{"id":575,"date":"2021-06-16T08:56:47","date_gmt":"2021-06-16T08:56:47","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?page_id=575"},"modified":"2021-07-06T13:11:32","modified_gmt":"2021-07-06T13:11:32","slug":"who-guidance","status":"publish","type":"page","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/policy\/medical-device-sector-regulatory-convergence\/world-health-organization-documents\/who-guidance\/","title":{"rendered":"WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices"},"content":{"rendered":"\n<section class=\"wp-block-uagb-columns uagb-columns__wrap uagb-columns__background-undefined uagb-columns__stack-mobile uagb-columns__valign-undefined uagb-columns__gap-0 alignundefined uagb-block-7ad17653\"><div class=\"uagb-columns__overlay\"><\/div><div class=\"uagb-columns__inner-wrap uagb-columns__columns-2\">\n<div class=\"wp-block-uagb-column uagb-column__wrap uagb-column__background-undefined uagb-block-a165081a\"><div class=\"uagb-column__overlay\"><\/div><div class=\"uagb-column__inner-wrap\">\n<div class=\"wp-block-image\"><figure class=\"aligncenter size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"191\" height=\"265\" src=\"http:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/WHO-Model-1-1.jpg\" alt=\"\" class=\"wp-image-585\"\/><\/figure><\/div>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-column uagb-column__wrap uagb-column__background-undefined uagb-block-c50289b7\"><div class=\"uagb-column__overlay\"><\/div><div class=\"uagb-column__inner-wrap\">\n<p class=\"mb-3\">The model suggests a progressive approach, establishing two levels of control to be adopted: basic and expanded. The use of these levels of control will depend on the maturity of the existing regulatory system in the country. It also suggests that countries use reliance mechanisms (a process in which a regulatory authority considers evaluation made by another authority in its decision-making process).<\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link\" href=\"https:\/\/apps.who.int\/iris\/bitstream\/handle\/10665\/255177\/9789241512350-eng.pdf;jsessionid=0223ABE7D11FA16C0F17AEC3B9706C8F?sequence=1\" target=\"_blank\" rel=\"noreferrer noopener\">READ THE DOCUMENT<\/a><\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/section>\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 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width=\"240\" height=\"98\">\t<\/div>\n\t\t<\/div>\n<\/div>\n\t<div class=\"swiper-slide\">\n\t<div class=\"wpcp-single-item\">\n\t\t\t<div class=\"wpcp-slide-image\">\n\t\t<img loading=\"lazy\" decoding=\"async\" class=\"skip-lazy\" src=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/member_advamed.jpg\" alt=\"member_advamed\" width=\"240\" height=\"65\">\t<\/div>\n\t\t<\/div>\n<\/div>\n\t\t\t<\/div>\n\t\t\t\t\t<div class=\"wpcp-swiper-dots swiper-pagination\"><\/div>\n\t\t\t\t<!-- If we need navigation buttons -->\n\t\t\t\t\t<div class=\"wpcp-prev-button swiper-button-prev\"><i class=\"fa fa-angle-left\"><\/i><\/div>\n\t\t\t<div class=\"wpcp-next-button swiper-button-next\"><i class=\"fa fa-angle-right\"><\/i><\/div>\n\t\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<\/div><\/section>\n","protected":false},"excerpt":{"rendered":"<p>The model suggests a progressive approach, establishing two levels of control to be adopted: basic and expanded. The use of these levels of control will depend on the maturity of the existing regulatory system in the country. It also suggests that countries use reliance mechanisms (a process in which a regulatory authority considers evaluation made&hellip;<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":2221,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","footnotes":""},"class_list":["post-575","page","type-page","status-publish","hentry","description-off"],"acf":[],"featured_image_src":null,"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices - Regulatory Convergence<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/policy\/medical-device-sector-regulatory-convergence\/world-health-organization-documents\/who-guidance\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices - Regulatory Convergence\" \/>\n<meta property=\"og:description\" content=\"The model suggests a progressive approach, establishing two levels of control to be adopted: basic and expanded. 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