{"id":3973,"date":"2025-06-10T20:29:07","date_gmt":"2025-06-10T20:29:07","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=3973"},"modified":"2025-06-10T20:29:07","modified_gmt":"2025-06-10T20:29:07","slug":"health-canada-mdl-equivalency-route-registration-in-mexico","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/health-canada-mdl-equivalency-route-registration-in-mexico\/","title":{"rendered":"Health Canada MDL and Their Application for FDA\/HC Equivalency Route Registration in Mexico"},"content":{"rendered":"<p class=\"ai-optimize-6 ai-optimize-introduction\"><span data-contrast=\"auto\">Manufacturers seeking to commercialize their medical devices in Canada must obtain a Medical Device Licence (MDL) from Health Canada (HC). Meanwhile, in Mexico, medical devices require a <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/ultimate-guide-for-regulatory-affairs-in-mexico\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Sanitary Registration<\/span><\/a><span data-contrast=\"auto\"> issued by COFEPRIS before they can be marketed.\u00a0 One of the most efficient pathways for obtaining this registration in Mexico is the <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/equivalency-agreement-summary\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Equivalency Agreement<\/span><\/a><span data-contrast=\"auto\"> route, which leverages prior approvals from recognized regulatory bodies, including HC, U.S. FDA and <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/japan-equivalency-agreement-for-medical-devices-in-mexico\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">MHLW\/PMDA<\/span><\/a><span data-contrast=\"auto\">. This article explores how MDLs can facilitate faster market entry in Mexico through this streamlined process.\u00a0\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-7\"><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n<h3 class=\"ai-optimize-8\"><b><span data-contrast=\"auto\">Understanding how devices are licensed in Canada<\/span><\/b><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/h3>\n<p class=\"ai-optimize-9\"><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-10\"><span data-contrast=\"auto\">Health Canada categorizes medical devices into four classes based on risk:\u00a0\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n<ul>\n<li class=\"ai-optimize-11\" 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\"><b><span data-contrast=\"auto\">Class I &#8211; Low risk<\/span><\/b><span data-contrast=\"auto\">: no MDL required; Medical Device Establishment License (MDEL) needed for manufacturers, importers, and distributors.\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li class=\"ai-optimize-12\" 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\"><b><span data-contrast=\"auto\">Class II &#8211; Moderate risk<\/span><\/b><span data-contrast=\"auto\">: requires an MDL\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li class=\"ai-optimize-13\" 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\"><b><span data-contrast=\"auto\">Class III &#8211; High risk<\/span><\/b><span data-contrast=\"auto\">: requires an MDL with additional clinical data\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li class=\"ai-optimize-14\" 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\"><b><span data-contrast=\"auto\">Class IV &#8211; Highest risk<\/span><\/b><span data-contrast=\"auto\">: requires an MDL with stringent clinical and technical reviews.\u00a0\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/li>\n<\/ul>\n<p class=\"ai-optimize-15\"><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:720}\">\u00a0<\/span><\/p>\n<h3 class=\"ai-optimize-16\"><b><span data-contrast=\"auto\">Summarized process to Obtain an MDL<\/span><\/b><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/h3>\n<p class=\"ai-optimize-17\"><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n<ol>\n<li class=\"ai-optimize-18\" data-leveltext=\"%1.\" data-font=\"Aptos\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:0,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[65533,0],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;%1.&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Determine device classification (Class I-IV).\u00a0\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/li>\n<li class=\"ai-optimize-18\" data-leveltext=\"%1.\" data-font=\"Aptos\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:0,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[65533,0],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;%1.&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Prepare technical documentation and QMS under ISO 13485\/MDSAP (Class II-IV).\u00a0\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/li>\n<li class=\"ai-optimize-18\" data-leveltext=\"%1.\" data-font=\"Aptos\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:0,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[65533,0],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;%1.&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Submit application to HC and perform payment of fees.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/li>\n<li class=\"ai-optimize-18\" data-leveltext=\"%1.\" data-font=\"Aptos\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:0,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[65533,0],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;%1.&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Undergo review\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/li>\n<li class=\"ai-optimize-18\" data-leveltext=\"%1.\" data-font=\"Aptos\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:0,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[65533,0],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;%1.&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">HC Issue MDL<\/span><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/li>\n<\/ol>\n<p class=\"ai-optimize-23\"><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n<h3 class=\"ai-optimize-24\"><b><span data-contrast=\"auto\">How to use MDL to leverage COFEPRIS Sanitary Registration in Mexico<\/span><\/b><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/h3>\n<p class=\"ai-optimize-25\"><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-26\"><span data-contrast=\"auto\">In Mexico there are two Registration Pathways:<\/span><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n<ol>\n<li class=\"ai-optimize-27\" data-leveltext=\"%1.\" data-font=\"Aptos\" data-listid=\"4\" data-list-defn-props=\"{&quot;134224900&quot;:true,&quot;335552541&quot;:0,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[65533,0],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;%1.&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><a href=\"https:\/\/www.gob.mx\/cofepris\/acciones-y-programas\/registro-de-dispositivos-medicos-nuevos\" target=\"_blank\" rel=\"noopener\"><b><span data-contrast=\"none\">Standard Route<\/span><\/b><\/a><b><span data-contrast=\"auto\"> (Ordinary Process): <\/span><\/b><span data-contrast=\"auto\">Requires full technical and legal documentation.\u00a0\u00a0<\/span><\/li>\n<li class=\"ai-optimize-27\" data-leveltext=\"%1.\" data-font=\"Aptos\" data-listid=\"4\" data-list-defn-props=\"{&quot;134224900&quot;:true,&quot;335552541&quot;:0,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[65533,0],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;%1.&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><a href=\"https:\/\/dof.gob.mx\/nota_detalle.php?codigo=5164641&amp;fecha=26\/10\/2010#gsc.tab=0\" target=\"_blank\" rel=\"noopener\"><b><span data-contrast=\"none\">Equivalency Agreement<\/span><\/b><\/a><b><span data-contrast=\"auto\"> (Fast-Track Process): Rely<\/span><\/b><span data-contrast=\"auto\"> on prior approvals from HC MDL.\u00a0\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/li>\n<\/ol>\n<p class=\"ai-optimize-29\"><span data-contrast=\"auto\">The main benefits of the Equivalency Route are the reduced documentation required, as only key approval documents are required.\u00a0 Faster approval, usually quicker than standard route.\u00a0\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-30\"><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-31\"><span data-contrast=\"auto\">Another point to consider is the possibility of lowering costs due to the reduced translations needed.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-32\"><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n<h3 class=\"ai-optimize-33\"><b><span data-contrast=\"auto\">Key <\/span><\/b><a href=\"https:\/\/veraqueconsulting.com\/checklist\/i\/requirements-for-medical-device-registration-equivalency-agreement\" target=\"_blank\" rel=\"noopener\"><b><span data-contrast=\"none\">Requirements<\/span><\/b><\/a><b><span data-contrast=\"auto\"> for Equivalency Route Submissions<\/span><\/b><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/h3>\n<p class=\"ai-optimize-34\"><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n<ul>\n<li class=\"ai-optimize-35\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" 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\">Valid MDL for Class (II-IV)\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li class=\"ai-optimize-36\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" 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\"><a href=\"https:\/\/veraqueconsulting.com\/mx\/good-manufacturing-practices-guide-for-mexico\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">GMP Certificate<\/span><\/a><span data-contrast=\"auto\">: ISO 13485 or MDSAP certificate.\u00a0\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li class=\"ai-optimize-37\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" 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\">ISO 17021 certificate (accreditation scope)<\/span><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/li>\n<\/ul>\n<p class=\"ai-optimize-38\"><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n<h3 class=\"ai-optimize-39\"><b><span data-contrast=\"auto\">Special considerations<\/span><\/b><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/h3>\n<p class=\"ai-optimize-40\"><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-41\"><span data-contrast=\"auto\">Devices classified as Class I in Canada are not eligible for Equivalency Route. Sometimes the <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/classification-and-grouping-ultimate-guide\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">classification of risk<\/span><\/a><span data-contrast=\"auto\"> is coincident in Mexico and Canada (Class II or Class III) but a new assessment must be done considering local rules.\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-42\"><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-43\"><span data-contrast=\"auto\">An important topic to consider is that all models intended to be registered in Mexico must be listed in the corresponding MDL.\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-44\"><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-45\"><span data-contrast=\"auto\">Whilst the Equivalency Route for HC does not require a Certificate of Free Sale, all the other legal documents must be <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/applicable-standards-for-medical-devices\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">apostilled<\/span><\/a><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-46\"><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n<h3 class=\"ai-optimize-47\"><b><span data-contrast=\"auto\">How an MDL Supports Equivalency Registration in Mexico<\/span><\/b><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/h3>\n<p class=\"ai-optimize-48\"><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n<ul>\n<li class=\"ai-optimize-49\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:774,&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\"><b><span data-contrast=\"auto\">Streamlined Submission<\/span><\/b><span data-contrast=\"auto\">: Since HC\u2019s licensing process aligns with international <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/applicable-standards-for-medical-devices\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">standards<\/span><\/a><span data-contrast=\"auto\">, manufacturers can <\/span><i><span data-contrast=\"auto\">reuse<\/span><\/i><span data-contrast=\"auto\"> much of their technical documentation for COFEPRIS submission.\u00a0\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li class=\"ai-optimize-50\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:774,&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\"><b><span data-contrast=\"auto\">Faster Market Entry<\/span><\/b><span data-contrast=\"auto\">: HC\u2019s MDL approval times are consistently lower that COFEPRIS so MDL can be leveraged for Mexico\u2019s equivalency review.\u00a0\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/li>\n<\/ul>\n<p class=\"ai-optimize-51\"><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:774}\">\u00a0<\/span><\/p>\n<h3 class=\"ai-optimize-52\"><b><span data-contrast=\"auto\">Conclusions<\/span><\/b><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/h3>\n<p class=\"ai-optimize-53\"><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-54\"><span data-contrast=\"auto\">For medical device manufacturers, accounting with an MDL not only grants access to the Canadian market but also simplifies entry into Mexico via the COFEPRIS Equivalency Route. By leveraging prior approvals, companies can reduce regulatory burdens, lower costs, and accelerate time-to-market.\u00a0\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-55\"><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-56\"><span data-contrast=\"auto\">However, navigating both Health Canada and COFEPRIS requirements demands careful planning. Partnering with regulatory experts can ensure compliance and optimize the approval process for both jurisdictions.\u00a0 Would you like additional insights into how to get successful equivalency registrations? Please contact us at <\/span><a href=\"mailto:contact@veraqueconsulting.com\"><span data-contrast=\"none\">Veraque<\/span><\/a><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Manufacturers seeking to commercialize their medical devices in Canada must obtain a Medical Device Licence (MDL) from Health Canada (HC). Meanwhile, in Mexico, medical devices require a Sanitary Registration issued by COFEPRIS before they can be marketed.\u00a0 One of the most efficient pathways for obtaining this registration in Mexico is the Equivalency Agreement route, which [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":3974,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9,390],"tags":[],"class_list":["post-3973","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>Health Canada MDL Equivalency Route Registration in Mexico - Veraque Mexico<\/title>\n<meta name=\"description\" content=\"This article explores how Health Canada MDLs can facilitate faster market entry in Mexico through the Equivalency Route Registration.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/veraqueconsulting.com\/mx\/health-canada-mdl-equivalency-route-registration-in-mexico\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Health Canada MDL and Their Application for FDA\/HC Equivalency Route Registration in Mexico\" \/>\n<meta property=\"og:description\" content=\"This article explores how Health Canada MDLs can facilitate faster market entry in Mexico through the Equivalency Route Registration.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/veraqueconsulting.com\/mx\/health-canada-mdl-equivalency-route-registration-in-mexico\/\" \/>\n<meta property=\"og:site_name\" content=\"Veraque Mexico\" \/>\n<meta property=\"article:published_time\" content=\"2025-06-10T20:29:07+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/2025\/06\/health_canada_MDL_equivalency_route_mexico.png\" \/>\n\t<meta property=\"og:image:width\" content=\"940\" \/>\n\t<meta property=\"og:image:height\" content=\"788\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"mkt1\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"mkt1\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/health-canada-mdl-equivalency-route-registration-in-mexico\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/health-canada-mdl-equivalency-route-registration-in-mexico\\\/\"},\"author\":{\"name\":\"mkt1\",\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/#\\\/schema\\\/person\\\/3f760cd8f7128ca81c70930dcfcc1e44\"},\"headline\":\"Health Canada MDL and Their Application for FDA\\\/HC Equivalency Route Registration in Mexico\",\"datePublished\":\"2025-06-10T20:29:07+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/health-canada-mdl-equivalency-route-registration-in-mexico\\\/\"},\"wordCount\":531,\"publisher\":{\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/health-canada-mdl-equivalency-route-registration-in-mexico\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/wp-content\\\/uploads\\\/sites\\\/3\\\/2025\\\/06\\\/health_canada_MDL_equivalency_route_mexico.png\",\"articleSection\":[\"Equivalency Agreement\",\"Mexico\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/health-canada-mdl-equivalency-route-registration-in-mexico\\\/\",\"url\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/health-canada-mdl-equivalency-route-registration-in-mexico\\\/\",\"name\":\"Health Canada MDL Equivalency Route Registration in Mexico - 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