The Standards Alliance is a public-private partnership between ANSI and USAID, which was announced by USAID in November 2012 as a funding facility designed to provide capacity-building assistance to developing countries, specifically related to implementation of the World Trade Organization (WTO) Technical Barriers to Trade (TBT) Agreement.
The main objectives of the program included:
- Increased understanding of WTO TBT principles
- Implementation of the Code of Good Practice for the Preparation, Adoption and Application of Standards
- Improved transparency in the development and/or modification of technical regulations
- More robust and transparent engagement with the private sector in standards development and use
During 2017-2019, the Advanced Medical Technology Association (AdvaMed) and the Coalition members implemented a project co-funded under the Standards Alliance initiative promoting good regulatory practices and medical device regulatory convergence with countries in Latin America, including Colombia, Mexico, Peru and the CAFTA-DR countries. The primary objective of this project proposal was to provide private sector resources and expertise in support of international, regional, sub-regional and national governmental initiatives in Latin America to adopt good regulatory practices in the medical device sector, aimed at helping governments in the region maximize their regulatory efficacy through the adoption of international best practices, including the implementation and reinforcement of policies promoting the use of internationally harmonized voluntary consensus standards and conformity assessment mechanisms.
This project was structured with two tiers, each with four phases as follows:
Tier 1 – Good Regulatory Practices (GRP) – Foundational/Cross-sectoral
- Phase 1 – Identification of international benchmarks
- Phase 2 – Gap analysis
- Phase 3 – Initiation of bilateral cooperation to fill gaps
- Phase 4 – Initiation of multilateral cooperation to fill gaps
Tier 2 – Medical Device Regulatory, Standards, Conformity Assessment Convergence
- Phase 1 – Identification of international benchmarks
- Phase 2 – Gap analysis
- Phase 3 – Initiation of bilateral cooperation to fill gaps
- Phase 4 – Initiation of multilateral cooperation to fill gaps
The results of this Standards Alliance GRP and Medical Device Regulatory Convergence Project 1.0 are available at the project website.
The Coalition continues to advance the work of Project 1.0 with medical device regulators in Latin America and is working with AdvaMed, ANSI and USAID on the development of future iterations of this initiative.
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