{"id":34720,"date":"2025-09-23T09:31:46","date_gmt":"2025-09-23T07:31:46","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=34720"},"modified":"2025-11-14T14:49:26","modified_gmt":"2025-11-14T13:49:26","slug":"regulatory-reliance-en-asia-malasia-china-y-malasia-singapur-aceleran-el-market-access","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/es\/2025\/09\/23\/regulatory-reliance-en-asia-malasia-china-y-malasia-singapur-aceleran-el-market-access\/","title":{"rendered":"Regulatory Reliance en Asia: Malasia-China y Malasia-Singapur aceleran el market access"},"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-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start 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-blend:overlay;--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p style=\"text-align: right;\"><em><strong>Traducido con IA<\/strong><\/em><\/p>\n<p>Se intensifican las iniciativas de <strong>cooperaci\u00f3n reglamentaria<\/strong> en Asia oriental y en el Sudeste asi\u00e1tico, destinadas a agilizar los procesos de evaluaci\u00f3n de los productos sanitarios y a acortar los tiempos de acceso al mercado. Dos programas piloto, <strong>Malasia-Singapur y Malasia-China<\/strong>, representan los casos m\u00e1s recientes y concretos de esta tendencia.<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.25;\" data-fontsize=\"32\" data-lineheight=\"40px\">Malasia y Singapur: Memorandum of Understanding y proyecto piloto de Regulatory Reliance<\/h3>\n<p>La <strong>Medical Device Authority (MDA)<\/strong> de Malasia y la <strong>Health Sciences Authority (HSA)<\/strong> de Singapur, el 22 de agosto de 2025, han firmado un <strong>Memorandum de Entendimiento (MoU)<\/strong> y lanzado el <strong>proyecto piloto \u00abMedical Device Regulatory Reliance Programme\u00bb<\/strong>, que tiene una duraci\u00f3n de <strong>seis meses<\/strong>, <strong>desde el 1 de septiembre de 2025 al 28 de febrero de 2026<\/strong>.<\/p>\n<p>Esta cooperaci\u00f3n reglamentaria en el \u00e1mbito del programa <strong>Malaysia-Singapore Medical Device Regulatory Reliance<\/strong> nace para facilitar un proceso de registro simplificado de los productos sanitarios entre los dos Pa\u00edses y para los <strong>productos sanitarios de clase B, C y D<\/strong>.<\/p>\n<p>Quien decida participar en el proyecto puede esperar tiempos de revisi\u00f3n reducidos para el registro de los productos sanitarios en ambos Pa\u00edses:<\/p>\n<ul>\n<li><strong>En Malasia:<\/strong> los productos ya aprobados por la HSA pueden ser sometidos a una <strong>verification route<\/strong> (proceso de revisi\u00f3n abreviado) a trav\u00e9s de un <strong>Conformity Assessment Body (CAB)<\/strong> reconocido por la MDA; la revisi\u00f3n a trav\u00e9s de este proceso est\u00e1 prevista en unos 30 d\u00edas laborables en lugar de los 60 del proceso de evaluaci\u00f3n de la conformidad completo.<\/li>\n<li><strong>En Singapur:<\/strong> los productos registrados en Malasia por la MDA pueden ser evaluados con un proceso de revisi\u00f3n abreviado que reduce los tiempos de evaluaci\u00f3n hasta un 30% para todos los productos sanitarios de clase B y D, respecto a los tiempos est\u00e1ndar actuales.<\/li>\n<\/ul>\n<p>Al t\u00e9rmino del proyecto piloto <strong>(28 de febrero de 2026<\/strong>) las autoridades evaluar\u00e1n los resultados y podr\u00e1n decidir si extender o hacer permanente el r\u00e9gimen de reliance.<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.25;\" data-fontsize=\"32\" data-lineheight=\"40px\">Malasia y China: proyecto piloto sobre los IVD<\/h3>\n<p>La <strong>MDA <\/strong>de Malasia y la <strong>National Medical Products Administration (NMPA)<\/strong> china han activado un <strong>proyecto piloto para productos IVD<\/strong>, basado en un <strong>Memorandum de Entendimiento<\/strong> firmado en noviembre de 2023. Esta iniciativa, que representa el <strong>primer acuerdo reglamentario rec\u00edproco a nivel global<\/strong> en el marco del <strong>Global Harmonization Working Party (GHWP)<\/strong>, tiene como objetivo acelerar el acceso al mercado para los IVD seleccionados.<\/p>\n<p>La <strong>fase piloto I<\/strong> se desarrolla <strong>desde el 30 de julio de 2025 al 30 de septiembre de 2025<\/strong>, con el objetivo de acelerar el acceso al mercado para IVD seleccionados.<\/p>\n<p>Gracias a estos acuerdos, la cooperaci\u00f3n bilateral se traduce en ventajas concretas en cuanto a los plazos. Para los <strong>IVD fabbricados en Malasia<\/strong>, el acceso al mercado chino puede ser notablemente acelerado a trav\u00e9s del programa <strong>Green Channel<\/strong>. An\u00e1logamente, los <strong>IVD de producci\u00f3n china<\/strong> se benefician en Malasia de una revisi\u00f3n m\u00e1s \u00e1gil gracias al <strong>Verification Pathway<\/strong>.<\/p>\n<p>Los <strong>criterios de elegibilidad<\/strong> para participar en este proyecto piloto son rigurosos y operativos:<\/p>\n<ul>\n<li><strong>IVD malayos en China:<\/strong> pueden acceder al llamado \u00ab<strong>China Green Channel<\/strong>\u00bb los IVD de <strong>Clase B, C o D aprobados por la MDA<\/strong>. El programa ofrece un proceso acelerado, con una significativa reducci\u00f3n de los tiempos de aprobaci\u00f3n respecto a las pr\u00e1cticas est\u00e1ndar.<\/li>\n<li><strong>IVD chinos en Malasia:<\/strong> pueden utilizar la <strong>Verification Pathway<\/strong> de la MDA los IVD de <strong>Clase II aprobados por la Provincial MPA o de Clase III aprobados por la NMPA<\/strong>.<\/li>\n<\/ul>\n<p>Entre los <strong>requisitos de elegibilidad<\/strong> para adherirse al proyecto:<\/p>\n<ul>\n<li>Se <strong>excluyen <\/strong>los propietarios de marca de terceros (ej. revendedor de marca, re-etiquetador, ensambladores).<\/li>\n<li>Se prev\u00e9 un <strong>l\u00edmite de 6 solicitudes por contacto<\/strong> (para la presentaci\u00f3n a la MDA).<\/li>\n<li>Las solicitudes relativas a <strong>enfermedades raras y productos sanitarios innovadores<\/strong> recibir\u00e1n prioridad.<\/li>\n<\/ul>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.25;\" data-fontsize=\"32\" data-lineheight=\"40px\">Un paso clave para las empresas del sector<\/h3>\n<p>Las iniciativas de <strong>cooperaci\u00f3n reglamentaria<\/strong> en Malasia-Singapur y Malasia-China son una se\u00f1al de que este impulso a la armonizaci\u00f3n est\u00e1 creando una <strong>nueva fuerza<\/strong> reglamentaria y econ\u00f3mica en la zona. Este escenario, no solo ofrece a los fabricantes procesos m\u00e1s r\u00e1pidos, sino que tambi\u00e9n solicita nuevas estrategias de acceso al mercado.<\/p>\n<p>Los fabricantes que sepan aprovechar la evoluci\u00f3n de estos acuerdos y posicionarse estrat\u00e9gicamente, ser\u00e1n los primeros en sacar provecho de la consolidaci\u00f3n de estas nuevas alianzas reglamentarias.<\/p>\n<h3><b data-olk-copy-source=\"MessageBody\">Actualizaci\u00f3n del 15 de octubre de 2025<\/b><\/h3>\n<div>En l\u00ednea con las tendencias de cooperaci\u00f3n, la Autoridad Malasia MDA ha consolidado y ampliado su v\u00eda de Dependencia Regulatoria (<i>Regulatory Reliance<\/i> o Abreviada).<\/div>\n<ul>\n<li><b>Ampliaci\u00f3n de Pa\u00edses Reconocidos:<\/b> Con la <strong><u><a id=\"OWAe45f2a64-7037-903f-0c0b-622898764a75\" title=\"https:\/\/www.mda.gov.my\/index.php\/doc-list\/circular-letter\" href=\"https:\/\/www.mda.gov.my\/index.php\/doc-list\/circular-letter\" data-auth=\"NotApplicable\" data-linkindex=\"7\">Circular MDA n.\u00ba 2\/2025<\/a><\/u><\/strong> (15 de octubre de 2025), la MDA ha a\u00f1adido formalmente a Singapur y Tailandia a la lista de Autoridades Regulatorias Reconocidas (que ya incluye a EE. UU., UE, Canad\u00e1, Australia, Jap\u00f3n y Reino Unido).<\/li>\n<li><b>Aclaraci\u00f3n Procesal:<\/b> La aplicaci\u00f3n de esta v\u00eda abreviada est\u00e1 ahora definida en detalle por las nuevas gu\u00edas <strong><u><a id=\"OWAc9b98b8b-5dda-bfe4-75ea-2dbbc5d7aac1\" title=\"https:\/\/www.mda.gov.my\/index.php\/documents\/ukk\/3767-final-draft-gd-conformity-assessment-body-cab-guide-for-conducting-conformity-assessment-by-way-of-verification-first-edition\/file\" href=\"https:\/\/www.mda.gov.my\/index.php\/documents\/ukk\/3767-final-draft-gd-conformity-assessment-body-cab-guide-for-conducting-conformity-assessment-by-way-of-verification-first-edition\/file\" data-auth=\"NotApplicable\" data-linkindex=\"8\">MDA\/GD\/0068<\/a><\/u><\/strong> (para Organismos de Evaluaci\u00f3n de la Conformidad) y <strong><u><a id=\"OWA5505913c-123d-c725-44a3-21565f3e4c04\" title=\"https:\/\/www.mda.gov.my\/index.php\/documents\/ukk\/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition\/file\" href=\"https:\/\/www.mda.gov.my\/index.php\/documents\/ukk\/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition\/file\" data-auth=\"NotApplicable\" data-linkindex=\"9\">MDA\/GD\/0070<\/a><\/u><\/strong> (para Fabricantes\/Establecimientos).<\/li>\n<\/ul>\n<div>\n<p>Este paso de programas piloto a un procedimiento est\u00e1ndar consolida el objetivo de reducir los tiempos de aprobaci\u00f3n y facilitar el acceso al mercado en Asia para los dispositivos m\u00e9dicos.<\/p>\n<\/div>\n<p>\ud83d\udc49 <em>Con Thema, tus productos sanitarios est\u00e1n siempre en regla, dondequiera que vayan. Descubre nuestros <\/em><a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/registrazioni-internazionali-extra-ue-dispositivi-medici-dm-e-medico-diagnostici-in-vitro-ivd\/\"><em>servicios<\/em><\/a><em>.<\/em><\/p>\n<p><strong> FUENTES:<\/strong><\/p>\n<ul>\n<li><a href=\"https:\/\/www.hsa.gov.sg\/medical-devices\/international-collaboration-medical-devices\/regulatory-reliance\">https:\/\/www.hsa.gov.sg\/medical-devices\/international-collaboration-medical-devices\/regulatory-reliance<\/a><\/li>\n<li><a href=\"https:\/\/mda.gov.my\/index.php\/announcement\/1623-press-release-singapore-reliance\">https:\/\/mda.gov.my\/index.php\/announcement\/1623-press-release-singapore-reliance<\/a><\/li>\n<li><a href=\"https:\/\/www.mda.gov.my\/index.php\/announcement\/1611-press-release-malaysia-leads-the-world-in-medical-device-regulatory-reliance\">https:\/\/www.mda.gov.my\/index.php\/announcement\/1611-press-release-malaysia-leads-the-world-in-medical-device-regulatory-reliance<\/a><\/li>\n<li><a href=\"https:\/\/portal.mda.gov.my\/index.php\/documents\/ukk\/3707-implementation-of-the-malaysia-china-medical-device-regulatory-reliance-programme-pilot-phase-i-30072025-2\/file\">https:\/\/portal.mda.gov.my\/index.php\/documents\/ukk\/3707-implementation-of-the-malaysia-china-medical-device-regulatory-reliance-programme-pilot-phase-i-30072025-2\/file<\/a><\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":34700,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[3],"tags":[2156,2159,1682,2157,1645,2158,2155],"class_list":["post-34720","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-es","tag-asia-es","tag-china-es","tag-ivd-es-2","tag-malasia","tag-productos-sanitarios-es","tag-singapur-es","tag-sudeste-asiatico"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Regulatory Reliance en Asia: Malasia-China y Malasia-Singapur aceleran el market access<\/title>\n<meta name=\"description\" content=\"Descubre c\u00f3mo los nuevos acuerdos reglamentarios entre Malasia, Singapur y China est\u00e1n acelerando el acceso al mercado para los fabricantes de productos sanitarios. 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