{"id":34704,"date":"2025-09-23T09:26:23","date_gmt":"2025-09-23T07:26:23","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=34704"},"modified":"2025-10-28T12:00:40","modified_gmt":"2025-10-28T11:00:40","slug":"mexico-a-summer-of-regulatory-overhaul","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2025\/09\/23\/mexico-a-summer-of-regulatory-overhaul\/","title":{"rendered":"Mexico: A Summer of Regulatory Overhaul"},"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-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; \"><strong><em>Translated with AI<\/em><\/strong><\/p>\n<\/p>\n<p>Mexico is undergoing a period of profound transformation. In recent months, the <strong>Federal Commission for the Protection against Sanitary Risks (COFEPRIS<\/strong>) has initiated a substantial review of its medical device registration system. The objective is clear: to simplify and streamline market access procedures while increasing user safety.<\/p>\n<p>This summer marked a turning point with a <strong>series of agreements<\/strong> designed to reshape regulatory processes in the Mexican market. This awaited revolution is well-received by manufacturers, given that Mexico, despite being a strategic market, has until now been hindered by long and complex authorization processes.<\/p>\n<h3 data-fontsize=\"32\" style=\"--fontSize: 32; line-height: 1.25;\" data-lineheight=\"40px\" class=\"fusion-responsive-typography-calculated\">July 2025 Agreement: New Rules for Low-Risk Devices<\/h3>\n<p>An important step in this reform was the <a href=\"https:\/\/dof.gob.mx\/nota_detalle_popup.php?codigo=5762237\">&#8220;<strong>Acuerdo de Dispositivos M\u00e9dicos Julio 2025<\/strong>,&#8221;<\/a> signed on July 6 and published on July 15 in the <em>Diario Oficial de la Federaci\u00f3n<\/em> (the Mexican Official Gazette).<\/p>\n<p>This document has fundamentally reformed the 2011 and 2014 regulations for low-risk Medical Devices, introducing a new structure based on <strong>three Annexes (Anexos):<\/strong><\/p>\n<ul>\n<li><strong>ANEXO UNO:<\/strong> lists low-risk devices with<strong> mandatory registration<\/strong>. For the first time, some previously exempt devices will now require registration. Manufacturers have a transition period with phased <strong>deadlines between 2025 and 2028<\/strong>, based on the product\u2019s submission number.<\/li>\n<\/ul>\n<ul>\n<li><strong>ANEXO DOS:<\/strong> lists low-risk devices<strong> exempt from registration<\/strong>. Although they do not require formal registration, these products must comply with specific obligations, including adherence to <strong>Good Manufacturing Practices (GMP<\/strong>), compliance with <strong>technovigilance standards<\/strong>, and the designation of a <strong>Mexico Authorized Representative<\/strong> (<strong>MRH<\/strong>).<\/li>\n<\/ul>\n<ul>\n<li><strong>ANEXO TRES:<\/strong> lists <strong>products not considered Medical Devices<\/strong>, providing greater clarity on which products are completely exempt from COFEPRIS regulation.<\/li>\n<\/ul>\n<p>It is crucial for manufacturers to verify the status of their products on the market as soon as possible to understand if a new registration is required or if documentation needs to be updated.<\/p>\n<h3 data-fontsize=\"32\" style=\"--fontSize: 32; line-height: 1.25;\" data-lineheight=\"40px\" class=\"fusion-responsive-typography-calculated\">August 22, 2025 Agreement: Simplification and Unification<\/h3>\n<p>Subsequently, an <a href=\"https:\/\/www.dof.gob.mx\/nota_detalle.php?codigo=5766390&amp;fecha=22\/08\/2025#gsc.tab=0\"><strong>Agreement<\/strong><\/a> aimed at substantially <strong>simplifying<\/strong> registration procedures was published on <strong>August 22, 2025<\/strong>.<\/p>\n<p>Among the main changes:<\/p>\n<ul>\n<li><strong>Consolidation of procedures:<\/strong> Registration procedures, previously differentiated by type (domestic manufacturing, importation, third-party manufacturing), have been <strong>merged into a single process.<\/strong><\/li>\n<li><strong>Reorganization of homoclaves:<\/strong> The agreement strengthens the use of unique alphanumeric codes (<strong>homoclaves<\/strong>) to identify each submission. Tables have been published that associate updated homoclaves with different device categories, such as COFEPRIS-04-070 for low-risk devices and COFEPRIS-04-060 for the ordinary pathway. This approach simplifies traceability and reduces redundancies.<\/li>\n<\/ul>\n<p>It is important to note that, as of October 6, the old procedures based on equivalency with authorizations from bodies like the FDA and Health Canada will no longer be accepted.<\/p>\n<p>This agreement <strong>does not override<\/strong> the previous <a href=\"https:\/\/www.thema-med.com\/2025\/07\/31\/il-messico-apre-le-porte-registrazione-abbreviata-per-dispositivi-medici-con-approvazione-internazionale\/\"><strong>July 18, 2025<\/strong><\/a> agreement, which formalizes the abbreviated pathway based on the recognition of approvals <strong>from Reference Regulatory Authorities<\/strong> (<strong>RRA<\/strong>).<\/p>\n<h3 data-fontsize=\"32\" style=\"--fontSize: 32; line-height: 1.25;\" data-lineheight=\"40px\" class=\"fusion-responsive-typography-calculated\">What This Means for Manufacturers<\/h3>\n<p>The direction taken by COFEPRIS is toward a more efficient, transparent, and predictable regulatory environment. For medical device manufacturers, it is essential to understand this new regulatory framework to adapt their registration strategy and ensure solid, long-term compliance in a market where further changes are expected.<\/p>\n<p><em><img decoding=\"async\" draggable=\"false\" role=\"img\" class=\"emoji\" alt=\"\ud83d\udc49\" src=\"https:\/\/s.w.org\/images\/core\/emoji\/16.0.1\/svg\/1f449.svg\"><\/em><em> Thema&#8217;s experts offer <\/em><a href=\"https:\/\/www.thema-med.com\/en\/services\/international-registrations-outside-the-eu\/\"><em>support<\/em><\/a><em> to assess the impact of these changes and define the best regulatory strategy to obtain or maintain a presence in the Mexican medical device market.<\/em><\/p>\n<p><strong>SOURCES:<\/strong><\/p>\n<ul>\n<li><a href=\"https:\/\/www.dof.gob.mx\/nota_detalle.php?codigo=5658607&amp;fecha=15\/07\/2025\">https:\/\/www.dof.gob.mx\/nota_detalle.php?codigo=5658607&amp;fecha=15\/07\/2025<\/a><\/li>\n<li><a href=\"https:\/\/www.gob.mx\/cofepris\/documentos\/acuerdo-de-la-secretaria-de-salud-por-el-que-se-modifica-el-anexo-2-del-acuerdo-de-la-secretaria-de-salud-por-el-que-se-establecen-los-requisitos-de-tramites-y-procedimientos-para-la-obtencion-de-registros-sanitarios-de-dispositivos-medicos\">https:\/\/www.gob.mx\/cofepris\/documentos\/acuerdo-de-la-secretaria-de-salud-por-el-que-se-modifica-el-anexo-2-del-acuerdo-de-la-secretaria-de-salud-por-el-que-se-establecen-los-requisitos-de-tramites-y-procedimientos-para-la-obtencion-de-registros-sanitarios-de-dispositivos-medicos<\/a><\/li>\n<li><a href=\"https:\/\/www.dof.gob.mx\/nota_detalle.php?codigo=5661234&amp;fecha=22\/08\/2025\">https:\/\/www.dof.gob.mx\/nota_detalle.php?codigo=5661234&amp;fecha=22\/08\/2025<\/a><\/li>\n<li><a href=\"https:\/\/www.gob.mx\/cofepris\/documentos\/acuerdo-por-el-que-se-establecen-las-homoclaves-y-procedimientos-para-la-obtencion-de-registros-sanitarios-y-demas-tramites-de-dispositivos-medicos\">https:\/\/www.gob.mx\/cofepris\/documentos\/acuerdo-por-el-que-se-establecen-las-homoclaves-y-procedimientos-para-la-obtencion-de-registros-sanitarios-y-demas-tramites-de-dispositivos-medicos<\/a><\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":34694,"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":[2],"tags":[2136,2042,2139,2138,2137,2041],"class_list":["post-34704","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en","tag-acuerdo-mexico","tag-cofepris-en","tag-homoclaves-en","tag-medical-device-registration-en","tag-medical-device-regulation-en-2","tag-mexico-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Mexico: Regulatory Updates for Medical Devices. 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