The Medicines Control Agency (MCA) has issued an urgent warning to the public, declaring it illegal to import, distribute, store, or sell medical devices, including in vitro diagnostics, without proper authorization in The Gambia. The announcement, made under the Medicines and Related Products Act of 2014, underscores the agency’s mandate to ensure the quality, safety, and efficacy of medicines and related products, including medical devices, herbal medicines, cosmetics, and household chemicals.
The MCA highlighted global concerns over substandard and falsified medical devices, particularly in vitro diagnostics, which can produce inaccurate laboratory results, leading to misdiagnoses, improper treatment, and increased health risks, such as higher morbidity and mortality. Citing recommendations from the World Health Organization and the African Union, the agency emphasized the need for stringent regulation to protect public safety.
All individuals and entities engaged in the trade of medical devices are required to obtain authorization from the MCA. Noncompliance with the Medicines and Related Substances Act, 1965, and the Medicines and Related Substances Regulations, 2011, will result in severe regulatory sanctions.
The public is encouraged to contact the MCA for further information via their toll-free QCell line at 1233, by calling 3363068, or by visiting their offices.
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