By Nelson Manneh
The Medicines Control Agency (MCA) has warned that the use of substandard and falsified in-vitro diagnostic devices in laboratory tests can lead to inaccurate results, wrong diagnoses, and inappropriate treatments, which in turn contribute to increased illness and death.
In a press release issued on June 5, 2025, the MCA emphasized that it is illegal to engage in the unauthorized import, distribution, storage, or sale of medical devices, including in-vitro diagnostics, in The Gambia.
“Anyone wishing to engage in the importation, distribution, storage, or sale of these devices must first obtain authorization from the Agency,” the MCA said.
The MCA, established under the Medicines and Related Products Act, 2014, regulates the safety, quality, and efficacy of medicines and related products in The Gambia. This includes herbal products, cosmetics, medical devices, in-vitro diagnostics, and household chemical substances.
The statement referenced global reports highlighting the dangers of counterfeit medical devices. It noted that both the World Health Organization (WHO) and the African Union have urged member states to enforce strict regulations to ensure public safety.
“All individuals and organizations must comply,” the release warned, noting that violations of the Medicines and Related Products Act, 2014, and its accompanying 2020 Regulations will result in severe regulatory sanctions.
