Regulation and Prequalification Department, World Health Organization, Geneva, Switzerland.
Programs, African Society for Laboratory Medicine, Lusaka, Zambia.
PLoS One. 2024 May 16;19(5):e0287495. doi: 10.1371/journal.pone.0287495. eCollection 2024.
The regulation of medical devices and In Vitro Diagnostic (IVD) medical devices have lagged significantly, especially in low- and middle-income countries. Disparities in regulating medical and IVD medical devices in Africa are below the global average. This may translate to poor access to quality-assured medical and IVD devices, resulting in undesirable health outcomes. Operational readiness to regulate medical and IVD devices at the Medicines Control Authority of Zimbabwe (MCAZ) was assessed. The aim was to determine the strengths and gaps and propose an action plan that can be monitored and evaluated to assess progress over time. We used the World Health Organization (WHO) Global Benchmarking Tool for medical devices and IVDs methodology to evaluate regulatory oversight of these products. Purposive sampling was used for data collection using researcher-administered global benchmarking tool factsheets and document reviews to evaluate the implementation of the regulatory functions. The regulatory functions assessed were the National Regulatory System, Registration and Market Authorization, Vigilance, Market Surveillance and Control, Licensing Establishment, Regulatory Inspection, Laboratory Testing, and Clinical Trials Oversight. The MCAZ attained maturity level 1, with a regulatory system score of 79%, registration and market authorization 44%, vigilance 27%, market surveillance and control 40%, licensing establishment 62%, regulatory inspection 68%, laboratory testing 88%, and clinical trials 18%. Condoms and gloves were the only regulated medical devices in Zimbabwe. IVDs were not regulated by the MCAZ. This review showed that the regulatory system is not robust, fit for purpose, responsive, transparent, or proportionate to the risk classification of medical devices and IVDs. It is crucial to amend the Medicines and Allied Substance Control Act to incorporate the definition and classification of medical devices and IVDs, regulatory authority establishment, licensing and registration, quality management system, conformity assessment, post-market surveillance, labeling and instructions for use, capacity building and training, and international harmonization.
医疗器械和体外诊断（IVD）医疗器械的监管明显滞后，尤其是在中低收入国家。非洲在监管医疗器械和 IVD 医疗器械方面的差距低于全球平均水平。这可能导致无法获得质量有保证的医疗和 IVD 设备，从而导致不良的健康结果。评估了津巴布韦药品管制局（MCAZ）监管医疗器械和 IVD 设备的准备情况。目的是确定优势和差距，并提出行动计划，该计划可以进行监测和评估，以随着时间的推移评估进展情况。我们使用世界卫生组织（WHO）全球医疗器械和 IVD 基准工具方法来评估这些产品的监管监督。采用目的性抽样，使用研究人员管理的全球基准工具情况说明书和文件审查来收集数据，以评估监管职能的实施情况。评估的监管职能包括国家监管系统、注册和市场授权、警戒、市场监测和控制、许可机构、监管检查、实验室测试和临床试验监督。MCAZ 达到成熟度级别 1，监管系统得分为 79%，注册和市场授权得分为 44%，警戒得分为 27%，市场监测和控制得分为 40%，许可机构得分为 62%，监管检查得分为 68%，实验室测试得分为 88%，临床试验得分为 18%。避孕套和手套是津巴布韦唯一受到监管的医疗器械。MCAZ 未对 IVD 进行监管。该审查表明，监管系统不够健全、适合目的、响应迅速、透明或与医疗器械和 IVD 的风险分类相称。必须修订《药品和相关物质管制法》，纳入医疗器械和 IVD 的定义和分类、监管机构的建立、许可和注册、质量管理体系、合格评定、上市后监测、标签和使用说明、能力建设和培训以及国际协调一致的内容。
