Regulation of Medical Devices in Zimbabwe: A qualitative study with key stakeholders

Abstract

Introduction: Medical devices play a crucial role in promoting public health. However, there is a disparity in the availability and readiness of medical device regulations in Resource-Limited Settings (RLS) compared to the global average. We conducted a study to explore the medical device regulation landscape and stakeholder perceptions in Zimbabwe. Methodology: Between June and November 2022, we administered questionnaires to representatives of the Medicines Control Authority of Zimbabwe (MCAZ), the Medical Laboratory and Clinical Scientists Council of Zimbabwe (MLCScCZ), and the National Microbiology Reference Laboratory (NMRL). We also conducted semi-structured interviews with 12 national-level critical stakeholders from these institutions to understand the current status of medical device regulations and the relationships between them. Additionally, we interviewed regulators from the South African Health Products Regulatory Authority, Tanzania, and World Health Organisation to learn about best practices in transitioning to medical device regulations. We used a thematic approach and an inductively developed common coding framework to analyse emerging themes. Results: Our findings indicate that the current legal framework needs to be revised to regulate medical devices effectively, as it does not specify the institution(s) responsible for regulating them. While the MCAZ regulates condoms and gloves, the MLCScCZ coordinates with the NMRL to register In Vitro Diagnostic Medical Devices for priority diseases. Other medical devices are not regulated. Furthermore, conformity assessments for product registration are not proportional to the risk classification of medical devices, and post-market surveillance activities are ineffective. Stakeholders recognise the need to collaborate and improve the regulation of medical devices. Conclusion: Zimbabwe must improve its regulatory framework for medical devices to ensure that safe medical devices of acceptable quality and performance are accessible. A solid legal foundation is necessary for harmonisation and reliance practices to reduce the regulatory burden on economic operators and ease the workload on regulators.