{"id":295,"date":"2020-01-14T00:13:16","date_gmt":"2020-01-14T00:13:16","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?page_id=295"},"modified":"2026-02-14T00:41:10","modified_gmt":"2026-02-14T00:41:10","slug":"mexican-registration-holder-ultimate-guide","status":"publish","type":"page","link":"https:\/\/veraqueconsulting.com\/mx\/mexican-registration-holder-ultimate-guide\/","title":{"rendered":"Mexican Registration Holder Ultimate Guide"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"295\" class=\"elementor elementor-295\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<header class=\"elementor-section elementor-top-section elementor-element elementor-element-7269d0c elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"7269d0c\" 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-c860216\" data-id=\"c860216\" 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-9473085 elementor-widget elementor-widget-image\" data-id=\"9473085\" 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=\"300\" height=\"70\" src=\"https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/2019\/11\/logo-300x70.png\" class=\"attachment-medium size-medium wp-image-22\" alt=\"\" srcset=\"https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/2019\/11\/logo-300x70.png 300w, https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/2019\/11\/logo.png 450w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/>\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-87bf79b\" data-id=\"87bf79b\" 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-15f71e1 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"15f71e1\" 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-9cc6c40\" data-id=\"9cc6c40\" 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-7d26ad4 elementor-widget elementor-widget-heading\" data-id=\"7d26ad4\" 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\">Mexican Registration Holder Ultimate Guide<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ba1782d elementor-widget elementor-widget-text-editor\" data-id=\"ba1782d\" 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>If you are evaluating a medical device for the Mexican market you are already selling through a distributor or using a registration holder, this guide will help you to understand:<\/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-e832fab elementor-align-start elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"e832fab\" 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=\"#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=\"#must-know\">\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 53.77 53.77\"><defs><style>.cls-1{fill:url(#linear-gradient);}.cls-2{fill:url(#linear-gradient-2);}.cls-3{fill:url(#linear-gradient-4);}.cls-4{fill:url(#linear-gradient-7);}.cls-5{fill:url(#linear-gradient-11);}.cls-6{fill:url(#linear-gradient-13);}<\/style><linearGradient id=\"linear-gradient\" x1=\"8.07\" y1=\"-0.58\" x2=\"8.07\" y2=\"54.97\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.2\" 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21.14\"><\/polygon><rect class=\"cls-5\" x=\"14.34\" y=\"17.92\" width=\"19.72\" height=\"1.79\"><\/rect><rect class=\"cls-5\" x=\"14.34\" y=\"21.51\" width=\"19.72\" height=\"1.79\"><\/rect><path class=\"cls-6\" d=\"M91.27,505H86.79v-1.16a6.27,6.27,0,1,0,1.79-12.28H86.79v-7.54l-9.49-9.49H45.57v52H77.83v1.79H99.34V513.11A8.07,8.07,0,0,0,91.27,505Zm-2.69,4.27-1.24-2.48h2.48Zm1.73,11.55-1.73,1.73-1.73-1.73,1.73-11.27Zm-1.73-18.51a4.49,4.49,0,0,1-4.48-4.48V497h2.69a8.11,8.11,0,0,1,5.93,2.61A4.49,4.49,0,0,1,88.58,502.36ZM93,497.42a9.9,9.9,0,0,0-6.23-2.23H84.1V493.4h4.48a4.47,4.47,0,0,1,4.43,4h0ZM77.83,477.64l5.9,5.9h-5.9v-5.9ZM47.36,524.76V476.37H76v9h9v6.27H82.31v6.27A6.27,6.27,0,0,0,85,503v2.08a8.07,8.07,0,0,0-7.17,8v11.65H47.36Zm50.18,1.79H79.62V513.11a6.28,6.28,0,0,1,5.74-6.25l1.4,2.81-1.82,11.82,3.64,3.64,3.64-3.64-1.82-11.82,1.4-2.81a6.28,6.28,0,0,1,5.74,6.25v13.44Z\" transform=\"translate(-45.57 -474.58)\"><\/path><\/g><\/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 the holder must have and know<\/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=\"#technovigilance\">\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 55.17 55.2\"><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=\"143.13\" y1=\"476.12\" x2=\"143.13\" y2=\"532.34\" 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=\"167.03\" y1=\"476.12\" x2=\"167.03\" y2=\"532.34\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-3\" x1=\"150.94\" y1=\"476.12\" x2=\"150.94\" y2=\"532.34\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-4\" x1=\"141.75\" y1=\"476.12\" x2=\"141.75\" y2=\"532.34\" xlink:href=\"#linear-gradient\"><\/linearGradient><\/defs><title>technovigilance<\/title><path class=\"cls-1\" d=\"M145.43,516.16a5.52,5.52,0,0,0-5.52,5.52,0.92,0.92,0,0,0,1.84,0,3.68,3.68,0,0,1,3.68-3.68A0.92,0.92,0,0,0,145.43,516.16Z\" transform=\"translate(-123.36 -475.7)\"><\/path><path class=\"cls-2\" d=\"M169.33,516.16a5.52,5.52,0,0,0-5.52,5.52,0.92,0.92,0,1,0,1.84,0,3.68,3.68,0,0,1,3.68-3.68A0.92,0.92,0,0,0,169.33,516.16Z\" transform=\"translate(-123.36 -475.7)\"><\/path><path class=\"cls-3\" d=\"M171.67,505.08a6.21,6.21,0,0,0-.53-1.13l-0.06-.14a0.91,0.91,0,0,0-.2-0.28,6.93,6.93,0,0,0-3.39-2.61v-2.24a4.6,4.6,0,0,0-4.6-4.6,4.55,4.55,0,0,0-2.76.94V478.46a2.76,2.76,0,0,0-2.76-2.76H126.12a2.76,2.76,0,0,0-2.76,2.76v46a2.76,2.76,0,0,0,2.76,2.76h12a9.18,9.18,0,0,0,16.53-5.39c0.09-.38.75-2.89,2.76-2.89s2.67,2.47,2.76,2.89a9.19,9.19,0,1,0,17.1-4.79Zm-45.56,20.27a0.92,0.92,0,0,1-.92-0.92v-46a0.92,0.92,0,0,1,.92-0.92h31.26a0.92,0.92,0,0,1,.92.92v22.07h-1.84v-1.84a4.6,4.6,0,1,0-9.19,0v2.24a6.91,6.91,0,0,0-3.39,2.62,0.93,0.93,0,0,0-.2.27l-0.07.15a6.25,6.25,0,0,0-.52,1.11L137.52,517a9.12,9.12,0,0,0-.51,8.34H126.12ZM145.43,529a7.34,7.34,0,0,1-6.68-10.41,0.92,0.92,0,0,0,.16-0.24l0.25-.53A7.36,7.36,0,1,1,145.43,529Zm12-12a3.91,3.91,0,0,0-2.13.61l1.19-5.95a0.92,0.92,0,1,0-1.8-.36l-1.17,5.85a9.17,9.17,0,0,0-12.3-3.7l4.07-8.73a5.06,5.06,0,0,1,3.19-2.31,0.92,0.92,0,0,0,.69-1.1,0.13,0.13,0,0,0,0,0v-2.68a2.76,2.76,0,0,1,5.52,0v4.06a6.94,6.94,0,0,0-1.52-1.25l-0.09,0-0.06,0a1,1,0,0,0-.33-0.07,0.92,0.92,0,0,0-.92.92,0.71,0.71,0,0,0,0,.07,0.88,0.88,0,0,0,0,.23l0.05,0.12a1,1,0,0,0,.11.16L152,503a0.87,0.87,0,0,0,.18.13,5.08,5.08,0,0,1,2.43,3.94,0.92,0.92,0,0,0,.92.85h0.07l0.09,0a0.89,0.89,0,0,0,.25-0.07h0a0.91,0.91,0,0,0,.5-0.81v-4.6h1.84V507a0.91,0.91,0,0,0,.51.81h0a0.89,0.89,0,0,0,.25.07l0.09,0h0.07a0.92,0.92,0,0,0,.92-0.85,5.08,5.08,0,0,1,2.39-3.92,0.93,0.93,0,0,0,.23-0.17l0-.06a0.88,0.88,0,0,0,.14-0.2l0-.08a0.9,0.9,0,0,0-1.17-1.18l-0.08,0-0.08,0a6.93,6.93,0,0,0-1.53,1.26v-4.06a2.76,2.76,0,0,1,5.52,0v2.92l0,0.08a1.06,1.06,0,0,0,.1.34l0.09,0.14,0.12,0.13,0.14,0.09,0.17,0.08,0.07,0a5.07,5.07,0,0,1,3.16,2.31l4.07,8.72a9.17,9.17,0,0,0-12.3,3.7l-1.17-5.85a0.92,0.92,0,1,0-1.8.36l1.19,5.95A3.91,3.91,0,0,0,157.38,517.08Zm12,12a7.36,7.36,0,1,1,6.28-11.17l0.25,0.53a0.91,0.91,0,0,0,.16.24A7.34,7.34,0,0,1,169.33,529Z\" transform=\"translate(-123.36 -475.7)\"><\/path><path class=\"cls-4\" d=\"M136.23,513.4a0.92,0.92,0,0,0,0-1.84h-1.84V508.8h3.68a0.92,0.92,0,1,0,0-1.84h-3.68v-2.76h6.44a0.92,0.92,0,1,0,0-1.84h-6.44v-2.76h10.11a0.92,0.92,0,0,0,0-1.84H134.39V495h11a0.92,0.92,0,0,0,0-1.84h-11v-2.76h20.23v0.92a0.92,0.92,0,1,0,1.84,0v-11a0.92,0.92,0,0,0-.92-0.92H128a0.92,0.92,0,0,0-.92.92v42.29a0.92,0.92,0,0,0,.92.92h5.52a0.92,0.92,0,0,0,.92-0.92V513.4h1.84Zm-3.68-1.84h-3.68V508.8h3.68v2.76Zm-3.68-25.74h3.68v2.76h-3.68v-2.76ZM132.55,507h-3.68v-2.76h3.68V507Zm0-4.6h-3.68v-2.76h3.68v2.76Zm0-4.6h-3.68V495h3.68v2.76Zm0-4.6h-3.68v-2.76h3.68v2.76Zm1.84-4.6v-2.76h20.23v2.76H134.39Zm20.23-4.6H134.39v-2.76h20.23V484Zm-22.07-2.76V484h-3.68v-2.76h3.68ZM128.88,518h3.68v3.68h-3.68V518Zm3.68-1.84h-3.68V513.4h3.68v2.76Z\" transform=\"translate(-123.36 -475.7)\"><\/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\">Details about the Technovigilance program<\/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<div class=\"elementor-element elementor-element-5dc964c elementor-widget elementor-widget-text-editor\" data-id=\"5dc964c\" 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 also advise reference to our <a href=\"https:\/\/veraqueconsulting.com\/mx\/ultimate-guide-for-regulatory-affairs-in-mexico\/\" target=\"_blank\" rel=\"noopener\">guide for regulatory affairs in Mexico<\/a>. This will provide a better sense of the overall regulatory process. In addition, our classification and grouping guide is the<br \/>best way to understand the first steps you can take for an excellent experience in the Mexican medical device sector.<\/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-573198e\" data-id=\"573198e\" 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-6100fad elementor-widget elementor-widget-spacer\" data-id=\"6100fad\" 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-149bf23 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"149bf23\" 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-f1c459f\" data-id=\"f1c459f\" 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-2f10579 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"2f10579\" 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-bcdccec elementor-widget elementor-widget-heading\" data-id=\"bcdccec\" 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-8ffa4e3 elementor-widget elementor-widget-text-editor\" data-id=\"8ffa4e3\" 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 this section, we will provide a better understanding of your legal responsibilities and\/or common roles in a project. These could be:<\/p>\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-5c4472d elementor-reverse-mobile elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5c4472d\" 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-22ac65e\" data-id=\"22ac65e\" 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-a46aafb elementor-invisible elementor-widget elementor-widget-image\" data-id=\"a46aafb\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_translateY_effect&quot;:&quot;yes&quot;,&quot;_animation&quot;:&quot;fadeInLeft&quot;,&quot;motion_fx_translateY_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:4,&quot;sizes&quot;:[]},&quot;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;motion_fx_devices&quot;:[&quot;desktop&quot;,&quot;tablet&quot;,&quot;mobile&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-c0366c8\" data-id=\"c0366c8\" 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-df11177 elementor-widget elementor-widget-heading\" data-id=\"df11177\" 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-470b02b elementor-widget elementor-widget-text-editor\" data-id=\"470b02b\" 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-44039fb elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"44039fb\" 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-540178a\" data-id=\"540178a\" 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-ef4e27b elementor-widget elementor-widget-heading\" data-id=\"ef4e27b\" 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-64c0fb4 elementor-widget elementor-widget-text-editor\" data-id=\"64c0fb4\" 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 the Mexican norm 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. Even though, most of the times the manufacturer is a third party manufacturer and the legal manufacturer is located outside Mexico, then the third party manufacturer only provides the good manufacturing practices certificate from 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-aa1cce4\" data-id=\"aa1cce4\" 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-f7aa727 elementor-invisible elementor-widget elementor-widget-image\" data-id=\"f7aa727\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_translateY_effect&quot;:&quot;yes&quot;,&quot;_animation&quot;:&quot;fadeInRight&quot;,&quot;motion_fx_translateY_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:4,&quot;sizes&quot;:[]},&quot;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;motion_fx_devices&quot;:[&quot;desktop&quot;,&quot;tablet&quot;,&quot;mobile&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-517d1e1 elementor-reverse-mobile elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"517d1e1\" 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-2744f50\" data-id=\"2744f50\" 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-bc498b9 elementor-invisible elementor-widget elementor-widget-image\" data-id=\"bc498b9\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_translateY_effect&quot;:&quot;yes&quot;,&quot;_animation&quot;:&quot;fadeInLeft&quot;,&quot;motion_fx_translateY_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:4,&quot;sizes&quot;:[]},&quot;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;motion_fx_devices&quot;:[&quot;desktop&quot;,&quot;tablet&quot;,&quot;mobile&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-b2841c5\" data-id=\"b2841c5\" 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-455f849 elementor-widget elementor-widget-heading\" data-id=\"455f849\" 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-8b1066f elementor-widget elementor-widget-text-editor\" data-id=\"8b1066f\" 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 main responsible for any affair related to the medical devices the holder owns. The holder is also responsible for complying with local warehouse regulations. In addition, it must have a Sanitary Responsible who oversees all the operations in the local warehouse. Finally, the holder is also responsible to maintain the technovigilance program (based on the Mexican norm NOM-240).<\/p><h5>Common role in a regulatory project<\/h5><p>The holder submits the paperwork and keeps a communication channel with the manufacturer to inform any adverse incidents.<\/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-8f61828 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"8f61828\" 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-1459cc2\" data-id=\"1459cc2\" 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-736a99d elementor-widget elementor-widget-heading\" data-id=\"736a99d\" 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-26ef988 elementor-widget elementor-widget-text-editor\" data-id=\"26ef988\" 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 throughout the regulatory project like 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-19365a9\" data-id=\"19365a9\" 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-9a47254 elementor-invisible elementor-widget elementor-widget-image\" data-id=\"9a47254\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_translateY_effect&quot;:&quot;yes&quot;,&quot;_animation&quot;:&quot;fadeInRight&quot;,&quot;motion_fx_translateY_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:4,&quot;sizes&quot;:[]},&quot;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;motion_fx_devices&quot;:[&quot;desktop&quot;,&quot;tablet&quot;,&quot;mobile&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-a65d404 elementor-reverse-mobile elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a65d404\" 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-4d079ce\" data-id=\"4d079ce\" 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-807546d elementor-invisible elementor-widget elementor-widget-image\" data-id=\"807546d\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_translateY_effect&quot;:&quot;yes&quot;,&quot;_animation&quot;:&quot;fadeInLeft&quot;,&quot;motion_fx_translateY_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:4,&quot;sizes&quot;:[]},&quot;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;motion_fx_devices&quot;:[&quot;desktop&quot;,&quot;tablet&quot;,&quot;mobile&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-5188f73\" data-id=\"5188f73\" 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-ae33a2f elementor-widget elementor-widget-heading\" data-id=\"ae33a2f\" 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-f17d621 elementor-widget elementor-widget-text-editor\" data-id=\"f17d621\" 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 or distributors, the local distributor responsibilities are the same as the holder except they are not the main point of contact with 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 references to this area.<\/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-4ed192c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4ed192c\" 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-b642565\" data-id=\"b642565\" 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-9b5a504 elementor-widget elementor-widget-text-editor\" data-id=\"9b5a504\" 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 style=\"text-align: center\">At this point you hopefully have a better understanding about the holder and other players involved in the regulatory process. As you can see, it does not matter how many participants are related to a medical device, the solely point of contact to the ministry of health in Mexico is the registration holder. In addition, as we have mentioned the holder must be compliant with the local warehouse regulation as well as with the technovigilance program. In the next section we will explain in greater detail what this means and your role.<\/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-779f0d6 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"779f0d6\" data-element_type=\"section\" data-e-type=\"section\" id=\"must-know\" 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-382d001\" data-id=\"382d001\" 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-8af222d elementor-widget elementor-widget-image\" data-id=\"8af222d\" 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<img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" src=\"https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/2020\/01\/must-know.svg\" class=\"attachment-large size-large wp-image-304\" alt=\"\" srcset=\"https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/\/2020\/01\/must-know.svg 150w, https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/\/2020\/01\/must-know.svg 300w, https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/\/2020\/01\/must-know.svg 1024w, https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/\/2020\/01\/must-know.svg 53w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\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<div class=\"elementor-element elementor-element-45aed07 elementor-widget elementor-widget-heading\" data-id=\"45aed07\" 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 this holder must have and know<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-68bbe8d elementor-widget elementor-widget-text-editor\" data-id=\"68bbe8d\" 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>Well, you already know that the holder must have a compliant warehouse. As mentioned in our guide for regulatory affairs in Mexico, there are two documents that set the warehouse requirements:<\/p>\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-9d6878f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"9d6878f\" 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-050eba2\" data-id=\"050eba2\" 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-2311389 elementor-widget elementor-widget-heading\" data-id=\"2311389\" 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<h5 class=\"elementor-heading-title elementor-size-default\">NOM-241. Medical device good manufacturing practices<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4ed84da elementor-widget elementor-widget-text-editor\" data-id=\"4ed84da\" 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>Details every requirement to be certified in Mexico for good manufacturing practices. It is also applicable for warehouses.<\/li><li>It is not required if you are exporting to Mexico. This is applicable, for companies settled in Mexico and manufacturing a medical device domestically. Please keep in mind, it is important to check first if your product is a medical device or not.<\/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<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-a3f54b9\" data-id=\"a3f54b9\" 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-c10a168 elementor-widget elementor-widget-heading\" data-id=\"c10a168\" 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<h5 class=\"elementor-heading-title elementor-size-default\">Supplement for health supplies<sup>1<\/sup><\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e034170 elementor-widget elementor-widget-text-editor\" data-id=\"e034170\" 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>\n \t<li>The Pharmacovigilance National Center <sup>2<\/sup> is in charge to prepare and update 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<\/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<div class=\"elementor-element elementor-element-d7bafa0 elementor-widget elementor-widget-text-editor\" data-id=\"d7bafa0\" 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 the opportunity to read both documents, you will find that some requirements are repeated or some are only mentioned in one, but not in the other. This is because the NOM-241 (for good manufacturing practices) is intended for manufactures, even though it also covers warehouses. On the other hand the supplement for health supplies establishments is focused on warehouses. Unfortunately, both are applicable to the holder in an audit.\n\nIn reference to audits, it may appear that the ministry of health must audit the holder to receive an authorization to legally warehouse medical devices. This is not totally true. The way it works is that the holder requests a notice<sup>3<\/sup> from the ministry of health. This only means that the ministry of health assumes (without visiting the holder) that the warehouse is compliant. Nevertheless, as of the time the holder submits this notice, the approved warehouse is subject of an audit.\n\nIn the case that your holder receives an audit, the ministry of health releases a report detailing any nonconformities. In such a case, if those nonconformities are not solved, the warehouse can be shutdown. Unfortunately this means that the sanitary registrations under the holder\u2019s name will be banned as well. Keep this in mind when you are working with a holder.\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-4260cee elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4260cee\" data-element_type=\"section\" data-e-type=\"section\" id=\"technovigilance\" 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-c837bcb\" data-id=\"c837bcb\" 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-2e1fea0 elementor-widget elementor-widget-image\" data-id=\"2e1fea0\" 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<img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" src=\"https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/2020\/01\/technovigilance-1.svg\" class=\"attachment-large size-large wp-image-305\" alt=\"\" srcset=\"https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/\/2020\/01\/technovigilance-1.svg 150w, https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/\/2020\/01\/technovigilance-1.svg 300w, https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/\/2020\/01\/technovigilance-1.svg 1024w, https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/\/2020\/01\/technovigilance-1.svg 55w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\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<div class=\"elementor-element elementor-element-4a94f4a elementor-widget elementor-widget-heading\" data-id=\"4a94f4a\" 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\">Technovigilance<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0501773 elementor-widget elementor-widget-text-editor\" data-id=\"0501773\" 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 addition to the two mentioned legal references (NOM241 and the supplement), the holder is also responsible for the technovigilance program. Technovigilance is similar to a surveillance program in other countries. All the details about this program are mentioned in the Mexican official norm (NOM):<\/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-01d5d31 elementor-widget elementor-widget-heading\" data-id=\"01d5d31\" 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\">NOM-240. Technovigilance program<\/h6>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8d4af97 elementor-widget elementor-widget-text-editor\" data-id=\"8d4af97\" 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 style=\"text-align: left\">A few concepts considered useful in order to understand the technovigilance program are:<\/p>\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-50f9943 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"50f9943\" 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-db626b1\" data-id=\"db626b1\" 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-9f76f08 elementor-widget elementor-widget-text-editor\" data-id=\"9f76f08\" 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>Adverse incident<sup>4<\/sup><\/h5>\nThis is any incident that is related to the medical device.\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-c6ebc4b\" data-id=\"c6ebc4b\" 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-7a73f65 elementor-widget elementor-widget-text-editor\" data-id=\"7a73f65\" 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>Notification<\/h5>\nThis can be a bit tricky. Notification means any formal communication to the ministry of health.\n<ul>\n \t<li>If it is the first event, it is called an initial notification<sup>5<\/sup>\n<h5><\/h5>\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<div class=\"elementor-element elementor-element-e905d1b elementor-widget elementor-widget-text-editor\" data-id=\"e905d1b\" 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>Then, if the holder submits an initial notification, it is necessary to present two more notifications:<\/p><ul><li>A second one that is called a following report<sup>6<\/sup>.<\/li><li>And the last one that is called a final report<sup>7<\/sup>.<\/li><\/ul>\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-a2780cf elementor-widget elementor-widget-text-editor\" data-id=\"a2780cf\" 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>Technovigilance information<sup>8<\/sup><\/h5>\nThis is different from the notification. This information is presented to renew your sanitary registration. This happens every 5 years (the time your sanitary registration expires). The technovigilance information is a summary of any incident and imported products related to the medical devices of the sanitary registration you want to renew.\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-d91964f elementor-widget elementor-widget-text-editor\" data-id=\"d91964f\" 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>Then, if the holder receives any information related to an adverse event the holder must analyze it and notify the ministry of health. It is worth mentioning that not all the events are notifiable. Most of the time this is because the medical device was used inadequately and outside the expected risk evaluation. For example, if a surgical instrument is used in a way that is totally outside the intended framework of use or without the expected risk analysis.<\/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-c8a2224 elementor-widget elementor-widget-text-editor\" data-id=\"c8a2224\" 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 know what the holder should do, but what if you are not the holder. A common question from our clients is what their role is within the technovigilance program. Using as a reference the players we mentioned at the beginning of this guide, we have:<\/p>\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-30bc52b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"30bc52b\" 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-33 elementor-inner-column elementor-element elementor-element-62388d2 animated-slow elementor-invisible\" data-id=\"62388d2\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeIn&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-1f161ac elementor-widget elementor-widget-image\" data-id=\"1f161ac\" 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<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<div class=\"elementor-element elementor-element-7d73c6f elementor-widget elementor-widget-heading\" data-id=\"7d73c6f\" 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<h5 class=\"elementor-heading-title elementor-size-default\">Manufacturer located abroad or in Mexico<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e6b80d0 elementor-widget elementor-widget-text-editor\" data-id=\"e6b80d0\" 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>The manufacturer must inform the holder about any adverse incident in or outside Mexico related to the medical devices the holder represents.<\/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<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-f845a31 animated-slow elementor-invisible\" data-id=\"f845a31\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeIn&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-a2361c5 elementor-widget elementor-widget-image\" data-id=\"a2361c5\" 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<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<div class=\"elementor-element elementor-element-fc47a14 elementor-widget elementor-widget-heading\" data-id=\"fc47a14\" 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<h5 class=\"elementor-heading-title elementor-size-default\">Holder in Mexico<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-81677db elementor-widget elementor-widget-text-editor\" data-id=\"81677db\" 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>Responsible for the technovigilance program. This includes notifying the authorities about any adverse incident as well as submitting the technovigilance information.<\/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<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-760a60c animated-slow elementor-invisible\" data-id=\"760a60c\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeIn&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-ec402e1 elementor-widget elementor-widget-image\" data-id=\"ec402e1\" 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<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<div class=\"elementor-element elementor-element-063a9f3 elementor-widget elementor-widget-heading\" data-id=\"063a9f3\" 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<h5 class=\"elementor-heading-title elementor-size-default\">Independent Regulatory Affairs Consultant Firm<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7098733 elementor-widget elementor-widget-text-editor\" data-id=\"7098733\" 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>No obligation (if not the holder).<\/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-inner-section elementor-element elementor-element-b8f90fb elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b8f90fb\" 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-7c6f741 animated-slow elementor-invisible\" data-id=\"7c6f741\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeIn&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-021d058 elementor-widget elementor-widget-image\" data-id=\"021d058\" 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<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<div class=\"elementor-element elementor-element-7279141 elementor-widget elementor-widget-heading\" data-id=\"7279141\" 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<h5 class=\"elementor-heading-title elementor-size-default\">Local Distributors<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-92fd202 elementor-widget elementor-widget-text-editor\" data-id=\"92fd202\" 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>If those are mentioned in the sanitary registration, they must inform the holder about any adverse incident in Mexico related to the medical devices the holder represents.<\/li><li>If they are not mentioned in the sanitary registration, they should inform to the ministry of health about any adverse incident.<\/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<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-410eb5a animated-slow elementor-invisible\" data-id=\"410eb5a\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeIn&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-3eaad3b elementor-widget elementor-widget-image\" data-id=\"3eaad3b\" 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<img decoding=\"async\" src=\"https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/2019\/12\/stkhldrs.svg\" class=\"attachment-full size-full wp-image-244\" 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<div class=\"elementor-element elementor-element-cc1d336 elementor-widget elementor-widget-heading\" data-id=\"cc1d336\" 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<h5 class=\"elementor-heading-title elementor-size-default\">Any Other<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0da94df elementor-widget elementor-widget-text-editor\" data-id=\"0da94df\" 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>Inform the ministry of health about any adverse incident.<\/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<div class=\"elementor-element elementor-element-ea19d55 elementor-widget elementor-widget-text-editor\" data-id=\"ea19d55\" 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 style=\"text-align: center\">As you can see the holder plays a major role during the lifespan of your medical devices in Mexico. <br><br>In addition to these obligations, the Mexican registration holder also:<\/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-d485b90 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"d485b90\" 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\">Participates with local distributors to provide signatures related to public bids. This is because the entity that legally owns the registrations in Mexico is the holder. <\/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\">Receives direct calls from public departments to know more about the medical device they legally represent. This is something that you would want to know as manufacturer.<\/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\">Must have a sanitary responsible. This is the highest authority in the warehouse and the person who signs every document related to sanitary matters.<\/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<div class=\"elementor-element elementor-element-8401911 elementor-widget elementor-widget-text-editor\" data-id=\"8401911\" 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 conclusion, the Mexican registration holder is a key partner for you as not only a legal representative, but also as an important stakeholder during the technovigilance processes. <br>At this point, you should now be more familiarized with how the holder must be compliant. We suggest checking if the holder is knowledgeable about his obligations. In our experience, there are areas of opportunity than can be covered on time and save your registration of a potential risk.<\/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-01697ce elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"01697ce\" 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-017450c\" data-id=\"017450c\" 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-37d76c4 elementor-widget elementor-widget-heading\" data-id=\"37d76c4\" 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-f06563e elementor-widget elementor-widget-text-editor\" data-id=\"f06563e\" 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<\/sup><span style=\"font-weight: 400\">Suplemento para establecimientos dedicados a la venta y suministro de medicamentos y dem\u00e1s insumos para la salud.<\/span><\/p><p><sup>2<\/sup> <span style=\"font-weight: 400\">Centro Nacional de Farmacovigilancia.<\/span><\/p><p><sup>3<\/sup> <span style=\"font-weight: 400\">Aviso de funcionamiento.<\/span><\/p><p><sup>4<\/sup><span style=\"font-weight: 400\">Incidente adverso.<\/span><\/p><p><sup>5<\/sup><span style=\"font-weight: 400\">Notificaci\u00f3n inicial.<\/span><\/p><p><sup>6<\/sup><span style=\"font-weight: 400\">Reporte de seguimiento.<\/span><\/p><p><sup>7<\/sup><span style=\"font-weight: 400\">Reporte final.<\/span><\/p><p><sup>8<\/sup><span style=\"font-weight: 400\">Informe de tecnovigilancia.<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-1d23adb elementor-hidden-tablet elementor-hidden-mobile elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1d23adb\" 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-33 elementor-top-column elementor-element elementor-element-314a5cb\" style=\"cursor: pointer;\" data-column-clickable=\"#stakeholders\" data-column-clickable-blank=\"_self\" data-id=\"314a5cb\" 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-902d5d7 elementor-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"902d5d7\" 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 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(-123.36 -475.7)\"><\/path><path class=\"cls-4\" d=\"M136.23,513.4a0.92,0.92,0,0,0,0-1.84h-1.84V508.8h3.68a0.92,0.92,0,1,0,0-1.84h-3.68v-2.76h6.44a0.92,0.92,0,1,0,0-1.84h-6.44v-2.76h10.11a0.92,0.92,0,0,0,0-1.84H134.39V495h11a0.92,0.92,0,0,0,0-1.84h-11v-2.76h20.23v0.92a0.92,0.92,0,1,0,1.84,0v-11a0.92,0.92,0,0,0-.92-0.92H128a0.92,0.92,0,0,0-.92.92v42.29a0.92,0.92,0,0,0,.92.92h5.52a0.92,0.92,0,0,0,.92-0.92V513.4h1.84Zm-3.68-1.84h-3.68V508.8h3.68v2.76Zm-3.68-25.74h3.68v2.76h-3.68v-2.76ZM132.55,507h-3.68v-2.76h3.68V507Zm0-4.6h-3.68v-2.76h3.68v2.76Zm0-4.6h-3.68V495h3.68v2.76Zm0-4.6h-3.68v-2.76h3.68v2.76Zm1.84-4.6v-2.76h20.23v2.76H134.39Zm20.23-4.6H134.39v-2.76h20.23V484Zm-22.07-2.76V484h-3.68v-2.76h3.68ZM128.88,518h3.68v3.68h-3.68V518Zm3.68-1.84h-3.68V513.4h3.68v2.76Z\" transform=\"translate(-123.36 -475.7)\"><\/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\tTechnovigilance\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>Mexican Registration Holder Ultimate Guide If you are evaluating a medical device for the Mexican market you are already selling through a distributor or using a registration holder, this guide will help you to understand: .cls-1{fill:url(#linear-gradient);}stkhldrs The stakeholders in a regulatory project in Mexico. .cls-1{fill:url(#linear-gradient);}.cls-2{fill:url(#linear-gradient-2);}.cls-3{fill:url(#linear-gradient-4);}.cls-4{fill:url(#linear-gradient-7);}.cls-5{fill:url(#linear-gradient-11);}.cls-6{fill:url(#linear-gradient-13);}must-know What the holder must have and know .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);}technovigilance Details about [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":449,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_canvas","meta":{"footnotes":""},"class_list":["post-295","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>Become a Sanitary Registration Holder in Mexico | Veraque<\/title>\n<meta name=\"description\" content=\"Your ultimate guide to stakeholders, requirements, and technovigilance. 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