Regulation of medical diagnostics and medical devices in the East African community partner states

BMC Health Services Research

Volumn 14, Issue 1, 2014, Pages

  Rugera, Simon Peter ^a   McNerney, Ruth ^b   Poon, Albert K ^b   Akimana, Gladys ^c   Mariki, Rehema Forgen ^d   Kajumbula, Henry ^e,f   Kamau, Elizabeth ^g   Mpawenimana, Servilien ^h   Said, Said Yusuf ⁱ   Toroitich, Anthony ^j   Ronoh, Wesley ^k   Sollis, Kimberly A ^b   Sonoiya, Stanley ^l   Peeling, Rosanna W ^b  

^a MBARARA UNIVERSITY OF SCIENCE AND TECHNOLOGY   (Uganda)

^b LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^c Ministry of Health   (Rwanda)

^d Tanzania Food and Drugs Authority   (Tanzania)

^e MINISTRY OF HEALTH   (Uganda)

^f MAKERERE UNIVERSITY   (Uganda)

^g KENYA MEDICAL RESEARCH INSTITUTE   (Kenya)

^h Ministry of Health   (Burundi)

ⁱ Zanzibar Food and Drugs Board   (Tanzania)

^j Dirct of Product Evaluation and Registration   (Kenya)

^k EAC GIZ Programme on Regional Integration   (Tanzania)

^l East African Community Secretariat   (Tanzania)

more..

Author keywords

Diagnostic test; East African community; IVD; Medical device; Regulation

Indexed keywords

AFRICA; DEVICE APPROVAL; DEVICES; DIAGNOSTIC TEST; GOVERNMENT REGULATION; HEALTH CARE POLICY; HUMAN; INTERVIEW; QUESTIONNAIRE;

AFRICA, EASTERN; DEVICE APPROVAL; DIAGNOSTIC TESTS, ROUTINE; EQUIPMENT AND SUPPLIES; GOVERNMENT REGULATION; HEALTH POLICY; HUMANS; INTERVIEWS AS TOPIC; QUESTIONNAIRES;

EID: 84920774473     PISSN: None     EISSN: 14726963     Source Type: Journal    
DOI: 10.1186/s12913-014-0524-2     Document Type: Article

References (12)

1. Salomon JA, Wang H, Freeman MK, Vos T, Flaxman AD, Lopez AD, Murray CJ: Healthy life expectancy for 187 countries, 1990-2010: a systematic analysis for the Global Burden Disease Study 2010. Lancet 2012, 380:2144-2162.
2. Corbett EL, Steketee RW, ter Kuile FO, Latif AS, Kamali A, Hayes RJ: HIV-1/AIDS and the control of other infectious diseases in Africa. Lancet 2002, 359:2177-2187.
3. World Health Organisation: Global Tuberculosis Report 2012. In Book Global Tuberculosis Report 2012. Geneva: WHO; 2012.
4. O'Meara WP, Mangeni JN, Steketee R, Greenwood B: Changes in the burden of malaria in sub-Saharan Africa. Lancet Infect Dis 2010, 10:545-555.
5. East African Community: East African Community Free Trade Agreement. In Book East African Community Free Trade Agreement. 118th edition. Arusha: East African Community; 1999. City.
6. Ndomondo-Sigonda M, Ambali A: The African medicines regulatory harmonization initiative: rationale and benefits. Clin Pharmacol Ther 2011, 89:176-178.
7. Global Harmonization Task Force: Principles of In Vitro Diagnostic Medical Devices Classification GHTF/SG1/N45. In Book Principles of In Vitro Diagnostic Medical Devices Classification GHTF/SG1/N45. Geneva; 2008.
8. Peeling RW, McNerney R: Emerging technologies in point-of-care molecular diagnostics for resource-limited settings. Expert Rev Mol Diagn 2014, 14:525-534.
9. McNerney R, Sollis K, Peeling R: Improving access to new diagnostics through harmonised regulation: priorities for action. African Journal of Laboratory Medicine, North America 2014, Available at: http://www.ajlmonline.org/index.php/ajlm/article/view/123/155. Date accessed: 10 July 2014.
10. Peeling R, McNerney R: Increasing access to diagnostics through technology transfer and local production. In Book Increasing access to diagnostics through technology transfer and local production. Geneva: WHO; 2011.
11. Ecclestone R: A model regulatory program for medical devices: an international guide. In Book A model regulatory program for medical devices: an international guide. Washington, D.C: World Health Organization and United States Food and Drug Administration; 2001.
12. Global Harmonization Task Force: Definition of the Terms 'Medical Device' and 'In Vitro Diagnostic (IVD) Medical Device GHTF/SG1/N071:2012. In Book Definition of the Terms 'Medical Device' and 'In Vitro Diagnostic (IVD) Medical Device GHTF/SG1/N071:2012; 2012.