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). The second phase of the Standards Alliance involves collaboration with U.S. private sector partners, U.S. government experts, and USAID eligible countries and regions over a five-year period. These include Latin America, Middle East, North Africa, sub-Saharan Africa, and Indo-Pacific regions.
SA2 builds upon the success of Phase 1 to support the capacity of developing countries in the areas of legal and regulatory framework, standards development, conformity assessment procedures, and private sector engagement.
Medical Device Regulatory Convergence Project
Amidst the COVID-19 pandemic, nations have scrambled to increase the production of and access to medical devices to prevent and treat the virus, such as rapid diagnostic test kits, ventilators, and personal protective equipment (PPE). However, countries cannot safely deploy these products without a strong medical device regulatory framework and knowledge of emergency use authorization (EUA) procedures and rules. The Standards Alliance Phase 2 COVID-19 Medical Device Regulatory Convergence Project (MDRC) increases the transparency and predictability of partner governments’ regulatory ecosystems for medical devices, aligning them with international standards and overall improving the National Quality Infrastructure. MDRC has ten partner countries across Latin America, Africa, and Southeast Asia.
The MDRC aims at: (1) building capacity of partner countries for standards and conformity assessment procedures related to medical device; (2) removing countries’ technical barriers to trade for medical devices; (3) increasing patient’s access to needed high-quality PPE and other medical technologies to respond to and recover from COVID-19 and future global health crises; and, (4) fostering private sector engagement in the medical technology regulatory space. Spearheaded by the Advanced Medical Technology Association (AdvaMed) and supported by a diverse team of experts, the project:
Government Engagement and Partner Organizations
MDRC is a partnership between USAID and the American National Standards Institute (ANSI) in collaboration with AdvaMed to advance regulatory convergence in partnership with standards developing organizations as well as national and regional health, trade, and regulatory authorities. The project will work through the Global Medical Technology Alliance (GMTA) and Global Diagnostics Alliance, and the Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector in conjunction with the International Medical Device Regulators Forum (IMDRF).
Reports and Important Documents
Facts Sheet MDRC
Facts Sheet Standards Alliance 2.0
Training including recordings and materials
The U.S. Agency for International Development (USAID) assists U.S. foreign policy by administering the U.S. foreign assistance program in more than 80 countries worldwide. USAID provides humanitarian assistance and economic support with the goal of promoting international good will, global development, and the expansion of stable, democratic societies and open financial markets.
The American National Standards Institute (ANSI) is a private non-profit organization whose mission is to enhance U.S. global competitiveness and the American quality of life by promoting, facilitating, and safeguarding the integrity of the voluntary standardization and conformity assessment system. Its membership is made up of businesses, professional societies and trade associations, standards developers, government agencies, and consumer and labor organizations.
AdvaMed is a trade association of over 400 member companies, ranging from the largest to the smallest medical technology innovators and enterprises that produce medical devices, diagnostic products and digital health technologies that are transforming health care through earlier disease detection, less invasive procedures, and more effective treatments.