Navigating regulatory landscape: A qualitative exploration of medical devices and in vitro diagnostic medical devices oversight in Zimbabwe through key stakeholder perspectives

Abstract

Medical devices and In Vitro Diagnostics (IVDs) are vital for public health and accessible healthcare. Still, there is an imbalance in high-quality products in Low and Middle-Income Countries (LMICs). Zimbabwe's regulatory framework for medical devices and IVDs is unclear, leading to ineffective compliance and surveillance. As a result, there are knowledge gaps regarding pre-market and post-market regulatory elements to ensure the safety, quality and performance of medical devices and IVDs used in Zimbabwe. Our study aimed to explore the current status of medical devices and IVD regulations in Zimbabwe. Semi-structured interviews were conducted with 12 regulators from the Medicines Control Authority of Zimbabwe (MCAZ) National Microbiology Reference Laboratory (NMRL), Medical Laboratory and Clinical Scientists Council (MLCScCZ) to understand the current status of medical devices and IVD regulations in Zimbabwe. Three participants completed a questionnaire to understand the regulatory landscape in Zimbabwe. Three key informant interviews were conducted with three regulators from the South African Health Products Regulatory Authority (SAHPRA), Tanzanian Medicines and Medical Devices Authority (TMDA), and World Health Organization Regulatory Systems Strengthening (WHO RSS) to learn best practices to create a roadmap for Zimbabwe. We analyzed qualitative data using a thematic analysis. The findings reveal significant deficiencies and gaps in the legal framework for regulating medical devices and IVDs, highlighting the need for a legal framework and the absence of more comprehensive regulations. Regulatory entities face capacity limitations, especially in regulating medical devices and IVDs. Conformity assessment processes, medical devices, IVD classification criteria, and post-market surveillance also represent challenges, highlighting the need for a well-defined framework and regulatory procedures. The Zimbabwean regulatory system pathway is reactive, prompting several regulatory initiatives to address needs. Despite facing challenges, there is recognition of the importance of collaboration among regulatory authorities, emphasizing a shared commitment to improving and strengthening medical devices and IVD regulations for improved patient safety. By advocating for a proactive, comprehensive, and legally sound approach, indicating the potential for collaboration and synergy, this study provides a foundation for well-informed policy recommendations to guide enhancements and build a framework for a resilient, efficient, and transparent regulatory environment in the Zimbabwe and African regions as a whole.

Fig 1. Flow chart of participants’ selection for data collection between June and November 2022.

(A) MCAZ’s Medical Devices and Microbiology Unit and Legal Department regulates condoms and Gloves. One participant completed the questionnaire, and five participants were selected for interviews. (B) MLCScCZ registers IVD. Four participants were selected for interviews, including one participant to complete the questionnaire. (C) NMRL conducts performance evaluations of IVDs to aid in the registration of IVDs. Four participants were selected for interviews, including one participant who completed the questionnaire. (D) The WHO’s Regulatory Systems Strengthening capacitates national regulatory authorities to strengthen their oversight for safe, quality, and effective medical products. One participant was selected for the interviews. (E)SAHPRA and TMDA are regulatory authorities in South Africa and Tanzania. One participant from each institution was interviewed.

Fig 2. Proposed stakeholder engagement and systems thinking approach for Zimbabwe medical devices and IVDs regulations.

Researchers, practitioners, leaders, and advocates are critical stakeholders in formulating and implementing medical devices and IVDs regulations. The integrated approach for effective regulation requires: Systems Organization: The organization of systems aims to comprehend and advance collaborative frameworks responsible for the regulation, facilitation, management, and promotion of medical devices and IVDs. This includes fostering systematic actions and facilitating continuous learning within the regulatory domain. System Dynamics: System dynamics play a crucial role in modeling the complex interactions within the regulatory system. This involves capturing the intricacies of factors influencing medical device utilization, such as legislative frameworks, research endeavors, control activities, industry dynamics, and socio-cultural factors. System Networks: System networks analyze collaborative relationships within the regulatory landscape. Their purpose is to enhance strategies for collaboration and minimize redundancy within the systems that oversee medical devices and IVDs. Systems Knowledge: System networks contribute to analyzing collaborative relationships, improving collaboration strategies, and mitigating redundancies within the broader context of medical device and IVDs regulation [26].

Fig 3. Proposed roadmap to create effective medical device and IVD regulations.

Step 1: Change of legislation, Step 2: Establishment of regulations for the regulatory functions of a national regulatory authority, Step 3: Resourcing of the regulatory authorities, Step 4: Guidance development to aid economic operators to comply with regulations, Step 5: Transition period for implementation of new regulations, monitoring, and evaluation of implementation of the regulatory system.