Court rules lab regulator lacks power over test kit imports

The court found that the board does not have the authority to regulate or validate medical devices sold in Kenya.

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A requirement by a State regulatory agency that all medical laboratory equipment imported into Kenya be certified by the American Food and Drug Administration (FDA) has been declared unlawful by the High Court.

Justice John Chigiti ruled that the requirement imposed by the Kenya Medical Laboratory Technicians and Technologists Board (KMLTTB) nearly five years ago, was unreasonable.

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Note: The results are not exact but very close to the actual.