The Medical Device Regulatory Convergence (MDRC) project, an activity under the Standards Alliance: Phase 2 program, is organizing a medical device regulatory workshop with the Africa Medical Devices Forum (AMDF) and the U.S. Food and Drug Administration (FDA). The event will be held on November 6-10, 2023, in Nairobi, Kenya.
The purpose of this workshop is to provide an exchange of information and capacity building between the AMDF, its member National Regulatory Authorities (NRAs), and relevant international NRAs and industry covering the core international references for medical device regulatory frameworks. The workshop will support and advance the AMDF 2023 Workplan and Training Plan; support the AMDF application as a Regional Harmonization Initiative (RHI); strengthen the soft infrastructure of medical device regulatory frameworks on the continent to incorporate global lessons learned from the COVID-19 pandemic; enable participants to better prepare for future health emergencies; and prevent the implementation of unnecessary regulatory barriers to medical technologies.
An in-person audience of 150 is expected, with NRA staff from the following AMDF member countries:
• Burkina Faso
• Central African Republic
• South Africa
Online participation is available. Register for virtual participation and view the event program.
The following week, a follow-up training will take place in South Africa focusing on good regulatory practice and technical competencies. For more information and to register for virtual attendance, click here.
About Standards Alliance: Phase 2
The Standards Alliance: Phase 2 (SA2) is a public-private partnership between U.S. Agency for International Development (USAID) and the American National Standards Institute (ANSI). It includes collaboration with U.S. private sector partners, U.S. government experts, and USAID eligible countries over a five-year period (2019-2026). A key goal of SA2 is to help increase the capacity of developing countries to implement accepted international best practices to reduce instances of poor quality and unsafe products, services, and infrastructure. Ultimately, better adoption and implementation of international standards will improve the quality and safety of goods on a global scale. SA2 conducts activities in the Latin America, Middle East, Africa, and Indo-Pacific regions.