{"id":14877,"date":"2026-02-02T10:50:12","date_gmt":"2026-02-02T15:50:12","guid":{"rendered":"https:\/\/bustamantefabara.com\/en\/?p=14877"},"modified":"2026-02-27T15:34:46","modified_gmt":"2026-02-27T20:34:46","slug":"arcsa-statement-on-comex-resolution-no-017-2025","status":"publish","type":"post","link":"https:\/\/bustamantefabara.com\/en\/arcsa-statement-on-comex-resolution-no-017-2025\/","title":{"rendered":"ARCSA Statement on COMEX Resolution No. 017-2025"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"14877\" class=\"elementor elementor-14877\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-23e75e5c e-con-full e-flex e-con e-parent\" data-id=\"23e75e5c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-1609b1bd e-con-full e-flex e-con e-child\" data-id=\"1609b1bd\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-69ec2d0f elementor-invisible elementor-widget elementor-widget-image\" data-id=\"69ec2d0f\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&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 fetchpriority=\"high\" decoding=\"async\" width=\"1601\" height=\"901\" src=\"https:\/\/bustamantefabara.com\/en\/wp-content\/uploads\/2026\/02\/Imagen-principal.webp\" class=\"attachment-full size-full wp-image-14878\" alt=\"\" srcset=\"https:\/\/bustamantefabara.com\/en\/wp-content\/uploads\/2026\/02\/Imagen-principal.webp 1601w, https:\/\/bustamantefabara.com\/en\/wp-content\/uploads\/2026\/02\/Imagen-principal-300x169.webp 300w, https:\/\/bustamantefabara.com\/en\/wp-content\/uploads\/2026\/02\/Imagen-principal-1024x576.webp 1024w, https:\/\/bustamantefabara.com\/en\/wp-content\/uploads\/2026\/02\/Imagen-principal-768x432.webp 768w, https:\/\/bustamantefabara.com\/en\/wp-content\/uploads\/2026\/02\/Imagen-principal-1536x864.webp 1536w\" sizes=\"(max-width: 1601px) 100vw, 1601px\" \/>\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>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-517017a2 e-flex e-con-boxed e-con e-parent\" data-id=\"517017a2\" 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-7060ddf2 e-con-full e-flex e-con e-child\" data-id=\"7060ddf2\" 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-433fcb12 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"433fcb12\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;}\" 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\">ARCSA Statement on COMEX Resolution No. 017-2025<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-73a0755c elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"73a0755c\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;}\" 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 class=\"p1\">On January 30, 2026, the National Agency for Regulation, Control and Sanitary Surveillance \u2013 ARCSA (\u201c<strong>ARCSA<\/strong>\u201d) issued a statement related to COMEX Resolution No. 017-2025 (the \u201cResolution\u201d). In this statement, ARCSA informs holders of products subject to sanitary control about the entry into force of the Resolution, which will take effect as of April 9, 2026, and which amends Article 4 regarding the authorization for the use of Sanitary Registrations and Sanitary Notifications by third parties for the importation, distribution, and commercialization of products under sanitary surveillance.<\/p><p class=\"p1\">The most relevant points are summarized below:<\/p><p class=\"p1\"><strong>1. Endorsement (\u201cendoso\u201d) and holder\u2019s responsibilities:<\/strong> RCSA indicates that it does not contemplate the transfer of<\/p><p class=\"p1\">responsibilities to third parties through the endorsement mechanism. Consequently, the responsibility arising from<\/p><p class=\"p1\">the Sanitary Registration or Sanitary Notification remains with the holder and\/or applicant and is non-transferable.<\/p><p class=\"p1\"><strong>2. Notification to ARCSA and procedure through the VUE:<\/strong> For the authorization to use Sanitary Registrations and Sanitary Notifications by third parties (for importation, distribution, and commercialization), ARCSA provides that the process must be managed exclusively through the Ecuadorian Single Window (Ventanilla \u00danica Ecuatoriana \u2013 <strong>VUE)<\/strong>.<\/p><p class=\"p1\">Within the VUE, the user must process the authorization through a modification procedure of the sanitary registration or notification, using the applicable \u201cReference Code\u201d according to the type of product. ARCSA has defined the following codes:<\/p><ul><li class=\"p1\"><strong>MDM01:<\/strong> Medical Devices<\/li><li class=\"p1\"><strong>MAE001:<\/strong> Food<\/li><li class=\"p1\"><strong>AUT:<\/strong> General Medicines, Biological Products, Natural Products, Homeopathic Products, Pesticides for domestic, public health, and industrial use, and Hygienic Products for industrial use<\/li><\/ul><p class=\"p1\">These codes will be used solely for authorizing the use of Sanitary Registrations and Sanitary Notifications, in order to incorporate third parties as importers and\/or distributors of the product, through the corresponding procedure in the VUE. To complete the process, the online modification form must be completed and the documents required by<\/p><p class=\"p1\">ARCSA must be attached:<\/p><ol><li class=\"p1\">Authorization Letter for Importers and\/or Distributors of Products for Human Use and Consumption; and<\/li><li class=\"p1\">Importer\u2013Distributor Template, in accordance with the official formats established by ARCSA.<\/li><\/ol><p class=\"p1\"><strong>Recommendation:<\/strong> Considering that the Resolution will enter into force on April 9, 2026\u2014on which date endorsements granted previously will cease to be valid\u2014we recommend that holders operating with third parties (importers\/distributors) anticipate the preparation of the documentation and the management of the procedure through the VUE, bearing in mind that the holder and\/or applicant retains the sanitary responsibility associated with the registration or notification.<\/p><p class=\"p1\">If you would like us to expand on the scope and implications for your operation (e.g., contractual adjustments, risk management, and compliance timeline), we will be glad to assist you. 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elementor-posts--skin-cards elementor-grid\" role=\"list\">\n\t\t\t\t<article class=\"elementor-post elementor-grid-item post-15116 post type-post status-publish format-standard has-post-thumbnail hentry category-bulletin\" role=\"listitem\">\n\t\t\t<div class=\"elementor-post__card\">\n\t\t\t\t<a class=\"elementor-post__thumbnail__link\" href=\"https:\/\/bustamantefabara.com\/en\/new-ministerial-agreement-regulating-the-authorization-procedure-for-special-work-shifts-or-schedules-2\/\" tabindex=\"-1\" target=\"_blank\"><div class=\"elementor-post__thumbnail\"><img decoding=\"async\" width=\"300\" height=\"95\" src=\"https:\/\/bustamantefabara.com\/en\/wp-content\/uploads\/2026\/03\/Portada-Web-EN-5-300x95.webp\" class=\"attachment-medium size-medium wp-image-15117\" alt=\"\" srcset=\"https:\/\/bustamantefabara.com\/en\/wp-content\/uploads\/2026\/03\/Portada-Web-EN-5-300x95.webp 300w, https:\/\/bustamantefabara.com\/en\/wp-content\/uploads\/2026\/03\/Portada-Web-EN-5-1024x325.webp 1024w, https:\/\/bustamantefabara.com\/en\/wp-content\/uploads\/2026\/03\/Portada-Web-EN-5-768x244.webp 768w, https:\/\/bustamantefabara.com\/en\/wp-content\/uploads\/2026\/03\/Portada-Web-EN-5.webp 1201w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/div><\/a>\n\t\t\t\t<div class=\"elementor-post__badge\">Legal Bulletin<\/div>\n\t\t\t\t<div class=\"elementor-post__text\">\n\t\t\t\t<h3 class=\"elementor-post__title\">\n\t\t\t<a href=\"https:\/\/bustamantefabara.com\/en\/new-ministerial-agreement-regulating-the-authorization-procedure-for-special-work-shifts-or-schedules-2\/\" target=&quot;_blank&quot;>\n\t\t\t\tMinisterial Agreement No. MDT-2026-087: Determination of the Living Wage for 2025 and Regulation of the Procedure for the Payment of the Economic Compensation\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\n\t\t<a class=\"elementor-post__read-more\" href=\"https:\/\/bustamantefabara.com\/en\/new-ministerial-agreement-regulating-the-authorization-procedure-for-special-work-shifts-or-schedules-2\/\" aria-label=\"Read more about Ministerial Agreement No. MDT-2026-087: Determination of the Living Wage for 2025 and Regulation of the Procedure for the Payment of the Economic Compensation\" tabindex=\"-1\" target=\"_blank\">\n\t\t\tLeer m\u00e1s \u00bb\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t<article class=\"elementor-post elementor-grid-item post-15107 post type-post status-publish format-standard has-post-thumbnail hentry category-bulletin\" role=\"listitem\">\n\t\t\t<div class=\"elementor-post__card\">\n\t\t\t\t<a class=\"elementor-post__thumbnail__link\" href=\"https:\/\/bustamantefabara.com\/en\/new-ministerial-agreement-regulating-the-authorization-procedure-for-special-work-shifts-or-schedules\/\" tabindex=\"-1\" target=\"_blank\"><div class=\"elementor-post__thumbnail\"><img decoding=\"async\" width=\"300\" height=\"95\" src=\"https:\/\/bustamantefabara.com\/en\/wp-content\/uploads\/2026\/03\/Portada-Web-EN-1-1-300x95.webp\" class=\"attachment-medium size-medium wp-image-15108\" alt=\"\" srcset=\"https:\/\/bustamantefabara.com\/en\/wp-content\/uploads\/2026\/03\/Portada-Web-EN-1-1-300x95.webp 300w, https:\/\/bustamantefabara.com\/en\/wp-content\/uploads\/2026\/03\/Portada-Web-EN-1-1-1024x325.webp 1024w, https:\/\/bustamantefabara.com\/en\/wp-content\/uploads\/2026\/03\/Portada-Web-EN-1-1-768x244.webp 768w, https:\/\/bustamantefabara.com\/en\/wp-content\/uploads\/2026\/03\/Portada-Web-EN-1-1.webp 1201w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/div><\/a>\n\t\t\t\t<div class=\"elementor-post__badge\">Legal Bulletin<\/div>\n\t\t\t\t<div class=\"elementor-post__text\">\n\t\t\t\t<h3 class=\"elementor-post__title\">\n\t\t\t<a href=\"https:\/\/bustamantefabara.com\/en\/new-ministerial-agreement-regulating-the-authorization-procedure-for-special-work-shifts-or-schedules\/\" target=&quot;_blank&quot;>\n\t\t\t\tNew Ministerial Agreement Regulating the Authorization Procedure for Special Work Shifts or Schedules\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\n\t\t<a class=\"elementor-post__read-more\" href=\"https:\/\/bustamantefabara.com\/en\/new-ministerial-agreement-regulating-the-authorization-procedure-for-special-work-shifts-or-schedules\/\" aria-label=\"Read more about New Ministerial Agreement Regulating the Authorization Procedure for Special Work Shifts or Schedules\" tabindex=\"-1\" target=\"_blank\">\n\t\t\tLeer m\u00e1s \u00bb\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t<article class=\"elementor-post elementor-grid-item post-15102 post type-post status-publish format-standard has-post-thumbnail hentry category-bulletin\" role=\"listitem\">\n\t\t\t<div class=\"elementor-post__card\">\n\t\t\t\t<a class=\"elementor-post__thumbnail__link\" href=\"https:\/\/bustamantefabara.com\/en\/recommended-reading-you-are-a-badass-by-jen-sincero\/\" tabindex=\"-1\" target=\"_blank\"><div class=\"elementor-post__thumbnail\"><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"95\" src=\"https:\/\/bustamantefabara.com\/en\/wp-content\/uploads\/2026\/03\/Portada-Wen-EN-300x95.webp\" class=\"attachment-medium size-medium wp-image-15103\" alt=\"\" srcset=\"https:\/\/bustamantefabara.com\/en\/wp-content\/uploads\/2026\/03\/Portada-Wen-EN-300x95.webp 300w, https:\/\/bustamantefabara.com\/en\/wp-content\/uploads\/2026\/03\/Portada-Wen-EN-1024x325.webp 1024w, https:\/\/bustamantefabara.com\/en\/wp-content\/uploads\/2026\/03\/Portada-Wen-EN-768x244.webp 768w, https:\/\/bustamantefabara.com\/en\/wp-content\/uploads\/2026\/03\/Portada-Wen-EN.webp 1201w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/div><\/a>\n\t\t\t\t<div class=\"elementor-post__badge\">Legal Bulletin<\/div>\n\t\t\t\t<div class=\"elementor-post__text\">\n\t\t\t\t<h3 class=\"elementor-post__title\">\n\t\t\t<a href=\"https:\/\/bustamantefabara.com\/en\/recommended-reading-you-are-a-badass-by-jen-sincero\/\" target=&quot;_blank&quot;>\n\t\t\t\tRecommended Reading: \u00abYou Are a Badass\u00bb by Jen Sincero\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\n\t\t<a class=\"elementor-post__read-more\" href=\"https:\/\/bustamantefabara.com\/en\/recommended-reading-you-are-a-badass-by-jen-sincero\/\" aria-label=\"Read more about Recommended Reading: \u00abYou Are a Badass\u00bb by Jen Sincero\" tabindex=\"-1\" target=\"_blank\">\n\t\t\tLeer m\u00e1s \u00bb\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t<\/div>\n\t\t\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\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>ARCSA Statement on COMEX Resolution No. 017-2025 On January 30, 2026, the National Agency for Regulation, Control and Sanitary Surveillance \u2013 ARCSA (\u201cARCSA\u201d) issued a<\/p>\n","protected":false},"author":2,"featured_media":14880,"comment_status":"closed","ping_status":"open","sticky":false,"template":"elementor_header_footer","format":"standard","meta":{"footnotes":""},"categories":[8],"tags":[],"class_list":["post-14877","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bulletin"],"_links":{"self":[{"href":"https:\/\/bustamantefabara.com\/en\/wp-json\/wp\/v2\/posts\/14877","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bustamantefabara.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/bustamantefabara.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/bustamantefabara.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/bustamantefabara.com\/en\/wp-json\/wp\/v2\/comments?post=14877"}],"version-history":[{"count":12,"href":"https:\/\/bustamantefabara.com\/en\/wp-json\/wp\/v2\/posts\/14877\/revisions"}],"predecessor-version":[{"id":14940,"href":"https:\/\/bustamantefabara.com\/en\/wp-json\/wp\/v2\/posts\/14877\/revisions\/14940"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/bustamantefabara.com\/en\/wp-json\/wp\/v2\/media\/14880"}],"wp:attachment":[{"href":"https:\/\/bustamantefabara.com\/en\/wp-json\/wp\/v2\/media?parent=14877"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bustamantefabara.com\/en\/wp-json\/wp\/v2\/categories?post=14877"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bustamantefabara.com\/en\/wp-json\/wp\/v2\/tags?post=14877"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}