Rugera Simon Peter, McNerney Ruth, Poon Albert K, Akimana Gladys, Mariki Rehema Forgen, Kajumbula Henry, Kamau Elizabeth, Mpawenimana Servilien, Said Said Yusuf, Toroitich Anthony, Ronoh Wesley, Sollis Kimberly A, Sonoiya Stanley, Peeling Rosanna W
Department of Medical Laboratory Sciences, Mbarara University of Science and Technology, Mbarara, Uganda.
BMC Health Serv Res. 2014 Oct 31;14:524. doi: 10.1186/s12913-014-0524-2.
Medical devices and in vitro diagnostic tests (IVD) are vital components of health delivery systems but access to these important tools is often limited in Africa. The regulation of health commodities by National Regulatory Authorities is intended to ensure their safety and quality whilst ensuring timely access to beneficial new products. Streamlining and harmonizing regulatory processes may reduce delays and unnecessary expense and improve access to new products. Whereas pharmaceutical products are widely regulated less attention has been placed on the regulation of other health products. A study was undertaken to assess regulation of medical diagnostics and medical devices across Partner States of the East African Community (EAC).
Data was collected during October 2012 through desk based review of documents and field research, including face to face interviews with the assistance of a structured questionnaire with closed and open ended questions. Key areas addressed were (i) existence and role of National Regulatory Authorities; (ii) policy and legal framework for regulation; (iii) premarket control; (iv) marketing controls; (v) post-marketing control and vigilance; (vi) country capacity for regulation; (vii) country capacity for evaluation studies for IVD and (viii) priorities and capacity building for harmonization in EAC Partner States.
Control of medical devices and IVDs in EAC Partner States is largely confined to national disease programmes such as tuberculosis, HIV and malaria. National Regulatory Authorities for pharmaceutical products do not have the capacity to regulate medical devices and in some countries laboratory based organisations are mandated to ensure quality of products used. Some activities to evaluate IVDs are performed in research laboratories but post market surveillance is rare. Training in key areas is considered essential to strengthening regulatory capacity for IVDs and other medical devices.
Regulation of medical devices and in vitro diagnostics has been neglected in EAC Partner States. Regulation is weak across the region, and although the majority of States have a legal mandate to regulate medical devices there is limited capacity to do so. Streamlining regulation in the EAC is seen as a positive aspiration with diagnostic tests considered a priority area for harmonisation.
医疗设备和体外诊断测试（IVD）是卫生服务系统的重要组成部分，但在非洲，获取这些重要工具的机会往往有限。国家监管机构对卫生用品的监管旨在确保其安全性和质量，同时确保及时获得有益的新产品。简化和协调监管流程可能会减少延误和不必要的费用，并改善新产品的获取。虽然药品受到广泛监管，但对其他卫生产品的监管关注较少。开展了一项研究，以评估东非共同体（EAC）各伙伴国对医疗诊断和医疗设备的监管情况。
2012年10月期间，通过对文件的案头审查和实地研究收集数据，包括在结构化问卷（有封闭式和开放式问题）的协助下进行面对面访谈。涉及的关键领域包括：（i）国家监管机构的存在和作用；（ii）监管的政策和法律框架；（iii）上市前控制；（iv）营销控制；（v）上市后控制和警戒；（vi）国家监管能力；（vii）国家对IVD评估研究的能力；（viii）东非共同体伙伴国协调的优先事项和能力建设。
东非共同体伙伴国对医疗设备和IVD的控制主要局限于国家疾病项目，如结核病、艾滋病毒和疟疾。药品国家监管机构没有能力监管医疗设备，在一些国家，基于实验室的组织被授权确保所用产品的质量。一些评估IVD的活动在研究实验室进行，但上市后监测很少。关键领域的培训被认为对加强IVD和其他医疗设备的监管能力至关重要。
东非共同体伙伴国忽视了对医疗设备和体外诊断的监管。整个地区的监管薄弱，虽然大多数国家有监管医疗设备的法律授权，但这样做的能力有限。简化东非共同体的监管被视为一个积极的愿望，诊断测试被视为协调的优先领域。
