{"id":21807,"date":"2022-07-25T10:59:11","date_gmt":"2022-07-25T08:59:11","guid":{"rendered":"http:\/\/www.thema-med.eu\/?page_id=21807"},"modified":"2023-01-24T15:00:29","modified_gmt":"2023-01-24T14:00:29","slug":"news","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/news\/","title":{"rendered":"News"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-background-position:left top;--awb-border-sizes-top:0px;--awb-border-sizes-bottom:0px;--awb-border-sizes-left:0px;--awb-border-sizes-right:0px;--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:0px;--awb-padding-bottom:0px;--awb-margin-bottom:20px;--awb-margin-bottom-medium:60px;--awb-margin-bottom-small:40px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-justify-content-center fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:15px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-blog-shortcode fusion-blog-shortcode-1 fusion-blog-archive fusion-blog-layout-medium fusion-blog-infinite\"><div class=\"fusion-posts-container fusion-posts-container-infinite\" data-pages=\"20\"><article id=\"blog-1-post-35730\" class=\"fusion-post-medium post-35730 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/06\/12\/fda-partially-recognizes-iso-10993-12025-what-changes-for-biocompatibility\/\" aria-label=\"FDA partially recognizes ISO 10993-1:2025: what changes for Biocompatibility\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/06\/immagini-tech-10-1-320x202.png\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/06\/immagini-tech-10-1-320x202.png 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/06\/immagini-tech-10-1-700x441.png 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/06\/12\/fda-partially-recognizes-iso-10993-12025-what-changes-for-biocompatibility\/\">FDA partially recognizes ISO 10993-1:2025: what changes for Biocompatibility<\/a><\/h2><div class=\"fusion-post-content-container\"><p>On May 25, 2026, the US FDA updated its database of recognized consensus standards (Recognition No 2-313), partially adopting the [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-06-12T11:10:09+02:00<\/span><span>12\/06\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35663\" class=\"fusion-post-medium post-35663 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/05\/28\/injectable-fillers-clarifications-from-the-italian-ministry-of-health-on-intended-users-and-distribution\/\" aria-label=\"Injectable Fillers: Clarifications from the Italian Ministry of Health on Intended Users and Distribution\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/05\/closeup-portrait-young-woman-doing-botox-procedures-by-professional-injection-making-lips-modern-devices-technology-medicine-cosmetology-therapy-320x202.jpg\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/05\/closeup-portrait-young-woman-doing-botox-procedures-by-professional-injection-making-lips-modern-devices-technology-medicine-cosmetology-therapy-320x202.jpg 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/05\/closeup-portrait-young-woman-doing-botox-procedures-by-professional-injection-making-lips-modern-devices-technology-medicine-cosmetology-therapy-700x441.jpg 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/05\/28\/injectable-fillers-clarifications-from-the-italian-ministry-of-health-on-intended-users-and-distribution\/\">Injectable Fillers: Clarifications from the Italian Ministry of Health on Intended Users and Distribution<\/a><\/h2><div class=\"fusion-post-content-container\"><p>On May 11, 2026, the Italian Ministry of Health published a Circular clarifying the distribution and sales modalities of injectable [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-05-28T11:41:22+02:00<\/span><span>28\/05\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35646\" class=\"fusion-post-medium post-35646 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/05\/22\/biocompatibility-and-biological-safety-of-medical-devices-whats-new-in-iso-standards-2025-2026\/\" aria-label=\"Biocompatibility and biological safety of medical devices: what\u2019s new in ISO Standards 2025 &#8211; 2026\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/05\/immagini-tech-4-1-320x202.png\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/05\/immagini-tech-4-1-320x202.png 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/05\/immagini-tech-4-1-700x441.png 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/05\/22\/biocompatibility-and-biological-safety-of-medical-devices-whats-new-in-iso-standards-2025-2026\/\">Biocompatibility and biological safety of medical devices: what\u2019s new in ISO Standards 2025 &#8211; 2026<\/a><\/h2><div class=\"fusion-post-content-container\"><p> In recent months, the regulatory framework governing the biological safety of Medical Devices has undergone a significant evolution. With [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-05-25T09:29:57+02:00<\/span><span>22\/05\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35621\" class=\"fusion-post-medium post-35621 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/05\/15\/regulation-eu-2026-977-new-rules-for-notified-bodies-on-timelines-costs-and-procedures\/\" aria-label=\"Regulation (EU) 2026\/977: new rules for Notified Bodies on timelines, costs and procedures\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/05\/img2-320x202.png\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/05\/img2-320x202.png 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/05\/img2-700x441.png 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/05\/15\/regulation-eu-2026-977-new-rules-for-notified-bodies-on-timelines-costs-and-procedures\/\">Regulation (EU) 2026\/977: new rules for Notified Bodies on timelines, costs and procedures<\/a><\/h2><div class=\"fusion-post-content-container\"><p> On 5 May 2026, Commission Implementing Regulation (EU) 2026\/977 was published, introducing a harmonised framework of quality and procedural [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-05-15T15:45:24+02:00<\/span><span>15\/05\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35580\" class=\"fusion-post-medium post-35580 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/04\/28\/mdcg-2021-24-rev-1-interpretative-updates-on-medical-device-classification\/\" aria-label=\"MDCG 2021-24 Rev.1: Interpretative Updates on Medical Device Classification\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/04\/tech-3-2-320x202.jpg\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/04\/tech-3-2-320x202.jpg 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/04\/tech-3-2-700x441.jpg 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/04\/28\/mdcg-2021-24-rev-1-interpretative-updates-on-medical-device-classification\/\">MDCG 2021-24 Rev.1: Interpretative Updates on Medical Device Classification<\/a><\/h2><div class=\"fusion-post-content-container\"><p>Translated with AI On April 20, 2026, Revision 1 of the MDCG 2021-24 guidance was published. This update introduces significant [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-04-29T09:20:47+02:00<\/span><span>28\/04\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35564\" class=\"fusion-post-medium post-35564 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/04\/21\/what-to-do-in-case-of-interruption-or-discontinuation-of-medical-device-supplythe-commission-clarifies-with-a-decision-tree-and-updated-faqs\/\" aria-label=\"What to do in case of interruption or discontinuation of medical device supply?The Commission clarifies with a Decision Tree and updated FAQs\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/04\/copertina-video-esmerise-30-320x202.jpg\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/04\/copertina-video-esmerise-30-320x202.jpg 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/04\/copertina-video-esmerise-30-700x441.jpg 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/04\/21\/what-to-do-in-case-of-interruption-or-discontinuation-of-medical-device-supplythe-commission-clarifies-with-a-decision-tree-and-updated-faqs\/\">What to do in case of interruption or discontinuation of medical device supply?The Commission clarifies with a Decision Tree and updated FAQs<\/a><\/h2><div class=\"fusion-post-content-container\"><p>Translated with AI. On 1 April 2026, the European Commission published the Article 10a Decision Tree and Revision 2 of [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-04-22T09:41:40+02:00<\/span><span>21\/04\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35511\" class=\"fusion-post-medium post-35511 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/04\/10\/regole-per-letichettatura-dei-dispositivi-medici-in-malesia-cosa-cambia-2\/\" aria-label=\"Health Canada: New Operational Guidance on Terms and Conditions (T&#038;Cs) for Class II\u2013IV Medical Devices\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/04\/copertina-video-esmerise-15-320x202.jpg\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/04\/copertina-video-esmerise-15-320x202.jpg 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/04\/copertina-video-esmerise-15-700x441.jpg 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/04\/10\/regole-per-letichettatura-dei-dispositivi-medici-in-malesia-cosa-cambia-2\/\">Health Canada: New Operational Guidance on Terms and Conditions (T&#038;Cs) for Class II\u2013IV Medical Devices<\/a><\/h2><div class=\"fusion-post-content-container\"><p>Translated with AIOn April 1, 2026, Health Canada published the \u201cGuidance on terms and conditions for class II to IV [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-04-10T14:48:02+02:00<\/span><span>10\/04\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35458\" class=\"fusion-post-medium post-35458 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/03\/27\/two-delegated-eu-regulations-expand-the-mdr-wet-list\/\" aria-label=\"Two Delegated EU Regulations expand the MDR WET List\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/03\/POST-LINKEDIN-SHORT-1344-x-768-px-8-320x202.png\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/03\/POST-LINKEDIN-SHORT-1344-x-768-px-8-320x202.png 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/03\/POST-LINKEDIN-SHORT-1344-x-768-px-8-700x441.png 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/03\/27\/two-delegated-eu-regulations-expand-the-mdr-wet-list\/\">Two Delegated EU Regulations expand the MDR WET List<\/a><\/h2><div class=\"fusion-post-content-container\"><p>Translated with AI On March 20, 2026, the European Commission adopted two delegated regulations, C (2026) 1809 and C (2026) [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-03-30T15:53:27+02:00<\/span><span>27\/03\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35445\" class=\"fusion-post-medium post-35445 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/03\/23\/medical-device-labelling-rules-in-malaysia-what-is-changing\/\" aria-label=\"Medical Device Labelling Rules in Malaysia: what is changing\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/03\/POST-LINKEDIN-SHORT-1344-x-768-px-4-320x202.png\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/03\/POST-LINKEDIN-SHORT-1344-x-768-px-4-320x202.png 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/03\/POST-LINKEDIN-SHORT-1344-x-768-px-4-700x441.png 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/03\/23\/medical-device-labelling-rules-in-malaysia-what-is-changing\/\">Medical Device Labelling Rules in Malaysia: what is changing<\/a><\/h2><div class=\"fusion-post-content-container\"><p>Translated with AI In February 2026, the Medical Device Authority (MDA) published the 7th edition of the guidance document \"Requirements [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-03-30T11:31:09+02:00<\/span><span>23\/03\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35414\" class=\"fusion-post-medium post-35414 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/03\/12\/australia-udi-guide-v2-0-how-to-properly-prepare-for-deadlines\/\" aria-label=\"Australia UDI Guide V2.0: how to properly prepare for deadlines\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/03\/IMG-WEBINAR-MASTER-SEMINAR-9-320x202.png\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/03\/IMG-WEBINAR-MASTER-SEMINAR-9-320x202.png 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/03\/IMG-WEBINAR-MASTER-SEMINAR-9-700x441.png 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/03\/12\/australia-udi-guide-v2-0-how-to-properly-prepare-for-deadlines\/\">Australia UDI Guide V2.0: how to properly prepare for deadlines<\/a><\/h2><div class=\"fusion-post-content-container\"><p>Translated with AIIn February 2026, the Australian Therapeutic Goods Administration (TGA) published version 2.0 of the official guide: \"Complying with [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-03-30T09:08:52+02:00<\/span><span>12\/03\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35377\" class=\"fusion-post-medium post-35377 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/02\/26\/mdsap-audit-approach-version-010-released-what-changes\/\" aria-label=\"MDSAP: Audit Approach Version 010 Released, what changes\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/02\/business-concept-glass-world-laptop-320x202.jpg\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/02\/business-concept-glass-world-laptop-320x202.jpg 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/02\/business-concept-glass-world-laptop-700x441.jpg 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/02\/26\/mdsap-audit-approach-version-010-released-what-changes\/\">MDSAP: Audit Approach Version 010 Released, what changes<\/a><\/h2><div class=\"fusion-post-content-container\"><p>On February 2, 2026, version 010 of the MDSAP AU P0002 \u2013 Audit Approach manual was released. This update comes [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-02-26T14:25:19+01:00<\/span><span>26\/02\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35362\" class=\"fusion-post-medium post-35362 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/02\/24\/compliance-program-7382-850-what-to-expect-from-the-new-fda-inspections\/\" aria-label=\"Compliance Program 7382.850: what to expect from the new FDA inspections\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/02\/BANNER-NEWSLETTER1-1200x600-1-320x202.jpg\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/02\/BANNER-NEWSLETTER1-1200x600-1-320x202.jpg 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/02\/BANNER-NEWSLETTER1-1200x600-1-700x441.jpg 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/02\/24\/compliance-program-7382-850-what-to-expect-from-the-new-fda-inspections\/\">Compliance Program 7382.850: what to expect from the new FDA inspections<\/a><\/h2><div class=\"fusion-post-content-container\"><p>On February 2, 2026, the U.S. Food and Drug Administration issued the Compliance Program Manual 7382.850. The comprehensive document serves [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-02-24T10:16:43+01:00<\/span><span>24\/02\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35352\" class=\"fusion-post-medium post-35352 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/02\/17\/south-korea-launches-fast-track-pathway-for-innovative-medical-devices\/\" aria-label=\"South Korea launches fast track pathway for innovative medical devices\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/02\/beautiful-architecture-building-320x202.jpg\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/02\/beautiful-architecture-building-320x202.jpg 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/02\/beautiful-architecture-building-700x441.jpg 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/02\/17\/south-korea-launches-fast-track-pathway-for-innovative-medical-devices\/\">South Korea launches fast track pathway for innovative medical devices<\/a><\/h2><div class=\"fusion-post-content-container\"><p>On 26 January 2026, the Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS) [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-02-17T13:53:22+01:00<\/span><span>17\/02\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35280\" class=\"fusion-post-medium post-35280 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/01\/29\/regulation-b-e-2568-in-thailand-a-unified-framework-for-medical-device-labelling\/\" aria-label=\"Regulation B.E. 2568 in Thailand: A Unified Framework for Medical Device Labeling\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/01\/POST-LINKEDIN-SHORT-1344-x-768-px1-1200x686-1-320x202.jpg\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/01\/POST-LINKEDIN-SHORT-1344-x-768-px1-1200x686-1-320x202.jpg 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/01\/POST-LINKEDIN-SHORT-1344-x-768-px1-1200x686-1-700x441.jpg 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/01\/29\/regulation-b-e-2568-in-thailand-a-unified-framework-for-medical-device-labelling\/\">Regulation B.E. 2568 in Thailand: A Unified Framework for Medical Device Labeling<\/a><\/h2><div class=\"fusion-post-content-container\"><p>Translated with AI The regulatory framework for medical device labelling in Thailand reached a comprehensive synthesis with the publication of [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-01-30T08:51:55+01:00<\/span><span>29\/01\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35209\" class=\"fusion-post-medium post-35209 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/01\/26\/clinical-decision-support-software-fda-guidance-provides-clarity\/\" aria-label=\"Clinical Decision Support Software: FDA Guidance Provides Clarity\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/01\/IMMAGINI-TECH-2025-1-320x202.png\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/01\/IMMAGINI-TECH-2025-1-320x202.png 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/01\/IMMAGINI-TECH-2025-1-700x441.png 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/01\/26\/clinical-decision-support-software-fda-guidance-provides-clarity\/\">Clinical Decision Support Software: FDA Guidance Provides Clarity<\/a><\/h2><div class=\"fusion-post-content-container\"><p>Translated with AI The evolution of digital health has blurred the lines between IT tools and Medical Devices. A key [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-01-30T08:51:17+01:00<\/span><span>26\/01\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35146\" class=\"fusion-post-medium post-35146 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/01\/14\/mdr-and-ivdr-reform-the-commissions-proposal-for-a-long-awaited-simplification\/\" aria-label=\"MDR and IVDR Reform: the Commission\u2019s Proposal for a Long-Awaited Simplification\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/01\/riforma-mdr-ivd-proposta-della-commissione-320x202.png\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/01\/riforma-mdr-ivd-proposta-della-commissione-320x202.png 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/01\/riforma-mdr-ivd-proposta-della-commissione-700x441.png 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/01\/14\/mdr-and-ivdr-reform-the-commissions-proposal-for-a-long-awaited-simplification\/\">MDR and IVDR Reform: the Commission\u2019s Proposal for a Long-Awaited Simplification<\/a><\/h2><div class=\"fusion-post-content-container\"><p>Translated with AI With the publication of the proposal for a Regulation COM(2025) 1023 final of 16 December 2025, the [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-01-30T08:50:12+01:00<\/span><span>14\/01\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35029\" class=\"fusion-post-medium post-35029 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2025\/12\/18\/tga-updates-the-guidance-on-essential-principles-for-medical-devices\/\" aria-label=\"TGA updates the guidance on Essential Principles for medical devices\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/12\/australia-tga-complying-with-the-essential-principles-medical-devices-320x202.jpg\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/12\/australia-tga-complying-with-the-essential-principles-medical-devices-320x202.jpg 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/12\/australia-tga-complying-with-the-essential-principles-medical-devices-700x441.jpg 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2025\/12\/18\/tga-updates-the-guidance-on-essential-principles-for-medical-devices\/\">TGA updates the guidance on Essential Principles for medical devices<\/a><\/h2><div class=\"fusion-post-content-container\"><p> Translated with AI On November 19, 2025, the Therapeutic Goods Administration (TGA) released the updated guidance \"Complying with the [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2025-12-19T13:15:14+01:00<\/span><span>18\/12\/2025<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35027\" class=\"fusion-post-medium post-35027 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2025\/12\/18\/breakthrough-devices-btx-new-opportunities-for-medtech-innovation-in-europe\/\" aria-label=\"Breakthrough Devices (BtX): New Opportunities for MedTech Innovation in Europe\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/12\/breakthrough-devices-btx-innovazione-medtech-europa-mdcg-2025-9.jpg-320x202.png\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/12\/breakthrough-devices-btx-innovazione-medtech-europa-mdcg-2025-9.jpg-320x202.png 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/12\/breakthrough-devices-btx-innovazione-medtech-europa-mdcg-2025-9.jpg-700x441.png 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2025\/12\/18\/breakthrough-devices-btx-new-opportunities-for-medtech-innovation-in-europe\/\">Breakthrough Devices (BtX): New Opportunities for MedTech Innovation in Europe<\/a><\/h2><div class=\"fusion-post-content-container\"><p>Translated with AI On December 16, 2025, the European Commission published the new guidance MDCG 2025-9 on \u201cBreakthrough Devices (BtX)\u201d. [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2025-12-22T15:00:53+01:00<\/span><span>18\/12\/2025<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<\/div><div class=\"fusion-infinite-scroll-trigger\"><\/div><div class=\"pagination infinite-scroll clearfix\" style=\"display:none;\"><span class=\"current\">1<\/span><a href=\"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/pages\/21807\/page\/2\/\" class=\"inactive\">2<\/a><a class=\"pagination-next\" rel=\"next\" href=\"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/pages\/21807\/page\/2\/\"><span class=\"page-text\">Next<\/span><span class=\"page-next\"><\/span><\/a><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":114,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-21807","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>News - Thema Med<\/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:\/\/www.thema-med.com\/en\/news\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"News - Thema Med\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.thema-med.com\/en\/news\/\" \/>\n<meta property=\"og:site_name\" content=\"Thema Med\" \/>\n<meta property=\"article:modified_time\" content=\"2023-01-24T14:00:29+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.thema-med.com\/en\/news\/\",\"url\":\"https:\/\/www.thema-med.com\/en\/news\/\",\"name\":\"News - 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