{"id":4009,"date":"2025-06-18T23:25:08","date_gmt":"2025-06-18T23:25:08","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=4009"},"modified":"2026-04-28T18:15:23","modified_gmt":"2026-04-28T18:15:23","slug":"mexicos-expanded-equivalency-agreement-for-medical-devices-key-implications","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/mexicos-expanded-equivalency-agreement-for-medical-devices-key-implications\/","title":{"rendered":"Mexico\u2019s Expanded Equivalency Agreement for Medical Devices: Key Implications"},"content":{"rendered":"<p><span data-contrast=\"auto\">Mexico\u2019s regulatory landscape has been active, presenting important updates. Previously, we discussed the agreement published on June 11, 2025. However, as that version will soon be obsolete, this article has been updated to reflect the latest <\/span><a href=\"https:\/\/www.dof.gob.mx\/nota_detalle.php?codigo=5763319&amp;fecha=18\/07\/2025#gsc.tab=0\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Agreement published on July 18 by the Mexican Ministry of Health in the Official Mexican Diary<\/span><\/a><span data-contrast=\"auto\">. This new agreement outlines the recognition of authorizations issued <\/span><b><span data-contrast=\"auto\">by reference regulatory authorities<\/span><\/b><span data-contrast=\"auto\">, as well as evaluations conducted under the World Health Organization (WHO) Prequalification Program.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">This update is important if your medical device or IVD has been approved <\/span><b><span data-contrast=\"auto\">by a regulatory authority of reference<\/span><\/b><span data-contrast=\"auto\">, especially in terms of timelines. In this article, we offer deeper insight into the changes<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Regulatory Equivalency and Expanded Recognition<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">As a reference, Mexico has previously implemented <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/equivalency-agreement-summary\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">equivalency agreement models<\/span><\/a><span data-contrast=\"auto\"> as a mechanism for <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/ultimate-guide-for-regulatory-affairs-in-mexico\/#timelines\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">streamlining<\/span><\/a><span data-contrast=\"auto\"> regulatory approval processes. Prior to this update, Mexico acknowledged authorizations from <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/health-canada-mdl-equivalency-route-registration-in-mexico\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Canada<\/span><\/a><span data-contrast=\"auto\">, <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/japan-equivalency-agreement-for-medical-devices-in-mexico\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Japan<\/span><\/a><span data-contrast=\"auto\">, and the United States.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">However, with this latest agreement, <\/span><b><span data-contrast=\"auto\">COFEPRIS has extended recognition to the MDSAP and IMDRF <\/span><\/b><span data-contrast=\"auto\">(International Medical Device Regulators Forum)<\/span> <a href=\"https:\/\/www.imdrf.org\/about\/management-committee\" target=\"_blank\" rel=\"noopener\"><b><span data-contrast=\"none\">Management Committee<\/span><\/b><\/a><span data-contrast=\"auto\">, which as of 2025 includes Regulatory Agencies from:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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\"><span data-contrast=\"auto\">Australia<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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\"><span data-contrast=\"auto\">Brazil<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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\"><span data-contrast=\"auto\">Canada<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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\"><span data-contrast=\"auto\">China<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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\"><span data-contrast=\"auto\">European Union<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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=\"6\" data-aria-level=\"1\"><span data-contrast=\"auto\">Japan<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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=\"7\" data-aria-level=\"1\"><span data-contrast=\"auto\">Russia<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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=\"8\" data-aria-level=\"1\"><span data-contrast=\"auto\">Singapore<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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=\"9\" data-aria-level=\"1\"><span data-contrast=\"auto\">South Korea<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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=\"10\" data-aria-level=\"1\"><span data-contrast=\"auto\">Switzerland<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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=\"11\" data-aria-level=\"1\"><span data-contrast=\"auto\">United Kingdom<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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=\"12\" data-aria-level=\"1\"><span data-contrast=\"auto\">United States of America<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">In other words, <\/span><span data-contrast=\"auto\">medical devices and IVDs approved by Regulatory Agencies from these countries are eligible for the equivalency agreement and would benefit from a 30 days working day revision period following submission.<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Special Considerations for Authorization Validity<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/h3>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">There are several key provisions to understand the relevance of this agreement:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"7\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Article 16 <\/span><\/b><span data-contrast=\"auto\">emphasizes that this pathway may only be used for the same product authorized by the reference regulatory authority, which must have the same essential basic characteristics.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"7\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Article 17 <\/span><\/b><span data-contrast=\"auto\">clarifies that if a product is registered in multiple reference countries, only one Certificate of Free Sales may be submitted. Therefore, using the registration from the country of origin, can help mitigate the risk of losing the Mexican registration if interest in another market is later withdrawn. Because, as <\/span><b><span data-contrast=\"auto\">article 18 <\/span><\/b><span data-contrast=\"auto\">states, the authorization document must remain valid throughout the application process.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"7\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Article 20 <\/span><\/b><span data-contrast=\"auto\">highlights that eligible authorizations must have undergone a complete and independent regulatory review.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Noteworthy Additions to the Agreement<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Articles 19 and 36 are especially notable, as they introduce elements not addressed in previous equivalency agreements:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"8\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Article 19 addresses &#8220;duplicate submissions&#8221;<\/span><\/b><span data-contrast=\"auto\"> and clearly states that applications submitted via this pathway that are already under review will be discarded.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"8\" data-list-defn-props=\"{&quot;335552541&quot;:1,&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;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Article 36 establishes<\/span><\/b> <b><span data-contrast=\"auto\">that COFEPRIS will not request any documentation or information beyond what is outlined in the current agreement. <\/span><\/b><span data-contrast=\"auto\">This unprecedented provision signals a commitment to streamlined processing.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Although the agreement sets a standard processing <\/span><span data-contrast=\"auto\">timeline of 30 working days<\/span><span data-contrast=\"auto\">, submitting under this regulatory framework may offer strategic benefits. Given its <\/span><b><span data-contrast=\"auto\">recent implementation, <\/span><\/b><span data-contrast=\"auto\">applications filed through this pathway may receive <\/span><b><span data-contrast=\"auto\">increased attention<\/span><\/b><span data-contrast=\"auto\"> from Mexican authorities, offering a potential advantage in prioritization and potentially expediting approvals. <\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<h3><strong>Frequently Asked Questions (FAQ)\u00a0<\/strong><\/h3>\n<ol>\n<li><strong> Are the 30 days promised by COFEPRIS counted as calendar days or working days?\u00a0<\/strong><\/li>\n<\/ol>\n<p><span data-contrast=\"auto\">The 30-day review period\u00a0established\u00a0under this equivalency agreement refers to working days (business days), not calendar days. This distinction is critical for regulatory planning, as weekends and official holidays are excluded from the timeline.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<ol start=\"2\">\n<li><strong>Which foreign regulatory agencies are accepted by COFEPRIS for medical device equivalency approvals in Mexico?<\/strong><\/li>\n<\/ol>\n<p><span data-contrast=\"auto\">COFEPRIS recognizes authorizations issued by regulatory agencies that are members of the IMDRF Management Committee or\u00a0operate\u00a0under MDSAP, as well as WHO Prequalification decisions. These include, among others:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<ul>\n<li><span data-contrast=\"auto\">United States\u00a0\u2013\u00a0<\/span><a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">FDA (Food and Drug Administration)<\/span><\/a><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">Canada\u00a0\u2013\u00a0<\/span><a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/medical-devices.html\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Health Canada<\/span><\/a><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">European Union\u00a0\u2013\u00a0<\/span><a href=\"https:\/\/www.ema.europa.eu\/en\/homepage\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">EMA<\/span><\/a><span data-contrast=\"auto\">\u00a0\/ National Competent Authorities<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">United Kingdom\u00a0\u2013\u00a0<\/span><a href=\"https:\/\/www.gov.uk\/government\/organisations\/medicines-and-healthcare-products-regulatory-agency\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">MHRA<\/span><\/a><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">Japan\u00a0\u2013\u00a0<\/span><a href=\"https:\/\/www.pmda.go.jp\/english\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">PMDA<\/span><\/a><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">Australia \u2013\u00a0<\/span><a href=\"https:\/\/www.tga.gov.au\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">TGA\u00a0(Therapeutic Goods Administration)<\/span><\/a><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">Brazil\u00a0\u2013\u00a0<\/span><a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">ANVISA<\/span><\/a><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">China \u2013\u00a0<\/span><a href=\"https:\/\/english.nmpa.gov.cn\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">NMPA\u00a0(National Medical Products Administration)<\/span><\/a><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">South Korea \u2013\u00a0<\/span><a href=\"https:\/\/www.mfds.go.kr\/eng\/index.do\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">MFDS\u00a0(Ministry of Food and Drug Safety)<\/span><\/a><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">Singapore \u2013\u00a0<\/span><a href=\"https:\/\/www.hsa.gov.sg\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">HSA\u00a0(Health Sciences Authority)<\/span><\/a><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">Switzerland\u00a0\u2013\u00a0<\/span><a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home.html\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Swissmedic<\/span><\/a><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">Russia\u00a0\u2013\u00a0<\/span><a href=\"https:\/\/roszdravnadzor.gov.ru\/en\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Roszdravnadzor<\/span><\/a><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">Medical devices and IVDs approved by these agencies may qualify for the Mexican regulatory equivalency pathway, provided all other requirements are met.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<ol start=\"3\">\n<li><strong> Can a product authorized in multiple reference countries be submitted under this pathway?\u00a0<\/strong><\/li>\n<\/ol>\n<p><span data-contrast=\"auto\">Yes. If a medical device or IVD is registered in more than one reference country, only one Certificate of Free Sale (CFS) is\u00a0required\u00a0for submission. Strategically, using the authorization from the country of origin\u00a0is often advisable, as the selected reference authorization must remain valid throughout the entire COFEPRIS review process. If that authorization is withdrawn or expires, the Mexican application may be affected.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Conclusions\u00a0<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The agreement officially goes into effect on <\/span><b><span data-contrast=\"auto\">August 29, 2025<\/span><\/b><span data-contrast=\"auto\">, making this a crucial period for medical device industry stakeholders seeking to leverage regulatory efficiencies in Mexico.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">If you have <\/span><b><span data-contrast=\"auto\">questions or comments<\/span><\/b><span data-contrast=\"auto\"> regarding this new equivalency agreement, feel free to <\/span><a href=\"mailto:contact@veraqueconsulting.com\"><span data-contrast=\"none\">contact Veraque<\/span><\/a><span data-contrast=\"auto\"> . You can also\u00a0 <\/span><a href=\"https:\/\/www.linkedin.com\/build-relation\/newsletter-follow?entityUrn=7281002133808635907\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">subscribe to our LinkedIn newsletter<\/span><\/a><span data-contrast=\"auto\"> to stay connected, and ensure you never miss regulatory insights.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Mexico\u2019s regulatory landscape has been active, presenting important updates. Previously, we discussed the agreement published on June 11, 2025. However, as that version will soon be obsolete, this article has been updated to reflect the latest Agreement published on July 18 by the Mexican Ministry of Health in the Official Mexican Diary. This new agreement [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":4333,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9,390],"tags":[],"class_list":["post-4009","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-equivalency-agreement","category-mexico"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Mexico&#039;s Expanded Equivalency Agreement: Key Implications - Veraque Mexico<\/title>\n<meta name=\"description\" content=\"Discover how Mexico&#039;s 2025 Equivalency Agreement streamlines medical device and IVD approvals by recognizing expanded reference authorities.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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