Post-market surveillance of medical devices in Ethiopia: Implementation status, regulatory challenges, and future perspectives

• DOI: 10.1177/25160435251329624
• Publication Date: 2025-03-26T07:22:07Z
• Authors: Meaza Giragn; Sisay Endale; Anteneh Belete

Background Medical devices (MDs) are critical components of healthcare systems, used for diagnosing and managing diseases. However, MDs have the potential for adverse events and hazards for patients that could be assessed through post market surveillance (PMS).

Objective This study was designed to assess the PMS systems, regulatory challenges, and future perspectives of MDs in Ethiopia.

Methods A mixed-methods study was conducted involving MDs importers in Addis Ababa and the Ethiopian Food and Drug Authority (EFDA). Data were collected using checklists and interview guides. Quantitative data were analyzed with Excel, while thematic analysis was applied to qualitative data. Results are presented as frequencies, percentages, and qualitative themes supported by verbatim quotes.

Results The survey checklist was completed by engaging one focal person from each importer, resulting in a total of 52 respondents. Additionally, 12 key informants (10 male and 2 women) participated in the qualitative interviews. Although 71% of importers had Standard Operating Procedures (SOPs) for PMS, only 13% implemented their PMS plans. Additionally, 54% and 19% of companies reported having dedicated experts and budgets for PMS, respectively. Challenges include mixed regulation of MDs and medicines, resource constraints, low awareness, and poor stakeholder collaboration. Suggested strategies include independent MD regulatory structures and enhanced stakeholder engagement.

Conclusions The study results revealed that MD PMS system is inconsistent among importers, and the EFDA has taken steps to improve the MDs PMS system. Strengthening regulatory frameworks and promoting collaboration among stakeholders are essential to mitigate current challenges.