title: Regulation of medical diagnostics and medical devices in the East African community partner states.
abstract: BACKGROUND
  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).
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Medical Laboratory Sciences, Mbarara University of Science and Technology, Mbarara, Uganda. sprugera@must.ac.ug.
authors.forename: Simon Peter
authors.initials: SP
authors.lastname: Rugera
authors.forename: Ruth
authors.initials: R
authors.lastname: McNerney
authors.forename: Albert K
authors.initials: AK
authors.lastname: Poon
authors.forename: Gladys
authors.initials: G
authors.lastname: Akimana
authors.forename: Rehema Forgen
authors.initials: RF
authors.lastname: Mariki
authors.forename: Henry
authors.initials: H
authors.lastname: Kajumbula
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Kamau
authors.forename: Servilien
authors.initials: S
authors.lastname: Mpawenimana
authors.forename: Said Yusuf
authors.initials: SY
authors.lastname: Said
authors.forename: Anthony
authors.initials: A
authors.lastname: Toroitich
authors.forename: Wesley
authors.initials: W
authors.lastname: Ronoh
authors.forename: Kimberly A
authors.initials: KA
authors.lastname: Sollis
authors.forename: Stanley
authors.initials: S
authors.lastname: Sonoiya
authors.forename: Rosanna W
authors.initials: RW
authors.lastname: Peeling
mesh_terms: D000351:Africa, Eastern; D018795:Device Approval; D003955:Diagnostic Tests, Routine; D004864:Equipment and Supplies; D033161:Government Regulation; D006291:Health Policy; D006801:Humans; D007407:Interviews as Topic; D011795:Surveys and Questionnaires