{"id":69,"date":"2021-05-13T02:59:40","date_gmt":"2021-05-13T02:59:40","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?page_id=69"},"modified":"2021-07-06T13:10:16","modified_gmt":"2021-07-06T13:10:16","slug":"medical-device-sector-regulatory-convergence","status":"publish","type":"page","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/policy\/medical-device-sector-regulatory-convergence\/","title":{"rendered":"Medical Device Sector Regulatory Convergence"},"content":{"rendered":"\n<p><strong>Medical Device Sector Regulatory Convergence&nbsp;<\/strong>is a concerted public-private effort to systematically pursue and maximize alignment of medical device sector-specific technical regulations, standards and conformity assessment criteria to internationally harmonized global standards.<\/p>\n\n\n\n<p>According to the WHO, more them two million different types of medical devices circulate on the world market, categorized into more than 22,000 groups of generic devices. The regulation of medical devices contributes to the reduction of potential risks arising from their use and allows the population access to safe, effective and high quality medical devices, contributing to better public health outcomes.<\/p>\n\n\n\n<p class=\"mb-3\">On the control of these products , it is important to implement a globally aligned approach that, at the same time, contributes to the access of safe products and do not impede innovation or create unnecessary barriers to trade.<\/p>\n\n\n\n<p>In this section you will find useful information on the following topics:<\/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-129a8dbe 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-ce2124cf\"><a target=\"_self\" aria-label=\"World Health Organization Documents\" rel=\"noopener noreferrer\" href=\"\/regulatory-convergence\/policy\/medical-device-sector-regulatory-convergence\/world-health-organization-documents\/\"><\/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\">World Health Organization Documents<\/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-0b216ea0\"><a target=\"_self\" aria-label=\"International Medical Device Regulators Forum\" rel=\"noopener noreferrer\" href=\"\/regulatory-convergence\/policy\/medical-device-sector-regulatory-convergence\/imdrf\/\"><\/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\">International Medical Device Regulators Forum<\/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-001d21a5\"><a target=\"_self\" aria-label=\"Medical Device Single Audit Program (MDSAP)\" rel=\"noopener noreferrer\" href=\"\/regulatory-convergence\/policy\/medical-device-sector-regulatory-convergence\/medical-device-single-audit-program-mdsap\/\"><\/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 Single Audit Program (MDSAP)<\/span><\/div><\/div><\/div>\n<\/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 .fancybox-navigation .fancybox-button:hover {background: #1e1e1e;}#sp-wp-carousel-free-id-118 .wpcp-swiper-dots {margin: 40px 0px 0px 0px;}.wpcp-wrapper-118 .swiper-wrapper .swiper-slide-kenburn, .wpcp-wrapper-118 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