Delese Mimi Darko, FDA Boss
The Food & Drugs Authority (FDA) has warned all social media marketing agencies advertising the sale of all kinds of unregistered medical devices, food and products, whether imported or locally manufactured, to desist from the practice.
According to the FDA, such practices are in contravention to the Public Health Act 2012 (Act 851) which empowers the FDA to test and approve drug, food, medical devices, household chemicals, tobacco, 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 FDA for its stakeholders in Cape Coast, explained that medical devices play a critical role in quality healthcare 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 and GH¢ 50,000 as per LI 2228 (2016).
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.”
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.
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 would involve checks and verification of registration status, visual inspection of products on labelling integrity, calibration, sample testing and risk-related.
The Acting Regional Director of the FDA, John Odai-Tettey, urged health professionals and the public to promptly report clinical failure of any medical device to the Authority for the necessary action to be taken.
He assured the public that the FDA had intensified its post-market surveillance exercise and encouraged the public to provide information on activities that are likely to compromise public health and safety.
