Medical Devises Regulation in Zimbabwe: An Evaluation of operational readiness

Background Regulation of medical devices has seriously lagged, especially in Resource-Limited Settings (RLS). There are disparities in regulating medical devices; in the African region, it is below the global average. This may translate into poor access to quality-assured medical devices and result in undesirable health outcomes. Operational readiness to regulate medical devices in Zimbabwe at the Medicines Control Authority of Zimbabwe (MCAZ), the designated National Regulatory Authority (NRA), is vital for planning and implementation. The study aimed to assess the readiness of the MCAZ to regulate medical devices by identifying the strengths and gaps and proposing an institutional development plan that can be monitored and evaluated to assess progress over time. Methods Quantitative study was conducted using the World Health Organization (WHO) Global Benchmarking Tool+ medical devices (GBT+ medical devices) methodology to evaluate the medical devices regulatory oversight at the MCAZ. Data were collected between June and August 2022 using standard checklists to assess the quality of implementation of medical devices’ regulatory functions; National Regulatory System (RS), Registration and Market Authorisation (MA), Vigilance (VL), Market Surveillance and Control (MC), Licensing Establishment (LI), Regulatory Inspection (RI), Laboratory Testing(LT), and Clinical Trials (CTs) Oversight. Results The MCAZ attained maturity level 1, with an RS score of 79%, MA-44%, VL-27%, MC-40%, LI-62%, RI-68%, LT-88%, and CT-18%. Condoms and gloves were the only regulated medical devices. Indicators on legal provisions, regulations, and guidelines across the regulatory functions were below the optimum requirement. Conclusion The legal provisions, regulations, and guidelines are inadequate for effectively regulating medical devices. The medical devices regulation requires review for it to be robust and fit-for-purpose, responsive, oriented to the outcome, predictable based on a standard and transparent approach, and the level of scrutiny proportionate to the risk classification of the medical device.