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.
The court found that the board does not have the power to control suppliers of clinical lab test kits in the country or to verify the quality of equipment and materials used for medical diagnosis.
The court also held that the board does not have the authority to regulate or validate medical devices sold in Kenya, including the test kits, reagents, and other equipment used for medical tests. Such power, the judge said, lies with the Pharmacy and Poisons Board.
The court quashed the KMLTTB’s decision to centralise the certification of medical laboratory equipment with a foreign agency, stating that the directive had no basis in law.
In 2021, the board directed laboratories to provide evidence of certification for test kits, reagents, and equipment from the United States FDA.
The KMLTTB’s intention to control the importation and supply of the equipment, it told the court, was to ensure the quality of diagnostic test kits and medical materials imported into the country.
“Kenyans continue to be subjected to risks of biological threats of diagnostic test kits already rejected, delisted and deleted from the list of quality In-Vitro Diagnostic Devices (IVDs) approved by Global Fund for HIV, malaria, and tuberculosis,” said KMLTTB in its court submissions.
The board also informed the court that certain industry players wished to remain unregulated and engage in unethical business practices, and that this was why they preferred to take shortcuts to comply with the requirements of the Pharmacy and Poisons Board (PPB), “where technical skills, competencies and knowledge for validation of IVDs is lacking”.
Furthermore, the board stated that the PPB was illegally issuing import permits, which some traders, including foreign nationals, were using to import, sell and distribute invalid SARS-COV-2 (Covid-19) testing equipment and kits.
It added that its decision to validate all kits and reagents was part of a greater effort to safeguard public health interests.
Single regulator
However, Justice Chigiti said that the legal mandate to regulate and validate medical devices is bestowed on the PPB, which is also government body.
“This court is satisfied that the PPB is the proper single regulatory body mandated to regulate and validate test kits/reagents, IVDs and other equipment used for medical tests fall under the definitions of health products and medicinal substances,” he said, referring to the PPB Act.
He added that matters of certification of the products is the responsibility of the Kenya Bureau of Standards (Kebs).
While ruling on a case filed by the Association of Medical Laboratory Diagnostics Suppliers, the judge said the decision of the regulatory body to ask industry players to prove their kits, and equipment had been certified by external bodies such as the American FDA was unreasonable.
“In any event, this created yet another requirement that the applicants should subject themselves to an international regulator on the basis of an SMS. This is not procedurally fair to the applicants, and I so hold,” said Justice Chigiti in the judgment dated June 3, 2025.
The association took the board to court over three memos and text messages sent four years ago, directing that all suppliers, vendors and distributors must be registered with the board.
Through its secretary, Feroz Nawab, the association claimed that there had been ongoing disputes between the PPB and the KMLTTB.
The court heard that the KMLTTB had introduced a parallel regulatory regime to that already in place by the PPB, which caused confusion and unnecessary huge costs for members of the association in complying with it.
The memos
One memo dated February 15, 2021, and addressed to members of the association asserted that the board was mandated by law to validate IVDs.
In another memo dated March 12, 2021, the board informed industry players that the issuance of pre-validation registration certificates was an ongoing activity and directed them to provide details of all reagents, kits, equipment, analysers, chemicals and consumables used in their facilities.
On December 21, 2021, in yet another memo, the board directed that the renewal of licences for all laboratories countrywide was subject to evidence that the test kits, reagents and equipment being used for clinical lab tests had been validated by the board.
The association said the memos had caused confusion over which body was responsible for granting authorisation.
“The court is in agreement with the petitioners that the cumulative effect of the contested memos is that the members of the association were unable to supply IVDs, reagents, and test kits to hospital and other clients unless they are validated by the KMLTTB despite having received approvals from the Pharmacy and Poisons Board, thus leading to double regulation. The association has made out a case of procedural impropriety on the part of KMLTTB,” said Justice Chigiti.
The dispute began when KMLTTB started registering IVD products at points of entry through the Kentrade single window system.
