{"id":8728,"date":"2025-09-30T11:05:14","date_gmt":"2025-09-30T03:05:14","guid":{"rendered":"https:\/\/regask.com\/?p=8728"},"modified":"2025-09-30T11:05:14","modified_gmt":"2025-09-30T03:05:14","slug":"les-etats-unis-lancent-une-enquete-sur-les-importations-de-dispositifs-medicaux-et-depi","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/u-s-launches-investigation-into-medical-device-and-ppe-imports\/","title":{"rendered":"Les \u00c9tats-Unis lancent une enqu\u00eate sur les dispositifs m\u00e9dicaux et les EPI\u2026"},"content":{"rendered":"<p>Sur <strong>26 septembre 2025<\/strong>, le <a href=\"https:\/\/media.bis.gov\/\"><strong>Bureau de l&#039;industrie et de la s\u00e9curit\u00e9 (BIS) du minist\u00e8re du Commerce des \u00c9tats-Unis<\/strong><\/a> a annonc\u00e9 un <strong>Enqu\u00eate au titre de l&#039;article 232<\/strong> pour savoir si la d\u00e9pendance aux importations de <strong>\u00e9quipements de protection individuelle (EPI), consommables m\u00e9dicaux et dispositifs m\u00e9dicaux<\/strong> pr\u00e9sente des risques pour la s\u00e9curit\u00e9 nationale des \u00c9tats-Unis. Le D\u00e9partement invite le public \u00e0 commenter cette affaire, avec une date limite de soumission fix\u00e9e au <strong>17 octobre 2025<\/strong>.<\/p>\n<div class=\"row\"  id=\"row-1290930071\">\n\n\t<div id=\"col-465665719\" 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>Port\u00e9e de l&#039;enqu\u00eate<\/h3>\n\t<div id=\"gap-1673517283\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1673517283 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>L\u2019enqu\u00eate couvre une large gamme de produits li\u00e9s aux soins de sant\u00e9, notamment <strong>EPI (masques, gants)<\/strong>, <strong>consommables m\u00e9dicaux (seringues, poches \u00e0 perfusion)<\/strong>, <strong>\u00e9quipements m\u00e9dicaux durables (lits d&#039;h\u00f4pitaux)<\/strong>, et <strong>dispositifs m\u00e9dicaux (stimulateurs cardiaques, respirateurs)<\/strong>. Le BIS \u00e9valuera la capacit\u00e9 de production nationale par rapport \u00e0 la demande, aux risques li\u00e9s aux cha\u00eenes d\u2019approvisionnement \u00e9trang\u00e8res concentr\u00e9es et aux vuln\u00e9rabilit\u00e9s potentielles cr\u00e9\u00e9es par les pratiques commerciales mondiales.<\/p>\n<p>Le Minist\u00e8re s\u2019int\u00e9resse particuli\u00e8rement aux donn\u00e9es sur :<\/p>\n<ul>\n<li>L&#039;\u00e9quilibre entre <strong>capacit\u00e9 de production nationale et demande am\u00e9ricaine<\/strong>.<\/li>\n<li>Risques li\u00e9s \u00e0 <strong>subventions \u00e9trang\u00e8res, restrictions \u00e0 l&#039;exportation et pratiques commerciales pr\u00e9datrices<\/strong>.<\/li>\n<li>La faisabilit\u00e9 de <strong>augmentation de la capacit\u00e9 de production am\u00e9ricaine<\/strong> pour r\u00e9duire la d\u00e9pendance aux importations.<\/li>\n<\/ul>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-465665719 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-408483005\" 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>Date limite de retour d&#039;information<\/h3>\n\t<div id=\"gap-521652824\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-521652824 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les commentaires du public doivent \u00eatre soumis \u00e0 la <a href=\"https:\/\/www.regulations.gov\/\"><strong>Portail de r\u00e9glementation f\u00e9d\u00e9rale<\/strong><\/a><strong> d&#039;ici le 17 octobre 2025<\/strong>. Les informations commerciales confidentielles doivent \u00eatre clairement identifi\u00e9es et accompagn\u00e9es d\u2019une version non confidentielle destin\u00e9e aux archives publiques.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-408483005 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-61786578\" 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-1199229970\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1199229970 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cette enqu\u00eate a des implications importantes pour le secteur de la sant\u00e9. Si le BIS d\u00e9termine que la d\u00e9pendance aux importations compromet la s\u00e9curit\u00e9 nationale des \u00c9tats-Unis, des mesures potentielles pourraient \u00eatre prises. <strong>restrictions commerciales telles que les tarifs ou les quotas<\/strong> pourraient suivre. Ces mesures pourraient <strong>augmenter les co\u00fbts d&#039;approvisionnement<\/strong>, perturber <strong>cha\u00eenes d&#039;approvisionnement mondiales<\/strong>, et accro\u00eetre la pression sur les fabricants am\u00e9ricains pour qu&#039;ils augmentent rapidement leur production. <strong>prestataires de soins de sant\u00e9, distributeurs et fabricants d&#039;appareils<\/strong>, le r\u00e9sultat pourrait affecter <strong>tarification, strat\u00e9gies d&#039;approvisionnement et acc\u00e8s rapide des patients<\/strong> aux produits critiques.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-61786578 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1771393111\" 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 y pr\u00eater attention<\/h3>\n\t<div id=\"gap-163599102\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-163599102 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cet avis est particuli\u00e8rement pertinent pour <strong>fabricants, distributeurs, prestataires de soins de sant\u00e9 et associations industrielles<\/strong> engag\u00e9s dans la production, l&#039;importation ou la distribution d&#039;EPI, de consommables et de dispositifs m\u00e9dicaux.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1771393111 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1390325836\" 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-849170294\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-849170294 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Compte tenu de la courte p\u00e9riode de commentaires, il est conseill\u00e9 aux parties prenantes de <strong>pr\u00e9parer des soumissions formelles avec des donn\u00e9es, des analyses et des perspectives<\/strong> sur la mani\u00e8re dont les restrictions potentielles pourraient affecter les op\u00e9rations. Suivi \u00e9troit du dossier d&#039;enqu\u00eate et consultation avec <strong>conseil commercial et r\u00e9glementaire<\/strong> sont recommand\u00e9es, car tout r\u00e9sultat politique pourrait remodeler <strong>r\u00e9silience de la cha\u00eene d&#039;approvisionnement et obligations de conformit\u00e9<\/strong> \u00e0 court terme.<\/p>\n<p>En participant activement, les organisations peuvent s&#039;assurer que leurs pr\u00e9occupations sont entendues et que les d\u00e9cisions politiques futures refl\u00e8tent la r\u00e9alit\u00e9 des cha\u00eenes d&#039;approvisionnement m\u00e9dicales. C&#039;est \u00e9galement une occasion cruciale d&#039;aligner les strat\u00e9gies d&#039;approvisionnement sur l&#039;\u00e9volution des cadres commerciaux et r\u00e9glementaires.<\/p>\n<p>Alors que les entreprises \u00e9valuent l\u2019impact de ces \u00e9volutions, elles se tournent de plus en plus vers des solutions avanc\u00e9es de renseignement r\u00e9glementaire pour obtenir des informations pr\u00e9dictives et une agilit\u00e9 en mati\u00e8re de conformit\u00e9.<\/p>\n<p><a href=\"https:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/a><strong> est une solution agentique pilot\u00e9e par l&#039;IA pour l&#039;intelligence r\u00e9glementaire et l&#039;orchestration des flux de travail <\/strong>Cela simplifie la conformit\u00e9, r\u00e9duit les risques et acc\u00e9l\u00e8re l&#039;entr\u00e9e sur le march\u00e9. En combinant contenu organis\u00e9, informations exploitables et documentation intelligente avec une communaut\u00e9 connect\u00e9e de plus de 1\u00a0700 experts, RegASK permet une ex\u00e9cution r\u00e9glementaire intelligente de bout en bout tout au long du cycle de vie du produit.<\/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\u00e9server une d\u00e9mo<\/a> aujourd&#039;hui.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1390325836 > .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-947478689\">\n\n\t<div id=\"col-16498398\" 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\t<div id=\"gap-631394644\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-631394644 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<h3>FAQ<\/h3>\n\t<div id=\"gap-703870391\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-703870391 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>Qu\u2019est-ce qu\u2019une enqu\u00eate en vertu de l\u2019article 232\u00a0?<\/h4>\n\t<div id=\"gap-1061089630\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1061089630 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Une enqu\u00eate au titre de l\u2019article 232 \u00e9value si certaines importations pr\u00e9sentent des risques pour la s\u00e9curit\u00e9 nationale des \u00c9tats-Unis, pouvant entra\u00eener des mesures commerciales telles que des tarifs douaniers ou des quotas.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-16498398 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1949674395\" 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>Quels produits sont inclus dans cette enqu\u00eate ?<\/h4>\n\t<div id=\"gap-1856193305\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1856193305 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>L&#039;enqu\u00eate porte sur <strong>EPI (masques, gants), consommables m\u00e9dicaux (seringues, sacs IV), \u00e9quipements m\u00e9dicaux durables (lits d&#039;h\u00f4pitaux) et dispositifs m\u00e9dicaux (stimulateurs cardiaques, respirateurs)<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1949674395 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1001582402\" 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>Quelle est la date limite pour soumettre des commentaires ?<\/h4>\n\t<div id=\"gap-197660054\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-197660054 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les commentaires du public doivent \u00eatre soumis \u00e0 la <a href=\"https:\/\/www.regulations.gov\/\"><strong>Portail de r\u00e9glementation f\u00e9d\u00e9rale<\/strong><\/a><strong> d&#039;ici le 17 octobre 2025<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1001582402 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-173114335\" 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>Quel r\u00f4le joue le RegASK pour aider les organisations \u00e0 s\u2019adapter aux changements r\u00e9glementaires ?<\/h4>\n\t<div id=\"gap-1482961873\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1482961873 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"https:\/\/regask.com\/fr\/\">RegASK<\/a> Aide les organisations \u00e0 s&#039;adapter aux \u00e9volutions r\u00e9glementaires gr\u00e2ce \u00e0 des donn\u00e9es issues de l&#039;IA et \u00e0 une orchestration des flux de travail optimis\u00e9e. Elle permet aux \u00e9quipes de suivre les mises \u00e0 jour en temps r\u00e9el, d&#039;\u00e9valuer les risques et de rationaliser les interventions, garantissant ainsi la conformit\u00e9 m\u00eame en cas d&#039;\u00e9volution des politiques, comme lors de l&#039;enqu\u00eate relative \u00e0 la Section 232.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-173114335 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Le 26 septembre 2025, le Bureau de l&#039;industrie et de la s\u00e9curit\u00e9 (BIS) du d\u00e9partement du Commerce des \u00c9tats-Unis a annonc\u00e9 une enqu\u00eate, men\u00e9e en vertu de l&#039;article 232, afin de d\u00e9terminer si la d\u00e9pendance aux importations d&#039;\u00e9quipements de protection individuelle (EPI), de consommables m\u00e9dicaux et de dispositifs m\u00e9dicaux repr\u00e9sente un risque pour la s\u00e9curit\u00e9 nationale am\u00e9ricaine. Le d\u00e9partement invite le public \u00e0 soumettre ses observations sur ce sujet, la date limite de d\u00e9p\u00f4t \u00e9tant fix\u00e9e au\u2026<\/p>","protected":false},"author":32,"featured_media":8729,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,33,39],"tags":[],"class_list":["post-8728","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-news","category-medical-devices-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>U.S. Launches Investigation into Medical Device and PPE Imports | RegASK<\/title>\n<meta name=\"description\" content=\"The U.S. is examining national security risks of imported medical devices and PPE. 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