ANSI - American National Standards Institute
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Standards Alliance Phase 2 Supports COVID-19 Response and Recovery

SA2 to Support Medical Device Standardization and Good Regulatory Practice

6/19/2020

In recognition of the importance of standardization and conformity assessment to the global response to the COVID-19 pandemic, the American National Standards Institute (ANSI) is pleased to announce that the Standards Alliance Phase 2 (SA2), as part of its public-private partnership with the United States Agency for International Development (USAID), will specifically address the COVID-19 response and recovery. To date, USAID has committed more than $1 billion to help fight the virus pandemic around the world, and ANSI is pleased that the critical role of standards that support public health and safety will be recognized with $3.5 million of federal funds and corresponding private sector funds obligated to the SA2.

The SA2 partnership will showcase how standardization and conformity assessment not only drive the global economy, but also facilitate an efficient response to the current pandemic, especially through medical device standardization and good regulatory practice.

The SA2 is a public-private partnership that promotes reciprocal trade with the U.S. by developing the capacity of partner countries in the areas of legal and regulatory framework, standards development, conformity assessment procedures, and private sector engagement to improve their understanding and application of standards and conformity assessment. Launched in 2019, the second phase of the project will last 5 years. SA2 builds on the past successes, lessons learned, and impact of the first phase of the Standards Alliance.

Among other initiatives undertaken in the first phase, ANSI worked with AdvaMed – a U.S. based trade association and ANSI member – to promote good regulatory practices and diminish trade barriers in the medical device sector in Latin America. ANSI expects to continue work with AdvaMed and other private sector partners to identify target countries and execute these activities.

To that end, the SA2 obligation will help reduce barriers to countries’ importation of U.S. medical devices, with special emphasis on COVID-19 testing kits; improve governments’ acceptance of international standards for medical equipment; diminish regulatory barriers and impediments; and train various agencies and the private sector on needed documentation and the proper use of medical devices and testing equipment. The cooperation of private sector experts with government agencies is imperative to provide knowledge and training that ensure the correct usage of medical devices and promote regulatory and standards harmonization that facilitate the importation of high-quality, efficient medical products used to prevent and treat the novel coronavirus.

“Standardization is a critical tool in addressing health and safety issues, including the COVID-19 outbreak," said Joseph Tretler, vice president of international policy, ANSI. "ANSI is proud for this opportunity to support the global response to the pandemic and looks forward to working with USAID and the private sector to execute the activities." Please reach out to standardsalliance@ansi.org for any inquiries.

Related news: ANSI and USAID Announce Implementation of Standards Alliance: Phase 2

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