Abstract
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 develo** 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.
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Data Availability
All basic data that are generated in the study are included in the manuscript. However, if additional more data are needed, the corresponding author Ayenew Ashenef can offer upon reasonable request.
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Funding
Addis Ababa University (AAU) supported this research through graduate students support programme while the Ethiopian Food and Drug Authority offered study sponsorship to Kebede Fufa.
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Conceptualization, study tools and design: KF, TM, AA. Data collection and acquisition: KF. Data Interpretation and analysis: KF, TM, AA. Drafting of the Manuscript: KF, TM. Manuscript reviewing and editing: AA, TM. Supervision: AA, TM. All authors had read and approved the final version of the manuscript submitted.
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There is not any conflict of interest to declare by the Authors. Although AAU and EFDA supported the study, both organizations did not have any role or influence in study design, data interpretation and writing of this manuscript. Informed consent was obtained from the study participants. The study was ethically cleared before commencement.
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Fufa, K., Marew, T. & Ashenef, A. Assessment of the Regulatory Approval Process of Medical Devices in Ethiopia: A Mixed Sequential Explanatory Study. Ther Innov Regul Sci 57, 987–996 (2023). https://doi.org/10.1007/s43441-023-00534-0
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DOI: https://doi.org/10.1007/s43441-023-00534-0