{"id":20386,"date":"2026-02-16T09:45:54","date_gmt":"2026-02-16T15:45:54","guid":{"rendered":"https:\/\/blplegal.com\/?p=20386"},"modified":"2026-02-16T09:45:54","modified_gmt":"2026-02-16T15:45:54","slug":"newsflash-actualizaciones-regulatorias-enero-2026","status":"publish","type":"post","link":"https:\/\/blplegal.com\/es\/newsflash-actualizaciones-regulatorias-enero-2026\/","title":{"rendered":"Newsflash: Actualizaciones Regulatorias \u2013 Enero 2026"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><b>Reconocimiento del t\u00e9rmino \u201cREF\u201d mediante etiqueta complementaria<\/b><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><b>Resoluci\u00f3n<\/b><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Si bien el RTCR 505:2022 no reconoce ni autoriza el uso del t\u00e9rmino \u201cREF\u201d para cumplir con el requisito del\u00a0<b>c\u00f3digo identificador del producto<\/b>, se permite aclarar mediante\u00a0<b>etiqueta complementaria<\/b>\u00a0que el \u201cREF\u201d indicado por el fabricante corresponde al c\u00f3digo identificador del producto, de conformidad con el numeral 19.1.5 del RTCR.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Se autoriza incluir en la etiqueta complementaria la siguiente leyenda:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><b>\u201cC\u00f3digo: l\u00e9ase en la etiqueta original REF como c\u00f3digo del producto\u201d.<\/b><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Esta aclaraci\u00f3n garantiza el cumplimiento de la normativa nacional y permite al usuario identificar correctamente la informaci\u00f3n exigida.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\" aria-level=\"2\"><b>Aspectos Clave<\/b>\u00a0<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n \t<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\">El reglamento exige utilizar \u00fanicamente la expresi\u00f3n oficial\u00a0<b>\u201cc\u00f3digo identificador del producto\u201d<\/b>\u00a0en el etiquetado. El t\u00e9rmino \u201cREF\u201d no est\u00e1 contemplado como denominaci\u00f3n v\u00e1lida para cumplir este requisito.\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n \t<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\">El t\u00e9rmino \u201cREF\u201d es ampliamente utilizado por fabricantes internacionales y aceptado por diversas autoridades regulatorias, entre ellas:\u00a0Food\u00a0and\u00a0Drug\u00a0Administration\u00a0(FDA) de los Estados Unidos,\u00a0Agencia Europea de Medicamentos (EMA),\u00a0Uni\u00f3n Europea bajo el Reglamento (UE) 2017\/745 (MDR),\u00a0Health\u00a0Canada,\u00a0Pharmaceuticals\u00a0and Medical\u00a0Devices\u00a0Agency (PMDA) de Jap\u00f3n\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n \t<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\">A pesar de su reconocimiento global, la nomenclatura \u201cREF\u201d no coincide con la terminolog\u00eda obligatoria establecida en el RTCR 505:2022.\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n \t<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\">Dado que la etiqueta complementaria puede emplearse para incorporar informaci\u00f3n obligatoria que no est\u00e9 claramente indicada en la etiqueta original, se autoriza su uso para aclarar que el \u201cREF\u201d se\u00f1alado por el fabricante corresponde al c\u00f3digo identificador del producto exigido por la normativa nacional.\u00a0<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><b>Etiqueta complementaria sobre origen de insumos en equipos biom\u00e9dicos<\/b><\/p>\n\n\n\n<p class=\"wp-block-paragraph\" aria-level=\"2\"><b>Resoluci\u00f3n<\/b>\u00a0<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">En el marco del RTCR 505:2022 \u201cEquipo y material biom\u00e9dico. Clasificaci\u00f3n, registro, importaci\u00f3n, etiquetado, publicidad, vigilancia y control\u201d, Decreto\u00a0N\u00b0\u00a043902-S, y con el fin de asegurar una correcta interpretaci\u00f3n del etiquetado de los equipos y materiales biom\u00e9dicos comercializados en el pa\u00eds, se autoriza el uso de etiqueta complementaria para aclarar el alcance de leyendas como \u201cPRODUCT OF XXXX\u201d incluidas en la etiqueta original.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Cuando la etiqueta original indique \u201cPRODUCT OF XXXX\u201d u otras expresiones similares, podr\u00e1 incorporarse en la etiqueta complementaria la siguiente leyenda:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><b>\u201cL\u00e9ase en la etiqueta original PRODUCT OF XXXX, como el origen de la materia prima\u201d.<\/b><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Asimismo, podr\u00e1 incluirse la indicaci\u00f3n:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><b>\u201cOrigen de la materia prima: XXXX.\u201d<\/b><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Esta aclaraci\u00f3n no modifica ni corrige la informaci\u00f3n contenida en la etiqueta original del fabricante, sino que precisa su significado, garantizando una adecuada diferenciaci\u00f3n entre el pa\u00eds del fabricante del equipo o material biom\u00e9dico \u2014cuya declaraci\u00f3n es obligatoria\u2014 y el origen de sus insumos.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\" aria-level=\"2\"><b>Aspectos Clave<\/b>\u00a0<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n \t<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\">El RTCR 505:2022 exige la identificaci\u00f3n clara del pa\u00eds del fabricante del equipo o material biom\u00e9dico.\u00a0Las leyendas como \u201cPRODUCT OF XXXX\u201d no sustituyen ni cumplen por s\u00ed mismas este requisito.\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n \t<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\">En la pr\u00e1ctica internacional, expresiones como \u201cPRODUCT OF XXXX\u201d suelen referirse exclusivamente al origen de una materia prima, componente o granel utilizado en el proceso de fabricaci\u00f3n.\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n \t<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\">Esta pr\u00e1ctica no contraviene el reglamento, siempre que la informaci\u00f3n obligatoria relativa al fabricante est\u00e9 debidamente incluida, claramente identificada y diferenciada en el etiquetado.\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n \t<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\">Con el fin de evitar interpretaciones err\u00f3neas por parte del usuario final, y en concordancia con el uso permitido de la etiqueta complementaria, resulta procedente aclarar expresamente que la referencia al pa\u00eds indicado corresponde \u00fanicamente al origen de la materia prima.\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n \t<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"5\" data-aria-level=\"1\">La utilizaci\u00f3n de la etiqueta complementaria en estos t\u00e9rminos contribuye a una interpretaci\u00f3n correcta del etiquetado y asegura el cumplimiento de la normativa nacional.\u00a0<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Reconocimiento del t\u00e9rmino \u201cREF\u201d mediante etiqueta complementaria Resoluci\u00f3n Si bien el RTCR 505:2022 no reconoce ni autoriza el uso del t\u00e9rmino \u201cREF\u201d para cumplir con el requisito del\u00a0c\u00f3digo identificador del producto, se permite aclarar mediante\u00a0etiqueta complementaria\u00a0que el \u201cREF\u201d indicado por el fabricante corresponde al c\u00f3digo identificador del producto, de conformidad con el numeral 19.1.5 del&#8230;<\/p>\n","protected":false},"author":6,"featured_media":20387,"comment_status":"closed","ping_status":"open","sticky":false,"template":"single-blog.php","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[242,304,303,289],"tags":[],"class_list":["post-20386","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","category-costa-rica-es","category-noticias","category-registro-sanitario-de-productos"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Newsflash: Actualizaciones Regulatorias \u2013 Enero 2026 - BLP Legal<\/title>\n<meta name=\"description\" content=\"Comunicados MS-DRPIRS-0155-2026 y 0156-2026 aclaran requisitos del RTCR 505:2022 sobre etiquetado biom\u00e9dico, 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