{"id":3041,"date":"2021-11-23T11:31:14","date_gmt":"2021-11-23T03:31:14","guid":{"rendered":"https:\/\/regask.com\/?p=3041"},"modified":"2024-10-25T02:05:32","modified_gmt":"2024-10-24T18:05:32","slug":"reglement-de-lueea-sur-les-dispositifs-medicaux","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/eaeu-medical-device-regulations\/","title":{"rendered":"Le r\u00e8glement centralis\u00e9 sur les dispositifs m\u00e9dicaux de l&#039;UEE entre en vigueur\u2026"},"content":{"rendered":"<p>\u00c0 compter du 1er janvier 2022, l&#039;Union \u00e9conomique eurasienne (UEE), form\u00e9e par la Bi\u00e9lorussie, le Kazakhstan, la Russie, l&#039;Arm\u00e9nie et le Kirghizistan, appliquera la nouvelle r\u00e9glementation commune pour les dispositifs m\u00e9dicaux que leur organisme de r\u00e9glementation, la Commission \u00e9conomique eurasienne (CEE), a \u00e9labor\u00e9e au cours des deux derni\u00e8res ann\u00e9es.<\/p>\n<p>Le nouveau r\u00e8glement harmonise les exigences relatives aux dispositifs m\u00e9dicaux avec celles des pays de l&#039;UEE et \u00e9tablit une proc\u00e9dure d&#039;enregistrement commune. Ce nouvel enregistrement devra toujours \u00eatre pr\u00e9sent\u00e9 aux autorit\u00e9s comp\u00e9tentes de l&#039;un des \u00c9tats membres, qui dirigeront le processus, mais sera valable pour l&#039;ensemble de l&#039;UEE.<\/p>\n<p>Les enregistrements \u00e0 venir doivent \u00eatre soumis conform\u00e9ment \u00e0 la nouvelle proc\u00e9dure \u00e0 compter du 1er janvier 2022. Les enregistrements nationaux existants qui expirent apr\u00e8s cette date resteront valables au maximum jusqu&#039;au 31 d\u00e9cembre 2026. \u00c0 compter du 1er janvier 2027, tous les dispositifs m\u00e9dicaux mis sur le march\u00e9 de l&#039;UEE devront \u00eatre enregistr\u00e9s conform\u00e9ment au nouveau r\u00e8glement.<\/p>\n<p>Contactez RegASK pour en savoir plus sur les changements r\u00e9glementaires relatifs aux dispositifs m\u00e9dicaux. <a href=\"https:\/\/regask.com\/fr\/contact-2\/\" target=\"_blank\" rel=\"noopener\">Contactez les experts de RegASK.<\/a><\/p>\n<p>&nbsp;<\/p>\n<a href=\"https:\/\/regask.com\/fr\/contact-2\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contactez RegASK pour plus de d\u00e9tails<\/span>\n\t<\/a>\n\n<a href=\"http:\/\/publication.pravo.gov.ru\/Document\/View\/0001202104300101\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>En savoir plus<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-1111243465\">\n\n\t<div id=\"col-1266255567\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/fr\/etudes-de-cas\/ressources-etudes-de-cas-dispositifs-medicaux\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lire les \u00e9tudes de cas sur le secteur des dispositifs m\u00e9dicaux<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>\u00c0 compter du 1er janvier 2022, l&#039;Union \u00e9conomique eurasiatique (UEE), form\u00e9e par la Bi\u00e9lorussie, le Kazakhstan, la Russie, l&#039;Arm\u00e9nie et le Kirghizistan, appliquera le nouveau r\u00e8glement commun relatif aux dispositifs m\u00e9dicaux, \u00e9labor\u00e9 ces deux derni\u00e8res ann\u00e9es par la Commission \u00e9conomique eurasiatique (CEE), leur organisme de r\u00e9glementation. Ce nouveau r\u00e8glement harmonise les exigences relatives aux dispositifs m\u00e9dicaux\u2026<\/p>","protected":false},"author":39,"featured_media":3003,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[522,39],"tags":[40],"class_list":["post-3041","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-russia-regulations","category-medical-devices-insights","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.5 (Yoast SEO v28.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>EAEU Medical Device Regulations | RegASK<\/title>\n<meta name=\"description\" content=\"New centralized medical device regulations are in force in the EAEU. 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Ensure compliance with RegASK&#039;s guidance.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/fr\/reglement-de-lueea-sur-les-dispositifs-medicaux\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2021-11-23T03:31:14+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-24T18:05:32+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2021\/10\/brain-nervous-system-medical-device.png\" \/>\n\t<meta property=\"og:image:width\" content=\"689\" \/>\n\t<meta property=\"og:image:height\" content=\"626\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/eaeu-medical-device-regulations\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/eaeu-medical-device-regulations\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"EAEU Centralised Medical Devices Regulation Enters in F&hellip;\",\"datePublished\":\"2021-11-23T03:31:14+00:00\",\"dateModified\":\"2024-10-24T18:05:32+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/eaeu-medical-device-regulations\\\/\"},\"wordCount\":237,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/eaeu-medical-device-regulations\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/10\\\/brain-nervous-system-medical-device.png\",\"keywords\":[\"Latest Insights\"],\"articleSection\":[\"Russia\",\"Medical Devices\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/eaeu-medical-device-regulations\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/eaeu-medical-device-regulations\\\/\",\"name\":\"EAEU Medical Device Regulations | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/eaeu-medical-device-regulations\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/eaeu-medical-device-regulations\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/10\\\/brain-nervous-system-medical-device.png\",\"datePublished\":\"2021-11-23T03:31:14+00:00\",\"dateModified\":\"2024-10-24T18:05:32+00:00\",\"description\":\"New centralized medical device regulations are in force in the EAEU. 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