{"id":1012,"date":"2021-06-16T12:26:24","date_gmt":"2021-06-16T12:26:24","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?page_id=1012"},"modified":"2021-06-16T13:19:01","modified_gmt":"2021-06-16T13:19:01","slug":"tier-2","status":"publish","type":"page","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/projects\/standards-alliance\/1-0\/tier-2\/","title":{"rendered":"Tier 2 \u2013 Medical Device Sector-Specific Good Regulatory Practices, Technical Regulations, Standards, And Conformity Assessment"},"content":{"rendered":"\n<h2 class=\"has-medium-font-size wp-block-heading\">Phase 1: Creation of Implementation Guide<\/h2>\n\n\n\n<p class=\"mb-3\">AdvaMed worked closely with the International Medical Device Regulators Forum (IMDRF), the Pan American Health Organization (PAHO), the U.S. Food and Drug Administration (FDA), the Latin American Medical Technology Alliance (ALDIMED), and the Latin American In Vitro Diagnostics Alliance (ALADDIV) to create an easy-to-use reference list of the international benchmarks for medical device technical regulations, standards, and conformity assessment mechanisms. This reference is included under\u00a0\u00a0<a href=\"\/regulatory-convergence\/projects\/standards-alliance\/1-0\/tier-2\/global-benchmark-documents\/\">International Benchmark Reference Documents \u2013 Tier 2<\/a>.<\/p>\n\n\n\n<h2 class=\"has-medium-font-size wp-block-heading\">Phase 2: Assessment and Gap Analysis<\/h2>\n\n\n\n<p>Using the sectoral reference guide as a benchmark, the Standards Alliance worked with participating countries to conduct assessments of existing Good Regulatory Practices, Technical Regulations, Standards, and Conformance Mechanisms for the medical devices sector.<\/p>\n\n\n\n<p>The gap analysis report including information on the relevant international and national standardization committees is available via the links below:<\/p>\n\n\n\n<div class=\"wp-block-uagb-icon-list uagb-icon-list__outer-wrap uagb-icon-list__layout-vertical uagb-icon-list__icon-at-top uagb-block-b1da925a mb-3\"><div class=\"uagb-icon-list__wrap\">\n<div class=\"wp-block-uagb-icon-list-child uagb-icon-list-repeater uagb-icon-list__wrapper uagb-block-a90ae448\"><a target=\"_blank\" aria-label=\"Medical Device Regulatory \/ Standards GAP Analysis Report (English)\" rel=\"noopener noreferrer\" href=\"http:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/STANDARDS-ALLIANCE-TIER-2-FINAL-REPORT-ENGLISH-Website.pdf\"><\/a><div class=\"uagb-icon-list__content-wrap\"><span class=\"uagb-icon-list__source-wrap\"><span class=\"uagb-icon-list__source-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 512 512\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg><\/span><\/span><div class=\"uagb-icon-list__label-wrap\"><span class=\"uagb-icon-list__label\">Medical Device Regulatory \/ Standards GAP Analysis Report (English)<\/span><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-icon-list-child uagb-icon-list-repeater uagb-icon-list__wrapper uagb-block-69e624e6\"><a target=\"_blank\" aria-label=\"Medical Device Regulatory \/ Standards GAP Analysis Report (Portuguese)\" rel=\"noopener noreferrer\" href=\"http:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/standard_alliance_tier2_final_report_pt.pdf\"><\/a><div class=\"uagb-icon-list__content-wrap\"><span class=\"uagb-icon-list__source-wrap\"><span class=\"uagb-icon-list__source-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 512 512\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg><\/span><\/span><div class=\"uagb-icon-list__label-wrap\"><span class=\"uagb-icon-list__label\">Medical Device Regulatory \/ Standards GAP Analysis Report (Portuguese)<\/span><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-icon-list-child uagb-icon-list-repeater uagb-icon-list__wrapper uagb-block-0a77d518\"><div class=\"uagb-icon-list__content-wrap\"><span class=\"uagb-icon-list__source-wrap\"><span class=\"uagb-icon-list__source-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 512 512\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg><\/span><\/span><div class=\"uagb-icon-list__label-wrap\"><span class=\"uagb-icon-list__label\">Medical Device Regulatory \/ Standards GAP Analysis Report Summary Video (Spanish with English subtitles)<\/span><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n<figure class=\"wp-block-embed is-type-video is-provider-youtube wp-block-embed-youtube wp-embed-aspect-16-9 wp-has-aspect-ratio\"><div class=\"wp-block-embed__wrapper\">\n<iframe loading=\"lazy\" title=\"Standards Alliance \u2013 Tier 2 Summary Video\" width=\"1200\" height=\"675\" src=\"https:\/\/www.youtube.com\/embed\/YAYh8kBO8tc?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture\" allowfullscreen><\/iframe>\n<\/div><\/figure>\n\n\n\n<div class=\"wp-block-uagb-icon-list uagb-icon-list__outer-wrap uagb-icon-list__layout-vertical uagb-icon-list__icon-at-top uagb-block-ee2f263f mb-3\"><div class=\"uagb-icon-list__wrap\">\n<div class=\"wp-block-uagb-icon-list-child uagb-icon-list-repeater uagb-icon-list__wrapper uagb-block-b1b6d60d\"><div class=\"uagb-icon-list__content-wrap\"><span class=\"uagb-icon-list__source-wrap\"><span class=\"uagb-icon-list__source-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 512 512\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg><\/span><\/span><div class=\"uagb-icon-list__label-wrap\"><span class=\"uagb-icon-list__label\">Medical Device Regulatory \/ Standards GAP Analysis Report &#8211; Standards Development Organizations &#8211; Supplemental Information<\/span><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n<h2 class=\"has-medium-font-size wp-block-heading\">Phase 3: Bilateral Cooperation<\/h2>\n\n\n\n<p class=\"mb-3\">Beginning with the development of the gap analysis, the Standards Alliance initiated work with each project country bilaterally to begin addressing the identified gaps with the international benchmarks.<\/p>\n\n\n\n<h2 class=\"has-medium-font-size wp-block-heading\">Phase 4: Multilateral Cooperation<\/h2>\n\n\n\n<p class=\"mb-3\">Beginning with the development of the gap analysis, the Standards Alliance initiated work with the project countries multilaterally to begin addressing the identified gaps with the international benchmarks. AdvaMed formally connected the Standards Alliance with the Pan American Health Organization annual meeting of medical device regulators, sharing best practices on medical device-specific good regulatory practices, technical regulations, standards, and conformity assessment policy implementing teams from participating countries.<\/p>\n\n\n\n<section class=\"wp-block-uagb-section uagb-section__wrap uagb-section__background-undefined uagb-block-c660273d\"><div class=\"uagb-section__overlay\"><\/div><div class=\"uagb-section__inner-wrap\">\n<h3 class=\"wp-block-heading has-text-align-center mb-2 has-normal-font-size\" id=\"regulatory-coalition-principal-members\">REGULATORY COALITION PRINCIPAL MEMBERS<\/h3>\n\n\n<style id=\"wp_carousel_dynamic_css118\">.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-bg{background: #0b0b0b;opacity: 0.8;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-navigation .fancybox-button .wpcp-fancybox-nav-arrow i {color: 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