{"id":24303,"date":"2025-12-19T08:01:46","date_gmt":"2025-12-19T11:01:46","guid":{"rendered":"https:\/\/sobelconsult.com\/fda-publishes-q3e-for-extractables-leachables\/"},"modified":"2025-12-19T10:08:16","modified_gmt":"2025-12-19T13:08:16","slug":"fda-publishes-q3e-for-extractables-leachables","status":"publish","type":"post","link":"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/","title":{"rendered":"Nouvelles : La FDA publie le Q3E pour les substances extractibles et lixiviables"},"content":{"rendered":"\n<p>La FDA a publi\u00e9 une <strong>nouvelle ligne directrice align\u00e9e sur l&rsquo;ICH Q3E pour soutenir l&rsquo;\u00e9valuation des substances extractibles et lessivables (E&amp;L), <\/strong>ainsi qu&rsquo;une documentation de soutien qui comprend des monographies pour les substances lessivables dites de classe 3.<\/p>\n\n<p>Le document renforce l&rsquo;approche bas\u00e9e sur le risque, ce qui signifie qu&rsquo;<strong>il augmente les attentes en la mati\u00e8re :<\/strong><\/p>\n\n<ul class=\"wp-block-list\">\n<li>la robustesse des \u00e9tudes analytiques,<\/li>\n\n\n\n<li>l&rsquo;\u00e9tablissement de limites d&rsquo;exposition, et<\/li>\n\n\n\n<li>la justification du lien entre les mat\u00e9riaux, les processus de fabrication et l&rsquo;utilisation pr\u00e9vue du produit.<\/li>\n<\/ul>\n\n<p>Dans la pratique, cela se traduit par un examen plus approfondi de la tra\u00e7abilit\u00e9 des donn\u00e9es, de la coh\u00e9rence scientifique et de la justification toxicologique dans l&rsquo;ensemble du dossier.  <strong>En particulier dans les demandes d&rsquo;autorisation aupr\u00e8s de la FDA.<\/strong><\/p>\n\n<p>Pour les fabricants qui s&rsquo;appuient sur les <a href=\"https:\/\/sobelconsult.com\/fr\/iso-10993-biocompatibility-what-changes-with-the-updated-standard\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u00e9valuations de biocompatibilit\u00e9<\/a>, l&rsquo;\u00e9valuation des risques chimiques et la s\u00e9curit\u00e9 des mat\u00e9riaux. Cette \u00e9volution devrait avoir <strong>un impact sur la planification des \u00e9tudes, les calendriers et la strat\u00e9gie de documentation.<\/strong> <\/p>\n\n<p>Les entreprises qui revoient de mani\u00e8re proactive leurs strat\u00e9gies d&rsquo;\u00e9valuation - en alignant les \u00e9tudes, les rapports et les justifications r\u00e9glementaires sur les attentes de Q3E - peuvent r\u00e9duire le risque de questions, de demandes d&rsquo;informations suppl\u00e9mentaires et de retards dans le processus r\u00e9glementaire. En outre, elles peuvent <strong>renforcer la qualit\u00e9 technique globale de leurs soumissions<\/strong>. <\/p>\n\n<p>Cliquez pour v\u00e9rifier la <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/q3e-guideline-extractables-and-leachables\">ligne directrice Q3E pour les mati\u00e8res extractibles et lessivables.<\/a><\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-health-canada-proposes-regulatory-changes-for-medical-devices\"><strong>Sant\u00e9 Canada propose des modifications r\u00e9glementaires pour les dispositifs m\u00e9dicaux<\/strong><\/h2>\n\n<p>Outre la nouvelle directive de la FDA sur les mati\u00e8res extractibles et lessivables, <strong>Sant\u00e9 Canada a \u00e9galement propos\u00e9 de moderniser les exigences r\u00e9glementaires applicables aux dispositifs m\u00e9dicaux.<\/strong><\/p>\n\n<p>Dans ce contexte, l&rsquo;agence canadienne a <a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/compliance-enforcement\/establishment-licences\/medical-devices-compliance-bulletin\/consultation-modernizing-mdel-framework-phase-ii.html\">entam\u00e9 des discussions sur des initiatives visant \u00e0 mettre \u00e0 jour le cadre r\u00e9glementaire du pays en mati\u00e8re de dispositifs m\u00e9dicaux<\/a>. Les ajustements potentiels peuvent avoir un impact sur les processus de conformit\u00e9 et la surveillance post-commercialisation. <\/p>\n\n<p><strong>Ce type de changement r\u00e9glementaire doit \u00eatre suivi de pr\u00e8s<\/strong>, car il peut influencer les d\u00e9lais, les exigences en mati\u00e8re de preuves et la planification des licences tout au long du cycle de vie du produit.<\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-anvisa-updates-medical-device-regularization-manual\"><strong>L&rsquo;Anvisa met \u00e0 jour le manuel de r\u00e9gularisation des dispositifs m\u00e9dicaux<\/strong><\/h2>\n\n<p>Au Br\u00e9sil, l&rsquo;Anvisa a publi\u00e9 une <strong>nouvelle version du <a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/assuntos\/noticias-anvisa\/2025\/anvisa-publica-nova-versao-de-manual-para-regularizacao-de-equipamentos-medicos\">manuel de r\u00e9gularisation des dispositifs m\u00e9dicaux<\/a>.<\/strong><\/p>\n\n<p>Le manuel regroupe des conseils actualis\u00e9s sur la <strong>classification, les exigences en mati\u00e8re de documentation et les proc\u00e9dures de r\u00e9gularisation r\u00e9glementaire dans le pays.<\/strong><\/p>\n\n<p>En cons\u00e9quence, le mat\u00e9riel devrait contribuer \u00e0 r\u00e9duire les interpr\u00e9tations divergentes et aider les fabricants \u00e0 prendre des d\u00e9cisions relatives \u00e0 la classification r\u00e9glementaire, \u00e0 la documentation et aux strat\u00e9gies de soumission.<\/p>\n\n<figure class=\"wp-block-image aligncenter size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"612\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/11\/Anvisa-Medical-Device-Registration-1024x612.jpg\" alt=\"Enregistrement des dispositifs m&#xE9;dicaux Anvisa sur l'ordinateur portable.\" class=\"wp-image-19147\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/11\/Anvisa-Medical-Device-Registration-1024x612.jpg 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/11\/Anvisa-Medical-Device-Registration-300x179.jpg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/11\/Anvisa-Medical-Device-Registration-768x459.jpg 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/11\/Anvisa-Medical-Device-Registration.jpg 1500w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n<h2 class=\"wp-block-heading\" id=\"h-china-publishes-new-guidelines-to-accelerate-cosmetic-market-entry\"><strong>La Chine publie de nouvelles lignes directrices pour acc\u00e9l\u00e9rer l&rsquo;entr\u00e9e sur le march\u00e9 des produits cosm\u00e9tiques<\/strong><\/h2>\n\n<p>Au-del\u00e0 de la mise \u00e0 jour du manuel du Br\u00e9sil et de la directive E&amp;L de la FDA, la <strong>Chine a publi\u00e9 de <a href=\"https:\/\/english.www.gov.cn\/news\/202511\/17\/content_WS691b1a63c6d00ca5f9a079e3.html\">nouvelles lignes directrices visant \u00e0 stimuler l&rsquo;innovation et \u00e0 acc\u00e9l\u00e9rer l&rsquo;acc\u00e8s au march\u00e9 des produits cosm\u00e9tiques.<\/a><\/strong><\/p>\n\n<p>Ces mesures visent \u00e0 accro\u00eetre la pr\u00e9visibilit\u00e9 de la r\u00e9glementation, \u00e0 adapter les processus d&rsquo;\u00e9valuation et \u00e0 encourager les produits innovants.<\/p>\n\n<p>Par cons\u00e9quent, les marques qui envisagent une expansion internationale (ou qui op\u00e8rent d\u00e9j\u00e0 dans la r\u00e9gion) disposent d&rsquo;un autre signal clair indiquant que l&rsquo;<strong>environnement r\u00e9glementaire \u00e9volue pour trouver un \u00e9quilibre entre rapidit\u00e9 et surveillance.<\/strong><\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-sobel-tip-iso-10993-1-guide-for-medical-devices\"><strong>Conseil Sobel : Guide ISO 10993-1 pour les dispositifs m\u00e9dicaux<\/strong><\/h2>\n\n<p>Nous avons abord\u00e9 pr\u00e9c\u00e9demment l&rsquo;\u00e9valuation des substances extractibles et lessivables. Mais saviez-vous que cette \u00e9valuation fait partie d&rsquo;une strat\u00e9gie de biocompatibilit\u00e9 plus large <strong>, structur\u00e9e autour de la norme ISO 10993-1 ?<\/strong> <\/p>\n\n<p>Cette norme constitue le fondement de l&rsquo;\u00e9valuation des risques biologiques et chimiques des dispositifs m\u00e9dicaux et indique comment d\u00e9finir, justifier et documenter la strat\u00e9gie d&rsquo;essai tout au long du cycle de vie du produit.<\/p>\n\n<p>R\u00e9cemment, <strong>la norme a fait l&rsquo;objet d&rsquo;importantes mises \u00e0 jour.<\/strong> Pour faciliter la compr\u00e9hension de l&rsquo;avant et de l&rsquo;apr\u00e8s, nous avons pr\u00e9par\u00e9 un <a href=\"https:\/\/sobelconsult.com\/fr\/materiais\/iso-10993-12025-guide\/\">Guide ISO 10993-1:2025<\/a>.<\/p>\n\n<p>\u00c9labor\u00e9 par l&rsquo;\u00e9quipe S\u00e9curit\u00e9 humaine de Sobel, le guide explique ce qu&rsquo;\u00e9tait la norme ISO 10993-1 auparavant, ce qui a chang\u00e9 et les actions attendues de la part des fabricants.  <strong>Cerise sur le g\u00e2teau : il est disponible en t\u00e9l\u00e9chargement gratuit !<\/strong><\/p>\n\n<p><strong>T\u00e9l\u00e9chargez maintenant :<\/strong> cliquez ici : https:\/\/sobelconsult.com\/materiais\/iso-10993-12025-guide<\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-why-do-these-updates-matter\">Pourquoi ces mises \u00e0 jour sont-elles importantes ?<\/h2>\n\n<p>Ces mises \u00e0 jour renforcent une tendance globale : une rigueur technique accrue, une recherche de pr\u00e9visibilit\u00e9 et des mises \u00e0 jour constantes des exigences r\u00e9glementaires, qu&rsquo;il s&rsquo;agisse de sujets hautement techniques (tels que les mati\u00e8res extractibles et les mati\u00e8res lixiviables) ou de changements structurels dans les cadres r\u00e9glementaires et les orientations op\u00e9rationnelles.<\/p>\n\n<p>Pour les entreprises op\u00e9rant sur des march\u00e9s r\u00e9glement\u00e9s, rester attentif \u00e0 ces \u00e9volutions fait partie d&rsquo;une planification efficace de la conformit\u00e9.<\/p>\n\n<p>Et n&rsquo;oubliez pas : si vous souhaitez recevoir ces mises \u00e0 jour rapidement, abonnez-vous gratuitement au <a href=\"https:\/\/sobelconsult.com\/?popup=810\">Sobel News Round Up<\/a> et recevez dans votre bo\u00eete aux lettres \u00e9lectronique tout ce qui peut avoir un impact sur votre entreprise.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>La FDA a publi\u00e9 une nouvelle ligne directrice align\u00e9e sur l&rsquo;ICH Q3E pour soutenir l&rsquo;\u00e9valuation des substances extractibles et lessivables (E&amp;L), ainsi qu&rsquo;une documentation de soutien qui comprend des monographies pour les substances lessivables dites de classe 3. Le document renforce l&rsquo;approche bas\u00e9e sur le risque, ce qui signifie qu&rsquo;il augmente les attentes en la [&hellip;]<\/p>\n","protected":false},"author":16,"featured_media":24010,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[314],"tags":[331,136,348,347],"class_list":["post-24303","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualites","tag-china-fr","tag-dispositifs-medicaux","tag-iso-10993-1-fr","tag-sante-canada"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.3 (Yoast SEO v26.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Nouvelles : La FDA publie le Q3E pour les substances extractibles et lixiviables - Sobel<\/title>\n<meta name=\"description\" content=\"D\u00e9couvrez les changements apport\u00e9s par la directive Q3E de la FDA sur les produits extractibles et lessivables, ainsi que les principales mises \u00e0 jour du Canada, du Br\u00e9sil et de la Chine.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nouvelles : La FDA publie le Q3E pour les substances extractibles et lixiviables\" \/>\n<meta property=\"og:description\" content=\"D\u00e9couvrez les changements apport\u00e9s par la directive Q3E de la FDA sur les produits extractibles et lessivables, ainsi que les principales mises \u00e0 jour du Canada, du Br\u00e9sil et de la Chine.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/\" \/>\n<meta property=\"og:site_name\" content=\"Sobel\" \/>\n<meta property=\"article:published_time\" content=\"2025-12-19T11:01:46+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-12-19T13:08:16+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/medical-device-ivd.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1000\" \/>\n\t<meta property=\"og:image:height\" content=\"667\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Bruna Marzarotto\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u00c9crit par\" \/>\n\t<meta name=\"twitter:data1\" content=\"Bruna Marzarotto\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/\"},\"author\":{\"name\":\"Bruna Marzarotto\",\"@id\":\"https:\/\/sobelconsult.com\/fr\/#\/schema\/person\/bd2753d272a36eb353492e956e803d3b\"},\"headline\":\"Nouvelles : La FDA publie le Q3E pour les substances extractibles et lixiviables\",\"datePublished\":\"2025-12-19T11:01:46+00:00\",\"dateModified\":\"2025-12-19T13:08:16+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/\"},\"wordCount\":934,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/sobelconsult.com\/fr\/#organization\"},\"image\":{\"@id\":\"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/medical-device-ivd.jpg\",\"keywords\":[\"China\",\"Dispositifs m\u00e9dicaux\",\"ISO 10993-1\",\"Sant\u00e9 Canada\"],\"articleSection\":[\"Actualit\u00e9s\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/\",\"url\":\"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/\",\"name\":\"Nouvelles : La FDA publie le Q3E pour les substances extractibles et lixiviables - Sobel\",\"isPartOf\":{\"@id\":\"https:\/\/sobelconsult.com\/fr\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/medical-device-ivd.jpg\",\"datePublished\":\"2025-12-19T11:01:46+00:00\",\"dateModified\":\"2025-12-19T13:08:16+00:00\",\"description\":\"D\u00e9couvrez les changements apport\u00e9s par la directive Q3E de la FDA sur les produits extractibles et lessivables, ainsi que les principales mises \u00e0 jour du Canada, du Br\u00e9sil et de la Chine.\",\"breadcrumb\":{\"@id\":\"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/#breadcrumb\"},\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/#primaryimage\",\"url\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/medical-device-ivd.jpg\",\"contentUrl\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/medical-device-ivd.jpg\",\"width\":1000,\"height\":667,\"caption\":\"medical device equipment.\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Accueil\",\"item\":\"https:\/\/sobelconsult.com\/fr\/home\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Nouvelles : La FDA publie le Q3E pour les substances extractibles et lixiviables\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/sobelconsult.com\/fr\/#website\",\"url\":\"https:\/\/sobelconsult.com\/fr\/\",\"name\":\"Sobel\",\"description\":\"Regulatory Consultancy\",\"publisher\":{\"@id\":\"https:\/\/sobelconsult.com\/fr\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/sobelconsult.com\/fr\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"fr-FR\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/sobelconsult.com\/fr\/#organization\",\"name\":\"Sobel\",\"url\":\"https:\/\/sobelconsult.com\/fr\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\/\/sobelconsult.com\/fr\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png\",\"contentUrl\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png\",\"width\":741,\"height\":290,\"caption\":\"Sobel\"},\"image\":{\"@id\":\"https:\/\/sobelconsult.com\/fr\/#\/schema\/logo\/image\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\/\/sobelconsult.com\/fr\/#\/schema\/person\/bd2753d272a36eb353492e956e803d3b\",\"name\":\"Bruna Marzarotto\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\/\/sobelconsult.com\/fr\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/0739b908e11e6bd3813c8c44709242bf98c50500b85aa4103b34b62b248ec195?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/0739b908e11e6bd3813c8c44709242bf98c50500b85aa4103b34b62b248ec195?s=96&d=mm&r=g\",\"caption\":\"Bruna Marzarotto\"}}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Nouvelles : La FDA publie le Q3E pour les substances extractibles et lixiviables - Sobel","description":"D\u00e9couvrez les changements apport\u00e9s par la directive Q3E de la FDA sur les produits extractibles et lessivables, ainsi que les principales mises \u00e0 jour du Canada, du Br\u00e9sil et de la Chine.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/","og_locale":"fr_FR","og_type":"article","og_title":"Nouvelles : La FDA publie le Q3E pour les substances extractibles et lixiviables","og_description":"D\u00e9couvrez les changements apport\u00e9s par la directive Q3E de la FDA sur les produits extractibles et lessivables, ainsi que les principales mises \u00e0 jour du Canada, du Br\u00e9sil et de la Chine.","og_url":"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/","og_site_name":"Sobel","article_published_time":"2025-12-19T11:01:46+00:00","article_modified_time":"2025-12-19T13:08:16+00:00","og_image":[{"width":1000,"height":667,"url":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/medical-device-ivd.jpg","type":"image\/jpeg"}],"author":"Bruna Marzarotto","twitter_card":"summary_large_image","twitter_misc":{"\u00c9crit par":"Bruna Marzarotto","Dur\u00e9e de lecture estim\u00e9e":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/#article","isPartOf":{"@id":"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/"},"author":{"name":"Bruna Marzarotto","@id":"https:\/\/sobelconsult.com\/fr\/#\/schema\/person\/bd2753d272a36eb353492e956e803d3b"},"headline":"Nouvelles : La FDA publie le Q3E pour les substances extractibles et lixiviables","datePublished":"2025-12-19T11:01:46+00:00","dateModified":"2025-12-19T13:08:16+00:00","mainEntityOfPage":{"@id":"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/"},"wordCount":934,"commentCount":0,"publisher":{"@id":"https:\/\/sobelconsult.com\/fr\/#organization"},"image":{"@id":"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/#primaryimage"},"thumbnailUrl":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/medical-device-ivd.jpg","keywords":["China","Dispositifs m\u00e9dicaux","ISO 10993-1","Sant\u00e9 Canada"],"articleSection":["Actualit\u00e9s"],"inLanguage":"fr-FR"},{"@type":"WebPage","@id":"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/","url":"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/","name":"Nouvelles : La FDA publie le Q3E pour les substances extractibles et lixiviables - Sobel","isPartOf":{"@id":"https:\/\/sobelconsult.com\/fr\/#website"},"primaryImageOfPage":{"@id":"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/#primaryimage"},"image":{"@id":"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/#primaryimage"},"thumbnailUrl":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/medical-device-ivd.jpg","datePublished":"2025-12-19T11:01:46+00:00","dateModified":"2025-12-19T13:08:16+00:00","description":"D\u00e9couvrez les changements apport\u00e9s par la directive Q3E de la FDA sur les produits extractibles et lessivables, ainsi que les principales mises \u00e0 jour du Canada, du Br\u00e9sil et de la Chine.","breadcrumb":{"@id":"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/#breadcrumb"},"inLanguage":"fr-FR","potentialAction":[{"@type":"ReadAction","target":["https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/"]}]},{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/#primaryimage","url":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/medical-device-ivd.jpg","contentUrl":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/medical-device-ivd.jpg","width":1000,"height":667,"caption":"medical device equipment."},{"@type":"BreadcrumbList","@id":"https:\/\/sobelconsult.com\/fr\/fda-publishes-q3e-for-extractables-leachables\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Accueil","item":"https:\/\/sobelconsult.com\/fr\/home\/"},{"@type":"ListItem","position":2,"name":"Nouvelles : La FDA publie le Q3E pour les substances extractibles et lixiviables"}]},{"@type":"WebSite","@id":"https:\/\/sobelconsult.com\/fr\/#website","url":"https:\/\/sobelconsult.com\/fr\/","name":"Sobel","description":"Regulatory Consultancy","publisher":{"@id":"https:\/\/sobelconsult.com\/fr\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/sobelconsult.com\/fr\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"fr-FR"},{"@type":"Organization","@id":"https:\/\/sobelconsult.com\/fr\/#organization","name":"Sobel","url":"https:\/\/sobelconsult.com\/fr\/","logo":{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/sobelconsult.com\/fr\/#\/schema\/logo\/image\/","url":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png","contentUrl":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png","width":741,"height":290,"caption":"Sobel"},"image":{"@id":"https:\/\/sobelconsult.com\/fr\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/sobelconsult.com\/fr\/#\/schema\/person\/bd2753d272a36eb353492e956e803d3b","name":"Bruna Marzarotto","image":{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/sobelconsult.com\/fr\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/0739b908e11e6bd3813c8c44709242bf98c50500b85aa4103b34b62b248ec195?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/0739b908e11e6bd3813c8c44709242bf98c50500b85aa4103b34b62b248ec195?s=96&d=mm&r=g","caption":"Bruna Marzarotto"}}]}},"_links":{"self":[{"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/posts\/24303","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/users\/16"}],"replies":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/comments?post=24303"}],"version-history":[{"count":0,"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/posts\/24303\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/media\/24010"}],"wp:attachment":[{"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/media?parent=24303"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/categories?post=24303"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/tags?post=24303"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}