{"id":3101,"date":"2026-01-15T00:00:00","date_gmt":"2026-01-14T23:00:00","guid":{"rendered":"https:\/\/pharegistrum.com\/removedores-de-manchas-dentales-productos-sanitarios-o-cosmeticos\/"},"modified":"2026-10-30T20:28:10","modified_gmt":"2026-10-30T19:28:10","slug":"removedores-de-manchas-dentales-productos-sanitarios-o-cosmeticos","status":"publish","type":"post","link":"https:\/\/pharegistrum.com\/es\/removedores-de-manchas-dentales-productos-sanitarios-o-cosmeticos\/","title":{"rendered":"Removedores de manchas dentales: \u00bfproductos sanitarios o cosm\u00e9ticos?"},"content":{"rendered":"

\ud83d\udca1 Curiosidad Reglamentaria:<\/p>\n

\u00bfSon los removedores de manchas dentales por microabrasi\u00f3n productos sanitarios o cosm\u00e9ticos?
La Versi\u00f3n 4 del Manual on Borderline and Classification for Medical Devices, publicada por el Borderline and Classification Working Group (MDCG), aclara que la eliminaci\u00f3n de manchas dentales con finalidad est\u00e9tica \u2014incluso por microabrasi\u00f3n\u2014 no constituye una finalidad m\u00e9dica.<\/p>\n

\ud83d\udc49 As\u00ed:
\u2714\ufe0f Solo podr\u00e1n clasificarse como productos sanitarios si existe evidencia cient\u00edfica s\u00f3lida que demuestre su uso en la prevenci\u00f3n, tratamiento o alivio de una enfermedad;
\u2714\ufe0f En ausencia de dicha evidencia, deber\u00e1n clasificarse como productos cosm\u00e9ticos.
La correcta cualificaci\u00f3n reglamentaria es esencial para asegurar la conformidad con el MDR y el IVDR y evitar marcos incorrectos.<\/p>\n

PhaRegistrum apoya a fabricantes y distribuidores en la interpretaci\u00f3n y aplicaci\u00f3n pr\u00e1ctica de estos requisitos.<\/p>\n

#Regulamenta\u00e7\u00e3o
#MedicalDevices
#MDR
#IVDR
#Borderline
#Cosmetics
#Compliance
#RegulatoryAffairs
#PhaRegistrum<\/p>\n

Ver publicaci\u00f3n original en LinkedIn<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

\u00bfSon los removedores de manchas dentales por microabrasi\u00f3n productos sanitarios o cosm\u00e9ticos? La Versi\u00f3n 4 del Manual on Borderline and Classification for Medical Devices, publicada por el Borderline and Classification Working\u2026<\/p>\n","protected":false},"author":0,"featured_media":2957,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[47],"tags":[],"class_list":["post-3101","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-linkedin-3"],"_links":{"self":[{"href":"https:\/\/pharegistrum.com\/es\/wp-json\/wp\/v2\/posts\/3101","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharegistrum.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharegistrum.com\/es\/wp-json\/wp\/v2\/types\/post"}],"replies":[{"embeddable":true,"href":"https:\/\/pharegistrum.com\/es\/wp-json\/wp\/v2\/comments?post=3101"}],"version-history":[{"count":1,"href":"https:\/\/pharegistrum.com\/es\/wp-json\/wp\/v2\/posts\/3101\/revisions"}],"predecessor-version":[{"id":3261,"href":"https:\/\/pharegistrum.com\/es\/wp-json\/wp\/v2\/posts\/3101\/revisions\/3261"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharegistrum.com\/es\/wp-json\/wp\/v2\/media\/2957"}],"wp:attachment":[{"href":"https:\/\/pharegistrum.com\/es\/wp-json\/wp\/v2\/media?parent=3101"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharegistrum.com\/es\/wp-json\/wp\/v2\/categories?post=3101"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharegistrum.com\/es\/wp-json\/wp\/v2\/tags?post=3101"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}