{"id":1128,"date":"2025-06-20T19:07:32","date_gmt":"2025-06-20T18:07:32","guid":{"rendered":"https:\/\/www.md-amconsulting.es\/?p=1128"},"modified":"2025-06-20T19:13:47","modified_gmt":"2025-06-20T18:13:47","slug":"requisitos-seguridad-aparatos-tatuaje-micropigmentacion","status":"publish","type":"post","link":"https:\/\/www.md-amconsulting.es\/index.php\/2025\/06\/20\/requisitos-seguridad-aparatos-tatuaje-micropigmentacion\/","title":{"rendered":"Requisitos de seguridad para aparatos de tatuaje y micropigmentaci\u00f3n bajo el RD 192\/2023"},"content":{"rendered":"\n<h4 class=\"wp-block-heading\">Requisitos de seguridad para aparatos de tatuaje y micropigmentaci\u00f3n bajo el RD 192\/2023<\/h4>\n\n\n\n<p>El <strong>Real Decreto <a href=\"https:\/\/www.boe.es\/buscar\/doc.php?id=BOE-A-2023-7416\">192\/2023<\/a><\/strong> establece los <strong>requisitos de seguridad aplicables a los aparatos de tatuaje y micropigmentaci\u00f3n<\/strong>, tambi\u00e9n conocidos como maquillaje permanente o semipermanente. Aunque estos productos no se consideran sanitarios, su uso invasivo exige un marco normativo riguroso.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">\u00bfQu\u00e9 productos est\u00e1n afectados?<\/h4>\n\n\n\n<p>Este Real Decreto regula los <strong>aparatos utilizados para tatuajes y micropigmentaci\u00f3n<\/strong>, es decir, aquellos que penetran la piel para introducir pigmento. Se incluyen:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Dispositivos para <strong>tatuajes profesionales<\/strong><\/li>\n\n\n\n<li>Aparatos de <strong>maquillaje permanente o semipermanente<\/strong> (micropigmentaci\u00f3n, dermopigmentaci\u00f3n, etc.)<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">\u00bfLlevan marcado CE?<\/h4>\n\n\n\n<p>No. Estos productos <strong>no pueden llevar marcado CE<\/strong>, ya que no est\u00e1n clasificados como productos sanitarios. Sin embargo, deben cumplir con estrictos <strong>requisitos de seguridad y funcionamiento<\/strong> para garantizar su uso seguro.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">\u00bfQu\u00e9 productos quedan fuera del RD 192\/2023?<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Tatuajes temporales no invasivos<\/li>\n\n\n\n<li>Pigmentos o tintes (regulados por REACH)<\/li>\n\n\n\n<li>Cursos de formaci\u00f3n o servicios educativos<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Licencia sanitaria y documentaci\u00f3n t\u00e9cnica<\/h4>\n\n\n\n<p>Los <strong>fabricantes, importadores y esterilizadores<\/strong> deben obtener una <strong>licencia de funcionamiento<\/strong> ante la AEMPS (Agencia Espa\u00f1ola de Medicamentos y Productos Sanitarios).<\/p>\n\n\n\n<p>Adem\u00e1s, es obligatorio disponer de una <strong>documentaci\u00f3n t\u00e9cnica<\/strong> completa que incluya:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Uso previsto del aparato<\/li>\n\n\n\n<li>Informaci\u00f3n de seguridad f\u00edsica, el\u00e9ctrica y mec\u00e1nica<\/li>\n\n\n\n<li>Manual de mantenimiento<\/li>\n\n\n\n<li>Cumplimiento de normas UNE aplicables<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Requisitos de etiquetado<\/h4>\n\n\n\n<p>Todos los aparatos de tatuaje y micropigmentaci\u00f3n deben incluir en el etiquetado:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Nombre y datos del fabricante o importador<\/li>\n\n\n\n<li>Finalidad del producto<\/li>\n\n\n\n<li>Advertencias y condiciones de uso<\/li>\n\n\n\n<li>Informaci\u00f3n sobre reutilizaci\u00f3n o si es de un solo uso<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Importaci\u00f3n desde terceros pa\u00edses<\/h4>\n\n\n\n<p>Los <strong>importadores<\/strong> tambi\u00e9n deben disponer de licencia sanitaria. Aunque los aparatos no llevan marcado CE, deben <strong>garantizar el cumplimiento de los requisitos de seguridad<\/strong> especificados por el RD 192\/2023.<\/p>\n\n\n\n<p>Si est\u00e1s involucrado en la fabricaci\u00f3n, importaci\u00f3n o distribuci\u00f3n de estos productos, aseg\u00farate de cumplir los <strong>requisitos de seguridad para aparatos de tatuaje y micropigmentaci\u00f3n<\/strong>. La normativa es clara y su cumplimiento es obligatorio para operar legalmente en Espa\u00f1a.<\/p>\n\n\n\n<p>\u00bfTienes dudas? Escr\u00edbenos a <strong><a>info@md-amconsulting.es<\/a><\/strong> o rellena el formulario de <a href=\"https:\/\/www.md-amconsulting.es\/index.php\/pagina-de-contacto\/\">contacto<\/a> y te ayudaremos a cumplir con la regulaci\u00f3n vigente.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Requisitos de seguridad para aparatos de tatuaje y micropigmentaci\u00f3n bajo el RD 192\/2023 El Real Decreto 192\/2023 establece los requisitos de seguridad aplicables a los aparatos de tatuaje y micropigmentaci\u00f3n, tambi\u00e9n conocidos como maquillaje permanente o semipermanente. Aunque estos productos no se consideran sanitarios, su uso invasivo exige un marco normativo riguroso. \u00bfQu\u00e9 productos est\u00e1n [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1129,"comment_status":"open","ping_status":"open","sticky":false,"template":"page-blog","format":"standard","meta":{"saved_in_kubio":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[50],"tags":[26,12,18,59,28,36],"class_list":["post-1128","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","tag-auditoria","tag-consultoria","tag-marcado-ce","tag-mdr","tag-poscomercializacion","tag-productos-sanitarios"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Aparatos 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