{"id":33048,"date":"2026-03-13T08:47:12","date_gmt":"2026-03-13T11:47:12","guid":{"rendered":"https:\/\/sobelconsult.com\/news-imdrf-publishes-regulatory-reliance-playbook\/"},"modified":"2026-03-13T14:25:32","modified_gmt":"2026-03-13T17:25:32","slug":"news-imdrf-publishes-regulatory-reliance-playbook","status":"publish","type":"post","link":"https:\/\/sobelconsult.com\/fr\/news-imdrf-publishes-regulatory-reliance-playbook\/","title":{"rendered":"Nouvelles : L’IMDRF publie le \u00ab\u00a0Regulatory Reliance Playbook\u00a0\u00bb (manuel de r\u00e9f\u00e9rence sur la r\u00e9glementation)"},"content":{"rendered":"\n

L’environnement r\u00e9glementaire des dispositifs m\u00e9dicaux a fait l’objet d’ajustements significatifs sur les diff\u00e9rents march\u00e9s. Dans ce contexte, une attention croissante est accord\u00e9e aux approches qui permettent aux autorit\u00e9s r\u00e9glementaires de s’appuyer sur des \u00e9valuations d\u00e9j\u00e0 r\u00e9alis\u00e9es par des autorit\u00e9s de r\u00e9f\u00e9rence de confiance, sans renoncer \u00e0 la responsabilit\u00e9 r\u00e9glementaire locale - c’est ce qu’on appelle la confiance r\u00e9glementaire. <\/p>\n\n

Les actions r\u00e9centes de l’IMDRF, de la FDA, de l’Anvisa et des r\u00e9gulateurs asiatiques montrent que cette approche gagne du terrain dans les discussions r\u00e9glementaires mondiales.<\/p>\n\n

Dans un secteur en constante \u00e9volution, il est essentiel de suivre ces initiatives afin d’aligner les strat\u00e9gies r\u00e9glementaires, d’anticiper les impacts et de r\u00e9duire l’incertitude.<\/p>\n\n

Vous trouverez ci-dessous les principaux d\u00e9veloppements r\u00e9glementaires de ces derni\u00e8res semaines.<\/p>\n\n

Conseil :<\/strong> Ceux qui s’abonnent \u00e0 Sobel News Round Up<\/em><\/a>notre lettre d’information gratuite, savent d\u00e9j\u00e0 tout cela, car ils re\u00e7oivent l’information en premier. Abonnez-vous et gardez une longueur d’avance ! <\/p>\n\n

L’IMDRF et la confiance r\u00e9glementaire<\/h2>\n\n

Tout d’abord, il est important de comprendre le concept de confiance r\u00e9glementaire.<\/p>\n\n

La confiance r\u00e9glementaire est la pratique par laquelle une autorit\u00e9 r\u00e9glementaire prend en compte et utilise, en tout ou en partie, des \u00e9valuations r\u00e9alis\u00e9es par d’autres autorit\u00e9s r\u00e9glementaires de confiance, tout en conservant la responsabilit\u00e9 de la d\u00e9cision finale au sein de sa propre juridiction.<\/p>\n\n

Cette approche vise \u00e0 \u00e9viter la duplication des efforts r\u00e9glementaires, \u00e0 promouvoir une utilisation plus efficace des ressources et \u00e0 acc\u00e9l\u00e9rer les processus d’examen, sans compromettre la s\u00e9curit\u00e9, l’efficacit\u00e9 ou la performance des produits.<\/p>\n\n

La confiance dans la r\u00e9glementation peut prendre diff\u00e9rentes formes, telles que des examens abr\u00e9g\u00e9s, la reconnaissance de d\u00e9cisions r\u00e9glementaires \u00e9trang\u00e8res ou des mod\u00e8les de partage des t\u00e2ches entre les autorit\u00e9s.<\/p>\n\n

Bien que le concept ne soit pas nouveau, son adoption s’est acc\u00e9l\u00e9r\u00e9e ces derni\u00e8res ann\u00e9es en raison de la complexit\u00e9 technologique croissante des dispositifs m\u00e9dicaux.<\/p>\n\n

Mais quelle est la place de l’IMDRF dans tout cela ?<\/p>\n\n

Fin f\u00e9vrier 2026, l’IMDRF (International Medical Device Regulators Forum) a publi\u00e9 le Playbook for Medical Device Regulatory Reliance Programs (Guide pour les programmes de confiance en mati\u00e8re de r\u00e9glementation des dispositifs m\u00e9dicaux)<\/em><\/a>.<\/p>\n\n

Ce document fournit des orientations pratiques aux autorit\u00e9s r\u00e9glementaires d\u00e9sireuses d’\u00e9laborer ou d’am\u00e9liorer des programmes formels de fiabilit\u00e9 r\u00e9glementaire pour les dispositifs m\u00e9dicaux et les diagnostics in vitro.<\/p>\n\n

\u00c9labor\u00e9 par le groupe de travail sur les bonnes pratiques d’examen de la r\u00e9glementation (GRRP), ce guide consolide les d\u00e9finitions, pr\u00e9sente des exemples de mod\u00e8les existants et d\u00e9crit des \u00e9tapes pratiques pour la mise en \u0153uvre de programmes fond\u00e9s sur la confiance dans la r\u00e9glementation, tout en renfor\u00e7ant de mani\u00e8re coh\u00e9rente l’ind\u00e9pendance r\u00e9glementaire et la responsabilit\u00e9 en mati\u00e8re de prise de d\u00e9cision.<\/p>\n\n

Pour les fabricants, cela repr\u00e9sente un changement significatif dans le paysage r\u00e9glementaire, avec des impacts potentiels sur les d\u00e9lais d’approbation, les strat\u00e9gies de soumission et la priorisation du march\u00e9.<\/p>\n\n

Les mises \u00e0 jour r\u00e9glementaires renforcent la tendance mondiale<\/h2>\n\n

Outre l’initiative IMDRF, d’autres d\u00e9veloppements r\u00e9cents renforcent la recherche d’une efficacit\u00e9 et d’une pr\u00e9visibilit\u00e9 r\u00e9glementaires accrues.<\/p>\n\n

Fonctions essentielles et priorit\u00e9s de la FDA<\/h3>\n\n

Aux \u00c9tats-Unis, la FDA a confirm\u00e9 que les fonctions essentielles et les priorit\u00e9s de son programme d’inspection<\/a> restaient inchang\u00e9es, malgr\u00e9 les r\u00e9cents changements de direction.<\/p>\n\n

L’agence continuera \u00e0 se concentrer sur les inspections fond\u00e9es sur les risques, les inspections pr\u00e9alables \u00e0 l’agr\u00e9ment et les activit\u00e9s de surveillance, y compris les inspections dans les installations internationales.<\/p>\n\n

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

Cette position renforce l’importance de syst\u00e8mes de qualit\u00e9 robustes<\/a> et d’une mise en conformit\u00e9 permanente pour les entreprises op\u00e9rant sur le march\u00e9.<\/p>\n\n

Le syst\u00e8me UDI est op\u00e9rationnel au Br\u00e9sil<\/h3>\n\n

Au Br\u00e9sil, l’Anvisa a lanc\u00e9 le syst\u00e8me d’identification unique des dispositifs m\u00e9dicaux (Siud<\/a>), align\u00e9 sur les directives de l’IMDRF.<\/p>\n\n

L’initiative renforce la tra\u00e7abilit\u00e9 et la surveillance apr\u00e8s la mise sur le march\u00e9, rapprochant le pays des pratiques r\u00e9glementaires adopt\u00e9es au niveau international et augmentant la transparence tout au long de la cha\u00eene d’approvisionnement.<\/p>\n\n

La Malaisie actualise les r\u00e8gles relatives \u00e0 l’achat de dispositifs m\u00e9dicaux<\/h3>\n\n

En Asie, l’autorit\u00e9 de r\u00e9gulation de la Malaisie a publi\u00e9 de nouvelles r\u00e8gles r\u00e9gissant l’acquisition de dispositifs m\u00e9dicaux<\/a> par les h\u00f4pitaux et les \u00e9tablissements de soins de sant\u00e9.<\/p>\n\n

Les r\u00e8glements pr\u00e9cisent que les fournisseurs impliqu\u00e9s dans les processus d’achat publics ou priv\u00e9s doivent se conformer pleinement aux exigences r\u00e9glementaires locales, y compris les licences appropri\u00e9es, ce qui renforce le r\u00f4le de la r\u00e9glementation dans les activit\u00e9s de commercialisation.<\/p>\n\n

La veille r\u00e9glementaire, un avantage concurrentiel<\/h2>\n\n

Les initiatives r\u00e9centes de l’IMDRF, de la FDA, de l’Anvisa et des autorit\u00e9s r\u00e9glementaires asiatiques montrent clairement que l’environnement r\u00e9glementaire mondial est en constante transformation.Pour les entreprises de dispositifs m\u00e9dicaux, le suivi de ces changements ne doit pas \u00eatre consid\u00e9r\u00e9 uniquement comme une obligation de conformit\u00e9, mais comme un outil strat\u00e9gique.<\/p>\n\n

Comprendre comment des concepts tels que la d\u00e9pendance r\u00e9glementaire sont int\u00e9gr\u00e9s dans les cadres r\u00e9glementaires peut aider les entreprises \u00e0 anticiper les sc\u00e9narios, \u00e0 r\u00e9duire les risques, \u00e0 optimiser les investissements et \u00e0 prendre des d\u00e9cisions plus \u00e9clair\u00e9es en mati\u00e8re d’expansion internationale.<\/p>\n\n

C’est pourquoi le fait de rester inform\u00e9 de ces \u00e9volutions peut faire toute la diff\u00e9rence dans votre prochaine strat\u00e9gie r\u00e9glementaire.<\/p>\n\n

Et n’oubliez pas : l’\u00e9quipe de Sobel est \u00e0 votre disposition pour vous guider<\/a> dans vos d\u00e9marches r\u00e9glementaires \u00e0 l’\u00e9chelle mondiale !<\/p>\n","protected":false},"excerpt":{"rendered":"

Comprendre le concept de d\u00e9pendance r\u00e9glementaire et comment les initiatives de l’IMDRF, de la FDA et de l’Anvisa ont un impact sur la r\u00e9glementation mondiale.<\/p>\n","protected":false},"author":16,"featured_media":33038,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[314],"tags":[315,252,295,136,85,117],"class_list":["post-33048","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualites","tag-actualites","tag-anvisa","tag-brazil","tag-dispositifs-medicaux","tag-fda","tag-leurope"],"yoast_head":"\nNouvelles : L'IMDRF publie le "Regulatory Reliance Playbook" (manuel de r\u00e9f\u00e9rence sur la r\u00e9glementation) - Sobel<\/title>\n<meta name=\"description\" content=\"Comprendre le concept de d\u00e9pendance r\u00e9glementaire et comment les initiatives de l'IMDRF, de la FDA et de l'Anvisa ont un impact sur la r\u00e9glementation mondiale.\" \/>\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-imdrf-publishes-regulatory-reliance-playbook\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nouvelles : L'IMDRF publie le "Regulatory Reliance Playbook" (manuel de r\u00e9f\u00e9rence sur la r\u00e9glementation)\" \/>\n<meta property=\"og:description\" content=\"Comprendre le concept de d\u00e9pendance r\u00e9glementaire et comment les initiatives de l'IMDRF, de la FDA et de l'Anvisa ont un impact sur la r\u00e9glementation mondiale.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sobelconsult.com\/fr\/news-imdrf-publishes-regulatory-reliance-playbook\/\" \/>\n<meta property=\"og:site_name\" content=\"Sobel\" \/>\n<meta property=\"article:published_time\" content=\"2026-03-13T11:47:12+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-03-13T17:25:32+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/03\/Playbook-IMDRF-reliance.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1845\" \/>\n\t<meta property=\"og:image:height\" content=\"871\" \/>\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-imdrf-publishes-regulatory-reliance-playbook\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/fr\\\/news-imdrf-publishes-regulatory-reliance-playbook\\\/\"},\"author\":{\"name\":\"Bruna Marzarotto\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/fr\\\/#\\\/schema\\\/person\\\/bd2753d272a36eb353492e956e803d3b\"},\"headline\":\"Nouvelles : L’IMDRF publie le \u00ab\u00a0Regulatory Reliance Playbook\u00a0\u00bb (manuel de r\u00e9f\u00e9rence sur la r\u00e9glementation)\",\"datePublished\":\"2026-03-13T11:47:12+00:00\",\"dateModified\":\"2026-03-13T17:25:32+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/fr\\\/news-imdrf-publishes-regulatory-reliance-playbook\\\/\"},\"wordCount\":1052,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/fr\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/fr\\\/news-imdrf-publishes-regulatory-reliance-playbook\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/Playbook-IMDRF-reliance.jpg\",\"keywords\":[\"Actualit\u00e9s\",\"Anvisa\",\"Brazil\",\"Dispositifs m\u00e9dicaux\",\"FDA\",\"L'Europe\"],\"articleSection\":[\"Actualit\u00e9s\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/fr\\\/news-imdrf-publishes-regulatory-reliance-playbook\\\/\",\"url\":\"https:\\\/\\\/sobelconsult.com\\\/fr\\\/news-imdrf-publishes-regulatory-reliance-playbook\\\/\",\"name\":\"Nouvelles : L'IMDRF publie le \\\"Regulatory Reliance Playbook\\\" (manuel de r\u00e9f\u00e9rence sur la r\u00e9glementation) - 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