ANALYSIS OF THE LEGAL AND INSTITUTIONAL FRAMEWORK FOR MEDICAL DEVICES IN UEMOA COUNTRIES

Abstract

ABSTRACT

Introduction: Medical devices (MDs), like drugs, must be regulated to ensure their effectiveness and safety. The objective of this study is to analyze existing data on MD regulation in WAEMU countries.

Methodology: This was a cross-sectional descriptive study that took place in the eight WAEMU countries from December 2023 to July 2024. Data collection was carried out on the websites of the national pharmaceutical regulatory agencies/directorates and confirmed by these structures. Then, a data analysis was carried out according to the information found in the literature and in accordance with the Decision on the harmonization of the regulation of MDs in the WAEMU member states.

Results: The texts identified in the eight countries are laws, decrees, orders, decisions, circular notes, information notes and modalities. The analysis shows that five of the eight countries have adopted the definition adopted by the WAEMU in 2022 and recommended by the WHO in 2019; three countries have provided for classification and labeling of MDs; five have requirements for Marketing Authorization. Seven countries have provided for quality control of MDs but only two have provided their import control. Deficiencies concerning the existence or completeness of regulatory texts were also noted.

Conclusion: Further efforts are needed to implement or complete effective regulations that take into account country realities.