{"id":1464,"date":"2021-02-25T19:43:54","date_gmt":"2021-02-25T19:43:54","guid":{"rendered":"https:\/\/veraqueconsulting.com\/cr\/?page_id=1464"},"modified":"2026-07-13T15:16:32","modified_gmt":"2026-07-13T15:16:32","slug":"ultimate-guide-for-regulatory-affairs-in-costa-rica","status":"publish","type":"page","link":"https:\/\/veraqueconsulting.com\/cr\/guides\/ultimate-guide-for-regulatory-affairs-in-costa-rica\/","title":{"rendered":"Ultimate Guide for Regulatory Affairs in Costa Rica"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1464\" class=\"elementor elementor-1464\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<header class=\"elementor-section elementor-top-section elementor-element elementor-element-eb957c0 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"eb957c0\" 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-f88245c\" data-id=\"f88245c\" 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-37f0ba4 elementor-widget elementor-widget-image\" data-id=\"37f0ba4\" 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\/cr\" target=\"_blank\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"300\" height=\"70\" src=\"https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/2019\/11\/logo-300x70.png\" class=\"attachment-medium size-medium wp-image-22\" alt=\"\" srcset=\"https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/2019\/11\/logo-300x70.png 300w, https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/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-35f0d3f\" data-id=\"35f0d3f\" 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-e92337f elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"e92337f\" 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-2a47da7\" data-id=\"2a47da7\" 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-7b9dc37 elementor-widget elementor-widget-heading\" data-id=\"7b9dc37\" 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 COSTA RICA\n<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b50e7fc elementor-widget elementor-widget-text-editor\" data-id=\"b50e7fc\" 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 is a great resource in case you are looking for an in-depth description of the full regulatory process for medical devices in Costa Rica.<br \/>For a general overview, <a href=\"https:\/\/veraqueconsulting.com\/cr\/\">you can check our website for each of the services we provide<\/a> or <a href=\"https:\/\/veraqueconsulting.com\/cr\/contact\/\">contact us directly<\/a>. We will be glad to send the information you are looking for.<\/p><p>Also, if you are still not sure if your product is a medical device, we invite you to check our <a href=\"https:\/\/veraqueconsulting.com\/cr\/guides\/classification-and-grouping-ultimate-guide\/\">Ultimate guide for classification and grouping in Costa Rica.<\/a> This is a good reference for the first step to get your medical devices approved in the Costa Rican 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-fff6226\" data-id=\"fff6226\" 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-cef8b10 elementor-widget elementor-widget-spacer\" data-id=\"cef8b10\" 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<div class=\"elementor-element elementor-element-8460d09 e-flex e-con-boxed e-con e-parent\" data-id=\"8460d09\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7535375 elementor-widget elementor-widget-spacer\" data-id=\"7535375\" 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\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1644206 e-flex e-con-boxed e-con e-parent\" data-id=\"1644206\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-dcf628f e-con-full e-flex e-con e-child\" data-id=\"dcf628f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d493bef elementor-widget elementor-widget-heading\" data-id=\"d493bef\" 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<\/div>\n\t\t<div class=\"elementor-element elementor-element-e794364 e-con-full e-flex e-con e-child\" data-id=\"e794364\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fc6541b elementor-widget elementor-widget-text-editor\" data-id=\"fc6541b\" 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><h5><span style=\"text-decoration: underline\"><a href=\"#ministry\">Inside the Ministry of Health (MoH) in Costa Rica<\/a><\/span><\/h5><\/li><li><h5><span style=\"text-decoration: underline\"><a href=\"#framework\">The legal framework surrounding a medical device in Costa Rica<\/a><\/span><\/h5><\/li><li><h5><span style=\"text-decoration: underline\"><a href=\"#stakeholders\">The stakeholders in a regulatory project in Costa Rica<\/a><\/span><\/h5><\/li><li><h5><span style=\"text-decoration: underline\"><a href=\"#register\">The routes to register a medical device<\/a><\/span><\/h5><\/li><li><h5><span style=\"text-decoration: underline\"><a href=\"#timelines\">Timelines<\/a><\/span><\/h5><\/li><li><h5><span style=\"text-decoration: underline\"><a href=\"#prevention\">What a prevention is<\/a><\/span><\/h5><\/li><li><h5><span style=\"text-decoration: underline\"><a href=\"#referenceszx\">Useful references<\/a><\/span><\/h5><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-696578c e-con-full e-flex e-con e-child\" data-id=\"696578c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-efa66db elementor-widget elementor-widget-text-editor\" data-id=\"efa66db\" 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.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9a5850a elementor-widget elementor-widget-text-editor\" data-id=\"9a5850a\" 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>\u00a0<\/p><p>\u00a0<\/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\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4005239 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4005239\" 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 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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-13aa047 elementor-widget elementor-widget-heading\" data-id=\"13aa047\" 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 the Ministry of Health in Costa Rica\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6041796 elementor-widget elementor-widget-text-editor\" data-id=\"6041796\" 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>According to the General Law of Health in Costa Rica, health is considered a public priority and it is protected by the State. <br \/>For this purpose, the Ministry of Health of Costa Rica (MoH) exercises the rectory of the National System of Health and is in charge of the regulation of medical supplies.<\/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-c71b68e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"c71b68e\" 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-36bed05\" data-id=\"36bed05\" 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-5df495c elementor-widget elementor-widget-menu-anchor\" data-id=\"5df495c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"framework\"><\/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-73af850 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"73af850\" 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 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\" stop-color=\"#ffc16f\"><\/stop><stop offset=\"0.63\" stop-color=\"#ff726f\"><\/stop><\/linearGradient><linearGradient id=\"linear-gradient-2\" x1=\"21.06\" y1=\"-0.58\" x2=\"21.06\" y2=\"54.97\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-4\" x1=\"22.4\" y1=\"-0.58\" x2=\"22.4\" y2=\"54.97\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-7\" x1=\"21.96\" y1=\"-0.58\" x2=\"21.96\" y2=\"54.97\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-11\" x1=\"24.2\" y1=\"-0.58\" x2=\"24.2\" y2=\"54.97\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-13\" x1=\"72.45\" y1=\"474\" x2=\"72.45\" y2=\"529.55\" xlink:href=\"#linear-gradient\"><\/linearGradient><\/defs><title>must-know<\/title><g id=\"Outline\"><polygon class=\"cls-1\" points=\"7.17 10.38 6.01 9.22 4.74 10.49 7.17 12.92 11.39 8.7 10.12 7.43 7.17 10.38\"><\/polygon><rect class=\"cls-2\" x=\"14.34\" y=\"7.17\" width=\"13.44\" height=\"1.79\"><\/rect><rect class=\"cls-2\" x=\"14.34\" y=\"10.75\" width=\"13.44\" height=\"1.79\"><\/rect><rect class=\"cls-3\" x=\"14.34\" y=\"28.68\" width=\"16.13\" height=\"1.79\"><\/rect><rect class=\"cls-3\" x=\"14.34\" y=\"32.26\" width=\"16.13\" height=\"1.79\"><\/rect><polygon class=\"cls-1\" points=\"10.12 28.04 8.06 30.1 6.01 28.04 4.74 29.31 6.8 31.36 4.74 33.42 6.01 34.69 8.06 32.63 10.12 34.69 11.39 33.42 9.33 31.36 11.39 29.31 10.12 28.04\"><\/polygon><rect class=\"cls-4\" x=\"14.34\" y=\"39.43\" width=\"15.23\" height=\"1.79\"><\/rect><rect class=\"cls-4\" x=\"14.34\" y=\"43.02\" width=\"15.23\" height=\"1.79\"><\/rect><polygon class=\"cls-1\" points=\"10.12 38.8 8.06 40.85 6.01 38.8 4.74 40.06 6.8 42.12 4.74 44.17 6.01 45.44 8.06 43.39 10.12 45.44 11.39 44.17 9.33 42.12 11.39 40.06 10.12 38.8\"><\/polygon><polygon class=\"cls-1\" points=\"7.17 21.14 6.01 19.98 4.74 21.25 7.17 23.67 11.39 19.45 10.12 18.19 7.17 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<\/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-70ab4c6 elementor-widget elementor-widget-heading\" data-id=\"70ab4c6\" 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 Costa Rica.\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fe8263f elementor-widget elementor-widget-text-editor\" data-id=\"fe8263f\" 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>The first step is to identify if your product is a medical device. You can check more about this in our Classification and Grouping Guide.<\/p><p>Once you have identified if your products are medical devices, you need to prepare all the paperwork to receive a sanitary registration based on specific requirements. As in any other country, these requirements are generally based on a legal framework.<\/p><p>In this section we provide a quick introduction to the main legal references that will help to bolster your dossier (the set of documents submitted to the local authority).<\/p><p>Regulations<\/p><ul><li style=\"font-weight: 300\">General Health Law <a href=\"http:\/\/www.pgrweb.go.cr\/scij\/Busqueda\/Normativa\/Normas\/nrm_texto_completo.aspx?param1=NRTC&amp;nValor1=1&amp;nValor2=6581&amp;nValor3=96425&amp;strTipM=TC\" target=\"_blank\" rel=\"noopener\">No. 5395<\/a><\/li><\/ul><ul><li style=\"font-weight: 300\"><a href=\"https:\/\/pgrweb.go.cr\/scij\/Busqueda\/Normativa\/Normas\/nrm_texto_completo.aspx?nValor1=1&amp;nValor2=99003\" target=\"_blank\" rel=\"noopener\">Decree No. 43902-S<\/a>: Regulation for the registration, classification, importation, and control of biomedical equipment and material. These are some of the relevant topics discussed in this document:<ul><li style=\"font-weight: 300\">Definition of what a Biomedical Equipment and Material (EMB \u2013 Equipo y Material Biom\u00e9dico) is \u2013 local definition for a medical device in Costa Rica. Throughout this document we will refer to EMB or Medical Device indistinctively.<\/li><li style=\"font-weight: 300\">Classification of the EMB, according to its sanitary risk, into four categories. These categories or classifications are based on what is recommended by the Pan American Health Organization (<a href=\"https:\/\/www.paho.org\/en\" target=\"_blank\" rel=\"noopener\">PAHO<\/a>) for Latin America, as well as the global harmonization efforts.<\/li><li style=\"font-weight: 300\">Specification of the information that the EMB labeling should contain.<\/li><li style=\"font-weight: 300\">Clarification that the validity of a registration is 5 years.<\/li><li style=\"font-weight: 300\">That all EMB must be sold and provided by a national manufacturer or from an importer authorized by the Ministry of Health with their current operation permit.<\/li><\/ul><\/li><li style=\"font-weight: 300\">Decree No. <a href=\"http:\/\/www.pgrweb.go.cr\/scij\/Busqueda\/Normativa\/Normas\/nrm_texto_completo.aspx?param1=NRTC&amp;nValor1=1&amp;nValor2=55998&amp;nValor3=61361&amp;strTipM=TC\" target=\"_blank\" rel=\"noopener\">32780-S<\/a><ul><li style=\"font-weight: 300\">This document defines the registration, inspection, surveillance, and control service fees.<\/li><\/ul><\/li><li style=\"font-weight: 300\">Decree No. <a href=\"http:\/\/www.pgrweb.go.cr\/scij\/Busqueda\/Normativa\/Normas\/nrm_texto_completo.aspx?param1=NRTC&amp;nValor1=1&amp;nValor2=80864&amp;nValor3=102803&amp;strTipM=TC\" target=\"_blank\" rel=\"noopener\">39342-S<\/a>: Regulation of the Technovigilance National System.<ul><li style=\"font-weight: 300\">Defines what Technovigilance is.<\/li><li style=\"font-weight: 300\">Establishes the types of events and factors that should be considered during a risk assessment.<\/li><li style=\"font-weight: 300\">Determines the manufacturer, importer, distributor, health professional, and user roles in the Technovigilance system.<\/li><\/ul><\/li><\/ul><p>Something important to highlight is that the regulatory requirements for products approved by the FDA in the USA are less in Costa Rica. This is part of the Ministry of Health recognition of international agencies.<\/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-d12035f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d12035f\" 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-1d710c3\" data-id=\"1d710c3\" 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-48b3a7f elementor-widget elementor-widget-menu-anchor\" data-id=\"48b3a7f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"stakeholders\"><\/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-da1d782 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"da1d782\" 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\" 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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-1f6c0c0 elementor-widget elementor-widget-heading\" data-id=\"1f6c0c0\" 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 Costa Rica\n<\/h2>\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-d9b78b0 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d9b78b0\" 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-59deaf8\" data-id=\"59deaf8\" 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-b9585a7 elementor-invisible elementor-widget elementor-widget-image\" data-id=\"b9585a7\" 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\/cr\/wp-content\/uploads\/sites\/5\/2020\/01\/outside-mexico.svg\" class=\"attachment-full size-full wp-image-277\" alt=\"Manufacturer located outside of Mexico\" \/>\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-a719288\" data-id=\"a719288\" 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-3d807f2 elementor-widget elementor-widget-text-editor\" data-id=\"3d807f2\" 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 style=\"font-weight: 300\">Manufacturer: responsible for the design, manufacture, packaging and labeling of an EMB (medical device).<\/li>\n \t<li style=\"font-weight: 300\">Registration holder: manages the sanitary registration and acts as legally responsible. This must be a Costa Rican entity.<\/li>\n \t<li style=\"font-weight: 300\">Product holder: entity that owns the products to be commercialized under a specific name or brand. The product holder is what is generally considered as the legal manufacturer in other countries. It could be the same manufacturer.<\/li>\n<\/ul>\n<h5><\/h5>\nYou can check more about these roles in our Costa Rica Registration Holder guide.\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-811f83d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"811f83d\" data-element_type=\"section\" data-e-type=\"section\" 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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-717ecd9\" data-id=\"717ecd9\" 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-ee0ec67 elementor-widget elementor-widget-menu-anchor\" data-id=\"ee0ec67\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"register\"><\/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-e5c21d5 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"e5c21d5\" 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-9628140 elementor-widget elementor-widget-heading\" data-id=\"9628140\" 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\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-eb38df3 elementor-widget elementor-widget-text-editor\" data-id=\"eb38df3\" 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 we have clarified the legal framework and requirements, a sanitary registration route must be identified.&nbsp;<\/p>\n<p>The most popular registration process is the Standard Process.<\/p>\n<p>In this route, a dossier must be prepared fulfilling the requested documents and information in the right order according to the regulations.<\/p>\n<p>The application of the registration is done via the system &#8220;registrelo&#8221; that requests you to have a digital signature. This signature is processed personally by the Registration Holder.<\/p>\n<p>Once the dossier is delivered, a proof of reception is granted in the system. At this moment the Ministry of Health begins the evaluation.&nbsp;<\/p>\n<p>The Ministry of Health will carry out the evaluation in two phases:<\/p>\n<ol>\n<li>A) Legal evaluation: The Ministry of Health verifies the conformity of the submitted paperwork in terms of the validity and authenticity of the legal documents. The Ministry of Health will take a period of 15 days upon submission of EMB (medical devices) class I and II, and a period of 30 days upon submission of EMB class III and IV.&nbsp;<\/li>\n<li>B) Technical evaluation: Another department within the Ministry of Health will perform the technical evaluation. This evaluation will take a period of 30 days upon submission.<\/li>\n<\/ol>\n<p>Consider that the mentioned timelines are the legal periods of time. Check the section for timelines as mentioned in this document below for more details about the real timelines.<\/p>\n<p>If the technical evaluation is qualified as positive, the registration will be granted and the corresponding certificate issued. The EMB (medical device) is now considered as approved by the Ministry of Health in Costa Rica for its use, importation, distribution and commercialization.<\/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-179e31b elementor-widget elementor-widget-text-editor\" data-id=\"179e31b\" 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>Considerations according to the device classification<\/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-2e29e98 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2e29e98\" 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-b1f5d13\" data-id=\"b1f5d13\" 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-885d3c2 elementor-tabs-view-vertical elementor-widget elementor-widget-tabs\" data-id=\"885d3c2\" 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-1421\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"true\" data-tab=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"elementor-tab-content-1421\" aria-expanded=\"false\">Class I<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-1422\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"2\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-1422\" aria-expanded=\"false\">Class II<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-1423\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"3\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-1423\" aria-expanded=\"false\">Class III y Class IV<\/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-1421\" aria-expanded=\"false\">Class I<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1421\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-1421\" tabindex=\"0\" hidden=\"false\"><p>The EMBs (medical devices) listed in the Annex 1 of the&nbsp;<a href=\"https:\/\/pgrweb.go.cr\/scij\/Busqueda\/Normativa\/Normas\/nrm_texto_completo.aspx?nValor1=1&amp;nValor2=99003\" target=\"_blank\">Decree No.43902-S<\/a>, are not required to be registered. In addition, based on the Decree No. 41387-S, the entire group of EMB (medical devices) considered class I, are exempt of registration.<\/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=\"2\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-1422\" aria-expanded=\"false\">Class II<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1422\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-1422\" tabindex=\"0\" hidden=\"hidden\"><p>These products require a series of basic documents.<\/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-1423\" aria-expanded=\"false\">Class III y Class IV<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1423\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-1423\" tabindex=\"0\" hidden=\"hidden\"><p>In addition to the documents required for class II products, more clinical and performance data is required to ensure its safety and effectiveness.<\/p><\/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-31b531c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"31b531c\" 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-c7e8ec6\" data-id=\"c7e8ec6\" 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-2451656 elementor-widget elementor-widget-menu-anchor\" data-id=\"2451656\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"timelines\"><\/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-6040952 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"6040952\" 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 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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-a99f101 elementor-widget elementor-widget-heading\" data-id=\"a99f101\" 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\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a6c351d elementor-widget elementor-widget-text-editor\" data-id=\"a6c351d\" 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>Even though the official timelines at the Ministry of Health (MoH) are hardly met due to the operational capacity, the estimated approval times are competitive compared to other countries in the region. Specifically:<\/p><ul><li style=\"font-weight: 300\">Class I (notification): 3 months.<\/li><li style=\"font-weight: 300\">New Registration Class II-IV: 4-14 months (depending the category).<\/li><li style=\"font-weight: 300\">Modification technical and legal: 4-14 months (depending the category).\u00a0<\/li><li style=\"font-weight: 300\">Renewals: 3-14 months (depending the category).<\/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-8e9b253 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"8e9b253\" 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-e29429d\" data-id=\"e29429d\" 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-d591d58 elementor-widget elementor-widget-menu-anchor\" data-id=\"d591d58\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"prevention\"><\/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-5eccb86 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"5eccb86\" 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-1afe574 elementor-widget elementor-widget-heading\" data-id=\"1afe574\" 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-76a0d06 elementor-widget elementor-widget-text-editor\" data-id=\"76a0d06\" 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>When applying for a registration, the regulatory teams of different companies often experience that the competent authority requests additional information &#8212; either to complement or clarify a particular situation. Costa Rica is not an exception. The Ministry of Health (MoH) may also issue this request that is known as prevention.\u00a0 In the case of this market, this process includes the following considerations:<\/p><p>\u00a0<\/p><p>Phase 1: Legal requirements review.<\/p><p>In the event that the documentation and requirements requested for the sanitary registration are not in compliance, the Ministry of Health may issue a prevention to the interested party.<\/p><p>The interested party (or applicant) has a period of 10 business days to respond to the requisition.\u00a0<\/p><p>An additional period of up to 3 months might be conceded, unless the situation from a technical point of view turns out to be complex, in which case a longer period is conceded.<\/p><p>In the case that the applicant does not respond before the expiration of the period of the initial 10 business days or even the additionally granted period, the application is considered as cancelled. In such case a new procedure must be started.<\/p><p>\u00a0<\/p><p>Phase 2: Technical evaluation of the requirements:<\/p><p>In case the revision of technical reports results in a non-compliant result, the Ministry of Health (MoH) will issue a prevention, giving the applicant 10 business days to gather the missing documents and respond.<\/p><p>If the period of 10 business days expires without receiving the information and clarifications from the interested party, the application will be cancelled, and the application would have to start over.<\/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-b1865b7 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b1865b7\" 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-da31722\" data-id=\"da31722\" 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-4d0bd09 elementor-widget elementor-widget-menu-anchor\" data-id=\"4d0bd09\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"referenceszx\"><\/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-65a0de1 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"65a0de1\" 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-6a57f5a elementor-widget elementor-widget-heading\" data-id=\"6a57f5a\" 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-facada9 elementor-widget elementor-widget-text-editor\" data-id=\"facada9\" 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>Useful references<\/p><ul><li><a href=\"https:\/\/www.ministeriodesalud.go.cr\/\" target=\"_blank\" rel=\"noopener\">Ministry of Health of Costa Rica<\/a>.<\/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-5bb1400 elementor-hidden-tablet elementor-hidden-mobile elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5bb1400\" 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-be4dd10\" style=\"cursor: pointer;\" data-column-clickable=\"#legal_framework\" data-column-clickable-blank=\"_self\" data-id=\"be4dd10\" 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-d007566 elementor-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"d007566\" 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<a href=\"#ministry\" class=\"elementor-icon\" tabindex=\"-1\" aria-label=\"Inside the Ministry of Health in Costa Rica\">\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\" 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\" 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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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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<\/a>\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<a href=\"#ministry\" >\n\t\t\t\t\t\t\tInside the Ministry of Health in Costa Rica\t\t\t\t\t\t<\/a>\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-9bdd11e\" style=\"cursor: pointer;\" data-column-clickable=\"#cofepris\" data-column-clickable-blank=\"_self\" data-id=\"9bdd11e\" 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-0183c69 elementor-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"0183c69\" 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<a href=\"#framework\" class=\"elementor-icon\" tabindex=\"-1\" aria-label=\"The legal framework surrounding a medical device in Costa Rica.\">\n\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" 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Rica.\t\t\t\t\t\t<\/a>\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-6906f3e\" style=\"cursor: pointer;\" data-column-clickable=\"#stakeholders\" data-column-clickable-blank=\"_self\" data-id=\"6906f3e\" 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-2f0f188 elementor-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"2f0f188\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div 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transform=\"translate(-266.17 -36.29)\"><\/path><\/svg>\t\t\t\t<\/a>\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<a href=\"#stakeholders\" >\n\t\t\t\t\t\t\tThe stakeholders in a regulatory project in Costa Rica\t\t\t\t\t\t<\/a>\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-243042c\" style=\"cursor: pointer;\" data-column-clickable=\"#routes\" data-column-clickable-blank=\"_self\" data-id=\"243042c\" 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-f29273f elementor-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"f29273f\" 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<a href=\"#register\" class=\"elementor-icon\" tabindex=\"-1\" aria-label=\"The routes to register a medical device\">\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 64.1 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 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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\t<\/a>\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<a href=\"#register\" >\n\t\t\t\t\t\t\tThe routes to register a medical device\t\t\t\t\t\t<\/a>\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-d6ef640\" style=\"cursor: pointer;\" data-column-clickable=\"#timelines\" data-column-clickable-blank=\"_self\" data-id=\"d6ef640\" 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-bd7a053 elementor-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"bd7a053\" 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<a href=\"#timelines\" class=\"elementor-icon\" tabindex=\"-1\" aria-label=\"Timelines\">\n\t\t\t\t<svg 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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<a href=\"#timelines\" >\n\t\t\t\t\t\t\tTimelines\t\t\t\t\t\t<\/a>\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-f771df3\" style=\"cursor: pointer;\" data-column-clickable=\"#prevention\" data-column-clickable-blank=\"_self\" data-id=\"f771df3\" 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-ced5430 elementor-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget 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class=\"cls-2\" x=\"26.7\" y=\"12.82\" width=\"29.9\" height=\"2.14\"><\/rect><\/svg>\t\t\t\t<\/a>\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<a href=\"#prevention\" >\n\t\t\t\t\t\t\tWhat is a prevention\t\t\t\t\t\t<\/a>\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-bbad2b0\" style=\"cursor: pointer;\" data-column-clickable=\"#references\" data-column-clickable-blank=\"_self\" data-id=\"bbad2b0\" 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-90efc7c elementor-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"90efc7c\" 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<a href=\"#referenceszx\" class=\"elementor-icon\" tabindex=\"-1\" aria-label=\"Useful references\">\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 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\" 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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<\/a>\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<a href=\"#referenceszx\" >\n\t\t\t\t\t\t\tUseful references\t\t\t\t\t\t<\/a>\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 COSTA RICA This is a great resource in case you are looking for an in-depth description of the full regulatory process for medical devices in Costa Rica.For a general overview, you can check our website for each of the services we provide or contact us directly. We will be [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":1287,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_canvas","meta":{"footnotes":""},"class_list":["post-1464","page","type-page","status-publish","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>Ultimate Guide for Regulatory Affairs in Costa Rica - Veraque Costa Rica Costa Rica<\/title>\n<meta name=\"description\" content=\"Register a medical device in Costa Rica: Understand the regulatory process and timelines for medical device approvals.\" \/>\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\/cr\/guides\/ultimate-guide-for-regulatory-affairs-in-costa-rica\/\" \/>\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 Costa Rica\" \/>\n<meta property=\"og:description\" content=\"Register a medical device in Costa Rica: Understand the regulatory process and timelines for medical device approvals.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/veraqueconsulting.com\/cr\/guides\/ultimate-guide-for-regulatory-affairs-in-costa-rica\/\" \/>\n<meta property=\"og:site_name\" content=\"Veraque Costa Rica\" \/>\n<meta property=\"article:modified_time\" content=\"2026-07-13T15:16:32+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/2019\/11\/logo.png\" \/>\n\t<meta property=\"og:image:width\" content=\"450\" \/>\n\t<meta property=\"og:image:height\" content=\"105\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\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=\"7 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/cr\\\/guides\\\/ultimate-guide-for-regulatory-affairs-in-costa-rica\\\/\",\"url\":\"https:\\\/\\\/veraqueconsulting.com\\\/cr\\\/guides\\\/ultimate-guide-for-regulatory-affairs-in-costa-rica\\\/\",\"name\":\"Ultimate Guide for Regulatory Affairs in Costa Rica - 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