Regulation of Medical Diagnostics and Medical Devices in the East African

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Regulation of Medical Diagnostics and Medical Devices in the East African Community Partner States. Simon Peter Rugera et al

Table S1 Documents Accessed

Document title Publisher Servilien Mpawenimana B1 Burundi baseline survey report (Burundi) Ministry of Medical Services and K1 Kenyan Health Policy 2012-2030 Ministry of Public Health and Sanitation (Kenya) Medical Laboratory Services of Kenya National Policy K2 Ministry of Health (Kenya) Guidelines 2006 Medical Laboratory Board K3 Regulation Of In-Vitro Devices (Kenya) Pharmacy and Poisons Board National Report for The Pharmacy and Poisons Board K4 Regulation of Medical Diagnostics (Including IVDs) and Kenya Medical Devices Ministry of Health National AIDs K5 List of Approved Test Kits & STI Control Programme- NASCOP (Kenya) Guidelines on submission of Documentation for Pharmacy and Poisons Board K6 st Registration of Medical Devices 1 Edition (2011) Kenya National Policy Guidelines for K7 Ministry of Health (Kenya) Medical Laboratory Equipment Management (2012) National Quality Management Guidance Framework for Ministry of Health-NASCOP K8 HIV Testing and Counselling in Kenya (Kenya) National AIDS and STI Control National Guidelines for HIV Testing and Counselling in Programme (NASCOP) K9 nd Kenya. 2 Edition 2010 Ministry of Public Health and Sanitation (Kenya) Ministry of Medical Services Sessional Paper on National Pharmaceutical K10 & Ministry of Public Health and Policy (2010) Sanitation (Kenya) Draft National Policy Guidelines on Parasitological Ministry of Public Health and K11 Diagnosis of Malaria and Malaria Vector Surveillance in Sanitation (Kenya) Kenya The Pharmacy and Poisons Act. Chapter 244 National Council for Law K12 Revised Edition 2009 Reporting (Kenya) National Council for Law K13 The Constitution of Kenya, 2010. Reporting (Kenya) National Council for Law K14 The Standards Act Reporting (Kenya) Kenya Medical Laboratory The Medical Laboratory Technicians and K15 Technicians & Technologists Technologists Act. Kenya Subsidiary Legislation, 2011 Board (Kenya) The Kenya Food and Drugs Administration Bill 2012 K16 Ministry of Health (Kenya) (Draft) Kenya Medical Laboratory Kenya Medical Laboratory Technicians & Technologists K17 Technicians & Technologists Board Strategic Plan 2012-2017 Board (Kenya) R1 Law N°12/99 Relating To The Pharmaceutical Art (1999) Ministry of Justice Assessment of Medicine Quality Assurance in Rwanda: Promoting the Quality of R2 Overview of Findings and Recommendations for Medicines Program (Rwanda) Consideration (2009) R3 Draft National Pharmaceutical Policy (2009) Ministry of Health (Rwanda) R4 Rwanda Health Financing Policy Ministry of Health (Rwanda) Government (Tanzania T1 The Tanzania Food, Drugs and Cosmetics Act, 2003 mainland) Draft Guidelines For Evaluation of Applications For Tanzania Food and Drugs T2 Registration of In Vitro Diagnostics Medical Devices Authority (Tanzania mainland) TFDA/DMC/DMDAE/G/005 Guidelines For Assessment of Applications For Tanzania Food and Drugs T3 Registration of Medical Devices Authority (Tanzania mainland) Sera Ya Afya - National Health Policy (2007) Ministry of Health and Social T4 (Document In Swahili) Welfare (Tanzania mainland) Guidance For Application of Import Permit For Tanzania Food and Drugs T5 Medical Devices Authority (Tanzania mainland) Guidelines on Submission of Documentation Tanzania Food and Drugs T6 For Registration of Medical Devices (2009) Authority (Tanzania mainland) Government (Tanzania T7 Private Health Laboratories Act 1997 mainland) Proposed Amendments of The Private Health Laboratory Regulation Act, No. 10 Of 1997 T8 (Tanzania mainland) Proposed Amendments of The Tanzania Food, Drugs and Cosmetics Act, No. 1 Of 2003 Ministry of Health and Social T9 Notification Of In Vitro Diagnostics Form Welfare (Tanzania mainland) Government (Tanzania T10 The Standards Act 2009 mainland) Rehema Mariki, Tanzania Food Report on Baseline Survey For Regulation of Medical T11 and Drugs Authority (Tanzania Diagnostics (Including IVDs) and Medical Devices mainland) Government of Zanzibar The Zanzibar Food, Drugs And Cosmetics T12 Ministry of Health (Tanzania Act, No. 2 Of 2006 Zanzibar) Government of Zanzibar Zanzibar Health Sector T13 Ministry of Health (Tanzania Performance Report 2010/2011 Zanzibar) Zanzibar Food Drugs and Guideline On Application Of Submission Of Medical T14 Cosmetics Board (Tanzania Devices (2012) Zanzibar) National Report for the Regulation of Medical Diagnostics Said Yussuf Said (Tanzania T15 (Including IVDs) and Medical Devices. Zanzibar) 23 Ministry of Health and Social T16 Zanzibar National Drug Policy (2006) Welfare (Tanzania Zanzibar) Zanzibar Medicine Policy Implementation Plan Ministry of Health and Social T17 2008 – 2012 Welfare (Tanzania Zanzibar) THE UGANDA NATIONAL BUREAU OF STANDARDS ACT Uganda Legal Information U1 1983 Institute (Uganda) Uganda National Health Laboratory U2 Ministry of Health (Uganda) Services Policy (2009) Uganda Legal Information U3 The Allied Health Professionals Act (1996) Institute (Uganda) Uganda Legal Information U4 National Drug Policy and Authority Act 1993 Institute (Uganda) National Drug Authority Guidelines for the conduct of National Drug Authority, U5 clinical trials Ministry Of Health (Uganda) Guidelines On Donation The National Drug Policy and National Drug Authority U6 Authority Regulations, 1997 (Uganda) Guidelines on GMP Inspection of Foreign Pharmaceutical National Drug Authority U7 Manufacturing Plants Use In Uganda 2007 (Uganda) Report on The Regulation of Medical Diagnostics and Simon Peter Rugera and Henry U8 Devices in Uganda Kajumbula (Uganda)