{"id":1439,"date":"2021-02-24T17:59:31","date_gmt":"2021-02-24T17:59:31","guid":{"rendered":"https:\/\/veraqueconsulting.com\/cr\/?page_id=1439"},"modified":"2025-04-07T19:54:00","modified_gmt":"2025-04-07T19:54:00","slug":"costa-rica-registration-holder","status":"publish","type":"page","link":"https:\/\/veraqueconsulting.com\/cr\/guides\/costa-rica-registration-holder\/","title":{"rendered":"Costa Rica Registration Holder"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1439\" class=\"elementor elementor-1439\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<header class=\"elementor-section elementor-top-section elementor-element elementor-element-4b59f0b elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"4b59f0b\" 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-23880a2\" data-id=\"23880a2\" 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-483d3c4 elementor-widget elementor-widget-image\" data-id=\"483d3c4\" 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-7ba3b82\" data-id=\"7ba3b82\" 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-a65b2e4 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"a65b2e4\" 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-d32d391\" data-id=\"d32d391\" 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-3c52929 elementor-widget elementor-widget-heading\" data-id=\"3c52929\" 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\">Costa Rica Registration Holder<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-96dd48f elementor-widget elementor-widget-text-editor\" data-id=\"96dd48f\" 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 Costa Rica Registration Holder (CRH) is the physical or legal entity who manages the sanitary registration of an EMB (Equipment or Biomedical Material) or Medical Device and who acts as the primary point of contact with the Ministry of Health (MoH). In addition, the holder is in charge of submitting any regulatory requirement to the authorities. In other words, the CRH plays a key role as your partner during the life cycle of the sanitary registration in Costa Rica.<br \/>Similarly, the Product Holder is another relevant party involved in this regulatory process. The Product Holder owns the EMB with a specific commercial name. In most cases the Product Holder is the legal manufacturer.<br \/>Article 3rd of the directive in Costa Rica No. 34482-S is well-detailed about the definitions of these entities and others who play a relevant role in the regulatory cycle. We have selected those that we consider important:<\/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-3aac03f\" data-id=\"3aac03f\" 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-89dcf6f elementor-widget elementor-widget-spacer\" data-id=\"89dcf6f\" 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-7b4cfa7 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7b4cfa7\" 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-590e9fd\" data-id=\"590e9fd\" 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-6a12928 elementor-widget elementor-widget-menu-anchor\" data-id=\"6a12928\" 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=\"manufacturer\"><\/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-6bf0d29 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"6bf0d29\" 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-390eaa1 elementor-widget elementor-widget-heading\" data-id=\"390eaa1\" 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\">Manufacturer<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a86161f elementor-widget elementor-widget-text-editor\" data-id=\"a86161f\" 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>Any physical or legal person, responsible for the design, manufacture, packaging and labeling of EMB with the intention of being marketed under its own name, whether these operations are carried out by that same person or by third parties on their behalf.<\/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-cf2e7eb elementor-reverse-mobile elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"cf2e7eb\" 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-bfd059b\" data-id=\"bfd059b\" 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-974b7a8 elementor-invisible elementor-widget elementor-widget-image\" data-id=\"974b7a8\" 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_devices&quot;:[&quot;desktop&quot;,&quot;tablet&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}}}\" 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=\"68\" height=\"50\" src=\"https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/2020\/01\/holder-mex.svg\" class=\"attachment-full size-full wp-image-274\" alt=\"Holder in 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-33594e6\" data-id=\"33594e6\" 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-9729b23 elementor-widget elementor-widget-heading\" data-id=\"9729b23\" 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\">Some of its responsibilities are<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d9ed26f elementor-widget elementor-widget-text-editor\" data-id=\"d9ed26f\" 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>Assure that the designed products work for the declared purpose.<\/li><li>In case of local manufacturers, maintain the Costa Rica Ministry of Health authorization with the valid operation permit.<\/li><li>Get and maintain a certificate of good manufacturing practices.<\/li><li>Develop and present a surveillance program.<\/li><li>Declare, in the case of refurbished or used EMBs, that the device preserves its quality, safety, and efficacy.<\/li><\/ul><p>\u00a0<\/p><p>It is worth mentioning that the Manufacturer is who in other countries is considered as the real manufacturer. On the other hand, the Product Holder is who is considered the legal manufacturer.<\/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-7e13c86 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7e13c86\" 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-778129a\" data-id=\"778129a\" 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-355a2a7 elementor-widget elementor-widget-heading\" data-id=\"355a2a7\" 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\">Importer<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-57cb922 elementor-widget elementor-widget-text-editor\" data-id=\"57cb922\" 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>Besides the relationship that it has with the Product Holder (the entity who owns the commercial name of the product), this entity imports the products and generally distribute them in the country<br \/><br \/><\/p><ul><li><span style=\"font-weight: 300;\">The importer must work through an operation permit and be mentioned in the sanitary registration in order to import the products to Costa Rica.<\/span><\/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-e84e071\" data-id=\"e84e071\" 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-0421457 elementor-invisible elementor-widget elementor-widget-image\" data-id=\"0421457\" 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_devices&quot;:[&quot;desktop&quot;,&quot;tablet&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}}}\" 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=\"63\" height=\"51\" src=\"https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/2020\/01\/distributor.svg\" class=\"attachment-full size-full wp-image-273\" alt=\"Local Distributors\" \/>\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-c82a884 elementor-reverse-mobile elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"c82a884\" 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-1942cba\" data-id=\"1942cba\" 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-ba360b9 elementor-invisible elementor-widget elementor-widget-image\" data-id=\"ba360b9\" 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_devices&quot;:[&quot;desktop&quot;,&quot;tablet&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}}}\" 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=\"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-65ce69d\" data-id=\"65ce69d\" 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-682ea93 elementor-widget elementor-widget-heading\" data-id=\"682ea93\" 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\">Distributor<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fe7a4de elementor-widget elementor-widget-text-editor\" data-id=\"fe7a4de\" 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>Any physical or legal person, national or foreign, who in his own name or that of a third party, is regularly engaged in distributing or marketing the EMB. As expected, the importer is usually the importer, as well.\u00a0<\/p><p>\u00a0<\/p><p>When a distributor is not able to perform an importation or is not mentioned in the sanitary registration, it is known as a sub-distributor.<\/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-de43815 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"de43815\" 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-7154cfa\" data-id=\"7154cfa\" 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-99fc291 elementor-widget elementor-widget-menu-anchor\" data-id=\"99fc291\" 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=\"techno\"><\/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-0a57714 elementor-widget elementor-widget-image\" data-id=\"0a57714\" 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\/cr\/wp-content\/uploads\/sites\/5\/2020\/01\/technovigilance-1.svg\" class=\"attachment-large size-large wp-image-305\" alt=\"Technovigilance\" srcset=\"https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/\/2020\/01\/technovigilance-1.svg 150w, https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/\/2020\/01\/technovigilance-1.svg 300w, https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/\/2020\/01\/technovigilance-1.svg 1024w, https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/\/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-0c14c2e elementor-widget elementor-widget-heading\" data-id=\"0c14c2e\" 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 role of the CRH in the Technovigilance\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7439e0e elementor-widget elementor-widget-text-editor\" data-id=\"7439e0e\" 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>Many other countries with a strong regulatory system, identifies the term of \u201cTechnovigilance\u201d as Post-Marketing Surveillance. This term refers to a system implemented by both the Ministry of Health and the private companies to monitor the approved medical devices that are being distributed in the country.<\/p><p>In Costa Rica, the Regulation of the National System of Technovigilance is identified with the code 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> and it seeks to establish the guidelines to implement the surveillance program.<\/p><p>The Costa Rica Registration Holder is the legal entity responsible to oversee the correct implementation of the technovigilance. Nevertheless, an efficient communication and interaction between all parties involved in the Medical Device cycle is a key factor for a successful surveillance program.<\/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<div class=\"elementor-element elementor-element-ac08a7e elementor-hidden-tablet elementor-hidden-mobile e-flex e-con-boxed e-con e-parent\" data-id=\"ac08a7e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;sticky&quot;:&quot;bottom&quot;,&quot;background_background&quot;:&quot;classic&quot;,&quot;sticky_effects_offset&quot;:600,&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<div class=\"e-con-inner\">\n\t\t<div class=\"make-column-clickable-elementor elementor-element elementor-element-ad7f8c6 e-con-full e-flex e-con e-child\" style=\"cursor: pointer;\" data-column-clickable=\"#stakeholders\" data-column-clickable-blank=\"_self\" data-id=\"ad7f8c6\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5ba22ab elementor-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"5ba22ab\" 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=\"#manufacturer\" class=\"elementor-icon\" tabindex=\"-1\" aria-label=\"Manufacturer\">\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\" 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\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=\"#manufacturer\" >\n\t\t\t\t\t\t\tManufacturer\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<\/div>\n\t\t<div class=\"make-column-clickable-elementor elementor-element elementor-element-d3a8104 e-con-full e-flex e-con e-child\" style=\"cursor: pointer;\" data-column-clickable=\"#must-know\" data-column-clickable-blank=\"_self\" data-id=\"d3a8104\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1e21c32 elementor-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"1e21c32\" 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=\"#techno\" class=\"elementor-icon\" tabindex=\"-1\" aria-label=\"The role of the CRH in the Technovigilance\">\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 55.17 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\" 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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<\/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=\"#techno\" >\n\t\t\t\t\t\t\tThe role of the CRH in the Technovigilance\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<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Costa Rica Registration Holder The Costa Rica Registration Holder (CRH) is the physical or legal entity who manages the sanitary registration of an EMB (Equipment or Biomedical Material) or Medical Device and who acts as the primary point of contact with the Ministry of Health (MoH). In addition, the holder is in charge of submitting [&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-1439","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>Sanitary registration holder in Costa Rica | Veraque<\/title>\n<meta name=\"description\" content=\"Discover key entities shaping the regulatory cycle. 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