{"id":299,"date":"2021-06-15T11:20:43","date_gmt":"2021-06-15T11:20:43","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?page_id=299"},"modified":"2021-06-16T12:27:11","modified_gmt":"2021-06-16T12:27:11","slug":"1-0","status":"publish","type":"page","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/projects\/standards-alliance\/1-0\/","title":{"rendered":"Standards Alliance 1.0"},"content":{"rendered":"\n

During 2017-2019, the\u00a0Advanced 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.<\/p>\n\n\n\n

This project was structured with two tiers, each with four phases as follows:<\/p>\n\n\n\n

Tier 1 – Good Regulatory Practices (GRP) – Foundational\/Cross-sectoral<\/h2>\n\n\n\n
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Phase 1 \u2013 Identification of international benchmarks<\/span><\/div><\/div><\/div>\n\n\n\n
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Phase 2 \u2013 Gap analysis<\/span><\/div><\/div><\/div>\n\n\n\n
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Phase 3 \u2013 Initiation of bilateral cooperation to fill gaps<\/span><\/div><\/div><\/div>\n\n\n\n
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Phase 4 \u2013 Initiation of multilateral cooperation to fill gaps<\/span><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n

Tier 2 – Medical Device Regulatory, Standards, Conformity Assessment Convergence<\/h2>\n\n\n\n
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Phase 1 \u2013 Identification of international benchmarks<\/span><\/div><\/div><\/div>\n\n\n\n
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Phase 2 \u2013 Gap analysis<\/span><\/div><\/div><\/div>\n\n\n\n
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Phase 3 \u2013 Initiation of bilateral cooperation to fill gaps<\/span><\/div><\/div><\/div>\n\n\n\n
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Phase 4 \u2013 Initiation of multilateral cooperation to fill gaps<\/span><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n

See more in the video below:<\/p>\n\n\n\n

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