{"id":8170,"date":"2025-10-11T11:19:42","date_gmt":"2025-10-11T11:19:42","guid":{"rendered":"https:\/\/kmslaser.com\/?p=8170"},"modified":"2025-10-19T13:05:24","modified_gmt":"2025-10-19T13:05:24","slug":"les-appareils-de-therapie-par-ondes-de-choc-importes-doivent-ils-repondre-aux-exigences-ou-a-la-certification-de-la-fda","status":"publish","type":"post","link":"https:\/\/kmslaser.com\/fr\/should-imported-shockwave-therapy-machines-meet-fda-requirements-or-certification\/","title":{"rendered":"Les machines import\u00e9es de th\u00e9rapie par ondes de choc doivent-elles r\u00e9pondre aux exigences ou \u00e0 la certification de la FDA ?"},"content":{"rendered":"<p><iframe data-testid=\"embed-iframe\" style=\"border-radius:12px\" src=\"https:\/\/open.spotify.com\/embed\/episode\/2PWlWN8VuBPgYV2y7pJsJp?utm_source=generator&amp;theme=0\" width=\"100%\" height=\"152\" frameborder=\"0\" allowfullscreen=\"\" allow=\"autoplay; clipboard-write; encrypted-media; fullscreen; picture-in-picture\" loading=\"lazy\"><\/iframe><\/p>\n<p style=\"float: right; margin-left: 15px; margin-bottom: 15px;\">\n  <img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/1close-up-product-photo-of-a-shockwave-machine-labe.jpg\" alt=\"Pi\u00e8ce en acier inoxydable \u00e9tiquet\u00e9e CE, ISO, FDA 510k (ID#1)\" class=\"top-image-square\">\n<\/p>\n<p>En tant que fabricant qui exporte des machines de th\u00e9rapie par ondes de choc de qualit\u00e9 m\u00e9dicale, j'aide souvent les acheteurs am\u00e9ricains \u00e0 confirmer si l'approbation de la FDA est obligatoire. De nombreux importateurs pensent qu'une marque CE ou une certification ISO suffit, mais aux \u00c9tats-Unis, ce n'est pas le cas.<\/p>\n<p><strong>Oui, les machines import\u00e9es de th\u00e9rapie par ondes de choc doivent r\u00e9pondre aux exigences de la FDA avant de pouvoir \u00eatre commercialis\u00e9es, distribu\u00e9es ou utilis\u00e9es cliniquement aux \u00c9tats-Unis. La plupart des mod\u00e8les n\u00e9cessitent soit une autorisation 510(k), soit une autorisation De Novo, en fonction de la classification et de l'usage pr\u00e9vu.<\/strong><\/p>\n<p>Le non-respect peut entra\u00eener la d\u00e9tention douani\u00e8re, le refus d'entr\u00e9e ou la saisie du produit.<\/p>\n<hr \/>\n<h2>L'approbation de la FDA est-elle obligatoire pour l'importation ?<\/h2>\n<p>De nombreux importateurs sont surpris que la conformit\u00e9 \u00e0 la FDA s'applique m\u00eame avant que l'appareil n'entre sur le march\u00e9 am\u00e9ricain, et non apr\u00e8s.<\/p>\n<p><strong>Oui, l'approbation de la FDA est obligatoire si l'appareil doit \u00eatre vendu, distribu\u00e9 ou utilis\u00e9 \u00e0 des fins th\u00e9rapeutiques aux \u00c9tats-Unis. Seuls quelques mod\u00e8les \u00e0 faible risque (par exemple, les appareils de massage g\u00e9n\u00e9ral) sont exempt\u00e9s.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/2a-u-s-customs-inspection-area-where-officers-revi.jpg\" alt=\"Agents des douanes inspectant un envoi de dispositifs m\u00e9dicaux dans un entrep\u00f4t (ID#2)\" title=\"Inspection douani\u00e8re\" \/><\/p>\n<p>Pour les voies d'approbation et les classes de risque, consultez le <strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/overview-device-regulation\/classify-your-medical-device\">syst\u00e8me de classification des dispositifs de la FDA<\/a><\/strong> <sup><a href=\"#footnote-1\" id=\"ref-1\">1<\/a><\/sup>.<br \/>\nLes importateurs devraient \u00e9galement consulter <strong><a href=\"https:\/\/www.fda.gov\/industry\/import-basics\/medical-devices\">les bases de l'importation de la FDA pour les dispositifs m\u00e9dicaux<\/a><\/strong> <sup><a href=\"#footnote-2\" id=\"ref-2\">2<\/a><\/sup> pour comprendre la documentation et le contr\u00f4le douanier.<\/p>\n<h3>Aper\u00e7u des classifications de la FDA<\/h3>\n<table>\n<thead>\n<tr>\n<th>Usage pr\u00e9vu \/ Type de mod\u00e8le<\/th>\n<th>Classe FDA<\/th>\n<th>Type d'approbation<\/th>\n<th>Exemple de code produit<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Th\u00e9rapie musculo-squelettique (par exemple, tendinopathie, soulagement de la douleur)<\/td>\n<td>Classe II<\/td>\n<td>510(k)<\/td>\n<td><strong>NPV<\/strong>, <strong>ISA<\/strong><\/td>\n<\/tr>\n<tr>\n<td>Th\u00e9rapie des plaies chroniques<\/td>\n<td>Classe II<\/td>\n<td>510(k)<\/td>\n<td><strong>PZL<\/strong><\/td>\n<\/tr>\n<tr>\n<td>Lithotripsie (fragmentation des calculs r\u00e9naux)<\/td>\n<td>Classe III<\/td>\n<td>PMA<\/td>\n<td><strong>78F<\/strong>, <strong>LITH<\/strong><\/td>\n<\/tr>\n<tr>\n<td>Vibration ou massage \u00e0 faible \u00e9nergie (all\u00e9gations non m\u00e9dicales)<\/td>\n<td>Classe I<\/td>\n<td>Exon\u00e9r\u00e9 (usage g\u00e9n\u00e9ral)<\/td>\n<td><strong>890.5660<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>Ce qui se passe sans autorisation de la FDA<\/h3>\n<p>Si un appareil import\u00e9 arrive sans 510(k) valide ou exemption, les douanes am\u00e9ricaines et la FDA peuvent :<\/p>\n<ul>\n<li><strong>Retenir l'exp\u00e9dition<\/strong> au port (voir <a href=\"https:\/\/www.accessdata.fda.gov\/cms_ia\/default.cfm\">Alertes d'importation<\/a>) <sup><a href=\"#footnote-3\" id=\"ref-3\">3<\/a><\/sup>.  <\/li>\n<li><strong>Refuser l'entr\u00e9e ou d\u00e9truire<\/strong> l'appareil.  <\/li>\n<li><strong>Mettre sur liste noire le fabricant ou l'importateur<\/strong> pour les importations futures.<\/li>\n<\/ul>\n<p>M\u00eame les unit\u00e9s de d\u00e9monstration ou les envois d'\u00e9chantillons doivent inclure une documentation sp\u00e9cifiant une utilisation non clinique (par exemple, \u201c pour exposition uniquement \u201d).<\/p>\n<hr \/>\n<h2>Comment v\u00e9rifier la conformit\u00e9 \u00e0 la FDA<\/h2>\n<p>Les acheteurs doivent toujours confirmer si le mod\u00e8le d'un fournisseur est approuv\u00e9 par la FDA avant l'achat. Ceci peut \u00eatre v\u00e9rifi\u00e9 publiquement.<\/p>\n<p><strong>Vous pouvez v\u00e9rifier l'approbation de la FDA en consultant le site officiel <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpmn\/pmn.cfm\">Base de donn\u00e9es 510(k) de la FDA<\/a><\/strong> <sup><a href=\"#footnote-4\" id=\"ref-4\">4<\/a><\/sup><br \/>\nou pour le <strong><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfRL\/rl.cfm\">base de donn\u00e9es d'enregistrement des \u00e9tablissements et de listage des dispositifs<\/a><\/strong> <sup><a href=\"#footnote-5\" id=\"ref-5\">5<\/a><\/sup>.<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/3a-professional-compliance-officer-reviews-fda-510-.jpg\" alt=\"Responsable r\u00e9glementaire examinant les documents de demande de la FDA (ID#3)\" title=\"Processus d&#039;examen de la FDA\" \/><\/p>\n<p>Si le mod\u00e8le n'a pas de pr\u00e9dicat, il peut n\u00e9cessiter <strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/selecting-de-novo-direct-class-ii-route-de-novo-classification\">une classification De Novo<\/a><\/strong> <sup><a href=\"#footnote-6\" id=\"ref-6\">6<\/a><\/sup> au lieu d'un 510(k) standard.<\/p>\n<h3>Liste de v\u00e9rification<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u00c9tape<\/th>\n<th>Ce qu'il faut v\u00e9rifier<\/th>\n<th>Exemple d'entr\u00e9e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>1<\/td>\n<td>Num\u00e9ro d'enregistrement FDA du fabricant<\/td>\n<td>par ex., 3012345678<\/td>\n<\/tr>\n<tr>\n<td>2<\/td>\n<td>Listage du dispositif avec le code produit correct<\/td>\n<td>\u201c PZL \u2013 Dispositif, onde de choc, pour la gu\u00e9rison des plaies \u201d<\/td>\n<\/tr>\n<tr>\n<td>3<\/td>\n<td>Num\u00e9ro 510(k) et date de d\u00e9cision<\/td>\n<td>par ex., <strong>K202112<\/strong> (approuv\u00e9 en 2021)<\/td>\n<\/tr>\n<tr>\n<td>4<\/td>\n<td>Agent ou importateur am\u00e9ricain indiqu\u00e9<\/td>\n<td>Enregistr\u00e9 sous le m\u00eame nom de fabricant<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>Drapeaux rouges<\/h3>\n<ul>\n<li>Le fournisseur ne fournit qu'un \u201c certificat CE \u201d.\u201d  <\/li>\n<li>Le num\u00e9ro FDA ne correspond pas au nom de l'entreprise.  <\/li>\n<li>Revendique l'enregistrement FDA sans preuve d'autorisation.<\/li>\n<\/ul>\n<p>L'enregistrement n'est pas une autorisation. Seule une lettre officielle 510(k) confirme l'autorisation de mise sur le march\u00e9 aux \u00c9tats-Unis.<\/p>\n<hr \/>\n<h2>Quels documents prouvent l'approbation de la FDA ?<\/h2>\n<p>D'apr\u00e8s mon exp\u00e9rience, les acheteurs devraient demander la documentation suivante pour v\u00e9rifier la conformit\u00e9 avant l'exp\u00e9dition.<\/p>\n<p><strong>Les documents prouvant la conformit\u00e9 FDA comprennent la lettre d'autorisation 510(k), l'enregistrement de la liste des appareils, le certificat d'enregistrement de l'\u00e9tablissement et l'\u00e9tiquetage correspondant \u00e0 l'indication autoris\u00e9e.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/4close-up-of-an-official-fda-510-k-clearance-lette.jpg\" alt=\"Document d&#039;approbation FDA 510(k) sign\u00e9 sur un bureau (ID#4)\" title=\"Approbation 510k\" \/><\/p>\n<p>Les acheteurs am\u00e9ricains devraient \u00e9galement s'assurer de la conformit\u00e9 avec <strong><a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-H\/part-820\">21 CFR Partie 820 R\u00e8glement sur le syst\u00e8me qualit\u00e9<\/a><\/strong> <sup><a href=\"#footnote-7\" id=\"ref-7\">7<\/a><\/sup> et<br \/>\n<strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/overview-device-regulation\/labeling-requirements\">Exigences de l'\u00e9tiquetage FDA pour les appareils<\/a><\/strong> <sup><a href=\"#footnote-8\" id=\"ref-8\">8<\/a><\/sup>.<\/p>\n<h3>Liste essentielle des documents FDA<\/h3>\n<table>\n<thead>\n<tr>\n<th>Nom du document<\/th>\n<th>Objectif \/ Utilisation de la v\u00e9rification<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>Lettre d'autorisation FDA 510(k)<\/strong><\/td>\n<td>Confirmation officielle de l'autorisation de mise sur le march\u00e9.<\/td>\n<\/tr>\n<tr>\n<td><strong>Dossier d'inscription de l'appareil<\/strong><\/td>\n<td>Indique le nom du produit, la classe et l'enregistrement du fabricant.<\/td>\n<\/tr>\n<tr>\n<td><strong>Enregistrement de l'\u00e9tablissement<\/strong><\/td>\n<td>Confirme que l'usine \u00e9trang\u00e8re et l'agent am\u00e9ricain sont enregistr\u00e9s.<\/td>\n<\/tr>\n<tr>\n<td><strong>Feuille d'\u00e9tiquetage et d'indications<\/strong><\/td>\n<td>Doit correspondre \u00e0 l'usage pr\u00e9vu approuv\u00e9 par la FDA.<\/td>\n<\/tr>\n<tr>\n<td><strong>Certificat de syst\u00e8me qualit\u00e9 (21 CFR 820)<\/strong><\/td>\n<td>Prouve la conformit\u00e9 aux normes de fabrication.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>Malentendus courants<\/h3>\n<ul>\n<li>Une entreprise peut \u00eatre \u201c enregistr\u00e9e aupr\u00e8s de la FDA \u201d sans que son <strong>appareil<\/strong> soit approuv\u00e9.  <\/li>\n<li>CE ou ISO 13485 ne sont pas <strong>des substituts<\/strong> \u00e0 l'approbation de la FDA.  <\/li>\n<li>Chaque mod\u00e8le n\u00e9cessite son propre num\u00e9ro 510(k).<\/li>\n<\/ul>\n<p>Plus d'informations sur les r\u00f4les des importateurs peuvent \u00eatre trouv\u00e9es dans <strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/overview-device-regulation\/establishment-registration-medical-devices\">les directives d'enregistrement des \u00e9tablissements de la FDA<\/a><\/strong> <sup><a href=\"#footnote-9\" id=\"ref-9\">9<\/a><\/sup>.<\/p>\n<hr \/>\n<h2>Les r\u00e8gles de la FDA s'appliquent-elles \u00e0 tous les mod\u00e8les ?<\/h2>\n<p>Tous les syst\u00e8mes \u00e0 ondes de choc ne sont pas r\u00e9glement\u00e9s de la m\u00eame mani\u00e8re. La classification d\u00e9pend de <strong>l'usage m\u00e9dical pr\u00e9vu<\/strong>, <strong>le niveau d'\u00e9nergie<\/strong>, et <strong>les all\u00e9gations marketing<\/strong>.<\/p>\n<p><strong>Oui, tous les mod\u00e8les vendus ou utilis\u00e9s \u00e0 des fins m\u00e9dicales aux \u00c9tats-Unis sont soumis aux r\u00e8gles de la FDA\u2014mais les mod\u00e8les \u00e0 basse \u00e9nergie de type \u201c massage \u201d peuvent \u00eatre exempt\u00e9s si aucune all\u00e9gation m\u00e9dicale n'est faite.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/5illustration-showing-four-types-of-shockwave-machi.jpg\" alt=\"Ligne de machines m\u00e9dicales \u00e0 ondes de choc avec les objectifs indiqu\u00e9s (ID#5)\" title=\"Ligne de produits Shockwave\" \/><\/p>\n<p>Pour les listes d'exemption, voir le <strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/510k-exempt-devices\">R\u00e9pertoire des dispositifs exempt\u00e9s de la FDA 510(k)<\/a><\/strong> <sup><a href=\"#footnote-10\" id=\"ref-10\">10<\/a><\/sup>.<\/p>\n<hr \/>\n<h2>Conclusion<\/h2>\n<p>Toute machine de lithotripsie import\u00e9e aux \u00c9tats-Unis pour un usage clinique doit \u00eatre conforme aux r\u00e9glementations de la FDA\u2014g\u00e9n\u00e9ralement par une autorisation 510(k) ou une PMA. V\u00e9rifiez toujours l'autorisation dans la base de donn\u00e9es de la FDA, demandez des documents officiels \u00e0 votre fournisseur et assurez-vous que l'\u00e9tiquetage et le marketing correspondent aux indications autoris\u00e9es.<br \/>\n<strong>La conformit\u00e9 n'est pas facultative\u2014c'est le fondement de l'importation l\u00e9gale et de l'exploitation s\u00fbre sur le march\u00e9 am\u00e9ricain.<\/strong><\/p>\n<hr \/>\n<h2>Notes de bas de page<\/h2>\n<p><span id=\"footnote-1\">1. Aper\u00e7u de la classification des dispositifs m\u00e9dicaux de la FDA. <a href=\"#ref-1\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-2\">2. Guide d'importation de la FDA pour les exp\u00e9ditions de dispositifs m\u00e9dicaux. <a href=\"#ref-2\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-3\">3. Alertes d'importation de la FDA pour les produits non conformes. <a href=\"#ref-3\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-4\">4. Base de donn\u00e9es de recherche d'approbation 510(k) de la FDA. <a href=\"#ref-4\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-5\">5. Base de donn\u00e9es d'enregistrement et de listage des dispositifs de la FDA. <a href=\"#ref-5\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-6\">6. Voie de classification De Novo pour les nouveaux dispositifs. <a href=\"#ref-6\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-7\">7. R\u00e8glement sur le syst\u00e8me qualit\u00e9 (21 CFR Partie 820). <a href=\"#ref-7\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-8\">8. R\u00e8gles de la FDA concernant l'\u00e9tiquetage et les indications des dispositifs. <a href=\"#ref-8\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-9\">9. Exigences d'enregistrement et d'agent am\u00e9ricain. <a href=\"#ref-9\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-10\">10. Liste des dispositifs exempt\u00e9s de 510(k) par la FDA. <a href=\"#ref-10\">\ufe0e<\/a><\/span>  <\/p>","protected":false},"excerpt":{"rendered":"<p>As a manufacturer that exports medical-grade shockwave therapy machines, I often help U.S. buyers confirm whether FDA clearance is mandatory. Many importers assume that a CE mark or ISO certification is enough\u2014but in the U.S., that\u2019s not the case. Yes, imported shockwave therapy machines must meet FDA requirements before they can be marketed, distributed, or [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":8174,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"default","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[60],"tags":[],"class_list":["post-8170","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-shockwave-therapy-machine"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Should Imported Shockwave Therapy Machines Meet FDA Requirements or Certification? - KMSLaser<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/kmslaser.com\/fr\/les-appareils-de-therapie-par-ondes-de-choc-importes-doivent-ils-repondre-aux-exigences-ou-a-la-certification-de-la-fda\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Should Imported Shockwave Therapy Machines Meet FDA Requirements or Certification?\" \/>\n<meta property=\"og:description\" content=\"As a manufacturer that exports medical-grade shockwave therapy machines, I often help U.S. buyers confirm whether FDA clearance is mandatory. Many importers assume that a CE mark or ISO certification is enough\u2014but in the U.S., that\u2019s not the case. 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