{"id":423,"date":"2021-06-15T13:07:27","date_gmt":"2021-06-15T13:07:27","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?page_id=423"},"modified":"2022-04-22T17:45:14","modified_gmt":"2022-04-22T17:45:14","slug":"national-standards-bodies-from-the-americas","status":"publish","type":"page","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/policy\/international-standardization\/standards-development-organizations-committees-and-standards-for-medical-technology\/national-standards-bodies-from-the-americas\/","title":{"rendered":"National Standards Bodies from the Americas"},"content":{"rendered":"\n<p class=\"justified\">Click&nbsp;<a href=\"http:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/SDOs-MDs-ISOIECASTM.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">here<\/a>&nbsp;for an overview of the National Standards Bodies of the Americas and their relationship with international Standards Developing Organizations and their medical device technical committees and subcommittees.<\/p>\n\n\n\n<p class=\"justified mb-3\">Links to National Standards Body Technical Committees for Medical Device Standardization:<\/p>\n\n\n\n<div class=\"wp-block-uagb-info-box mb-3 uagb-infobox__outer-wrap uagb-block-f43bbd68\"><div class=\"uagb-infobox__content-wrap uagb-infobox uagb-infobox-has-image uagb-infobox-icon-left uagb-infobox-left uagb-infobox-stacked-tablet uagb-infobox-image-valign-middle uagb-infobox-enable-border-radius \"><div class=\"uagb-ifb-left-right-wrap\"><div class=\"uagb-ifb-content\"><div class=\"uagb-ifb-title-wrap\"><span class=\"uagb-ifb-title-prefix\">Argentina<\/span><h3 class=\"uagb-ifb-title\"><a href=\"http:\/\/www.iram.org.ar\/\" target=\"_blank\" rel=\"noreferrer noopener\">IRAM &#8211; Instituto Argentino de Normalizaci\u00f3n y Certificaci\u00f3n<\/a><\/h3><\/div><div class=\"uagb-ifb-text-wrap\"><p class=\"uagb-ifb-desc\">Comit\u00e9 &#8211; Productos y Tecnologia para el Cuidado de la Salud<\/p><\/div><\/div><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-info-box mb-3 uagb-infobox__outer-wrap uagb-block-b06c65df\"><div class=\"uagb-infobox__content-wrap uagb-infobox uagb-infobox-has-image uagb-infobox-icon-left uagb-infobox-left uagb-infobox-stacked-tablet uagb-infobox-image-valign-middle uagb-infobox-enable-border-radius \"><div class=\"uagb-ifb-left-right-wrap\"><div class=\"uagb-ifb-content\"><div class=\"uagb-ifb-title-wrap\"><span class=\"uagb-ifb-title-prefix\">Brazil<\/span><h3 class=\"uagb-ifb-title\"><a href=\"https:\/\/www.cb26.org.br\/\" target=\"_blank\" rel=\"noreferrer noopener\">ABNT CB-26<\/a><br><a href=\"https:\/\/cb36.org.br\/\" target=\"_blank\" rel=\"noreferrer noopener\">ABNT CB-36<\/a> <\/h3><\/div><div class=\"uagb-ifb-text-wrap\"><\/div><\/div><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-info-box mb-3 uagb-infobox__outer-wrap uagb-block-9cf8b30e\"><div class=\"uagb-infobox__content-wrap uagb-infobox uagb-infobox-has-image uagb-infobox-icon-left uagb-infobox-left uagb-infobox-stacked-tablet uagb-infobox-image-valign-middle uagb-infobox-enable-border-radius \"><div class=\"uagb-ifb-left-right-wrap\"><div class=\"uagb-ifb-content\"><div class=\"uagb-ifb-title-wrap\"><span class=\"uagb-ifb-title-prefix\">Colombia<\/span><h3 class=\"uagb-ifb-title\"><a href=\"https:\/\/www.icontec.org\/\" target=\"_blank\" rel=\"noreferrer noopener\">ICONTEC &#8211; Instituto Colombiano de Normas T\u00e9cnicas y Certificaci\u00f3n<\/a><\/h3><\/div><div class=\"uagb-ifb-text-wrap\"><\/div><\/div><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-info-box mb-3 uagb-infobox__outer-wrap uagb-block-91f107a5\"><div class=\"uagb-infobox__content-wrap uagb-infobox uagb-infobox-has-image uagb-infobox-icon-left uagb-infobox-left uagb-infobox-stacked-tablet uagb-infobox-image-valign-middle uagb-infobox-enable-border-radius \"><div class=\"uagb-ifb-left-right-wrap\"><div class=\"uagb-ifb-content\"><div class=\"uagb-ifb-title-wrap\"><span class=\"uagb-ifb-title-prefix\">Costa Rica<\/span><h3 class=\"uagb-ifb-title\"><a href=\"https:\/\/inteco.org\/en_US\/\" target=\"_blank\" rel=\"noreferrer noopener\">INTECO &#8211; Instituto de Normas T\u00e9cnicas de Costa Rica<\/a><\/h3><\/div><div class=\"uagb-ifb-text-wrap\"><\/div><\/div><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-info-box mb-3 uagb-infobox__outer-wrap uagb-block-7bb1e25c\"><div class=\"uagb-infobox__content-wrap uagb-infobox uagb-infobox-has-image uagb-infobox-icon-left uagb-infobox-left uagb-infobox-stacked-tablet uagb-infobox-image-valign-middle uagb-infobox-enable-border-radius \"><div class=\"uagb-ifb-left-right-wrap\"><div class=\"uagb-ifb-content\"><div class=\"uagb-ifb-title-wrap\"><span class=\"uagb-ifb-title-prefix\">Mexico<\/span><h3 class=\"uagb-ifb-title\"><a href=\"https:\/\/www.gob.mx\/se\/\" target=\"_blank\" rel=\"noreferrer noopener\">DGN &#8211; Direcci\u00f3n General de Normas<\/a><\/h3><\/div><div class=\"uagb-ifb-text-wrap\"><\/div><\/div><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-info-box mb-3 uagb-infobox__outer-wrap uagb-block-95eff9ec\"><div class=\"uagb-infobox__content-wrap uagb-infobox uagb-infobox-has-image uagb-infobox-icon-left uagb-infobox-left uagb-infobox-stacked-tablet uagb-infobox-image-valign-middle uagb-infobox-enable-border-radius \"><div class=\"uagb-ifb-left-right-wrap\"><div class=\"uagb-ifb-content\"><div class=\"uagb-ifb-title-wrap\"><span class=\"uagb-ifb-title-prefix\">Peru<\/span><h3 class=\"uagb-ifb-title\"><a href=\"https:\/\/www.inacal.gob.pe\/\" target=\"_blank\" rel=\"noreferrer noopener\">INACAL &#8211; Instituto Nacional de Calidad<\/a><\/h3><\/div><div class=\"uagb-ifb-text-wrap\"><\/div><\/div><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-info-box justified mb-3 uagb-infobox__outer-wrap uagb-block-17f86602\"><div class=\"uagb-infobox__content-wrap uagb-infobox uagb-infobox-has-image uagb-infobox-icon-left uagb-infobox-left uagb-infobox-stacked-tablet uagb-infobox-image-valign-middle uagb-infobox-enable-border-radius \"><div class=\"uagb-ifb-left-right-wrap\"><div class=\"uagb-ifb-content\"><div class=\"uagb-ifb-title-wrap\"><span class=\"uagb-ifb-title-prefix\">United States<\/span><\/div><div class=\"uagb-ifb-text-wrap\"><p class=\"uagb-ifb-desc\">The U.S. uses international standards directly from&nbsp;<a href=\"\/regulatory-convergence\/policy\/international-standardization\/standards-development-organizations-committees-and-standards-for-medical-technology\/iso-iec\/\">ISO\/IEC<\/a>,&nbsp;<a href=\"\/regulatory-convergence\/policy\/international-standardization\/standards-development-organizations-committees-and-standards-for-medical-technology\/astm-international\/\">ASTM International<\/a>, and from&nbsp;<a href=\"https:\/\/www.ansi.org\/\" target=\"_blank\" rel=\"noreferrer noopener\">ANSI<\/a>&nbsp;accredited Standards Developing Organizations such as&nbsp;<a href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/policy\/international-standardization\/standards-development-organizations-committees-and-standards-for-medical-technology\/\">AAMI<\/a>,&nbsp;<a href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/policy\/international-standardization\/standards-development-organizations-committees-and-standards-for-medical-technology\/\">CLSI<\/a>, and&nbsp;<a href=\"\/regulatory-convergence\/policy\/international-standardization\/standards-development-organizations-committees-and-standards-for-medical-technology\/mita\/\">MITA<\/a>&nbsp;which either generally base their standards on those of ISO\/IEC or that submit their standards to become ISO\/IEC standards \u2013 working through and supporting the U.S. mirror committees to ISO and IEC and administering the ISO\/IEC committees.<\/p><\/div><\/div><\/div><\/div><\/div>\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: #ccc;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-navigation .fancybox-button .wpcp-fancybox-nav-arrow i:hover {color: #fff;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-navigation .fancybox-button {background: #1e1e1e;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper 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