{"id":34969,"date":"2026-05-11T11:29:16","date_gmt":"2026-05-11T14:29:16","guid":{"rendered":"https:\/\/sobelconsult.com\/news-anvisa-regulatory-sandbox-and-global-updates\/"},"modified":"2026-05-12T05:56:43","modified_gmt":"2026-05-12T08:56:43","slug":"news-anvisa-regulatory-sandbox-and-global-updates","status":"publish","type":"post","link":"https:\/\/sobelconsult.com\/fr\/news-anvisa-regulatory-sandbox-and-global-updates\/","title":{"rendered":"Nouvelles : L’Anvisa Regulatory Sandbox et les mises \u00e0 jour mondiales"},"content":{"rendered":"\n

L’innovation, la surveillance post-commercialisation et l’\u00e9volution des attentes en mati\u00e8re de conformit\u00e9 sont en train de remodeler le paysage r\u00e9glementaire dans le monde entier. Et comme les autorit\u00e9s r\u00e9glementaires s’adaptent aux nouvelles technologies et aux demandes du march\u00e9, les fabricants doivent rester attentifs aux changements qui peuvent avoir un impact direct sur les strat\u00e9gies d’acc\u00e8s au march\u00e9.<\/strong> <\/p>\n\n

Dans ce contexte, Anvisa a fait un grand pas en avant avec sa nouvelle initiative \u00ab\u00a0Regulatory Sandbox\u00a0\u00bb (bac \u00e0 sable r\u00e9glementaire) ax\u00e9e sur les cosm\u00e9tiques personnalis\u00e9s. Mais au-del\u00e0 du Br\u00e9sil, il y a aussi des mises \u00e0 jour pertinentes concernant la surveillance apr\u00e8s la mise sur le march\u00e9 en Chine, des discussions autour des exigences MDR et IVDR en Europe<\/a>, et des changements \u00e0 la norme ISO 10993-7. <\/p>\n\n

Nous avons rassembl\u00e9 ci-dessous les derni\u00e8res nouveaut\u00e9s en mati\u00e8re de r\u00e9glementation et expliqu\u00e9 pourquoi elles m\u00e9ritent l’attention des fabricants.<\/p>\n\n

Anvisa fait progresser le \u00ab\u00a0bac \u00e0 sable\u00a0\u00bb r\u00e9glementaire pour les produits cosm\u00e9tiques personnalis\u00e9s<\/strong><\/h2>\n\n

Anvisa a annonc\u00e9 les r\u00e9sultats de l’\u00e9tape de s\u00e9lection pr\u00e9liminaire pour son \u00ab\u00a0Regulatory Sandbox\u00a0\u00bb (bac \u00e0 sable r\u00e9glementaire)<\/a><\/strong> ax\u00e9 sur les produits de soins personnels personnalis\u00e9s, les cosm\u00e9tiques et les parfums.<\/p>\n\n

Quatre projets innovants ont \u00e9t\u00e9 jug\u00e9s \u00e9ligibles pour passer \u00e0 la phase suivante,<\/strong> qui comprend une \u00e9valuation technique d\u00e9taill\u00e9e des propositions soumises par les entreprises participantes.<\/p>\n\n

Cette initiative fait partie de l’environnement r\u00e9glementaire exp\u00e9rimental d’Anvisa. Il a \u00e9t\u00e9 con\u00e7u pour permettre aux entreprises de tester des mod\u00e8les commerciaux innovants dans des conditions r\u00e9glementaires contr\u00f4l\u00e9es. <\/p>\n\n

Le nouveau \u00ab\u00a0bac \u00e0 sable\u00a0\u00bb r\u00e9glementaire pourrait permettre aux entreprises de d\u00e9velopper et de tester des solutions cosm\u00e9tiques personnalis\u00e9es sur le lieu de vente. Ces activit\u00e9s peuvent \u00eatre men\u00e9es dans le cadre d’assouplissements r\u00e9glementaires temporaires et de protocoles adapt\u00e9s. <\/p>\n\n

Ce mouvement refl\u00e8te une tendance croissante dans le secteur des cosm\u00e9tiques : la demande croissante de personnalisation, de num\u00e9risation et d’exp\u00e9riences de consommation sur mesure<\/strong>.<\/p>\n\n

La Chine renforce les exigences en mati\u00e8re de surveillance apr\u00e8s la mise sur le march\u00e9<\/strong><\/h2>\n\n

La Chine a publi\u00e9 de nouvelles lignes directrices renfor\u00e7ant les exigences en mati\u00e8re de surveillance<\/a><\/strong> pour les dispositifs m\u00e9dicaux.<\/p>\n\n

Les r\u00e8gles actualis\u00e9es mettent davantage l’accent sur les activit\u00e9s d’\u00e9valuation des risques et sur des examens plus stricts des rapports p\u00e9riodiques, ce qui accro\u00eet les attentes en mati\u00e8re de conformit\u00e9 pour les fabricants locaux et \u00e9trangers.<\/p>\n\n

Cela signifie que les entreprises op\u00e9rant sur le march\u00e9 chinois peuvent avoir besoin de syst\u00e8mes de surveillance post-commercialisation plus robustes, de pratiques de documentation plus solides et d’un suivi plus \u00e9troit des obligations r\u00e9glementaires locales.<\/p>\n\n

Les activit\u00e9s post-commercialisation deviennent de plus en plus strat\u00e9giques pour maintenir la conformit\u00e9 et l’acc\u00e8s au march\u00e9 \u00e0 long terme.<\/p>\n\n

\"\"<\/figure>\n\n

Les organismes notifi\u00e9s s’inqui\u00e8tent de la r\u00e9vision du MDR et de l’IVDR<\/strong><\/h2>\n\n

Team-NB a fait part de ses pr\u00e9occupations concernant les r\u00e9visions propos\u00e9es pour les cadres MDR et IVDR en Europe<\/a><\/strong>.<\/p>\n\n

Selon l’association, la r\u00e9duction des exigences en mati\u00e8re de surveillance apr\u00e8s la mise sur le march\u00e9 pourrait cr\u00e9er des risques r\u00e9glementaires et avoir un impact potentiel sur la s\u00e9curit\u00e9 des patients au fil du temps.<\/strong><\/p>\n\n

La discussion met en \u00e9vidence le fait que la surveillance apr\u00e8s la mise sur le march\u00e9 reste l’un des piliers centraux du syst\u00e8me r\u00e9glementaire europ\u00e9en, en particulier dans le cadre du MDR et de l’IVDR.<\/p>\n\n

Pour les fabricants, il s’agit d’un rappel important que le paysage r\u00e9glementaire europ\u00e9en continue d’\u00e9voluer. Cela n\u00e9cessite \u00e9galement un suivi constant des discussions l\u00e9gislatives et r\u00e9glementaires. <\/p>\n\n

La norme ISO 10993-7:2026 introduit des mises \u00e0 jour de l’\u00e9valuation biologique<\/strong><\/h2>\n\n

L’Organisation internationale de normalisation a officiellement mis \u00e0 jour la norme ISO 10993-7:2026 avec des crit\u00e8res r\u00e9vis\u00e9s concernant les r\u00e9sidus de st\u00e9rilisation<\/a>.<\/strong><\/p>\n\n

La norme actualis\u00e9e introduit une approche davantage ax\u00e9e sur le risque, prenant en compte des facteurs tels que la population de patients et la dur\u00e9e d’utilisation lors de la d\u00e9finition des limites acceptables.<\/p>\n\n

En outre, la nouvelle version fournit des orientations plus d\u00e9taill\u00e9es sur la mise sur le march\u00e9 des produits et les m\u00e9thodes d’\u00e9valuation.<\/p>\n\n

Cette mise \u00e0 jour renforce l’attente croissante des fabricants de fournir des justifications scientifiques plus solides tout au long des activit\u00e9s d’\u00e9valuation biologique et des processus de gestion des risques.<\/p>\n\n

Conseil : <\/strong>L’\u00e9valuation biologique soul\u00e8ve souvent des questions chez les fabricants, en particulier lorsqu’elle est compar\u00e9e aux \u00e9valuations cliniques et toxicologiques. Dans notre dernier article de blog, nous expliquons les diff\u00e9rences entre ces \u00e9valuations<\/a>, comment elles sont li\u00e9es les unes aux autres et pourquoi elles sont essentielles tout au long du processus r\u00e9glementaire.<\/strong> <\/p>\n\n

Innovation, surveillance apr\u00e8s la mise sur le march\u00e9 et adaptation de la r\u00e9glementation<\/strong><\/h2>\n\n

Chaque semaine, les autorit\u00e9s r\u00e9glementaires du monde entier introduisent des mises \u00e0 jour qui peuvent avoir un impact direct sur les fabricants de dispositifs m\u00e9dicaux, de produits de diagnostic in vitro et de produits cosm\u00e9tiques.<\/p>\n\n

Qu’il s’agisse de la mise en place de l’Environnement r\u00e9glementaire au Br\u00e9sil, des exigences plus strictes en mati\u00e8re de surveillance post-commercialisation ou de l’\u00e9volution des normes internationales, ces changements montrent que les strat\u00e9gies r\u00e9glementaires doivent s’adapter en permanence \u00e0 l’innovation et aux attentes en mati\u00e8re de conformit\u00e9 \u00e0 l’\u00e9chelle mondiale.<\/p>\n\n

Plus que jamais, il est essentiel de rester inform\u00e9 pour r\u00e9duire les risques, \u00e9viter les retards et maintenir la comp\u00e9titivit\u00e9 sur des march\u00e9s r\u00e9glement\u00e9s de plus en plus complexes.<\/p>\n\n

Vous souhaitez rester au fait des \u00e9volutions du secteur et des mises \u00e0 jour r\u00e9glementaires ? Abonnez-vous \u00e0 notre lettre d’information. Inscrivez-vous en cliquant sur le bouton ci-dessous !<\/strong><\/p>\n\n

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Recevez les nouvelles !<\/strong><\/a><\/div>\n<\/div>\n\n

Laissez l’information vous aider \u00e0 r\u00e9duire les risques, \u00e0 \u00e9viter les retouches et \u00e0 maintenir la comp\u00e9titivit\u00e9 !<\/p>\n","protected":false},"excerpt":{"rendered":"

Anvisa fait progresser son initiative \u00ab\u00a0Regulatory Sandbox\u00a0\u00bb pour les cosm\u00e9tiques personnalis\u00e9s, tandis que les r\u00e9gulateurs mondiaux renforcent la surveillance apr\u00e8s la mise sur le march\u00e9.<\/p>\n","protected":false},"author":16,"featured_media":34958,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[314],"tags":[315,252,295,327,136,97,117],"class_list":["post-34969","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualites","tag-actualites","tag-anvisa","tag-brazil","tag-china","tag-dispositifs-medicaux","tag-iso","tag-leurope"],"yoast_head":"\nNouvelles : L'Anvisa Regulatory Sandbox et les mises \u00e0 jour mondiales - Sobel<\/title>\n<meta name=\"description\" content=\"Anvisa fait progresser son initiative "Regulatory Sandbox" pour les cosm\u00e9tiques personnalis\u00e9s, tandis que les r\u00e9gulateurs mondiaux renforcent la surveillance apr\u00e8s la mise sur le march\u00e9.\" \/>\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\/news-anvisa-regulatory-sandbox-and-global-updates\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nouvelles : L'Anvisa Regulatory Sandbox et les mises \u00e0 jour mondiales\" \/>\n<meta property=\"og:description\" content=\"Anvisa fait progresser son initiative "Regulatory Sandbox" pour les cosm\u00e9tiques personnalis\u00e9s, tandis que les r\u00e9gulateurs mondiaux renforcent la surveillance apr\u00e8s la mise sur le march\u00e9.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sobelconsult.com\/fr\/news-anvisa-regulatory-sandbox-and-global-updates\/\" \/>\n<meta property=\"og:site_name\" content=\"Sobel\" \/>\n<meta property=\"article:published_time\" content=\"2026-05-11T14:29:16+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-05-12T08:56:43+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/cosmetic-test.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=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/fr\\\/news-anvisa-regulatory-sandbox-and-global-updates\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/fr\\\/news-anvisa-regulatory-sandbox-and-global-updates\\\/\"},\"author\":{\"name\":\"Bruna Marzarotto\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/fr\\\/#\\\/schema\\\/person\\\/bd2753d272a36eb353492e956e803d3b\"},\"headline\":\"Nouvelles : L’Anvisa Regulatory Sandbox et les mises \u00e0 jour mondiales\",\"datePublished\":\"2026-05-11T14:29:16+00:00\",\"dateModified\":\"2026-05-12T08:56:43+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/fr\\\/news-anvisa-regulatory-sandbox-and-global-updates\\\/\"},\"wordCount\":1056,\"publisher\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/fr\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/fr\\\/news-anvisa-regulatory-sandbox-and-global-updates\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2026\\\/05\\\/cosmetic-test.jpg\",\"keywords\":[\"Actualit\u00e9s\",\"Anvisa\",\"Brazil\",\"China\",\"Dispositifs m\u00e9dicaux\",\"ISO\",\"L'Europe\"],\"articleSection\":[\"Actualit\u00e9s\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/fr\\\/news-anvisa-regulatory-sandbox-and-global-updates\\\/\",\"url\":\"https:\\\/\\\/sobelconsult.com\\\/fr\\\/news-anvisa-regulatory-sandbox-and-global-updates\\\/\",\"name\":\"Nouvelles : L'Anvisa Regulatory Sandbox et les mises \u00e0 jour mondiales - 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