Standards Alliance Phase 2 COVID-19 Medical Device Regulatory Convergence Project (MDRC)

Standards Alliance 2.0

The Standards Alliance Phase 2 (SA2) was 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 involved 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 built 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 (MDRC)

Amidst the COVID-19 pandemic, nations 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) increased 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 had eight partner countries across Latin America, Africa, and Southeast Asia.

The MDRC aimed 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:

Delivered tailored training to central regulatory coordination bodies, on cross-sectoral good regulatory practices (GRPs) and international standardization that is required for regulatory convergence in the medical device sector.

Delivered tailored technical training on medical device-speciﬁc GRPs and international standardization and conformity assessment, to health regulatory bodies, that directly facilitates regulatory convergence in the medical device sector.

Advised agencies of partner governments on the adoption of international benchmarks for EUAs and related emergency regulatory frameworks and approval processes, providing a transparent, convergent, predictable, and agile international reference so medical devices are received across and within borders at points of care in times of health crisis.

Assisted customs authorities in understanding and following the import criteria and policies set by the health ministries and centers of disease control for addressing COVID-19.

Established an international reference center for Emergency Regulatory Response, in collaboration with the Global Medical Technology Alliance, including an easy to use digital library that complies information from the FDA or other relevant agencies of the newest medical devices released by the industry to fight the COVID-19 pandemic.

Latin America

Africa

Southeast Asia

Government Engagement and Partner Organizations

MDRC began as was 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 worked 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).

Today, the MDRC continues with its global mission, working with aid and development agencies, medical device regulatory authorities, international organizations, industry, subject matter experts and other stakeholders to advance medical device regulatory convergence, regulatory reliance, good regulatory practices, global health system strengthening, and the elimination of technical barriers to trade and other unnecessary non-tariff barriers between patients and life-saving medical technologies.

Reports and Important Documents

ABOUT USAID

The U.S. Agency for International Development (USAID) previously administered the U.S. foreign assistance programs in more than 80 countries worldwide. USAID provided 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.

ABOUT ANSI

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.

ABOUT ADVAMED

AdvaMed is a trade association of over 500 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.