Policy Analysis of Regulatory Challenges for Medical Devices and In Vitro Diagnostics in Achieving Universal Health Coverage in Zimbabwe

Zimbabwe's regulation of medical devices and in vitro diagnostics (IVDs) lags behind that of medicines and vaccines despite the country's goal of achieving Universal Health Coverage (UHC) by 2030.This study, conducted from June to December 2022, rigorously evaluated Zimbabwe's regulatory framework for medical devices and IVDs using a comprehensive policy analysis framework.The study's methodology, which included document review and comparative analysis, was designed to align the regulatory framework with the UHC goal.The READ (Ready, Extract, Analyze, and Distill) approach systematically assessed the relationship between medical device regulations and national health strategic goals.Fourteen documents were analysed, revealing that current regulations under the Medicines and Allied Substances Control Act are insufficient for ensuring quality-assured medical devices and IVDs due to a lack of explicit definitions and standards, leading to inconsistent regulatory practices.The study found fragmented regulatory approaches, overlapping institutional responsibilities, and a lack of effective incorporation of medical device and IVD regulations in national health strategy and related policies, hindering UHC achievement.The study recommends comprehensive policy changes to harmonise regulations, clarify institutional roles, and integrate medical device and IVD regulations into the national health strategy.This ensures access to safe, effective, quality medical devices and IVDs, promoting Zimbabwe's UHC goals by 2030.