The impact of the Absence of Medical Device-Specific Legislation on Access to Medical Equipment in Gabon

Impact of the lack of a legislative framework for medical devices on the availability of medical equipment and regional disparities in access to health technologies in Gabon

Abstract

Abstract

Medical devices (MDs) are essential to healthcare quality and the achievement of universal health coverage. The World Health Organization (WHO) recommends that countries establish a dedicated regulatory framework to ensure their quality, safety, and performance. In Gabon, however, medical devices are mainly regulated under legislation governing medicines. This study aimed to assess the potential impact of the absence of a specific regulatory framework for medical devices on access to medical equipment. A descriptive documentary study with an analytical purpose was conducted using Gabonese legislative and regulatory texts, National Health Development Plans, the ANMAPS Importers' Practical Guide, and data collected from the Grande Pharmacie des Forestiers. The regulatory framework was assessed against WHO recommendations, while the territorial distribution of 171 medical equipment items was analysed across the country's 10 health regions. The findings revealed the absence of provisions on risk classification, conformity assessment, materiovigilance, and post-market surveillance. They also showed a marked concentration of medical equipment in three health regions (70.8%) and a low national availability (0.944 equipment per 10,000 inhabitants). These findings suggest that the lack of a dedicated regulatory framework may weaken medical device governance and contribute to regional inequalities in access to medical equipment in Gabon.