Assessment of the Regulatory Approval Process of Medical Devices in Ethiopia: A Mixed Sequential Explanatory Study

Background: Cognizant of indispensable role as important health intervention tools, the global medical devices industry continues to bring new medical devices with varying degrees of technologies and complexities. Ensuring the safety, good performance and timely access of them have become challenging for regulatory authorities, particularly for developing countries including Ethiopia. In Ethiopia, the role of the regulatory authority is complicated further because of the lack of specific policies. Medical devices regulation is still being dealt under drug policy. Objectives: This study was aimed to assess the regulatory approval processes of medical devices in Ethiopia. Methods: A mixed sequential explanatory study design was employed. Quantitative data were collected using a structured self-administered questionnaire and standard checklist; qualitative data were collected through in-depth interviews using a semi-structured guide. Results: Retrospective trend analysis (2015 to 2018) indicated that 3,804 medical devices were registered in Ethiopia. Findings from the quantitative study indicated that 73.3% of regulatory experts had commendable knowledge on the medical devices regulatory system. However, gaps were identified in inspection and auditing (63.8%), practically understanding the system and procedures (24.3%), and having competencies in executing the critical core functions (6.9%). The top five challenges reported include (i) lack of capacity to assess dossiers (80.8%); (ii) lack of effective legislation (64.1%); (iii) provision of ambiguous feedback on deficiencies after dossier evaluations and delay in their communication (63.9%); (iv) long waiting time for approval (61.1%); and (v) lack of experienced and qualified staff (55.7%). In addition, the absence of a specific policy for medical device regulation presents a great hurdle. Conclusion: Basic functional systems and procedures for the regulation of medical devices in Ethiopia are present. However, there are still gaps that are impeding effective regulation of medical devices especially for those with advanced features and complex-monitoring modalities.