FDA Warns Against The Use Of Unregistered Medical Devices

Accra, Dec. 07, GNA - The Food and Drugs Authority (FDA) Ghana, has cautioned all medical facilities, both public and private, against the use of unregistered medical devices, whether imported or locally manufactured.

'All health facilities, both public and private, whether they are for orthodox or alternative medical practices, are to ensure that all medical devices, prior to their importation into the country and use within the facilities, must be registered by the FDA,' it stated.

In a statement signed by Mrs Delese A. A. Darko, the Chief Executive Officer of the FDA, and copied to the Ghana News Agency, the FDA stated that medical 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.

'It is thus required that all medical devices manufactured, imported, distributed, sold and used in Ghana, must be regulated by the FDA. Regulation of medical devices is primarily to ensure that they are safe, meet the required standard, and perform as specified in the indications for use,' it said.

It explained that medical devices played critical roles in quality health care hence the need for their regulation.

Additionally, it said, 'The FDA would like to bring to the attention of institutions dealing in medical devices that donation of medical devices are regulated by the FDA under the Public Health Act, 2012, Act 851.

'Consequently, prior to the receipt of any donated medical devices, the registration status of such medical devices must be cleared with the FDA,' it said.

The FDA explained, 'A medical device is 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'.

It urged managers of health facilities, persons in charge of such facilities, and others whose roles included the acquisition of medical devices for such facilities, which include laboratories and diagnostic centres to be mindful of the provisions made in the Public Health Act and act accordingly.

GNA