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.
Table 1.
Characteristics of interview participants interviewed in Zimbabwe between June to November 2022.
Table 2.
Summary of medical devices and IVD regulatory elements assessed using the questionnaire.
Table 3.
Primary themes arising from interviews with regulatory stakeholders in the medical device sector in Zimbabwe.
Table 4.
Characteristics of key informants that participated in interviews outside Zimbabwe.
Table 5.
Main themes emerging from interviews with key informants outside Zimbabwe.
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].
Table 6.
Recommendations on the amendment of the medicines and allied substances control act.
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.