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Standards Alliance Phase 2

Standards Alliance: Phase 2 Medical Devices Regulatory Workshop Convenes in Kenya


As part of efforts to prevent the implementation of unnecessary regulatory barriers to medical technologies, the Medical Device Regulatory Convergence (MDRC) project—an activity under the Standards Alliance: Phase 2 program—convened a medical device regulatory workshop with the Africa Medical Devices Forum (AMDF) and the U.S. Food and Drug Administration (FDA) in Nairobi, Kenya.

The workshop, which took place on November 6-10 and brought together approximately 150 attendees from 10 African countries, fostered information exchange 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. Members of the U.S. FDA attended in person to train attendees from Kenya, South Africa, and Ghana (covered by MDRC) as well as representatives from Botswana, Burkina Faso, Central African Republic, Ethiopia, Gabon, Nigeria, Tanzania, and Zambia (covered by AMDF), as well as private sector attendees from surrounding countries and the Middle East.

A key goal of Standards Alliance: Phase 2 (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, increased adoption and implementation of international standards will improve the quality and safety of goods on a global scale, as well as contribute to increased trade and quality of life (or GDP/income, etc.).

As the MDRC project aims to increase patients’ access to high-quality PPE and other medical technologies to respond to and recover from COVID-19, the workshop provided international lessons learned from the COVID-19 pandemic and ways to prepare for future health emergencies. As long as barriers to trade exist, they bottleneck the supply chain and prevent doctors and patients from getting much-needed medical supplies. To that end, countries cannot safely deploy PPE and medical devices without a strong medical device regulatory framework; as such, the 5-day workshop underscored the need to prevent the implementation of unnecessary regulatory barriers to medical technologies, and highlighted ways to improve general medical device NRA public administration to improve public health outcomes. Furthermore, it focused on trainings for conformity assessment, international harmonization, and good reliance practices.

Sessions included a discussion on ISO 14971:2019, Medical Devices - Application of Risk Management to Medical Devices, and how it is incorporated into ISO 13485:2016, Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes. Other sessions covered standards for regulatory use; conformity assessment activities to build regulators’ confidence in device safety and performance; optimizing standards for regulatory purposes; and the World Trade Organization Agreement on Technical Barriers to Trade (WTO/TBT) and what it means for health regulatory authorities.

The program was the final training of the MDRC as part of SA2, but the MDRC team remains available as a legacy of the project to help assist with questions and challenges as part of their journey in compliance with international law and best practices. Great strides were made within the regulatory side as well as the standards side, with space being intentionally created for bilateral meetings between ANSI, KEBS, and ARSO, as well as government-to-government meetings occurring in a parallel track to conformity assessment trainings on the IEC EE scheme. The MDRC team has now continued south to Pretoria to hold SAHPRA-specific trainings tailored to their needs.

Standards Alliance Phase 2 Image 2 Standards Alliance Phase 2 Nov 15

About Standards Alliance: Phase 2

The Standards Alliance: Phase 2 (SA2) is a public-private partnership between the 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 between 2019 and 2024. SA2 conducts activities in the Latin America, Middle East, Africa, and Indo-Pacific regions.


Jana Zabinski

Senior Director, Communications & Public Relations


[email protected]

Beth Goodbaum

Journalist/Communications Specialist


[email protected]