{"id":9268,"date":"2025-11-26T17:41:51","date_gmt":"2025-11-26T09:41:51","guid":{"rendered":"https:\/\/regask.com\/?p=9268"},"modified":"2025-12-02T20:09:25","modified_gmt":"2025-12-02T12:09:25","slug":"lautorite-de-securite-des-produits-medicaux-de-singapour-hsa-publie-des-directives-actualisees-sur-le-regroupement-et-les-exigences-de-soumission-en-matiere-de-conformite-des-dispositifs-medica","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/hsa-singapore-issues-updated-guidance-on-medical-device-compliance-grouping-and-submission-requirements\/","title":{"rendered":"L&#039;autorit\u00e9 de s\u00e9curit\u00e9 des m\u00e9dicaments de Singapour (HSA) publie des directives actualis\u00e9es sur les dispositifs m\u00e9dicaux\u2026"},"content":{"rendered":"<p>Le 5 novembre 2025, <strong><a href=\"https:\/\/www.hsa.gov.sg\/\">Autorit\u00e9 des sciences de la sant\u00e9 (HSA)<\/a><\/strong> Singapour a publi\u00e9 de nouveaux documents d&#039;orientation d\u00e9crivant les exigences r\u00e9glementaires pour <strong>Enregistrement des dispositifs m\u00e9dicaux, conformit\u00e9, crit\u00e8res de regroupement et proc\u00e9dures de soumission.<\/strong> Cette mise \u00e0 jour vise \u00e0 simplifier les proc\u00e9dures r\u00e9glementaires tout en renfor\u00e7ant les exigences de s\u00e9curit\u00e9 et de performance des dispositifs m\u00e9dicaux fournis \u00e0 Singapour. Ces lignes directrices s&#039;appliquent \u00e0 <strong>fabricants, importateurs, grossistes et autres parties prenantes<\/strong> op\u00e9rant tout au long de la cha\u00eene d&#039;approvisionnement des dispositifs m\u00e9dicaux.<\/p>\n<div class=\"row\"  id=\"row-552397887\">\n\n\t<div id=\"col-929747384\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>Aper\u00e7u des directives mises \u00e0 jour<\/h3>\n\t<div id=\"gap-1645441282\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1645441282 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les nouvelles publications clarifient les crit\u00e8res de <strong>variantes autoris\u00e9es et non autoris\u00e9es des analyseurs IVD (diagnostic in vitro)<\/strong> sous le <strong>groupe familial<\/strong> Dans ce cadre, les variantes qui modifient les fonctions de diagnostic n\u00e9cessitent des listes distinctes, tandis que les variantes autoris\u00e9es peuvent \u00eatre regroup\u00e9es plus efficacement selon les r\u00e8gles existantes.<\/p>\n<p>Les lignes directrices pr\u00e9sentent \u00e9galement des attentes d\u00e9taill\u00e9es concernant <strong>dispositifs m\u00e9dicaux utilisant l&#039;apprentissage automatique,<\/strong> n\u00e9cessitant la documentation de l&#039;entra\u00eenement du mod\u00e8le, de sa validation, de ses vuln\u00e9rabilit\u00e9s potentielles et de son int\u00e9gration dans les flux de travail cliniques.<\/p>\n<p>Pour <strong>dispositifs m\u00e9dicaux connect\u00e9s,<\/strong> HSA exige la soumission de <strong>cybers\u00e9curit\u00e9<\/strong> des preuves ainsi que des plans pour la d\u00e9tection et la gestion continues des menaces.<\/p>\n<p>De plus, la mise \u00e0 jour renforce la n\u00e9cessit\u00e9 de <strong>ISO 13485 ou SS 620 (RGPD \u2013 Bonnes pratiques de distribution des dispositifs m\u00e9dicaux)<\/strong> certification tout au long de la cha\u00eene d&#039;approvisionnement, \u00e0 l&#039;exception de <strong>Dispositifs de classe A<\/strong> qui r\u00e9pondent \u00e0 des exigences de d\u00e9claration sp\u00e9cifiques. Les parties prenantes doivent \u00e9galement veiller \u00e0 ce que ces d\u00e9clarations soient faites en temps opportun.<strong> renouvellement des licences de distributeurs via le syst\u00e8me SHARE (Singapore Health Product Access and Regulatory E-System),<\/strong> avec renouvellement automatique disponible pour les utilisateurs GIRO, et doit \u00eatre mis \u00e0 jour <strong>notifications relatives aux dispositifs m\u00e9dicaux de classe A<\/strong> avant l&#039;importation ou la fourniture.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-929747384 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1999289244\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>Pourquoi c&#039;est important<\/h3>\n\t<div id=\"gap-1627484853\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1627484853 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La version actualis\u00e9e des directives apporte des pr\u00e9cisions sur le regroupement des dispositifs, la documentation relative aux dispositifs dot\u00e9s d&#039;IA, les mesures de cybers\u00e9curit\u00e9 et les certifications de qualit\u00e9 de la cha\u00eene d&#039;approvisionnement. Ces exigences favorisent la coh\u00e9rence r\u00e9glementaire, simplifient l&#039;enregistrement des produits et garantissent le respect continu des normes de s\u00e9curit\u00e9 et de performance de Singapour, sans alourdir inutilement les proc\u00e9dures administratives.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1999289244 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1867945117\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>Qui devrait examiner cette mise \u00e0 jour ?<\/h3>\n\t<div id=\"gap-651313748\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-651313748 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cette publication concerne <strong>Affaires r\u00e9glementaires, assurance qualit\u00e9, \u00e9quipes de d\u00e9veloppement d&#039;IA et de logiciels, fabricants, importateurs,<\/strong> et <strong>grossistes<\/strong> traitant des dispositifs m\u00e9dicaux \u00e0 Singapour, en particulier ceux g\u00e9rant les analyseurs IVD, les dispositifs connect\u00e9s ou les technologies bas\u00e9es sur l&#039;apprentissage automatique.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1867945117 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1501640001\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>Prochaines \u00e9tapes<\/h3>\n\t<div id=\"gap-157559532\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-157559532 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les parties prenantes devraient consulter les lignes directrices mises \u00e0 jour concernant les comptes d&#039;\u00e9pargne sant\u00e9 (CES) afin de confirmer que les classifications des produits sont conformes aux <strong>groupe familial<\/strong> crit\u00e8res. Les \u00e9quipes r\u00e9glementaires doivent \u00e9valuer la documentation relative \u00e0 <strong>appareils dot\u00e9s de capacit\u00e9s d&#039;apprentissage automatique<\/strong> et appareil connect\u00e9 <strong>preuves en mati\u00e8re de cybers\u00e9curit\u00e9,<\/strong> v\u00e9rifier <strong>ISO 13485 ou SS 620<\/strong> des certifications tout au long de la cha\u00eene d&#039;approvisionnement, et garantir <strong>Notifications de classe A<\/strong> sont mises \u00e0 jour avant l&#039;importation ou la livraison. \u00c0 mesure que les organisations affinent leurs strat\u00e9gies de conformit\u00e9, <a href=\"https:\/\/regask.com\/fr\/\">RegASK<\/a> soutient la surveillance proactive et l&#039;alignement sur les attentes \u00e9volutives de la HSA de Singapour.<\/p>\n<p>RegASK est un leader <strong>plateforme de renseignement r\u00e9glementaire et d&#039;orchestration des flux de travail d&#039;IA agentique<\/strong> Cette solution permet aux organisations internationales op\u00e9rant dans des secteurs fortement r\u00e9glement\u00e9s, tels que les biens de consommation et les sciences de la vie, d&#039;anticiper et de g\u00e9rer efficacement des environnements r\u00e9glementaires complexes. En combinant une intelligence artificielle avanc\u00e9e et l&#039;expertise de sp\u00e9cialistes, RegASK fournit des informations pr\u00e9dictives exploitables en temps opportun et une automatisation compl\u00e8te, simplifiant ainsi les processus de conformit\u00e9, att\u00e9nuant les risques et acc\u00e9l\u00e9rant l&#039;acc\u00e8s au march\u00e9 dans plus de 157 pays.<\/p>\n<p><a href=\"https:\/\/regask.com\/fr\/produit\/\">En savoir plus<\/a> ou <a href=\"https:\/\/regask.com\/fr\/reserver-une-demo\/\">R\u00e9servez une d\u00e9monstration d\u00e8s maintenant. <\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1501640001 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-881160041\">\n\n\t<div id=\"col-1964903418\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>FAQ<\/h3>\n\t<div id=\"gap-2061697749\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2061697749 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>Quels changements ont \u00e9t\u00e9 introduits pour les analyseurs IVD dans les nouvelles directives de la HSA\u00a0?<\/h4>\n\t<div id=\"gap-1318441840\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1318441840 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La mise \u00e0 jour pr\u00e9cise que les variantes d&#039;analyseurs IVD affectant la fonction de diagnostic n\u00e9cessitent des listes s\u00e9par\u00e9es, tandis que les variantes autoris\u00e9es peuvent \u00eatre regroup\u00e9es sous les crit\u00e8res FAMILY.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1964903418 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1285021407\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>Quelles sont les exigences en mati\u00e8re de documentation pour les dispositifs m\u00e9dicaux utilisant l&#039;apprentissage automatique\u00a0?<\/h4>\n\t<div id=\"gap-954243847\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-954243847 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les fabricants doivent fournir des d\u00e9tails sur l&#039;entra\u00eenement du mod\u00e8le, sa validation, ses vuln\u00e9rabilit\u00e9s et la mani\u00e8re dont il s&#039;int\u00e8gre au flux de travail clinique pr\u00e9vu.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1285021407 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1623240115\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>Existe-t-il de nouvelles exigences de certification pour les acteurs de la cha\u00eene d&#039;approvisionnement des dispositifs m\u00e9dicaux\u00a0?<\/h4>\n\t<div id=\"gap-431028509\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-431028509 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Oui. La certification ISO 13485 ou SS 620 (RGPD) est requise tout au long de la cha\u00eene d&#039;approvisionnement, \u00e0 l&#039;exception des dispositifs de classe A qui r\u00e9pondent \u00e0 des conditions de d\u00e9claration sp\u00e9cifiques.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1623240115 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-834144676\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>Comment le programme RegASK peut-il aider les entreprises \u00e0 r\u00e9pondre aux directives mises \u00e0 jour de la HSA\u00a0?<\/h4>\n\t<div id=\"gap-908613826\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-908613826 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>RegASK aide les organisations \u00e0 suivre l&#039;\u00e9volution des exigences en mati\u00e8re de comptes HSA et \u00e0 \u00e9valuer leur niveau de pr\u00e9paration \u00e0 la conformit\u00e9 gr\u00e2ce \u00e0 des renseignements r\u00e9glementaires pr\u00e9dictifs.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-834144676 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>On 5 November 2025, the Health Sciences Authority (HSA) of Singapore released new guidance documents outlining regulatory requirements for medical device registration, compliance, grouping criteria, and submission processes. The update aims to streamline regulatory pathways while reinforcing safety and performance expectations for medical devices supplied in Singapore. The guidance applies to manufacturers, importers, wholesalers, and&#8230;<\/p>","protected":false},"author":41,"featured_media":9270,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,39,583],"tags":[],"class_list":["post-9268","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-medical-devices-insights","category-singapore-regulations"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>HSA Singapore Issues Updated Guidance for Device Compliance<\/title>\n<meta name=\"description\" content=\"Explore HSA Singapore&#039;s updated guidance on medical device compliance for improved registration and submission processes.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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