According to the FDA, such practices are in contravention to the Public Health Act 2012, (Act 851) which empowered the Authority to test and approve drug, food, medical devices, household chemicals, tobacco and tobacco products, amongst others before they are sold on the market.
The Head of Medical Devices Department at the FDA, Joseph Yaw-Bernie Bernie, who gave the warning at a day’s capacity-building workshop organised by the Authority for its stakeholders in Cape Coast on Tuesday, explained that medical devices played a critical role in quality health care delivery, hence the need for their regulation.
“A person shall not advertise a drug, a herbal medicinal product, cosmetic, medical device, or household chemical substance to the general public as a treatment, preventive or cure for a disease, disorder or an abnormal physical state, unless the advertisement has been approved by the Authority,” he said.
Consequently, he said individuals or entities who flout the laws could suffer either a “summary conviction and/or a fine of not less than 7, 500 Penalty Units” or pay administrative fines between GH¢ 25,000.00 and GH¢ 50,000 as per LI 2228 (2016).
Mr Bernie explained that aside its regulating mandate, the FDA was also to control the use of manufactured medicines, household chemicals, medical devices, cosmetics, pharmaco-vigilante and undertake post-market-surveillance and the control of imports and exports of regulated products coming into the region and country at large, to maintain wholesomeness of food and drug items.
He said medical devices were “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.”
Additionally, Mr Bernie entreated management of various public and private health facilities across the country to discard all defective medical devices to safeguard public health and safety and re-echoed the need to prioritise the registration of medical devices and equipment.
He also counselled manufacturers and importers to desist from importing, selling and distributing unregistered products and warned that those who failed to comply with the directive and were caught 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 the Authority to deliver on its mandate.
Mr Geoffrey Arthur, of the Medical Devices Cosmetic Household Chemical substances Inspectorate Department, announced plans to scale up market surveillance to guarantee public safety.
The exercise will involve checks and verification of registration status, visual inspection of products on labeling integrity, calibration, sample testing and risk related.
Mr John Odai-Tettey, the Acting Regional Director of the Authority, urged health professionals and the public to promptly report clinical failure of any medical device to the Authority for the necessary action.
He assured the public that the FDA had intensified its post-market surveillance exercise and encouraged the public to provide information on activities that were likely to compromise public health and safety.