{"id":239,"date":"2019-12-23T19:03:45","date_gmt":"2019-12-23T19:03:45","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?page_id=239"},"modified":"2026-07-13T15:18:55","modified_gmt":"2026-07-13T15:18:55","slug":"ultimate-guide-for-regulatory-affairs-in-mexico","status":"publish","type":"page","link":"https:\/\/veraqueconsulting.com\/mx\/ultimate-guide-for-regulatory-affairs-in-mexico\/","title":{"rendered":"Ultimate Guide for Regulatory Affairs in Mexico"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"239\" class=\"elementor elementor-239\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<header class=\"elementor-section elementor-top-section elementor-element elementor-element-130fc6f elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"130fc6f\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;sticky&quot;:&quot;top&quot;,&quot;sticky_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;,&quot;mobile&quot;],&quot;sticky_offset&quot;:0,&quot;sticky_effects_offset&quot;:0,&quot;sticky_anchor_link_offset&quot;:0}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-5c931d5\" data-id=\"5c931d5\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-793a026 elementor-widget elementor-widget-image\" data-id=\"793a026\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/veraqueconsulting.com\/mx\/\" target=\"_blank\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"450\" height=\"105\" src=\"https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/2019\/11\/logo.png\" class=\"attachment-full size-full wp-image-22\" alt=\"\" srcset=\"https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/2019\/11\/logo.png 450w, https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/2019\/11\/logo-300x70.png 300w\" sizes=\"(max-width: 450px) 100vw, 450px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-8a95575\" data-id=\"8a95575\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/header>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-ef572d5 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"ef572d5\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-c3f96d5\" data-id=\"c3f96d5\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-b354d53 elementor-widget elementor-widget-heading\" data-id=\"b354d53\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Ultimate Guide for Regulatory Affairs in Mexico.<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9f546dd elementor-widget elementor-widget-text-editor\" data-id=\"9f546dd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>In Veraque we are interested in providing you with the latest news and detailed information about regulatory and quality affairs in Mexico. This is a great resource, in case you are looking for an indepth description of the full regulatory process in Mexico. For a general overview you can check our website for each of the services we provide or contact us directly. We would be glad to send the information you are looking for. Also, if you are still not sure if your product is a medical device, we invite you to check our ultimate guide for classification and grouping. This is a great reference for the first step you want to take in the Mexican market.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-b30c98f\" data-id=\"b30c98f\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2b2c379 elementor-widget elementor-widget-spacer\" data-id=\"2b2c379\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-f02f75a elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"f02f75a\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-2da675b\" data-id=\"2da675b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-3e0c172 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3e0c172\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-a56c890\" data-id=\"a56c890\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-0fc7a32 elementor-widget elementor-widget-heading\" data-id=\"0fc7a32\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">To facilitate your information search, this guide details each of the following topics:<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-63cb7f9\" data-id=\"63cb7f9\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5efc1c6 elementor-align-start elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"5efc1c6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"#legal_framework\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"Layer_1\" data-name=\"Layer 1\" viewBox=\"0 0 55.15 72.03\"><defs><style>.cls-1{fill:url(#linear-gradient);}.cls-2{fill:url(#linear-gradient-2);}.cls-3{fill:url(#linear-gradient-5);}.cls-4{fill:url(#linear-gradient-7);}.cls-5{fill:url(#linear-gradient-9);}.cls-6{fill:url(#linear-gradient-10);}.cls-7{fill:url(#linear-gradient-11);}.cls-8{fill:url(#linear-gradient-12);}.cls-9{fill:url(#linear-gradient-13);}.cls-10{fill:url(#linear-gradient-14);}.cls-11{fill:url(#linear-gradient-17);}.cls-12{fill:url(#linear-gradient-19);}.cls-13{fill:url(#linear-gradient-20);}.cls-14{fill:url(#linear-gradient-21);}.cls-15{fill:url(#linear-gradient-23);}.cls-16{fill:url(#linear-gradient-24);}<\/style><linearGradient id=\"linear-gradient\" x1=\"76.11\" y1=\"1\" x2=\"76.11\" y2=\"104.04\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.2\" stop-color=\"#ffc16f\"><\/stop><stop offset=\"0.63\" stop-color=\"#ff726f\"><\/stop><\/linearGradient><linearGradient id=\"linear-gradient-2\" x1=\"102.56\" y1=\"1\" x2=\"102.56\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-5\" x1=\"73.3\" y1=\"1\" x2=\"73.3\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-7\" x1=\"126.2\" y1=\"1\" x2=\"126.2\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-9\" x1=\"81.18\" y1=\"1\" x2=\"81.18\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-10\" x1=\"100.31\" y1=\"1\" x2=\"100.31\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-11\" x1=\"121.7\" y1=\"1\" x2=\"121.7\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-12\" x1=\"103.71\" y1=\"1\" x2=\"103.71\" y2=\"104.04\" 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class=\"cls-7\" d=\"M121.7,104.59a1.12,1.12,0,0,1-1.13-1.13V92.21a1.13,1.13,0,1,1,2.25,0v11.26A1.12,1.12,0,0,1,121.7,104.59Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-8\" d=\"M117.22,81h-27a1.13,1.13,0,0,1,0-2.25h27A1.13,1.13,0,1,1,117.22,81Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-9\" d=\"M110.46,84.35H96.95a1.13,1.13,0,0,1,0-2.25h13.51A1.13,1.13,0,0,1,110.46,84.35Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-10\" d=\"M113.83,48.33H93.58a1.13,1.13,0,0,1,0-2.25h20.26A1.13,1.13,0,0,1,113.83,48.33Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-8\" d=\"M103.71,70.85a1.12,1.12,0,0,1-1.13-1.13V43.83a1.13,1.13,0,0,1,2.25,0V69.72A1.13,1.13,0,0,1,103.71,70.85Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-8\" d=\"M112.71,70.85h-18a1.13,1.13,0,0,1,0-2.25h18A1.13,1.13,0,0,1,112.71,70.85Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-11\" d=\"M93.58,61.84a4.51,4.51,0,0,1-4.5-4.5,1.13,1.13,0,1,1,2.25,0,2.25,2.25,0,0,0,4.5,0,1.13,1.13,0,0,1,2.25,0A4.51,4.51,0,0,1,93.58,61.84Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-11\" d=\"M97,58.46H90.2a1.13,1.13,0,0,1,0-2.25H97A1.13,1.13,0,1,1,97,58.46Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-12\" d=\"M90.2,58.46A1.13,1.13,0,0,1,89.13,57l3.38-10.13a1.13,1.13,0,1,1,2.14.71L91.27,57.69A1.13,1.13,0,0,1,90.2,58.46Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-13\" d=\"M97,58.46a1.12,1.12,0,0,1-1.07-.77L92.51,47.56a1.13,1.13,0,1,1,2.14-.71L98,57a1.12,1.12,0,0,1-.71,1.42A1.1,1.1,0,0,1,97,58.46Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-14\" d=\"M113.83,61.84a4.51,4.51,0,0,1-4.5-4.5,1.13,1.13,0,0,1,2.25,0,2.25,2.25,0,0,0,4.5,0,1.13,1.13,0,1,1,2.25,0A4.51,4.51,0,0,1,113.83,61.84Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-14\" d=\"M117.21,58.46h-6.75a1.13,1.13,0,0,1,0-2.25h6.75A1.13,1.13,0,0,1,117.21,58.46Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-15\" d=\"M110.46,58.46A1.13,1.13,0,0,1,109.39,57l3.38-10.13a1.13,1.13,0,1,1,2.14.71l-3.38,10.13A1.13,1.13,0,0,1,110.46,58.46Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-16\" d=\"M117.21,58.46a1.12,1.12,0,0,1-1.07-.77l-3.38-10.13a1.13,1.13,0,1,1,2.14-.71L118.28,57a1.12,1.12,0,0,1-.71,1.42A1.1,1.1,0,0,1,117.21,58.46Z\" transform=\"translate(-72.17 -32.56)\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">The legal framework surrounding a medical device in Mexico.<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"#cofepris\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"Layer_1\" data-name=\"Layer 1\" viewBox=\"0 0 72.83 72.83\"><defs><style>.cls-1{fill:url(#linear-gradient);}.cls-2{fill:url(#linear-gradient-2);}.cls-3{fill:url(#linear-gradient-3);}.cls-4{fill:url(#linear-gradient-4);}<\/style><linearGradient id=\"linear-gradient\" x1=\"196.77\" y1=\"1\" x2=\"196.77\" y2=\"104.04\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.2\" stop-color=\"#ffc16f\"><\/stop><stop offset=\"0.63\" stop-color=\"#ff726f\"><\/stop><\/linearGradient><linearGradient id=\"linear-gradient-2\" x1=\"185.89\" y1=\"1\" x2=\"185.89\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-3\" x1=\"197.94\" y1=\"1\" x2=\"197.94\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-4\" x1=\"210.04\" y1=\"1\" x2=\"210.04\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><\/defs><title>cofeprs<\/title><path 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class=\"elementor-icon-list-text\">Inside COFEPRIS<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"#stakeholders\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"Layer_1\" data-name=\"Layer 1\" viewBox=\"0 0 64.57 64.57\"><defs><style>.cls-1{fill:url(#linear-gradient);}<\/style><linearGradient id=\"linear-gradient\" x1=\"298.46\" y1=\"1\" x2=\"298.46\" y2=\"104.04\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.2\" stop-color=\"#ffc16f\"><\/stop><stop offset=\"0.63\" stop-color=\"#ff726f\"><\/stop><\/linearGradient><\/defs><title>stkhldrs<\/title><path class=\"cls-1\" 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transform=\"translate(-266.17 -36.29)\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">The stakeholders in a regulatory project in Mexico.<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"#routes\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"Layer_1\" data-name=\"Layer 1\" viewBox=\"0 0 64.1 63.57\"><defs><style>.cls-1{fill:url(#linear-gradient);}.cls-2{fill:url(#linear-gradient-3);}.cls-3{fill:url(#linear-gradient-5);}<\/style><linearGradient id=\"linear-gradient\" x1=\"415.41\" y1=\"1\" x2=\"415.41\" y2=\"104.04\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.2\" stop-color=\"#ffc16f\"><\/stop><stop offset=\"0.63\" stop-color=\"#ff726f\"><\/stop><\/linearGradient><linearGradient id=\"linear-gradient-3\" x1=\"366.67\" y1=\"1\" x2=\"366.67\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-5\" x1=\"391.3\" y1=\"1\" x2=\"391.3\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><\/defs><title>pths<\/title><path class=\"cls-1\" d=\"M415.41,100.36a1.06,1.06,0,0,1-.75-0.31C414,99.36,408,93.19,408,89.13a7.43,7.43,0,1,1,14.83,0c0,4.06-6,10.23-6.66,10.92A1.06,1.06,0,0,1,415.41,100.36Zm0-17a5.53,5.53,0,0,0-5.3,5.72c0,2.16,3,6.13,5.3,8.63,2-2.14,5.3-6.26,5.3-8.63A5.53,5.53,0,0,0,415.41,83.41Z\" transform=\"translate(-359.26 -36.79)\"><\/path><path class=\"cls-1\" d=\"M417.53,91.88h-4.24a1.06,1.06,0,0,1-1.06-1.06V86.59a1.06,1.06,0,0,1,1.06-1.06h4.24a1.06,1.06,0,0,1,1.06,1.06v4.24A1.06,1.06,0,0,1,417.53,91.88Zm-3.18-2.12h2.12V87.65h-2.12v2.12Z\" transform=\"translate(-359.26 -36.79)\"><\/path><path class=\"cls-2\" 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class=\"elementor-icon-list-text\">Timelines.<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"#prevention\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"Layer_1\" data-name=\"Layer 1\" viewBox=\"0 0 64.08 64.08\"><defs><style>.cls-1{fill:url(#linear-gradient);}.cls-2{fill:url(#linear-gradient-2);}.cls-3{fill:url(#linear-gradient-3);}.cls-4{fill:url(#linear-gradient-4);}.cls-5{fill:url(#linear-gradient-5);}.cls-6{fill:url(#linear-gradient-6);}.cls-7{fill:url(#linear-gradient-8);}.cls-8{fill:url(#linear-gradient-9);}.cls-9{fill:url(#linear-gradient-10);}.cls-10{fill:url(#linear-gradient-12);}.cls-11{fill:url(#linear-gradient-13);}<\/style><linearGradient id=\"linear-gradient\" x1=\"477.66\" y1=\"1\" x2=\"477.66\" y2=\"104.04\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.2\" stop-color=\"#ffc16f\"><\/stop><stop offset=\"0.63\" stop-color=\"#ff726f\"><\/stop><\/linearGradient><linearGradient id=\"linear-gradient-2\" x1=\"41.65\" y1=\"-35.54\" x2=\"41.65\" y2=\"67.51\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-3\" x1=\"34.17\" y1=\"-35.54\" x2=\"34.17\" y2=\"67.51\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-4\" x1=\"45.39\" y1=\"-35.54\" x2=\"45.39\" y2=\"67.51\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-5\" x1=\"42.72\" y1=\"-35.54\" x2=\"42.72\" y2=\"67.51\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-6\" x1=\"46.99\" y1=\"-35.54\" x2=\"46.99\" y2=\"67.51\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-8\" x1=\"55\" y1=\"-35.54\" x2=\"55\" y2=\"67.51\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-9\" x1=\"53.4\" y1=\"-35.54\" x2=\"53.4\" y2=\"67.51\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-10\" x1=\"37.38\" y1=\"-35.54\" x2=\"37.38\" y2=\"67.51\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-12\" x1=\"29.9\" y1=\"-35.54\" x2=\"29.9\" y2=\"67.51\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-13\" x1=\"45.92\" y1=\"-35.54\" x2=\"45.92\" y2=\"67.51\" xlink:href=\"#linear-gradient\"><\/linearGradient><\/defs><title>prvntion<\/title><path class=\"cls-1\" d=\"M508.63,36.54H465.91a1.07,1.07,0,0,0-1.07,1.07V55.76h-4.38a9.94,9.94,0,0,0-7.66,3.59,7.82,7.82,0,0,1-6,2.82h-1.17V64.3h1.17a9.94,9.94,0,0,0,7.66-3.59,7.82,7.82,0,0,1,6-2.82h4.23l13.58,3.62a2,2,0,0,1,.71,3.57,2,2,0,0,1-1.76.35L465.12,62.2a1.07,1.07,0,0,0-1.23.55L463,64.53a7.27,7.27,0,0,1-6.54,4h-2.3v2.14h2.3a9.39,9.39,0,0,0,8.38-5.11V85.66H462a7.88,7.88,0,0,1-6.39-3.29,10,10,0,0,0-8.13-4.19h-1.82v2.14h1.82a7.88,7.88,0,0,1,6.39,3.29A10,10,0,0,0,462,87.8h2.88V99.55a1.07,1.07,0,0,0,1.07,1.07h42.72a1.07,1.07,0,0,0,1.07-1.07V37.61A1.07,1.07,0,0,0,508.63,36.54Zm-1.07,61.94H467V64.91l9.72,2.59a4.16,4.16,0,0,0,2.14-8L467,56.3V38.67h40.58v59.8Z\" transform=\"translate(-445.62 -36.54)\"><\/path><rect class=\"cls-2\" x=\"30.97\" y=\"5.34\" width=\"21.36\" height=\"2.14\"><\/rect><rect class=\"cls-3\" x=\"30.97\" y=\"18.15\" width=\"6.41\" height=\"2.14\"><\/rect><rect class=\"cls-4\" x=\"39.51\" y=\"18.15\" width=\"11.75\" height=\"2.14\"><\/rect><rect class=\"cls-5\" x=\"37.38\" y=\"23.49\" width=\"10.68\" height=\"2.14\"><\/rect><rect class=\"cls-6\" x=\"37.38\" y=\"28.83\" width=\"19.22\" height=\"2.14\"><\/rect><rect class=\"cls-2\" x=\"26.7\" y=\"34.17\" width=\"29.9\" height=\"2.14\"><\/rect><rect class=\"cls-7\" x=\"53.4\" y=\"18.15\" width=\"3.2\" height=\"2.14\"><\/rect><rect class=\"cls-8\" x=\"50.19\" y=\"23.49\" width=\"6.41\" height=\"2.14\"><\/rect><rect class=\"cls-9\" x=\"26.7\" y=\"39.51\" width=\"21.36\" height=\"2.14\"><\/rect><rect class=\"cls-2\" x=\"26.7\" y=\"44.85\" width=\"29.9\" height=\"2.14\"><\/rect><rect class=\"cls-10\" x=\"26.7\" y=\"50.19\" width=\"6.41\" height=\"2.14\"><\/rect><rect class=\"cls-11\" x=\"35.24\" y=\"50.19\" width=\"21.36\" height=\"2.14\"><\/rect><rect class=\"cls-8\" x=\"50.19\" y=\"39.51\" width=\"6.41\" height=\"2.14\"><\/rect><rect class=\"cls-2\" x=\"26.7\" y=\"12.82\" width=\"29.9\" height=\"2.14\"><\/rect><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">What a prevention is.<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"#references\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"Layer_1\" data-name=\"Layer 1\" viewBox=\"0 0 67.52 58.52\"><defs><style>.cls-1{fill:url(#linear-gradient);}.cls-2{fill:url(#linear-gradient-2);}.cls-3{fill:url(#linear-gradient-3);}.cls-4{fill:url(#linear-gradient-4);}.cls-5{fill:url(#linear-gradient-5);}.cls-6{fill:url(#linear-gradient-6);}.cls-7{fill:url(#linear-gradient-7);}.cls-8{fill:url(#linear-gradient-8);}.cls-9{fill:url(#linear-gradient-9);}<\/style><linearGradient id=\"linear-gradient\" x1=\"580.33\" y1=\"1\" x2=\"580.33\" y2=\"104.04\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.2\" stop-color=\"#ffc16f\"><\/stop><stop offset=\"0.63\" stop-color=\"#ff726f\"><\/stop><\/linearGradient><linearGradient id=\"linear-gradient-2\" x1=\"552.2\" y1=\"1\" x2=\"552.2\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-3\" x1=\"608.47\" y1=\"1\" x2=\"608.47\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-4\" x1=\"571.89\" y1=\"1\" x2=\"571.89\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-5\" x1=\"578.65\" y1=\"1\" x2=\"578.65\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-6\" x1=\"569.64\" y1=\"1\" x2=\"569.64\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-7\" x1=\"576.96\" y1=\"1\" x2=\"576.96\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-8\" x1=\"573.58\" y1=\"1\" x2=\"573.58\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-9\" x1=\"579.77\" y1=\"1\" x2=\"579.77\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><\/defs><title>refrnce<\/title><path class=\"cls-1\" d=\"M608.47,39.32H552.2a5.63,5.63,0,0,0-5.63,5.63V83.21a5.63,5.63,0,0,0,5.63,5.63h31l5,5v2.91a1.13,1.13,0,0,0,1.13,1.13h12.38a1.13,1.13,0,0,0,1.13-1.13V93.78a12.56,12.56,0,0,0,2.84-5h2.79a5.63,5.63,0,0,0,5.63-5.63V44.94A5.63,5.63,0,0,0,608.47,39.32ZM555.58,86.58H552.2a3.38,3.38,0,0,1-3.38-3.38V44.94a3.38,3.38,0,0,1,3.38-3.38h3.38v45Zm2.25,0v-45h45V75.33a9.52,9.52,0,0,1-6.75.86,3.51,3.51,0,0,0-3.38-.67V74.81a11.25,11.25,0,0,0-3.38-22h-18a11.25,11.25,0,0,0,0,22.51H586v6.29l-0.89-.89A3.51,3.51,0,0,0,580,85.6l0.09,0.09L581,86.58H557.83Zm37.36-25.9A6.75,6.75,0,1,0,586,69.91v3.17H571.33a9,9,0,0,1,0-18h18a9,9,0,0,1,3.38,17.35V69.91A6.75,6.75,0,0,0,595.18,60.68Zm-8.83,0A4.5,4.5,0,0,1,592.71,67V66.33a3.38,3.38,0,0,0-6.75,0v0.73A4.5,4.5,0,0,1,586.35,60.7ZM604,85.18a10.33,10.33,0,0,1-3,7.35,1.13,1.13,0,0,0-.33.8v2.25H590.46V93.33a1.13,1.13,0,0,0-.33-0.8l-5.63-5.63-2.81-2.81a1.26,1.26,0,1,1,1.78-1.78l2.81,2.81a1.13,1.13,0,0,0,1.92-.8v-18a1.13,1.13,0,0,1,2.25,0V78.7a1.13,1.13,0,1,0,2.25,0,1.13,1.13,0,1,1,2.25,0,1.13,1.13,0,1,0,2.25,0,1.13,1.13,0,0,1,2.25,0,1.13,1.13,0,1,0,2.25,0,1.13,1.13,0,1,1,2.25,0v6.48Zm7.88-21.11V83.21a3.38,3.38,0,0,1-3.38,3.38h-2.34a12.82,12.82,0,0,0,.08-1.4V78.7a3.35,3.35,0,0,0-1.13-2.5V41.57h3.38a3.38,3.38,0,0,1,3.38,3.38V64.07Z\" transform=\"translate(-546.57 -39.32)\"><\/path><path class=\"cls-2\" d=\"M553.23,63.65a1,1,0,0,0-.61-0.61,1.15,1.15,0,0,0-1.23.24,1.16,1.16,0,0,0-.24.37,1.06,1.06,0,0,0,0,.86,1.32,1.32,0,0,0,.24.37,1.13,1.13,0,0,0,1.92-.8A0.94,0.94,0,0,0,553.23,63.65Z\" transform=\"translate(-546.57 -39.32)\"><\/path><path class=\"cls-3\" d=\"M608.47,60.7a3.38,3.38,0,1,0,3.38,3.38A3.38,3.38,0,0,0,608.47,60.7Zm0,4.5a1.13,1.13,0,1,1,1.13-1.13A1.13,1.13,0,0,1,608.47,65.2Z\" transform=\"translate(-546.57 -39.32)\"><\/path><path class=\"cls-4\" d=\"M572.46,58.45h-1.13a1.13,1.13,0,0,0,0,2.25h1.13A1.13,1.13,0,0,0,572.46,58.45Z\" transform=\"translate(-546.57 -39.32)\"><\/path><path class=\"cls-5\" d=\"M580.33,58.45H577a1.13,1.13,0,0,0,0,2.25h3.38A1.13,1.13,0,0,0,580.33,58.45Z\" transform=\"translate(-546.57 -39.32)\"><\/path><path class=\"cls-6\" d=\"M570.2,62.95h-1.13a1.13,1.13,0,0,0,0,2.25h1.13A1.13,1.13,0,0,0,570.2,62.95Z\" transform=\"translate(-546.57 -39.32)\"><\/path><path class=\"cls-7\" d=\"M579.21,62.95h-4.5a1.13,1.13,0,1,0,0,2.25h4.5A1.13,1.13,0,0,0,579.21,62.95Z\" transform=\"translate(-546.57 -39.32)\"><\/path><path class=\"cls-8\" d=\"M574.71,67.45h-2.25a1.13,1.13,0,0,0,0,2.25h2.25A1.13,1.13,0,0,0,574.71,67.45Z\" transform=\"translate(-546.57 -39.32)\"><\/path><path class=\"cls-9\" d=\"M580.33,67.45h-1.13a1.13,1.13,0,0,0,0,2.25h1.13A1.13,1.13,0,0,0,580.33,67.45Z\" transform=\"translate(-546.57 -39.32)\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Useful references.<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-1f58574 elementor-widget elementor-widget-text-editor\" data-id=\"1f58574\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>You can check any chapter independently if you are looking for a specific topic.<br \/>Finally, to keep things as easy as possible, we place every translation to Spanish in the footnotes.<br \/>We encourage you to use these translated terms if you are looking for a specific term in the<br \/>internet. Please note that the Spanish-English translations we use in this document are not official<br \/>terms.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-934e55a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"934e55a\" data-element_type=\"section\" data-e-type=\"section\" id=\"legal_framework\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-f1e58c0\" data-id=\"f1e58c0\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-11c8f4e elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"11c8f4e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"Layer_1\" data-name=\"Layer 1\" viewBox=\"0 0 55.15 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xlink:href=\"#linear-gradient\"><\/linearGradient><\/defs><title>legal-fw<\/title><path class=\"cls-1\" d=\"M78.93,104.59a6.75,6.75,0,0,1,0-13.51,1.13,1.13,0,0,1,0,2.25,4.5,4.5,0,0,0,0,9A1.13,1.13,0,1,1,78.93,104.59Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-2\" d=\"M126.2,93.34H78.93a1.13,1.13,0,0,1,0-2.25H126.2A1.13,1.13,0,0,1,126.2,93.34Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-2\" d=\"M126.2,104.59H78.93a1.13,1.13,0,1,1,0-2.25H126.2A1.13,1.13,0,1,1,126.2,104.59Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-1\" d=\"M73.3,40.44a1.13,1.13,0,0,1-1.13-1.13,6.76,6.76,0,0,1,6.75-6.75,1.13,1.13,0,1,1,0,2.25,4.51,4.51,0,0,0-4.5,4.5A1.13,1.13,0,0,1,73.3,40.44Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-3\" d=\"M73.3,99a1.12,1.12,0,0,1-1.13-1.13V39.31a1.13,1.13,0,1,1,2.25,0V97.84A1.12,1.12,0,0,1,73.3,99Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-2\" 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class=\"cls-8\" d=\"M117.22,81h-27a1.13,1.13,0,0,1,0-2.25h27A1.13,1.13,0,1,1,117.22,81Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-9\" d=\"M110.46,84.35H96.95a1.13,1.13,0,0,1,0-2.25h13.51A1.13,1.13,0,0,1,110.46,84.35Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-10\" d=\"M113.83,48.33H93.58a1.13,1.13,0,0,1,0-2.25h20.26A1.13,1.13,0,0,1,113.83,48.33Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-8\" d=\"M103.71,70.85a1.12,1.12,0,0,1-1.13-1.13V43.83a1.13,1.13,0,0,1,2.25,0V69.72A1.13,1.13,0,0,1,103.71,70.85Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-8\" d=\"M112.71,70.85h-18a1.13,1.13,0,0,1,0-2.25h18A1.13,1.13,0,0,1,112.71,70.85Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-11\" d=\"M93.58,61.84a4.51,4.51,0,0,1-4.5-4.5,1.13,1.13,0,1,1,2.25,0,2.25,2.25,0,0,0,4.5,0,1.13,1.13,0,0,1,2.25,0A4.51,4.51,0,0,1,93.58,61.84Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-11\" d=\"M97,58.46H90.2a1.13,1.13,0,0,1,0-2.25H97A1.13,1.13,0,1,1,97,58.46Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-12\" d=\"M90.2,58.46A1.13,1.13,0,0,1,89.13,57l3.38-10.13a1.13,1.13,0,1,1,2.14.71L91.27,57.69A1.13,1.13,0,0,1,90.2,58.46Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-13\" d=\"M97,58.46a1.12,1.12,0,0,1-1.07-.77L92.51,47.56a1.13,1.13,0,1,1,2.14-.71L98,57a1.12,1.12,0,0,1-.71,1.42A1.1,1.1,0,0,1,97,58.46Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-14\" d=\"M113.83,61.84a4.51,4.51,0,0,1-4.5-4.5,1.13,1.13,0,0,1,2.25,0,2.25,2.25,0,0,0,4.5,0,1.13,1.13,0,1,1,2.25,0A4.51,4.51,0,0,1,113.83,61.84Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-14\" d=\"M117.21,58.46h-6.75a1.13,1.13,0,0,1,0-2.25h6.75A1.13,1.13,0,0,1,117.21,58.46Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-15\" d=\"M110.46,58.46A1.13,1.13,0,0,1,109.39,57l3.38-10.13a1.13,1.13,0,1,1,2.14.71l-3.38,10.13A1.13,1.13,0,0,1,110.46,58.46Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-16\" d=\"M117.21,58.46a1.12,1.12,0,0,1-1.07-.77l-3.38-10.13a1.13,1.13,0,1,1,2.14-.71L118.28,57a1.12,1.12,0,0,1-.71,1.42A1.1,1.1,0,0,1,117.21,58.46Z\" transform=\"translate(-72.17 -32.56)\"><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-25ac258 elementor-widget elementor-widget-heading\" data-id=\"25ac258\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">The legal framework surrounding a medical device in Mexico.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b098eb0 elementor-widget elementor-widget-text-editor\" data-id=\"b098eb0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Once you have identified if your products are medical devices, you may want to start preparing all the paperwork to receive a sanitary registration. However, you now need to know which\u00a0documents are necessary and who requires you to present them. As in any other country, these requirements are generally based on a legal framework. In this guide we want to provide a quick introduction about the main legal references that will help you to bolster your dossier (the set of documents you will need to submit to the local authority).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3b41595 elementor-tabs-view-vertical elementor-widget elementor-widget-tabs\" data-id=\"3b41595\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"tabs.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-tabs\">\n\t\t\t<div class=\"elementor-tabs-wrapper\" role=\"tablist\" >\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-6211\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"true\" data-tab=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"elementor-tab-content-6211\" aria-expanded=\"false\">Laws<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-6212\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"2\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-6212\" aria-expanded=\"false\">Regulations<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-6213\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"3\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-6213\" aria-expanded=\"false\">Mexican Official Norms (NOM) <\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-6214\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"4\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-6214\" aria-expanded=\"false\">Agreements<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-6215\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"5\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-6215\" aria-expanded=\"false\">Supplements<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t<div class=\"elementor-tabs-content-wrapper\" role=\"tablist\" aria-orientation=\"vertical\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"true\" data-tab=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"elementor-tab-content-6211\" aria-expanded=\"false\">Laws<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-6211\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-6211\" tabindex=\"0\" hidden=\"false\"><ol type=\"a\">\n \t<li>The general law of health<sup>1<\/sup><strong>.<\/strong>\n<ol type=\"i\">\n \t<li>Defines a medical device as a health supply in general terms.<\/li>\n \t<li>Divides medical devices in 6 groups.\n<ol>\n \t<li>Medical equipment.<\/li>\n \t<li>Prosthesis.<\/li>\n \t<li>In-Vitro Diagnostic devices.<\/li>\n \t<li>Odontology related devices.<\/li>\n \t<li>Surgical materials and wound care related devices.<\/li>\n \t<li>Hygiene related devices.<\/li>\n<\/ol>\n<\/li>\n \t<li>Classifies advertising into two branches:\n<ol>\n \t<li>For healthcare experts.<\/li>\n \t<li>For the population.<\/li>\n<\/ol>\n<\/li>\n \t<li>States that a medical device sanitary registration lasts 5 years.<\/li>\n<\/ol>\n<\/li>\n \t<li>The general law for public administration procedures<sup>2<\/sup>.\n<ol type=\"i\">\n \t<li>This document describes the obligations and rights when you submit a document to any public office in Mexico (including the ministry of health) and the rules to process and respond to such an inquiry.<\/li>\n<\/ol>\n<\/li>\n<\/ol><\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"2\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-6212\" aria-expanded=\"false\">Regulations<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-6212\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-6212\" tabindex=\"0\" hidden=\"hidden\"><ol type=\"a\">\n \t<li>\nHealth Supplies regulation<sup>3<\/sup>\n<ol type=\"I\">\n \t<li>States that there are 3 different classifications for medical devices.\n<strong>Important Note:<\/strong> This, however, is not true since there are 4 medical device classes in Mexico. You can check our ultimate guide for classification and grouping for more references.<\/li>\n \t<li>Details the Sanitary Responsible role. This is a key person you must identify and appoint in any regulatory process. More references can be found in the stakeholders section of this document.<\/li>\n \t<li>Defines the timelines for responses. 30 to 35 work days upon submission. This is not the case for most of the submissions you will make.\nFor a better estimate, please check the timeline section of this guide.<\/li>\n \t<li>Makes a general reference to the required documents you will\nneed to present. Do not use this as your final checklist. There is a more detailed set of documents referenced in other legal documents.<\/li>\n \t<li>States that you must submit a renewal 150 natural days before the sanitary registration expiration date.<\/li>\n \t<li>Details the different types of import permits.<\/li>\n \t<li>States that advertising intended for health experts only requires a\nnotice (not a permit).<\/li>\n<\/ol>\n<\/li>\n<\/ol><\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"3\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-6213\" aria-expanded=\"false\">Mexican Official Norms (NOM) <\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-6213\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-6213\" tabindex=\"0\" hidden=\"hidden\">Mexican Official Norms (NOM)<sup>4<\/sup>\n<ol type=\"a\">\n \t<li>NOM-137. Medical device labelling requirements.\n<ol type=\"i\">\n \t<li>It also states you can add a second label for the missing requirements based on this norm.<\/li>\n \t<li>Although not mentioned in this document, you are not obliged to comply with this norm upon entrance in customs. Nevertheless, the label with the missing information must be included before delivering it to the final client.<\/li>\n<\/ol>\n<\/li>\n \t<li>NOM-240. Technovigilance program.\n<ol type=\"i\">\n \t<li>Details the processes to correctly run a surveillance program in Mexico.<\/li>\n<\/ol>\n<\/li>\n \t<li>NOM-241. Medical device good manufacturing practices.\n<ol type=\"i\">\n \t<li>Details every requirement to be certified in Mexico for good manufacturing practices. It is also applicable for warehouses.<\/li>\n \t<li>It is not required if you are exporting to Mexico. This is only applicable for companies settled in Mexico and manufacturing a medical device. Please keep in mind, you always need to check first if your product is a medical device or not.<\/li>\n<\/ol>\n<\/li>\n<\/ol><\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"4\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-6214\" aria-expanded=\"false\">Agreements<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-6214\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-6214\" tabindex=\"0\" hidden=\"hidden\"><ol type=\"a\">\n \t<li>FDA (US Food and Drug Administration), HC (Health Canada) and MHLW (Japan Ministry of Health, Labour and Welfare) Equivalency Agreement.<sup>5<\/sup>\n<ol type=\"i\">\n \t<li>This agreement details the requirements for the so called FDA&amp;HC&amp;MHLW equivalency agreements. More details about the routes to register a medical device in Mexico can be found in this document.<\/li>\n<\/ol>\n<\/li>\n \t<li>Agreement that classifies and codifies the health supplies that are subject to control by the ministry of health<sup>6<\/sup>.\n<ol type=\"i\">\n \t<li>Identifies the tariff code for every health supply that concerns the ministry of health. This is a useful document to determine if the tariff code you will use to export a product will require any sort of permit. Share it with your customs broker.<\/li>\n \t<li>Keep in mind that this document is constantly being updated through amendments.<\/li>\n<\/ol>\n<\/li>\n \t<li>Agreement in which the Ministry of Economy disseminates rules and criteria for Trade Commerce matters<sup>7<\/sup>.\n<ol type=\"i\">\n \t<li>This agreement specifies if you need to pay a special fee based on the tariff code or if you need to comply with any other Mexican Official Norm. Share it with your customs broker for a better reference and to avoid extra requirements or complications.<\/li>\n<\/ol>\n<\/li>\n \t<li>Agreement that lists the services and formats applicable to the ministry of Health<sup>8<\/sup>.\n<ol type=\"i\">\n \t<li>Use this, in case you want to check all the services you can utilize through the ministry of health. Useful if you are a regulatory affairs consultant.<\/li>\n<\/ol>\n<\/li>\n \t<li>Agreement that lists all the low risk medical devices and those products that are not considered medical devices<sup>9<\/sup>.\n<ol type=\"i\">\n \t<li>This is your best reference in case you want to know if your product is not considered a medical device or a low risk class medical device. Unfortunately, this is not based on tariff codes.<\/li>\n<\/ol>\n<\/li>\n<\/ol><\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"5\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-6215\" aria-expanded=\"false\">Supplements<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-6215\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-6215\" tabindex=\"0\" hidden=\"hidden\"><ol type=\"a\">\n \t<li>Supplement for health supplies establishments<sup>10<\/sup>.\n<ol type=\"i\">\n \t<li>\nThe Pharmacovigilance National Center<sup>11<\/sup> is in charge of the preparation and any updates to this document. This is the gold standard reference for every medical device warehouse to understand what it is required to properly operate a warehouse in Mexico.<\/li>\n<\/ol>\n<\/li>\n \t<li>\nSupplement for Medical Devices<sup>12<\/sup>.\n<ol type=\"i\">\n \t<li>Again, the Pharmacovigilance National Center is in charge of this supplement. This document lists several (but not all) medical devices with the list of tests that you must do to get a sanitary registration. It also describes the analytical methods. The ministry of health reviewers uses this document as a reference to validate the tests you present.<\/li>\n \t<li>This document also has the classifications and grouping rules.<\/li>\n<\/ol>\n<\/li>\n<\/ol><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b9260c6 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b9260c6\" data-element_type=\"section\" data-e-type=\"section\" id=\"cofepris\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-91f1ba2\" data-id=\"91f1ba2\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-cb7c43c elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"cb7c43c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"Layer_1\" data-name=\"Layer 1\" viewBox=\"0 0 72.83 72.83\"><defs><style>.cls-1{fill:url(#linear-gradient);}.cls-2{fill:url(#linear-gradient-2);}.cls-3{fill:url(#linear-gradient-3);}.cls-4{fill:url(#linear-gradient-4);}<\/style><linearGradient id=\"linear-gradient\" x1=\"196.77\" y1=\"1\" x2=\"196.77\" y2=\"104.04\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.2\" stop-color=\"#ffc16f\"><\/stop><stop offset=\"0.63\" stop-color=\"#ff726f\"><\/stop><\/linearGradient><linearGradient id=\"linear-gradient-2\" x1=\"185.89\" y1=\"1\" x2=\"185.89\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-3\" x1=\"197.94\" y1=\"1\" x2=\"197.94\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-4\" x1=\"210.04\" y1=\"1\" x2=\"210.04\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><\/defs><title>cofeprs<\/title><path class=\"cls-1\" d=\"M196.77,105a36.42,36.42,0,1,1,36.42-36.42A36.46,36.46,0,0,1,196.77,105Zm0-70.56a34.15,34.15,0,1,0,34.15,34.15A34.18,34.18,0,0,0,196.77,34.43Z\" transform=\"translate(-160.35 -32.16)\"><\/path><path class=\"cls-2\" d=\"M184.94,77.5l-9.2,5.29c-0.19.11-.38,0.23-0.57,0.33a1.45,1.45,0,0,1-2.27-1.35q0-2.27,0-4.53,0-10.8,0-21.6c0-1.71,1-2.3,2.54-1.44l9.06,5.21c0.14,0.08.29,0.14,0.44,0.2a28.78,28.78,0,0,0,3.73,2.14c0.27,0.18.54,0.37,0.82,0.53L197.73,67c1.54,0.89,1.56,2.09,0,3-1.8,1-3.61,2.07-5.4,3.14a40.2,40.2,0,0,0-3.72,2.24A28,28,0,0,0,184.94,77.5Zm7.91-8.9a1.18,1.18,0,0,0-.2-0.21l-15.56-9c-0.75-.43-0.54.18-0.54,0.49,0,5.77,0,11.54,0,17.31,0,0.63.09,0.78,0.69,0.42,2.39-1.41,4.79-2.79,7.19-4.18Z\" transform=\"translate(-160.35 -32.16)\"><\/path><path class=\"cls-3\" d=\"M188.65,61.75a28.78,28.78,0,0,1-3.73-2.14c0-1.26.11-2.53,0-3.77-0.18-1.9,1.36-2.45,2.7-1.62,2.69,1.67,5.48,3.19,8.23,4.77,0.38,0.22.77,0.4,1.16,0.61,1.2,0.77,2.44,1.49,3.72,2.14,0.32,0.21.63,0.43,1,.62,2.78,1.6,5.57,3.19,8.34,4.8a1.49,1.49,0,0,1,0,2.78c-0.82.49-1.67,1-2.49,1.44l-6.8,4q-1.88,1-3.66,2.11l-8.34,4.78-1.35.78A1.5,1.5,0,0,1,185,81.69c0-1.4,0-2.8,0-4.19a28,28,0,0,1,3.71-2.11c0,0.81,0,1.63,0,2.64L205,68.58c-0.18-.13-0.28-0.22-0.39-0.29L198.79,65c-3.16-1.82-6.33-3.63-9.48-5.46-0.49-.29-0.66-0.25-0.64.35S188.66,61.11,188.65,61.75Z\" transform=\"translate(-160.35 -32.16)\"><\/path><path class=\"cls-4\" d=\"M200.72,61.73c-1.27-.65-2.51-1.37-3.72-2.14,0-1.35,0-2.69,0-4,0-1.54,1.12-2.19,2.44-1.43l22.61,13c1.34,0.77,1.34,2,0,2.82-7.7,4.47-2.31,1.36-22.5,13-1.42.82-2.51,0.2-2.52-1.46,0-1.35,0-2.69,0-4q1.78-1.15,3.66-2.11c0,0.83,0,1.66,0,2.66l16.38-9.49-16.4-9.44v2.62Z\" transform=\"translate(-160.35 -32.16)\"><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-41ceb63 elementor-widget elementor-widget-heading\" data-id=\"41ceb63\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Inside COFEPRIS<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1e89cb2 elementor-widget elementor-widget-text-editor\" data-id=\"1e89cb2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\tMedical devices in Mexico are regulated by COFEPRIS<sup>13<\/sup>, a Federal Commission that belongs to the Ministry of Health.\n\nIn this section, we want to give you a quick overview of what it means to get a document into COFEPRIS and the commissions involved. Once you know this, it will be easy to understand why you are submitting letters to a certain commission or what your regulatory consultant must do to properly submit and receive documents.<br>\n\nThe first step is to program a meeting to get your documents submitted. This must be done in person for many processes, but not for all of them. For instance, import permits can be submitted electronically. This is not the case for a new registration submission.<br>\n\nOnce you have formally submitted, the Sanitary Authorization Commission<sup>14<\/sup> is in charge to review and approve your request. Then, every letter you submit must be addressed to the Sanitary Authorization Commissioner in turn.<br>\n\nIt is also of interest that the Sanitary Operation Commission<sup>15<\/sup> is in charge of auditing your warehouse or any facility if located in Mexico.\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4b40c03 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4b40c03\" data-element_type=\"section\" data-e-type=\"section\" id=\"stakeholders\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-d7d2ee0\" data-id=\"d7d2ee0\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-18da6b0 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"18da6b0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"Layer_1\" data-name=\"Layer 1\" viewBox=\"0 0 64.57 64.57\"><defs><style>.cls-1{fill:url(#linear-gradient);}<\/style><linearGradient id=\"linear-gradient\" x1=\"298.46\" y1=\"1\" x2=\"298.46\" y2=\"104.04\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.2\" stop-color=\"#ffc16f\"><\/stop><stop offset=\"0.63\" stop-color=\"#ff726f\"><\/stop><\/linearGradient><\/defs><title>stkhldrs<\/title><path class=\"cls-1\" d=\"M316.22,70.74l-7-8.89a15,15,0,0,0,4.23-9.42h10.81v1.18a5.38,5.38,0,1,0,2.15,0V51.35a1.08,1.08,0,0,0-1.08-1.08H313.46a15,15,0,0,0-3.15-8.18l1.5-1.5h12.66a3.23,3.23,0,1,0,0-2.15H311.36a1.08,1.08,0,0,0-.76.32l-1.74,1.74a15,15,0,0,0-25.42,9.78h-9l-3.52-7.91a3.22,3.22,0,1,0-2.23.29l4.06,9.14a1.08,1.08,0,0,0,1,.64h9.74a15,15,0,0,0,4.15,9.34l-9.08,9.08a10.75,10.75,0,1,0-3.19,21.26l0.53,0.07v5.43a1.08,1.08,0,0,0,1.08,1.08h9.88a3.23,3.23,0,1,0,0-2.15H278V92.17a10.75,10.75,0,0,0,2.9-20.69l8.28-8.28a15,15,0,0,0,18.42.07l6,7.6A15.07,15.07,0,1,0,316.22,70.74Zm12.36-11.86a3.23,3.23,0,1,1-3.23-3.23A3.23,3.23,0,0,1,328.58,58.88ZM327.5,38.44a1.08,1.08,0,1,1-1.08,1.08A1.08,1.08,0,0,1,327.5,38.44Zm-58.09,2.15a1.08,1.08,0,1,1,1.08-1.08A1.08,1.08,0,0,1,269.41,40.59Zm20.44,55.94a1.08,1.08,0,1,1-1.08,1.08A1.08,1.08,0,0,1,289.85,96.53Zm-8.61-7.62a8.53,8.53,0,0,1-8.61,0V86.85a4.3,4.3,0,1,1,8.61,0v2.06Zm-6.45-10.67a2.15,2.15,0,1,1,2.15,2.15A2.15,2.15,0,0,1,274.79,78.24Zm8.61-2.48a8.61,8.61,0,0,1,0,11.38V86.85a6.45,6.45,0,0,0-3.34-5.65,4.3,4.3,0,1,0-6.23,0,6.45,6.45,0,0,0-3.34,5.65v0.29A8.61,8.61,0,1,1,283.39,75.76ZM306,61.81a12.82,12.82,0,0,1-15.06,0V59.2a3.55,3.55,0,0,1,3.55-3.55h2.39l-1.56,3.9a1.08,1.08,0,0,0,.24,1.16l2.15,2.15a1.08,1.08,0,0,0,1.52,0l2.15-2.15a1.08,1.08,0,0,0,.24-1.16L300,55.65h2.39A3.55,3.55,0,0,1,306,59.2v2.61h0Zm-7.38-17.47a1.07,1.07,0,0,0-.1.21C298,46.19,295,46.81,293.14,47c0.29-3.61,2-5.32,5.32-5.32,3.05,0,4.73,1.44,5.21,4.46L300.08,44A1.08,1.08,0,0,0,298.61,44.34Zm1.33,2.05,3.84,2.31c-0.43,2.63-3.68,4.8-5.33,4.8a6.78,6.78,0,0,1-5.23-4.36C295.07,49,298.39,48.43,299.94,46.4Zm-0.59,13.3-0.89.89-0.89-.89,0.89-2.22Zm3.8-6.15A7.47,7.47,0,0,0,306,48.12c0-7.11-4.1-8.61-7.53-8.61s-7.53,1.49-7.53,8.61a7.47,7.47,0,0,0,2.84,5.43,5.68,5.68,0,0,0-5,5.65v0.65a12.91,12.91,0,1,1,19.36,0V59.2A5.68,5.68,0,0,0,303.15,53.55Zm20,42.68a12.82,12.82,0,0,1-15.06,0V93.63a3.55,3.55,0,0,1,3.55-3.55h2.39L312.51,94a1.08,1.08,0,0,0,.24,1.16l2.15,2.15a1.08,1.08,0,0,0,1.52,0l2.15-2.15a1.08,1.08,0,0,0,.24-1.16l-1.56-3.9h2.39a3.55,3.55,0,0,1,3.55,3.55v2.61Zm-6-15.42h0L321,83.13c-0.43,2.63-3.68,4.8-5.33,4.8a6.78,6.78,0,0,1-5.23-4.36C312.28,83.42,315.6,82.86,317.15,80.82Zm-6.8.59h0c0.29-3.6,2-5.32,5.32-5.32,3.05,0,4.73,1.44,5.21,4.46L317.3,78.4a1.08,1.08,0,0,0-1.57.58C315.18,80.61,312.24,81.23,310.35,81.41Zm6.21,12.71-0.89.89-0.89-.89,0.89-2.22Zm8.79,0.16V93.63a5.68,5.68,0,0,0-5-5.65,7.47,7.47,0,0,0,2.84-5.43c0-7.11-4.1-8.61-7.53-8.61s-7.53,1.49-7.53,8.61A7.47,7.47,0,0,0,311,88a5.68,5.68,0,0,0-5,5.65v0.65A12.91,12.91,0,1,1,325.35,94.28Z\" transform=\"translate(-266.17 -36.29)\"><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4785d54 elementor-widget elementor-widget-heading\" data-id=\"4785d54\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">The stakeholders in a regulatory project in Mexico.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5705815 elementor-widget elementor-widget-text-editor\" data-id=\"5705815\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\tIf you are a manufacturer, an independent regulatory consultant, or a local distributor, it is important to understand the key roles of the main stakeholders of every regulatory project in Mexico. This will provide a better understanding of your legal responsibilities and\/or common roles in a project.\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-44801f5 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"44801f5\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-d243fec\" data-id=\"d243fec\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-df7f387 elementor-invisible elementor-widget elementor-widget-image\" data-id=\"df7f387\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"54\" height=\"58\" src=\"https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/2020\/01\/outside-mexico.svg\" class=\"attachment-full size-full wp-image-277\" alt=\"\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-24070a7\" data-id=\"24070a7\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-fa2204e elementor-widget elementor-widget-heading\" data-id=\"fa2204e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Manufacturer located outside of Mexico<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6593128 elementor-widget elementor-widget-text-editor\" data-id=\"6593128\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h5>Legal responsibilities<\/h5><p>The legal and\/or real manufacturer does not have any legal binding with the ministry of health in Mexico.<\/p><h5>Common role in a regulatory project<\/h5><p>They supply the necessary paperwork for the ministry of health. Please keep in mind that only Mexican legal entities can submit documents to the ministry of health. Therefore, the manufacturer requires a representative (a holder).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-6b8bafc elementor-reverse-mobile elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6b8bafc\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-206f36e\" data-id=\"206f36e\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-0dbe132 elementor-widget elementor-widget-heading\" data-id=\"0dbe132\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Manufacturer located in Mexico<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-48c6b4c elementor-widget elementor-widget-text-editor\" data-id=\"48c6b4c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h5>Legal responsibilities<\/h5><p>The manufacturer must be compliant with the local good manufacturing practices (based on NOM-241).<\/p><h5>Common role in a regulatory project<\/h5><p>They can play the role of a Holder since they are located in Mexico. However, usually the manufacturer is a third party and the legal manufacturer is located outside of Mexico, then the third party manufacturer only provides the good manufacturing practices certificate to the Mexican Ministry of Health.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-8d46dcf\" data-id=\"8d46dcf\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-0fa821c elementor-invisible elementor-widget elementor-widget-image\" data-id=\"0fa821c\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"55\" height=\"57\" src=\"https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/2020\/01\/inside-mex.svg\" class=\"attachment-full size-full wp-image-276\" alt=\"\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-c34fa51 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"c34fa51\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-a693f01\" data-id=\"a693f01\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-8e36ddd elementor-invisible elementor-widget elementor-widget-image\" data-id=\"8e36ddd\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"68\" height=\"50\" src=\"https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/2020\/01\/holder-mex.svg\" class=\"attachment-full size-full wp-image-274\" alt=\"\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-8616d55\" data-id=\"8616d55\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-193dae2 elementor-widget elementor-widget-heading\" data-id=\"193dae2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Holder in Mexico<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a791747 elementor-widget elementor-widget-text-editor\" data-id=\"a791747\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h5>Legal responsibilities<\/h5><p>The ministry of health considers the holder as the<br \/>responsible party for any affairs related to the medical devices the holder owns.\u00a0The holder is also responsible for complying with local warehouse regulations. In\u00a0addition, the manufacturer must have a Sanitary Responsible who oversees all the operations in the local warehouse. Finally, the holder is also responsible to<br \/>maintain the technovigilance program (based on NOM-240). More details are covered in our registration holder ultimate guide.<\/p><h5>Common role in a regulatory project<\/h5><p>The holder submits the paperwork and\u00a0maintains a communication channel with the manufacturer to inform him about any adverse incident.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-39f453c elementor-reverse-mobile elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"39f453c\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-f6922e4\" data-id=\"f6922e4\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-0b6b6f8 elementor-widget elementor-widget-heading\" data-id=\"0b6b6f8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Independent Regulatory Affairs Consulting Firm<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b1dc569 elementor-widget elementor-widget-text-editor\" data-id=\"b1dc569\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h5>Legal responsibilities<\/h5><p>If they are not the holders, they do not have any legal responsibility.<\/p><h5>Common role in a regulatory project<\/h5><p>They can play a role as your holder or help you in some processes during the regulatory project such as peer-review.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-05e56b7\" data-id=\"05e56b7\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c790d2e elementor-invisible elementor-widget elementor-widget-image\" data-id=\"c790d2e\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"56\" height=\"56\" src=\"https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/2020\/01\/consultor.svg\" class=\"attachment-full size-full wp-image-275\" alt=\"\" srcset=\"https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/\/2020\/01\/consultor.svg 150w, https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/\/2020\/01\/consultor.svg 300w, https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/\/2020\/01\/consultor.svg 1024w, https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/\/2020\/01\/consultor.svg 56w\" sizes=\"(max-width: 56px) 100vw, 56px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-4a271d1 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4a271d1\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-3b4cd91\" data-id=\"3b4cd91\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-146156c elementor-invisible elementor-widget elementor-widget-image\" data-id=\"146156c\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"63\" height=\"51\" src=\"https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/2020\/01\/distributor.svg\" class=\"attachment-full size-full wp-image-273\" alt=\"\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-190c2c6\" data-id=\"190c2c6\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3b44a26 elementor-widget elementor-widget-heading\" data-id=\"3b44a26\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Local Distributors<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ead86b9 elementor-widget elementor-widget-text-editor\" data-id=\"ead86b9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h5>Legal responsibilities<\/h5><p>If they are not the holders and are mentioned in the sanitary registration as importers and distributors, the local distributor responsibilities are the same as the holder, except they are not the main point of contact to the ministry of health. In other words, the local distributor is subject to receiving audits to its warehouse and is required to have a Sanitary Responsible and report any adverse incident.<\/p><h5>Common role in a regulatory project<\/h5><p>They can play a role as your holder and\/or commercial activities. Please check our registration holder ultimate guide for more information about this.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6cd697b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6cd697b\" data-element_type=\"section\" data-e-type=\"section\" id=\"routes\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;background_motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;background_motion_fx_translateY_effect&quot;:&quot;yes&quot;,&quot;background_motion_fx_translateY_direction&quot;:&quot;negative&quot;,&quot;background_motion_fx_translateY_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:4,&quot;sizes&quot;:[]},&quot;background_motion_fx_translateY_affectedRange&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:0,&quot;end&quot;:100}},&quot;background_motion_fx_devices&quot;:[&quot;desktop&quot;,&quot;tablet&quot;,&quot;mobile&quot;]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-65cd274 elementor-hidden-tablet elementor-hidden-phone\" data-id=\"65cd274\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-51ea5f3\" data-id=\"51ea5f3\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-676dc0b elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"676dc0b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"Layer_1\" data-name=\"Layer 1\" viewBox=\"0 0 64.1 63.57\"><defs><style>.cls-1{fill:url(#linear-gradient);}.cls-2{fill:url(#linear-gradient-3);}.cls-3{fill:url(#linear-gradient-5);}<\/style><linearGradient id=\"linear-gradient\" x1=\"415.41\" y1=\"1\" x2=\"415.41\" y2=\"104.04\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.2\" stop-color=\"#ffc16f\"><\/stop><stop offset=\"0.63\" stop-color=\"#ff726f\"><\/stop><\/linearGradient><linearGradient id=\"linear-gradient-3\" x1=\"366.67\" y1=\"1\" x2=\"366.67\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-5\" x1=\"391.3\" y1=\"1\" x2=\"391.3\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><\/defs><title>pths<\/title><path class=\"cls-1\" d=\"M415.41,100.36a1.06,1.06,0,0,1-.75-0.31C414,99.36,408,93.19,408,89.13a7.43,7.43,0,1,1,14.83,0c0,4.06-6,10.23-6.66,10.92A1.06,1.06,0,0,1,415.41,100.36Zm0-17a5.53,5.53,0,0,0-5.3,5.72c0,2.16,3,6.13,5.3,8.63,2-2.14,5.3-6.26,5.3-8.63A5.53,5.53,0,0,0,415.41,83.41Z\" transform=\"translate(-359.26 -36.79)\"><\/path><path class=\"cls-1\" d=\"M417.53,91.88h-4.24a1.06,1.06,0,0,1-1.06-1.06V86.59a1.06,1.06,0,0,1,1.06-1.06h4.24a1.06,1.06,0,0,1,1.06,1.06v4.24A1.06,1.06,0,0,1,417.53,91.88Zm-3.18-2.12h2.12V87.65h-2.12v2.12Z\" transform=\"translate(-359.26 -36.79)\"><\/path><path class=\"cls-2\" d=\"M366.67,55.86a1.06,1.06,0,0,1-.75-0.31c-0.68-.69-6.66-6.85-6.66-10.92a7.43,7.43,0,1,1,14.83,0c0,4.06-6,10.23-6.66,10.92A1.06,1.06,0,0,1,366.67,55.86Zm0-17a5.53,5.53,0,0,0-5.3,5.72c0,2.16,3,6.13,5.3,8.63,2-2.14,5.3-6.26,5.3-8.63A5.53,5.53,0,0,0,366.67,38.91Z\" transform=\"translate(-359.26 -36.79)\"><\/path><path class=\"cls-2\" d=\"M368.79,47.39h-4.24a1.06,1.06,0,0,1-1.06-1.06V42.09A1.06,1.06,0,0,1,364.55,41h4.24a1.06,1.06,0,0,1,1.06,1.06v4.24A1.06,1.06,0,0,1,368.79,47.39Zm-3.18-2.12h2.12V43.15h-2.12v2.12Z\" transform=\"translate(-359.26 -36.79)\"><\/path><path class=\"cls-3\" d=\"M409.05,100.36H372.5a5.83,5.83,0,1,1,0-11.65h25.43a3.71,3.71,0,1,0,0-7.42H365.08a5.83,5.83,0,1,1,0-11.65h52.44a3.71,3.71,0,1,0,0-7.42H378.86a5.83,5.83,0,0,1,0-11.65h28.61a3.71,3.71,0,0,0,0-7.42h-27a1.06,1.06,0,1,1,0-2.12h27a5.83,5.83,0,0,1,0,11.65H378.86a3.71,3.71,0,1,0,0,7.42h38.67a5.83,5.83,0,1,1,0,11.65H365.08a3.71,3.71,0,1,0,0,7.42h32.84a5.83,5.83,0,1,1,0,11.65H372.5a3.71,3.71,0,0,0,0,7.42h36.55A1.06,1.06,0,0,1,409.05,100.36Z\" transform=\"translate(-359.26 -36.79)\"><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3aacbe1 elementor-widget elementor-widget-heading\" data-id=\"3aacbe1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">The routes to register a medical device in Mexico<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bd90f61 elementor-widget elementor-widget-text-editor\" data-id=\"bd90f61\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>At this point, we have identified the rules and specific documents that lay behind every medical device sold in Mexico. In addition, we have identified the main stakeholders in a regulatory project, detailing the COFEPRIS departments related to your paperwork assessment. Now, it is time to talk in detail about the routes you can choose. It is worth mentioning that you may want to\u00a0check our ultimate guides for\u00a0<a href=\"https:\/\/veraqueconsulting.com\/mx\/classification-and-grouping-ultimate-guide\/\" target=\"_blank\" rel=\"noopener\">classification and grouping<\/a>\u00a0and\u00a0<a href=\"https:\/\/veraqueconsulting.com\/mx\/mexican-registration-holder-ultimate-guide\/\" target=\"_blank\" rel=\"noopener\">Mexican registration holder<\/a>\u00a0to know\u00a0more about the first steps to take and the role of your holder in Mexico.<\/p><p>As in any country, we have to start with the medical device classification and grouping to identify the best regulatory pathway. Then, once you have achieved the classification and grouping assessment, you will end up with the following options:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6679837 elementor-align-start elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"6679837\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Class I low risk<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Class I<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Class II<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Class III<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Not a medical device<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-0a6c505 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"0a6c505\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-08b7815\" data-id=\"08b7815\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1b7a6b1 elementor-tabs-view-vertical elementor-widget elementor-widget-tabs\" data-id=\"1b7a6b1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"tabs.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-tabs\">\n\t\t\t<div class=\"elementor-tabs-wrapper\" role=\"tablist\" >\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-2881\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"true\" data-tab=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"elementor-tab-content-2881\" aria-expanded=\"false\">Options for a non-medical device<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-2882\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"2\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-2882\" aria-expanded=\"false\"> Options for Class I low risk<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-2883\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"3\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-2883\" aria-expanded=\"false\">Options for Class I, II, III<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t<div class=\"elementor-tabs-content-wrapper\" role=\"tablist\" aria-orientation=\"vertical\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"true\" data-tab=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"elementor-tab-content-2881\" aria-expanded=\"false\">Options for a non-medical device<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2881\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-2881\" tabindex=\"0\" hidden=\"false\"><p>If your products are not considered medical devices, you don\u2019t need to do any further process. Nevertheless, if the device is to be included in a public bid in Mexico, then there are chances that the bidder requires a ministry of health letter stating that the product is not a medical device. As discussed earlier in this guide, the legal framework includes a non-medical device official list. This is a key reference in case you want to defend the point. Keep in mind that distributors are the ones who participate in the bids, and it depends on their so called access department (or related) experience if your product should have such letter or not (even if your product is clearly listed in the non-medical device official list). Therefore, it might be better to check with your distributors to see if they require a letter from the ministry of health or not.<\/p><p>In case you choose to confirm with the ministry of health if your product is a medical device or not. You have two options.<\/p><ul><li>Prepare and submit an open inquiry<sup>16<\/sup>.<ul><li>This is a letter justifying your reasons being to confirm that the product is not a medical device.<\/li><li>The process is free but does not have a clear timeline for response. Sometimes, the authority does not even respond.<\/li><\/ul><\/li><li>Submit a dossier as a class I low risk device.<ul><li>The required documents to submit for a class I low risk are minimal (more details in the section requirements for the route you choose).<\/li><li>The authority response is within a 3-6 months period and you will have a formal response either if COFEPRIS considers the device as a non-medical device or as a class I low risk, or even a higher class (class I, II or III). In other words:<ul><li>If it is not a medical device, COFEPRIS will detail the reasons.<\/li><li>If it is a class I low risk, COFEPRIS will deliver a sanitary registration.<\/li><li>If it is a class I, II, III, COFEPRIS will inform it and require the missing documents (check the following sections for more details).<\/li><\/ul><\/li><\/ul><\/li><\/ul><\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"2\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-2882\" aria-expanded=\"false\"> Options for Class I low risk<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2882\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-2882\" tabindex=\"0\" hidden=\"hidden\"><p>We discussed in the section \u201cthe legal framework surrounding a medical device in Mexico\u201d that there is an agreement that lists the non-medical devices and class I low risk devices. In the last section, we talked about a non-medical device, but what about if it is included in this list as a class I low risk device. Well, we might say you are fortunate since the paperwork you have to consider is minimal. Specifically, commercial brochures, instructions for use and labels, but no technical studies. In addition, it is necessary to consider a few legal documents: a power of attorney and distribution letters.\u00a0<\/p><p>Finally yet importantly, you need a Holder. As mentioned in the \u201cstakeholder in a regulatory project in Mexico\u201d, the Holder in Mexico plays a key role for a successful experience in the country. We invite you to visit our ultimate guide about the holder role as your partner in Mexico.\u00a0<\/p><p>A note to conclude this section is that this is the only class of medical device that is not subject to any other route or alternative, as we will see in the options you have for class I, II and III. Don\u00b4t worry! The good news is that this is not only a process requiring few documents, but also one that receives fast responses (3-6 months).<\/p><\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"3\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-2883\" aria-expanded=\"false\">Options for Class I, II, III<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2883\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-2883\" tabindex=\"0\" hidden=\"hidden\"><p>In case you consider your product is a class I, II or III medical device in Mexico, you have two regulatory pathways. First, you want to make sure that the product has been correctly classified. In our experience, some manufacturers take for granted that if their product is a class I in their country (e.g. USA) then it should be the same classification in Mexico.<br \/>This is not necessarily true and we strongly recommend doing a classification and grouping based on the Mexican laws. We invite you to visit our\u00a0<a href=\"https:\/\/veraqueconsulting.com\/mx\/classification-and-grouping-ultimate-guide\/\" target=\"_blank\" rel=\"noopener\">ultimate guide for classification and grouping\u00a0<\/a>for further references.<\/p><p>Then, when you feel comfortable with the medical device classification, you must choose one of the two regulatory pathways the Ministry of Health offers. These are:<\/p><p>1. Standard.<\/p><ul><li>As its name indicates, this is the traditional route you can use. Compared with the equivalency route, the number of documents you have to present is more and it takes more time (more details in the timeframes section in this guide), both for compilation and for timeframe response.<\/li><\/ul><p>2. Equivalency agreement route.<\/p><ul><li>This is applicable for medical devices approved by any IMDRF Management Committee Regulatory Agency\u00a0<a href=\"https:\/\/veraqueconsulting.com\/mx\/mexicos-expanded-equivalency-agreement-for-medical-devices-key-implications\/\" target=\"_blank\" rel=\"noopener\">(beyond the previously recognized U.S., Canada and Japan).<\/a><ul><li><span style=\"background-color: transparent\">Compared with the standard process, the number of documents you have to present is less as well as the timeframe to receive a response from the authority.\u00a0<\/span><\/li><\/ul><\/li><\/ul><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-f8bbd48 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"f8bbd48\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-f284d28\" data-id=\"f284d28\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-a99bd98 elementor-widget elementor-widget-text-editor\" data-id=\"a99bd98\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>This may sound complicated, but you only have to check first which options are available for you. Then, balance time and requirements between options.&nbsp;<span style=\"font-size: 1rem\">At this point, you now know the classification of the product and the pathway you want to follow.&nbsp;<\/span><\/p>\n<p>We want to end this section by describing the processes you can do or have to do with your sanitary registration in Mexico:<\/p>\n<ul>\n<li>New Registration.<\/li>\n<li>Modification.\n<ul>\n<li>Technical.\n<ul>\n<li>In case, you want to add a product or change a manufacturer. There are more options for which you can contact us for more details.<\/li>\n<\/ul>\n<\/li>\n<li>Administrative.\n<ul>\n<li>The most common are rights transfer or add\/take off local distributors.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<li>Renewals.\n<ul>\n<li>Your sanitary registration lasts 5 years.<\/li>\n<li>150 days before expiration, you have to submit the renewal application. In addition, you have to submit the technovigilance information 3 months prior those 150 days. Therefore, we generally recommend starting this process one year before expiration.<\/li>\n<\/ul>\n<\/li>\n<li>Import Permits.\n<ul>\n<li>This is applicable for some products even if they have a sanitary registration. Some implants or high-risk products are considered in this group.&nbsp;<\/li>\n<li>As with class I low risk devices, you only have one option for submission.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2631c84 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2631c84\" data-element_type=\"section\" data-e-type=\"section\" id=\"timelines\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-01b37a0\" data-id=\"01b37a0\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1dfc2a7 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"1dfc2a7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"Layer_1\" data-name=\"Layer 1\" viewBox=\"0 0 89.47 64.36\"><defs><style>.cls-1{fill:url(#linear-gradient);}.cls-2{fill:url(#linear-gradient-2);}.cls-3{fill:url(#linear-gradient-3);}.cls-4{fill:url(#linear-gradient-5);}<\/style><linearGradient id=\"linear-gradient\" x1=\"706.3\" y1=\"1\" x2=\"706.3\" y2=\"104.04\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.2\" stop-color=\"#ffc16f\"><\/stop><stop offset=\"0.63\" stop-color=\"#ff726f\"><\/stop><\/linearGradient><linearGradient id=\"linear-gradient-2\" x1=\"725.87\" y1=\"1\" x2=\"725.87\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-3\" x1=\"729.74\" y1=\"1\" x2=\"729.74\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-5\" x1=\"675.63\" y1=\"1\" x2=\"675.63\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><\/defs><title>tmlnes<\/title><path class=\"cls-1\" d=\"M712.79,42.89A6.49,6.49,0,1,0,705,49.24v13a6.49,6.49,0,0,0,0,12.72l0,13a6.49,6.49,0,1,0,2.6,0l0-13a6.49,6.49,0,0,0,0-12.7v-13A6.5,6.5,0,0,0,712.79,42.89Zm-10.37,0a3.88,3.88,0,1,1,3.88,3.88A3.88,3.88,0,0,1,702.42,42.89Zm7.77,51.38a3.88,3.88,0,1,1-3.88-3.88A3.88,3.88,0,0,1,710.18,94.27Zm0-25.69a3.88,3.88,0,1,1-3.88-3.88A3.88,3.88,0,0,1,710.18,68.58Z\" transform=\"translate(-653.87 -36.4)\"><\/path><path class=\"cls-2\" d=\"M717.44,49.12H734.3a1.3,1.3,0,0,0,1.3-1.3V37.95a1.3,1.3,0,0,0-1.3-1.3H717.44a1.3,1.3,0,0,0-1.3,1.3v9.87A1.3,1.3,0,0,0,717.44,49.12Zm1.3-9.87H733v7.27H718.74V39.25Z\" transform=\"translate(-653.87 -36.4)\"><\/path><path class=\"cls-3\" d=\"M742,62.34h-24.6a1.3,1.3,0,0,0-1.3,1.3v9.87a1.3,1.3,0,0,0,1.3,1.3H742a1.3,1.3,0,0,0,1.3-1.3V63.64A1.3,1.3,0,0,0,742,62.34Zm-1.3,9.87h-22V64.94h22v7.27Z\" transform=\"translate(-653.87 -36.4)\"><\/path><path class=\"cls-2\" d=\"M734.3,88H717.44a1.3,1.3,0,0,0-1.3,1.3V99.2a1.3,1.3,0,0,0,1.3,1.3H734.3a1.3,1.3,0,0,0,1.3-1.3V89.33A1.3,1.3,0,0,0,734.3,88ZM733,97.9H718.74V90.63H733V97.9Z\" transform=\"translate(-653.87 -36.4)\"><\/path><path class=\"cls-4\" d=\"M686.7,64.05a1.3,1.3,0,0,0-1.18-.76h0a1.3,1.3,0,0,0-1.18.75l-2.76,5.85L676.67,60V54.3h10.4a1.3,1.3,0,0,0,1-2.17l-3.61-4L688,44a1.3,1.3,0,0,0-1-2.17h-11.7a1.3,1.3,0,0,0-1.3,1.3V60l-4.66,9.42L666.93,64a1.3,1.3,0,0,0-1.18-.75h0a1.3,1.3,0,0,0-1.18.76L654,87.31a1.3,1.3,0,0,0,1.19,1.84h4.45l-1.18,2.39a1.3,1.3,0,0,0,1.17,1.88h31.52a1.3,1.3,0,0,0,1.17-1.88l-1.18-2.39h5a1.3,1.3,0,0,0,1.19-1.84Zm-10-19.58h7.49l-2.45,2.75a1.3,1.3,0,0,0,0,1.73l2.45,2.75h-7.49V44.47ZM657.19,86.55l8.57-18.84,2.16,4.66-7,14.18h-3.72Zm4.51,4.27L675.36,63.2,689,90.83H661.7Zm28.12-4.27-6.77-13.69,2.44-5.18,8.58,18.86h-4.25Z\" transform=\"translate(-653.87 -36.4)\"><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b2e26f5 elementor-widget elementor-widget-heading\" data-id=\"b2e26f5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Timelines<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2677471 elementor-widget elementor-widget-text-editor\" data-id=\"2677471\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>We have talked a lot about the timelines. In an effort to make this easy for you, this is a summary for different pathways and processes. Please consider that none of them is based on legal information but rather on our experience throughout the years. In addition, this time is based upon submission of your documents to COFEPRIS.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4503ea0 elementor-widget elementor-widget-text-editor\" data-id=\"4503ea0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>Class I low risk: 3 months.<\/li><li>Class I, II, III Standard Pathway: 16+ months.<\/li><li>Class I, II, III Equivalency Agreement Pathway: 8+ months.<\/li><li>Administrative Modification (any pathway): 6 months.<\/li><li>Technical Modification (any pathway): 16+ months.<\/li><li>Renewals (Standard or Equivalency Agreement): 8 months.<\/li><li>Import Permits: 3-4 weeks.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-a8f3a56 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a8f3a56\" data-element_type=\"section\" data-e-type=\"section\" id=\"prevention\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-22d3196\" data-id=\"22d3196\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-fa79d94 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"fa79d94\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"Layer_1\" data-name=\"Layer 1\" viewBox=\"0 0 64.08 64.08\"><defs><style>.cls-1{fill:url(#linear-gradient);}.cls-2{fill:url(#linear-gradient-2);}.cls-3{fill:url(#linear-gradient-3);}.cls-4{fill:url(#linear-gradient-4);}.cls-5{fill:url(#linear-gradient-5);}.cls-6{fill:url(#linear-gradient-6);}.cls-7{fill:url(#linear-gradient-8);}.cls-8{fill:url(#linear-gradient-9);}.cls-9{fill:url(#linear-gradient-10);}.cls-10{fill:url(#linear-gradient-12);}.cls-11{fill:url(#linear-gradient-13);}<\/style><linearGradient id=\"linear-gradient\" x1=\"477.66\" y1=\"1\" x2=\"477.66\" y2=\"104.04\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.2\" stop-color=\"#ffc16f\"><\/stop><stop offset=\"0.63\" stop-color=\"#ff726f\"><\/stop><\/linearGradient><linearGradient id=\"linear-gradient-2\" x1=\"41.65\" y1=\"-35.54\" x2=\"41.65\" y2=\"67.51\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-3\" x1=\"34.17\" y1=\"-35.54\" x2=\"34.17\" y2=\"67.51\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-4\" x1=\"45.39\" y1=\"-35.54\" x2=\"45.39\" y2=\"67.51\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-5\" x1=\"42.72\" y1=\"-35.54\" x2=\"42.72\" y2=\"67.51\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-6\" x1=\"46.99\" y1=\"-35.54\" x2=\"46.99\" y2=\"67.51\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-8\" x1=\"55\" y1=\"-35.54\" x2=\"55\" y2=\"67.51\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-9\" x1=\"53.4\" y1=\"-35.54\" x2=\"53.4\" y2=\"67.51\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-10\" x1=\"37.38\" y1=\"-35.54\" x2=\"37.38\" y2=\"67.51\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-12\" x1=\"29.9\" y1=\"-35.54\" x2=\"29.9\" y2=\"67.51\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-13\" x1=\"45.92\" y1=\"-35.54\" x2=\"45.92\" y2=\"67.51\" xlink:href=\"#linear-gradient\"><\/linearGradient><\/defs><title>prvntion<\/title><path class=\"cls-1\" d=\"M508.63,36.54H465.91a1.07,1.07,0,0,0-1.07,1.07V55.76h-4.38a9.94,9.94,0,0,0-7.66,3.59,7.82,7.82,0,0,1-6,2.82h-1.17V64.3h1.17a9.94,9.94,0,0,0,7.66-3.59,7.82,7.82,0,0,1,6-2.82h4.23l13.58,3.62a2,2,0,0,1,.71,3.57,2,2,0,0,1-1.76.35L465.12,62.2a1.07,1.07,0,0,0-1.23.55L463,64.53a7.27,7.27,0,0,1-6.54,4h-2.3v2.14h2.3a9.39,9.39,0,0,0,8.38-5.11V85.66H462a7.88,7.88,0,0,1-6.39-3.29,10,10,0,0,0-8.13-4.19h-1.82v2.14h1.82a7.88,7.88,0,0,1,6.39,3.29A10,10,0,0,0,462,87.8h2.88V99.55a1.07,1.07,0,0,0,1.07,1.07h42.72a1.07,1.07,0,0,0,1.07-1.07V37.61A1.07,1.07,0,0,0,508.63,36.54Zm-1.07,61.94H467V64.91l9.72,2.59a4.16,4.16,0,0,0,2.14-8L467,56.3V38.67h40.58v59.8Z\" transform=\"translate(-445.62 -36.54)\"><\/path><rect class=\"cls-2\" x=\"30.97\" y=\"5.34\" width=\"21.36\" height=\"2.14\"><\/rect><rect class=\"cls-3\" x=\"30.97\" y=\"18.15\" width=\"6.41\" height=\"2.14\"><\/rect><rect class=\"cls-4\" x=\"39.51\" y=\"18.15\" width=\"11.75\" height=\"2.14\"><\/rect><rect class=\"cls-5\" x=\"37.38\" y=\"23.49\" width=\"10.68\" height=\"2.14\"><\/rect><rect class=\"cls-6\" x=\"37.38\" y=\"28.83\" width=\"19.22\" height=\"2.14\"><\/rect><rect class=\"cls-2\" x=\"26.7\" y=\"34.17\" width=\"29.9\" height=\"2.14\"><\/rect><rect class=\"cls-7\" x=\"53.4\" y=\"18.15\" width=\"3.2\" height=\"2.14\"><\/rect><rect class=\"cls-8\" x=\"50.19\" y=\"23.49\" width=\"6.41\" height=\"2.14\"><\/rect><rect class=\"cls-9\" x=\"26.7\" y=\"39.51\" width=\"21.36\" height=\"2.14\"><\/rect><rect class=\"cls-2\" x=\"26.7\" y=\"44.85\" width=\"29.9\" height=\"2.14\"><\/rect><rect class=\"cls-10\" x=\"26.7\" y=\"50.19\" width=\"6.41\" height=\"2.14\"><\/rect><rect class=\"cls-11\" x=\"35.24\" y=\"50.19\" width=\"21.36\" height=\"2.14\"><\/rect><rect class=\"cls-8\" x=\"50.19\" y=\"39.51\" width=\"6.41\" height=\"2.14\"><\/rect><rect class=\"cls-2\" x=\"26.7\" y=\"12.82\" width=\"29.9\" height=\"2.14\"><\/rect><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6afe6bc elementor-widget elementor-widget-heading\" data-id=\"6afe6bc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What is a prevention<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-53e0cc3 elementor-widget elementor-widget-text-editor\" data-id=\"53e0cc3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\tIf you have already submitted you dossier and are waiting for a response from the ministry of health, you may receive a response requesting more documents. This is what we call a prevention<sup>17<\/sup> and lists the missing documents and the reasons they are missing or which documents do not suffice. Receiving a prevention does not necessarily mean that a bad job has been done, sometimes the authority requires a clearer view of what you submitted.\n\nIn any case, the timeframe within which to respond is between 10-35 working days. If no response is submitted, the submission is cancelled. The question is when the clock starts for the timing. This is how it works:\n<ul>\n \t<li>The ministry of health informs through their webpage that you have an answer (however, you may not know if it is a prevention or not).<\/li>\n \t<li>The holder must go for such response to the ministry of health facilities. Once the response is picked up the time starts running.<\/li>\n<\/ul>\n<span style=\"font-size: 1rem\">\nAn important note: If you do not pick up the prevention, after some period of time the authority sends it to the Mexican Holder warehouse through standard mailbox service and the time runs once the ministry of health mails the document, not when the Mexican Holder receives it. In conclusion, your Holder must be aware of any communication from the authority, otherwise you could lose all the time you have invested so far.<\/span>\n\nNow, if you respond to the prevention within those 10-35 working days, the authority will take around 3-6 months to achieve the next response. This is in general terms. On the other hand, if the response you provided is insufficient, most of the time, your submission will be rejected and you have to start over again.\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-478f61f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"478f61f\" data-element_type=\"section\" data-e-type=\"section\" id=\"references\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-d528863\" data-id=\"d528863\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-05ffa32 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"05ffa32\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"Layer_1\" data-name=\"Layer 1\" viewBox=\"0 0 67.52 58.52\"><defs><style>.cls-1{fill:url(#linear-gradient);}.cls-2{fill:url(#linear-gradient-2);}.cls-3{fill:url(#linear-gradient-3);}.cls-4{fill:url(#linear-gradient-4);}.cls-5{fill:url(#linear-gradient-5);}.cls-6{fill:url(#linear-gradient-6);}.cls-7{fill:url(#linear-gradient-7);}.cls-8{fill:url(#linear-gradient-8);}.cls-9{fill:url(#linear-gradient-9);}<\/style><linearGradient id=\"linear-gradient\" x1=\"580.33\" y1=\"1\" x2=\"580.33\" y2=\"104.04\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.2\" stop-color=\"#ffc16f\"><\/stop><stop offset=\"0.63\" stop-color=\"#ff726f\"><\/stop><\/linearGradient><linearGradient id=\"linear-gradient-2\" x1=\"552.2\" y1=\"1\" x2=\"552.2\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-3\" x1=\"608.47\" y1=\"1\" x2=\"608.47\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-4\" x1=\"571.89\" y1=\"1\" x2=\"571.89\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-5\" x1=\"578.65\" y1=\"1\" x2=\"578.65\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-6\" x1=\"569.64\" y1=\"1\" x2=\"569.64\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-7\" x1=\"576.96\" y1=\"1\" x2=\"576.96\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-8\" x1=\"573.58\" y1=\"1\" x2=\"573.58\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-9\" x1=\"579.77\" y1=\"1\" x2=\"579.77\" y2=\"104.04\" xlink:href=\"#linear-gradient\"><\/linearGradient><\/defs><title>refrnce<\/title><path class=\"cls-1\" d=\"M608.47,39.32H552.2a5.63,5.63,0,0,0-5.63,5.63V83.21a5.63,5.63,0,0,0,5.63,5.63h31l5,5v2.91a1.13,1.13,0,0,0,1.13,1.13h12.38a1.13,1.13,0,0,0,1.13-1.13V93.78a12.56,12.56,0,0,0,2.84-5h2.79a5.63,5.63,0,0,0,5.63-5.63V44.94A5.63,5.63,0,0,0,608.47,39.32ZM555.58,86.58H552.2a3.38,3.38,0,0,1-3.38-3.38V44.94a3.38,3.38,0,0,1,3.38-3.38h3.38v45Zm2.25,0v-45h45V75.33a9.52,9.52,0,0,1-6.75.86,3.51,3.51,0,0,0-3.38-.67V74.81a11.25,11.25,0,0,0-3.38-22h-18a11.25,11.25,0,0,0,0,22.51H586v6.29l-0.89-.89A3.51,3.51,0,0,0,580,85.6l0.09,0.09L581,86.58H557.83Zm37.36-25.9A6.75,6.75,0,1,0,586,69.91v3.17H571.33a9,9,0,0,1,0-18h18a9,9,0,0,1,3.38,17.35V69.91A6.75,6.75,0,0,0,595.18,60.68Zm-8.83,0A4.5,4.5,0,0,1,592.71,67V66.33a3.38,3.38,0,0,0-6.75,0v0.73A4.5,4.5,0,0,1,586.35,60.7ZM604,85.18a10.33,10.33,0,0,1-3,7.35,1.13,1.13,0,0,0-.33.8v2.25H590.46V93.33a1.13,1.13,0,0,0-.33-0.8l-5.63-5.63-2.81-2.81a1.26,1.26,0,1,1,1.78-1.78l2.81,2.81a1.13,1.13,0,0,0,1.92-.8v-18a1.13,1.13,0,0,1,2.25,0V78.7a1.13,1.13,0,1,0,2.25,0,1.13,1.13,0,1,1,2.25,0,1.13,1.13,0,1,0,2.25,0,1.13,1.13,0,0,1,2.25,0,1.13,1.13,0,1,0,2.25,0,1.13,1.13,0,1,1,2.25,0v6.48Zm7.88-21.11V83.21a3.38,3.38,0,0,1-3.38,3.38h-2.34a12.82,12.82,0,0,0,.08-1.4V78.7a3.35,3.35,0,0,0-1.13-2.5V41.57h3.38a3.38,3.38,0,0,1,3.38,3.38V64.07Z\" transform=\"translate(-546.57 -39.32)\"><\/path><path class=\"cls-2\" d=\"M553.23,63.65a1,1,0,0,0-.61-0.61,1.15,1.15,0,0,0-1.23.24,1.16,1.16,0,0,0-.24.37,1.06,1.06,0,0,0,0,.86,1.32,1.32,0,0,0,.24.37,1.13,1.13,0,0,0,1.92-.8A0.94,0.94,0,0,0,553.23,63.65Z\" transform=\"translate(-546.57 -39.32)\"><\/path><path class=\"cls-3\" d=\"M608.47,60.7a3.38,3.38,0,1,0,3.38,3.38A3.38,3.38,0,0,0,608.47,60.7Zm0,4.5a1.13,1.13,0,1,1,1.13-1.13A1.13,1.13,0,0,1,608.47,65.2Z\" transform=\"translate(-546.57 -39.32)\"><\/path><path class=\"cls-4\" d=\"M572.46,58.45h-1.13a1.13,1.13,0,0,0,0,2.25h1.13A1.13,1.13,0,0,0,572.46,58.45Z\" transform=\"translate(-546.57 -39.32)\"><\/path><path class=\"cls-5\" d=\"M580.33,58.45H577a1.13,1.13,0,0,0,0,2.25h3.38A1.13,1.13,0,0,0,580.33,58.45Z\" transform=\"translate(-546.57 -39.32)\"><\/path><path class=\"cls-6\" d=\"M570.2,62.95h-1.13a1.13,1.13,0,0,0,0,2.25h1.13A1.13,1.13,0,0,0,570.2,62.95Z\" transform=\"translate(-546.57 -39.32)\"><\/path><path class=\"cls-7\" d=\"M579.21,62.95h-4.5a1.13,1.13,0,1,0,0,2.25h4.5A1.13,1.13,0,0,0,579.21,62.95Z\" transform=\"translate(-546.57 -39.32)\"><\/path><path class=\"cls-8\" d=\"M574.71,67.45h-2.25a1.13,1.13,0,0,0,0,2.25h2.25A1.13,1.13,0,0,0,574.71,67.45Z\" transform=\"translate(-546.57 -39.32)\"><\/path><path class=\"cls-9\" d=\"M580.33,67.45h-1.13a1.13,1.13,0,0,0,0,2.25h1.13A1.13,1.13,0,0,0,580.33,67.45Z\" transform=\"translate(-546.57 -39.32)\"><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-de0dd41 elementor-widget elementor-widget-heading\" data-id=\"de0dd41\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Useful references<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-24788bf elementor-widget elementor-widget-text-editor\" data-id=\"24788bf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>We offer some useful references you can check in the internet. You can use an automatic translator to have a better understanding of these documents. If this is not sufficiently clear or difficult to access for information feel free to contact us with any questions, and we will be glad to help you.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3b3f4f8 elementor-widget elementor-widget-text-editor\" data-id=\"3b3f4f8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"text-decoration: underline\"><a href=\"https:\/\/www.gob.mx\/cofepris\" target=\"_blank\" rel=\"noopener\">Cofepris Webpage<\/a><\/span><\/p><p><span style=\"text-decoration: underline\"><a href=\"http:\/\/dof.gob.mx\/\" target=\"_blank\" rel=\"noopener\">Official Mexican Diary<\/a><\/span><\/p><p>For any legal framework review. If you have the name in Spanish of the legal document you are looking for, type it in an internet search engine and check if it directs you to the Official Mexican Diary webpage, this is the most trust-worthy reference you may have.<\/p><p><span style=\"text-decoration: underline\"><a href=\"https:\/\/www.farmacopea.org.mx\/\" target=\"_blank\" rel=\"noopener\">Mexican Pharmacopeia<\/a><\/span><\/p><p>The legal Pharmacopeia offers general reference for any supplement you may be interested in. Keep in mind that accessing these documents has a cost.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-367dfd5 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"367dfd5\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-857cf17\" data-id=\"857cf17\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-620d2da elementor-widget elementor-widget-heading\" data-id=\"620d2da\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h6 class=\"elementor-heading-title elementor-size-default\">References<\/h6>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d3adf06 elementor-widget elementor-widget-text-editor\" data-id=\"d3adf06\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><sup>1\u00a0<\/sup><span style=\"font-weight: 400\">Ley General de Salud.<\/span><\/p><p><sup>2\u00a0<\/sup><span style=\"font-weight: 400\">Ley Federal de Procedimiento Administrativo.<br \/><\/span><\/p><p><sup>3\u00a0<\/sup><span style=\"font-weight: 400\">Reglamento de Insumos para la Salud.<br \/><\/span><\/p><p><sup>4\u00a0<\/sup><span style=\"font-weight: 400\">Normas Oficiales Mexicanas (NOM)<br \/><\/span><\/p><p><sup>5 <\/sup><span style=\"font-weight: 400\">Acuerdo por el que se reconocen como equivalentes a los requisitos establecidos en los art\u00edculos 179 y 180 del reglamento de insumos para la salud [\u2026]. The MHLW and FDA\/HC are separate agreements.<br \/><\/span><\/p><p><sup>6 <\/sup><span style=\"font-weight: 400\">Acuerdo que establece la clasificaci\u00f3n y codificaci\u00f3n de mercanc\u00edas y productos cuya importaci\u00f3n, exportaci\u00f3n, internaci\u00f3n o salida est\u00e1 sujeta a regulaci\u00f3n sanitaria por parte de la Secretar\u00eda de Salud.<br \/><\/span><\/p><p><sup>7 <\/sup><span style=\"font-weight: 400\">Acuerdo por el que la Secretar\u00eda de Econom\u00eda emite reglas y criterios de car\u00e1cter general en materia de Comercio Exterior.<br \/><\/span><\/p><p><sup>8 <\/sup><span style=\"font-weight: 400\">Acuerdo por el que se dan a conocer los tr\u00e1mites y servicios, as\u00ed como los formatos que aplica la Secretar\u00eda de Salud, a trav\u00e9s de la COFEPRIS.<br \/><\/span><\/p><p><sup>9 <\/sup><span style=\"font-weight: 400\">Acuerdo por el que da a conocer el listado de insumos para la salud considerados como de bajo riesgo para efectos de obtenci\u00f3n del Registro Sanitario, y de aquellos productos que por su naturaleza, caracter\u00edsticas propias y uso no se consideran como insumos para la salud y por ende no requieren Registro Sanitario.<br \/><\/span><\/p><p><sup>10 <\/sup><span style=\"font-weight: 400\"> Suplemento para establecimientos dedicados a la venta y suministro de medicamentos y dem\u00e1s insumos para la salud.<br \/><\/span><\/p><p><sup>11 <\/sup><span style=\"font-weight: 400\"> Centro Nacional de Farmacovigilancia.<br \/><\/span><\/p><p><sup>12 <\/sup><span style=\"font-weight: 400\"> Suplemento para Dispositivos M\u00e9dicos.<br \/><\/span><\/p><p><sup>13 <\/sup><span style=\"font-weight: 400\"> Comisi\u00f3n Federal para la Protecci\u00f3n contra Riesgos Sanitarios.<br \/><\/span><\/p><p><sup>14 <\/sup><span style=\"font-weight: 400\"> Comisi\u00f3n de Autorizaci\u00f3n Sanitaria.<br \/><\/span><\/p><p><sup>15 <\/sup><span style=\"font-weight: 400\"> Comisi\u00f3n de Operaci\u00f3n Sanitaria.<br \/><\/span><\/p><p><sup>16 <\/sup><span style=\"font-weight: 400\"> Escrito libre.<br \/><\/span><\/p><p><sup>17 <\/sup><span style=\"font-weight: 400\"> Prevenci\u00f3n.<br \/><\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-0b5ada9 elementor-hidden-tablet elementor-hidden-mobile elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"0b5ada9\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;sticky&quot;:&quot;bottom&quot;,&quot;background_background&quot;:&quot;classic&quot;,&quot;sticky_effects_offset&quot;:&quot;600&quot;,&quot;sticky_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;,&quot;mobile&quot;],&quot;sticky_offset&quot;:0,&quot;sticky_anchor_link_offset&quot;:0}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"make-column-clickable-elementor elementor-column elementor-col-14 elementor-top-column elementor-element elementor-element-8ea8447\" style=\"cursor: pointer;\" data-column-clickable=\"#legal_framework\" data-column-clickable-blank=\"_self\" data-id=\"8ea8447\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9bb87f8 elementor-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"9bb87f8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon\">\n\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"Layer_1\" data-name=\"Layer 1\" viewBox=\"0 0 55.15 72.03\"><defs><style>.cls-1{fill:url(#linear-gradient);}.cls-2{fill:url(#linear-gradient-2);}.cls-3{fill:url(#linear-gradient-5);}.cls-4{fill:url(#linear-gradient-7);}.cls-5{fill:url(#linear-gradient-9);}.cls-6{fill:url(#linear-gradient-10);}.cls-7{fill:url(#linear-gradient-11);}.cls-8{fill:url(#linear-gradient-12);}.cls-9{fill:url(#linear-gradient-13);}.cls-10{fill:url(#linear-gradient-14);}.cls-11{fill:url(#linear-gradient-17);}.cls-12{fill:url(#linear-gradient-19);}.cls-13{fill:url(#linear-gradient-20);}.cls-14{fill:url(#linear-gradient-21);}.cls-15{fill:url(#linear-gradient-23);}.cls-16{fill:url(#linear-gradient-24);}<\/style><linearGradient id=\"linear-gradient\" x1=\"76.11\" y1=\"1\" x2=\"76.11\" y2=\"104.04\" 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d=\"M97,58.46a1.12,1.12,0,0,1-1.07-.77L92.51,47.56a1.13,1.13,0,1,1,2.14-.71L98,57a1.12,1.12,0,0,1-.71,1.42A1.1,1.1,0,0,1,97,58.46Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-14\" d=\"M113.83,61.84a4.51,4.51,0,0,1-4.5-4.5,1.13,1.13,0,0,1,2.25,0,2.25,2.25,0,0,0,4.5,0,1.13,1.13,0,1,1,2.25,0A4.51,4.51,0,0,1,113.83,61.84Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-14\" d=\"M117.21,58.46h-6.75a1.13,1.13,0,0,1,0-2.25h6.75A1.13,1.13,0,0,1,117.21,58.46Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-15\" d=\"M110.46,58.46A1.13,1.13,0,0,1,109.39,57l3.38-10.13a1.13,1.13,0,1,1,2.14.71l-3.38,10.13A1.13,1.13,0,0,1,110.46,58.46Z\" transform=\"translate(-72.17 -32.56)\"><\/path><path class=\"cls-16\" d=\"M117.21,58.46a1.12,1.12,0,0,1-1.07-.77l-3.38-10.13a1.13,1.13,0,1,1,2.14-.71L118.28,57a1.12,1.12,0,0,1-.71,1.42A1.1,1.1,0,0,1,117.21,58.46Z\" transform=\"translate(-72.17 -32.56)\"><\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<span  >\n\t\t\t\t\t\t\tThe legal framework surrounding a medical device in Mexico\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"make-column-clickable-elementor elementor-column elementor-col-14 elementor-top-column elementor-element elementor-element-5193ea1\" style=\"cursor: pointer;\" data-column-clickable=\"#cofepris\" data-column-clickable-blank=\"_self\" data-id=\"5193ea1\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-dec059d elementor-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"dec059d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon\">\n\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"Layer_1\" data-name=\"Layer 1\" viewBox=\"0 0 72.83 72.83\"><defs><style>.cls-1{fill:url(#linear-gradient);}.cls-2{fill:url(#linear-gradient-2);}.cls-3{fill:url(#linear-gradient-3);}.cls-4{fill:url(#linear-gradient-4);}<\/style><linearGradient id=\"linear-gradient\" x1=\"196.77\" y1=\"1\" x2=\"196.77\" y2=\"104.04\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.2\" stop-color=\"#ffc16f\"><\/stop><stop offset=\"0.63\" 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d=\"M579.21,62.95h-4.5a1.13,1.13,0,1,0,0,2.25h4.5A1.13,1.13,0,0,0,579.21,62.95Z\" transform=\"translate(-546.57 -39.32)\"><\/path><path class=\"cls-8\" d=\"M574.71,67.45h-2.25a1.13,1.13,0,0,0,0,2.25h2.25A1.13,1.13,0,0,0,574.71,67.45Z\" transform=\"translate(-546.57 -39.32)\"><\/path><path class=\"cls-9\" d=\"M580.33,67.45h-1.13a1.13,1.13,0,0,0,0,2.25h1.13A1.13,1.13,0,0,0,580.33,67.45Z\" transform=\"translate(-546.57 -39.32)\"><\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<span  >\n\t\t\t\t\t\t\tUseful references\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Ultimate Guide for Regulatory Affairs in Mexico. In Veraque we are interested in providing you with the latest news and detailed information about regulatory and quality affairs in Mexico. This is a great resource, in case you are looking for an indepth description of the full regulatory process in Mexico. For a general overview you [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":450,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_canvas","meta":{"footnotes":""},"class_list":["post-239","page","type-page","status-publish","has-post-thumbnail","hentry"],"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>Medical Device Regulatory Affairs Guide for Mexico | Veraque<\/title>\n<meta name=\"description\" content=\"Expert guidance on medical device regulations in Mexico. Learn the regulatory process to register your medical device in COFEPRIS.\" \/>\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\/ultimate-guide-for-regulatory-affairs-in-mexico\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Ultimate Guide for Regulatory Affairs in Mexico\" \/>\n<meta property=\"og:description\" content=\"Expert guidance on medical device regulations in Mexico. Learn the regulatory process to register your medical device in COFEPRIS.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/veraqueconsulting.com\/mx\/ultimate-guide-for-regulatory-affairs-in-mexico\/\" \/>\n<meta property=\"og:site_name\" content=\"Veraque Mexico\" \/>\n<meta property=\"article:modified_time\" content=\"2026-07-13T15:18:55+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/2019\/11\/ILUSTRACIONES-VERAQUE-1.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1920\" \/>\n\t<meta property=\"og:image:height\" content=\"1440\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"18 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/ultimate-guide-for-regulatory-affairs-in-mexico\\\/\",\"url\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/ultimate-guide-for-regulatory-affairs-in-mexico\\\/\",\"name\":\"Medical Device Regulatory Affairs Guide for Mexico | Veraque\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/ultimate-guide-for-regulatory-affairs-in-mexico\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/ultimate-guide-for-regulatory-affairs-in-mexico\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/wp-content\\\/uploads\\\/sites\\\/3\\\/2019\\\/11\\\/ILUSTRACIONES-VERAQUE-1.jpg\",\"datePublished\":\"2019-12-23T19:03:45+00:00\",\"dateModified\":\"2026-07-13T15:18:55+00:00\",\"description\":\"Expert guidance on medical device regulations in Mexico. 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