Background: Medical devices and in vitro diagnostic tests (IVD) are vital components of health delivery systems but\naccess to these important tools is often limited in Africa. The regulation of health commodities by National\nRegulatory Authorities is intended to ensure their safety and quality whilst ensuring timely access to beneficial new\nproducts. Streamlining and harmonizing regulatory processes may reduce delays and unnecessary expense and improve\naccess to new products. Whereas pharmaceutical products are widely regulated less attention has been placed on the\nregulation of other health products. A study was undertaken to assess regulation of medical diagnostics and medical\ndevices across Partner States of the East African Community (EAC).\nMethods: Data was collected during October 2012 through desk based review of documents and field research, including\nface to face interviews with the assistance of a structured questionnaire with closed and open ended questions. Key\nareas addressed were (i) existence and role of National Regulatory Authorities; (ii) policy and legal framework for\nregulation; (iii) premarket control; (iv) marketing controls; (v) post-marketing control and vigilance; (vi) country capacity\nfor regulation; (vii) country capacity for evaluation studies for IVD and (viii) priorities and capacity building for\nharmonization in EAC Partner States.\nResults: Control of medical devices and IVDs in EAC Partner States is largely confined to national disease programmes\nsuch as tuberculosis, HIV and malaria. National Regulatory Authorities for pharmaceutical products do not have the\ncapacity to regulate medical devices and in some countries laboratory based organisations are mandated to ensure\nquality of products used. Some activities to evaluate IVDs are performed in research laboratories but post market\nsurveillance is rare. Training in key areas is considered essential to strengthening regulatory capacity for IVDs and other\nmedical devices.\nConclusions: Regulation of medical devices and in vitro diagnostics has been neglected in EAC Partner States.\nRegulation is weak across the region, and although the majority of States have a legal mandate to regulate medical\ndevices there is limited capacity to do so. Streamlining regulation in the EAC is seen as a positive aspiration with\ndiagnostic tests considered a priority area for harmonisation.
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