FDA Warns Against The Use Of Unregistered Medical Devices

The Food and Drugs Authority (FDA) has cautioned members of the Ghana Federation for Traditional Herbal Medicine Practitioners Association (GAFTRAM) against the use of unregistered medical devices, whether imported or locally manufactured.

     Mr Joseph Yaw-Bernie Bennie, the Head of Medical Devices Department of the Authority, explained that medical devices played critical roles in quality health care delivery, hence the need for their regulation.

     He counselled manufacturers and importers to desist from importing, selling and distributing unregistered products.

     Mr Bennie said this at a forum organised by GAFTRAM for its members on guidelines for regulating the registration of medical devices held in the Central Regional capital, Cape Coast, on Wednesday.

    He said medical devices are "any instrument, apparatus, implement, medical equipment, machine, contrivance, implant, in-vitro reagent, a component, or an accessory, which is intended for use in the diagnosis of disease or any other condition, or in cure, mitigation, treatment or prevention of disease in humans and animals and which does not achieve any of its principal intended purposes through chemical action within the body of the human being or any other animal."

    He said such devices were regulated as part of the mandate of the Food and Drugs Authority (FDA) as specified in Part 7 of the Public Health Act, 2012, Act 851.

    Additionally, he entreated management of various public and private health facilities across the country to discard all defective medical devices to safeguard public health and safety.

    He warned that those who failed to comply with the directive and were caught doing the wrong thing would be prosecuted in accordance with the law.

    Mr Bennie asked the public to offer the Authority any relevant and timely information regarding suspected unregistered products to enable it to deliver on its mandate.