Following a notice of concern from the World Health Organization, the National Agency for Food and Drug Administration and Control (NAFDAC) has stepped up regulatory oversight of selected malaria and HIV diagnostic test kits linked to quality compliance issues.
In a statement issued on Tuesday, the agency said the alert was triggered after the WHO flagged concerns during an inspection of a foreign manufacturing facility, where gaps were identified in adherence to international quality standards.
NAFDAC explained that although the products had previously undergone local registration processes, the recent developments prompted additional scrutiny to ensure that only safe and effective medical devices remain in circulation.
The agency clarified that available records indicate the affected kits have not entered the Nigerian market. However, it warned that any discovery of the products within the country would be treated as a regulatory violation and handled accordingly.
To prevent potential risks, NAFDAC has instructed its field offices across the country to intensify monitoring activities and strengthen inspections of diagnostic products in markets, healthcare facilities and distribution channels.
The agency urged healthcare providers, importers and distributors to source medical devices only from authorised suppliers and to verify documentation before procurement.
NAFDAC reaffirmed its commitment to protecting public health through continuous surveillance, enforcement actions and collaboration with international regulatory partners to maintain high standards for medicines and medical devices in Nigeria.
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