{"id":16139,"date":"2025-01-16T11:01:48","date_gmt":"2025-01-16T14:01:48","guid":{"rendered":"https:\/\/allende.com\/?p=16139"},"modified":"2025-01-16T11:03:07","modified_gmt":"2025-01-16T14:03:07","slug":"new-anmat-disposition-incorporating-the-mercosur-technical-regulations-for-the-registration-of-medical-devices","status":"publish","type":"post","link":"https:\/\/allende.com\/en\/life-sciences-en\/new-anmat-disposition-incorporating-the-mercosur-technical-regulations-for-the-registration-of-medical-devices-01-16-2025\/","title":{"rendered":"New ANMAT Disposition Incorporating the MERCOSUR Technical Regulations for the registration of Medical Devices"},"content":{"rendered":"<p>Through Disposition No. 64\/2025, the National Administration of Medicines, Food and Medical Technology (ANMAT) incorporated GMC Resolution No. 25\/21 (the \u201c<u>Resolution<\/u>\u201d) into the national legal framework. The Resolution established the \u201cMERCOSUR Technical Regulations for the Registration of Medical Devices\u201d (the \u201c<u>RTM<\/u>\u201d).<\/p>\n<p>The Resolution updated the registration criteria for medical devices within MERCOSUR member states. It also outlines the classification criteria for medical devices and their accessories, as well as the minimum general requirements for their registration. Used or refurbished medical devices, as well as medical devices for <em>in vitro<\/em> diagnostics, are excluded from the scope of the Resolution.<\/p>\n<p>As a result of adopting this Resolution, ANMAT Disposition No. 2318\/02 and ANMAT Disposition No. 1285\/04 were repealed. The latter had previously incorporated the earlier MERCOSUR GMC Resolution No. 40\/00 regarding the prior RTM.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Through Disposition No. 64\/2025, the National Administration of Medicines, Food and Medical Technology (ANMAT) incorporated GMC Resolution No. 25\/21 (the \u201cResolution\u201d) into the national legal framework. The Resolution established the \u201cMERCOSUR Technical Regulations for the Registration of Medical Devices\u201d (the \u201cRTM\u201d). The Resolution updated the registration criteria for medical devices within MERCOSUR member states. It [&hellip;]<\/p>\n","protected":false},"author":11,"featured_media":16137,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_eb_attr":"","footnotes":""},"categories":[53],"tags":[],"class_list":["post-16139","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-life-sciences-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>New ANMAT Disposition Incorporating the MERCOSUR Technical Regulations for the registration of Medical Devices - Allende &amp; Brea - Estudio Jur\u00eddico<\/title>\n<meta name=\"description\" content=\"Through Disposition No. 64\/2025, the National Administration of Medicines, Food and Medical Technology (ANMAT) incorporated GMC Resolution No. 25\/21 (the\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/allende.com\/en\/life-sciences-en\/new-anmat-disposition-incorporating-the-mercosur-technical-regulations-for-the-registration-of-medical-devices-01-16-2025\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"New ANMAT Disposition Incorporating the MERCOSUR Technical Regulations for the registration of Medical Devices - 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