Quarterly Reporting Standard Format for IPs Final

The program aims to promote regulatory convergence, good regulatory practice, and the adherence and adoption of international standards in developing countries. SA2 focuses on medical devices to support the COVID-19 response, with a goal of establishing an efficient medical device regulatory environment and framework that facilitates the COVID-19 response and diminishes technical barriers to trade. The program engages target populations, including foreign government officials, ministries, private sector, industry groups, civil society, consumer interest groups, business professionals, trade policy experts, and academia. The objective of SA2 is to build on the past successes, lessons learned, and impact measured to-date from the first iteration of the Standards Alliance and to support the capacity of developing countries in the areas of legal and regulatory framework, standards development, conformity assessment procedures, and private sector engagement. SA2 includes activities in markets representing a variety of geographical regions and levels of economic development, subject to the agreement of USAID. In consultation with USAID Missions, U.S. government, and private sector experts, ANSI selects the countries/regions based on demonstrated commitment and readiness for assistance, as well as U.S. private sector interest and development impact. In June 2020, USAID recognized the critical role standards and conformity assessment play in advancing public health and safety during global health emergencies and obligated $3.5 million to SA2. This SA2 project will promote regulatory convergence in the context of COVID-19, good regulatory practice (GRP), and the adherence and adoption of international medical device standards. Year 2 of SA2 entailed significant progress in the implementation of the COVID-19 Medical Device and Regulatory Convergence (MDRC) program and the finalization of all sub-award agreements. MDRC achieved the most substantive progress by launching the Inter-American Coalition for Regulatory Convergence, solidifying international partnerships with relevant government and private sectors organizations, and executing medical device and good regulatory practice trainings and high-level meetings. SA2 also began early implementation and contract approval of other sub-awards in the Water, Sanitation, and Hygiene (WASH) and energy sectors, and support for the African Organization of Standardization (ARSO). ANSI has launched SA2 content on the website, which will continue to be updated throughout the rest of the program. The geographic coverage of SA2 includes Brazil, Colombia, Peru, Mexico, Ghana, Kenya, South Africa, Zambia, West Africa (regional), and Indo-Pacific (regional). The reporting period for this document is July 12, 2020, to July 11, 2021.