Ekeigwe, Abigail; Clase, Kari; Byrn, Stephen R.; Shivanand, Paddy; and Ekeocha, Zita, "Medical Devices Regulation in West Africa – A Situation Analysis" (2019). BIRS Faculty and Staff Creative Materials. Paper 1.
Date of this Version
Medical devices, Regulations, Guidelines, Harmonization, West Africa
Harmonization of medical devices regulation is receiving strong global attention through the International Medical Devices Regulator’s Forum, an offshoot of the Global Harmonization Task Force on medical devices. Other current trends include the Global Medical Devices Nomenclature and the Medical Devices Single Audit Program. The medical devices regulatory field is in a state of constant innovations; technologies and new regulations and guidelines are evolving to meet the changing needs and trends. This is a veritable development because medical devices and technologies are assuming significant strategic roles in the healthcare value chain – prevention, diagnostics, treatment and cure of diseases – in which they act as “force multipliers,” affecting the economics of healthcare.
The questions then are – what is the situation of medical devices regulations in Africa? Is Africa trending along with the global harmonization of medical devices regulation?
This research focuses on the state of medical devices regulations in West Africa. The research question is – what is the current state of medical devices regulations in West Africa.
To answer this question, a review of publicly available data was conducted. First, the World Health Organization’s website was reviewed for the most current data on the status of West African countries’ medical devices regulations. Then, all the available websites of National Medicines Regulatory Authorities in West Africa were reviewed to ascertain their current medical devices regulatory status.
The results show that West African countries are lagging behind in the regulation of medical devices. Only 28% and 17% of the countries have regulations and guidelines respectively.
It is recommended that the international partners sensitize, educate and support the national medicines regulatory authorities in West Africa to build their regulatory framework for medical devices using the World Health Organization’s model.