FDA Inaugurates TAC on Medical Devices Regulations in Ghana

The Food and Drugs Authority (FDA) has inaugurated a nine-member Technical Advisory Committee on Medical Devices (TAC-MD) to provide the requisite technical advice for the regulation of medical advices in Ghana and its related issues.

The Committee would also provide independent medical and scientific advice to the FDA on safety, quality and performance of medical devices manufactured, imported, distributed or used in Ghana for the purposes of registering these devices as well as for pre-market conformity assessment.

Inaugurating the committee, Mr Hudu Mogtari, the Chief Executive Officer of FDA, said the inauguration of the committee was in fulfilment of the mandate stipulated in the Public Health Act, 2012, (Act 851), Part 7, 118, which gives FDA the ultimate responsibility to grant market authorization to applicants for medical devices meant for the Ghanaian market and the requisite authourisation in the event of export.

He explained that to implement the provision in the Act, it has provided the required guidelines and its accompanying forms for registration of medical devices as well as established a Department dedicated to the implementation of the law, policies and guidelines required for the effective regulation of medical devices in Ghana.

“The basic goal is to protect public health and safety by ensuring that only safe devices are available on the market. Safety is a risk management issue and it is based upon proper identification, assessment, evaluation and control of the risk associated with the use of the medical device.”

The Committee is made up of Dr Yacub Ahmed, a Biomedical Engineer with Komfo Anokye Teaching Hospital, Kumasi, Mr Isaac Owusu Adjakwah, a Clinical Engineer with Korle Bu Teaching Hospital, Dr Elsie Effah Kaufmann, Head of the Biomedical Engineering Department, University of Ghana, and Dr Nicholas Adjabu, Head of the Clinical Engineering Department of Ghana Health Service.

The rest are Dr Nichodemus Kafui Gebe, Head of Biomedical Engineering, Ministry of Health, Dr Lawrence A Sereboe, Head of the Cardiothoracic Centre, Korle Bu Teaching Hospital, Dr P.R. Asman of the Mediwise International Company Limited, and Professor Geoffrey Emi-Raynolds, Nuclear Radiology Scientist with the Atomic Energy Commission.

The TAC-MD would among others respond to requests from FDA to review and make recommendations on specific issues concerning the safety and effectiveness of medical devices, review guidelines and other related documents.

It would also recommend exemption of certain devices from the applications of portions of the Act and advice on any possible risks to health associated with the use of portions of the Act.

Mr Mogtari noted that regulation of medical devices was premised on risk assessment and risk management with the ultimate aim of ensuring and guaranteeing quality, performance and safety; and the safety of the patient and user.

The CEO explained that medical devices are indispensable in healthcare delivery from prevention, through diagnosis and mitigation to treatment and necessary to ensure that their roles were not compromised due to lack of safety or performance.

Medical device is an instrument, apparatus, medical equipment, machine, in vitro reagent or any other similar accessory which is intended for use in the diagnosis of a disease or any other condition in the cure, treatment and prevention of disease in human and animals.

Mr Mogtari urged the committee to be dedicated, loyal and committed in the discharge of their duties adding, “Your dedication and loyalty of your profession and other associations should not negatively affect the performance of your duties as TAC-MD members.”

Ms Akua Amartey, Acting CEO in Charge of Medical Devices Cosmetics and Household Chemicals, explained that medical devices were consuming a gradual progression to the forefront of issues of concern in quality delivery of healthcare.

“The people of Ghana would be expecting that your valuable professional knowledge and experience would be exhibited for their benefit,” she added.