Abstract:

Zimbabwe's regulation of medical devices and in vitro diagnostics (IVDs) lags behind that of medicines and vaccines despite the country's goal of achieving Universal Health Coverage (UHC) by 2030. This study, conducted from June to December 2022, rigorously evaluated Zimbabwe's regulatory framework for medical devices and IVDs using a comprehensive policy analysis framework. The study's methodology, which included document review and comparative analysis, was designed to align the regulatory framework with the UHC goal. The READ (Ready, Extract, Analyze, and Distill) approach systematically assessed the relationship between medical device regulations and national health strategic goals. Fourteen documents were analysed, revealing that current regulations under the Medicines and Allied Substances Control Act are insufficient for ensuring quality-assured medical devices and IVDs due to a lack of explicit definitions and standards, leading to inconsistent regulatory practices. The study found fragmented regulatory approaches, overlapping institutional responsibilities, and a lack of effective incorporation of medical device and IVD regulations in national health strategy and related policies, hindering UHC achievement. The study recommends comprehensive policy changes to harmonise regulations, clarify institutional roles, and integrate medical device and IVD regulations into the national health strategy. This ensures access to safe, effective, quality medical devices and IVDs, promoting Zimbabwe's UHC goals by 2030.

References:

[1].  European Commission, 2017, MDR - Regulation (EU) 2017/746 on in-vitro diagnostic medical devices: Official Journal of the European Union, 1–175, https://www.emergogroup.com/sites/default/files/europe-medical-devices-regulation.pdf%0Ah

[2].  European Commission, 2017, Regulation (EU) 2017/745 of The European Parliament and of the Council on Medical Devices, Official Journal of the European Union, 5(8), 1-175, doi: 10.1177/2165079915576935.

[3].  Global Harmonization Task Force, 2006, Principles of Medical Devices Classification, 1–27, https://www.imdrf.org/sites/default/files/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n15-2006-guidance-classification-060627.pdf

[4].  International Medical Devices Regulators Forum, 2018, Essential Principles of Safety and Performance of Medical Devices, International Medical Device Regulators Forum., 12-27, https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-181031-grrp-essential-principles-n47.pdf

[5].  World Health Organization, 2018, Health products policy and standards, Good Manufacturing Practices https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/regulations

[6].  Hubner, S., Maloney, C., Phillips, S. D., Doshi, P., Mugaga, J., Ssekitoleko, R. T, Mueller, J. L, Fitzgerald, T. N., 2021, The evolving landscape of medical device regulation in East, Central, and Southern Africa, Global Health Science and Practice, 9(1), 136–148, doi: 10.9745/GHSP-D-20-00578.

[7].  Dacombe, R., Watson, V., Nyirenda, L., Madanhire, C., Simwinga, M., Chepuka, L., Johnson, C., Corbett, E., Hatzold, K., Taegtmeyer, M., 2019, Regulation of HIV self-testing in Malawi, Zambia and Zimbabwe: a qualitative study with key stakeholders, Journal of the International AIDS Society, 22(S1), 5–11, doi: 10.1002/jia2.25229.

[8].  Reddy, K. S. and Mathur, M. R., 2018, Universal Health Coverage, in Equity and Access, Oxford University Press, 305–322, doi: 10.1093/oso/9780199482160.003.0015.

[9].  World Health Organization, 2017, Leave no one behind. Strengthening Health Systems for UHC and the SDGs in Africa, WHO Regional Office for Africa, Licence: CC BY-NC-SA 3.0 IGO., 252–256, doi: 10.1080/15027570410006228.

[10]. World Health Organization, 2017, WHO global model regulatory framework for medical devices including in vitro diagnostic medical devices, WHO Medical Device Technical series. Licence: CC BY-NC-SA 3.0 IGO, https://www.who.int/medical_devices/publications/global_model_regulatory_framework_meddev/en/

[11]. Walt, G. and Gilson, L., 1994, Reforming the health sector in developing countries: The central role of policy analysis, Health Policy and Planning. Oxford Academic, 353–370, doi: 10.1093/heapol/9.4.353.

[12]. Kayesa, N. K. and Shung-King, M., 2021, The role of document analysis in health policy analysis studies in low and middle-income countries: Lessons for HPA researchers from a qualitative systematic review, Health Policy OPEN, (2), 100024, doi: 10.1016/j.hpopen.2020.100024.

[13]. Walt, G., Schiffman, J., Schneider, H., Murray, S. F., Brugha, R., and Gilson, L., 2008, 'Doing' health policy analysis: Methodological and conceptual reflections and challenges, Health Policy and Planning. Oxford University Press, 308–317, doi: 10.1093/heapol/czn024.

[14]. Sidibé, C. S., Becquet, V., Brückner, T. Y., Touré, O., Traoré, L. F., Broerse, J. E. W., and Dieleman, M., 2022, Adoption of harmonisation policy for the midwives’ training programme in Mali: A policy analysis, PLOS Global Public Health, 2(11), e0001296, doi: 10.1371/journal.pgph.0001296.

[15]. Walt, G. and Gilson, L., 1994, Reforming the health sector in developing countries: The central role of policy analysis, Health Policy and Planning. Oxford Academic, 353–370, doi: 10.1093/heapol/9.4.353.

[16]. Bowen, G. A., 2009, Document analysis as a qualitative research method, Qualitative Research Journal, 9(2), 27–40, doi: 10.3316/QRJ0902027.

[17]. Dalglish, S. L., Khalid, H. and McMahon, S. A., 2020, Document analysis in health policy research: The READ approach, Health Policy and Planning, 35(10), 1424–1431, doi: 10.1093/heapol/czaa064.

[18]. World Health Organization (WHO), 2020, Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics, 50, https://www.who.int/publications/i/item/9789240015319

[19]. De Maria, C., Di Pietro, L., Díaz Lantada, A., Makobore, P. N., Mridha, M., Ravizza, A., Torop, J., and Ahluwalia, A., 2018, Safe innovation: On medical device legislation in Europe and Africa, Health Policy and Technology, 7(2), 156–165, doi: 10.1016/j.hlpt.2018.01.012.

[20]. World Health Organization (WHO), 2017, WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices., WHO Medical Device Technical series. Licence: CC BY-NC-SA 3.0 IGO. http://apps.who.int/bookorders.%0Ahttp://apps.who.int/bookorders.%0Ahttps://www.who.int/medical_devices/publications/global_model_regulatory_framework_meddev/en/%0Ahttp://www.who.int/medicines/areas/quality_safety/quality_assurance/2016-07-27Modelregulato

[21]. Global Harmonization Task Force, 2012, Principles of Conformity Assessment for Medical Devices, Ghtf/Sg1/N78:2012, https://www.imdrf.org/sites/default/files/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n78-2012-conformity-assessment-medical-devices-121102.pdf

[22]. Kuchenmüller, T., Chapman, E., Takahashi, R., Lester, L., Reinap, M., Ellen, Haby, M. M., 2022, A comprehensive monitoring and evaluation framework for evidence to policy networks, Evaluation and Program Planning, 91(102053), 1–23, doi: 10.1016/j.evalprogplan.2022.102053.A.

[23]. Allen, L. N., 2022, The philosophical foundations of “health for all” and Universal Health Coverage, International Journal for Equity in Health, 21(1), 1–7, doi: 10.1186/s12939-022-01780-8