or in vitro diagnostic medical devices with Ghana-FDA and market your devices in the country, please do not hesitate to contact us.
