{"id":5128,"date":"2024-11-05T08:50:22","date_gmt":"2024-11-05T08:50:22","guid":{"rendered":"https:\/\/customscomplete.com\/?p=5128"},"modified":"2024-11-21T11:06:29","modified_gmt":"2024-11-21T11:06:29","slug":"envio-de-productos-sanitarios-para-procesamiento-y-ensayos","status":"publish","type":"post","link":"https:\/\/customscomplete.com\/es\/medical-devices-shipping-for-processing-and-trials\/","title":{"rendered":"Env\u00edo de productos sanitarios para procesamiento y ensayos"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"5128\" class=\"elementor elementor-5128\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-ba538d7 elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ba538d7\" 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-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-58e2ebf\" data-id=\"58e2ebf\" 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-abaa949 elementor-widget elementor-widget-heading\" data-id=\"abaa949\" 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\">MEDICAL DEVICES SHIPPING <\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-75d4284 elementor-widget elementor-widget-text-editor\" data-id=\"75d4284\" 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><strong>Shipping medical devices<\/strong> for processing and trials involves a complex regulatory framework, particularly under the EU\u2019s <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=celex%3A32017R0745\"><strong>Medical Device Regulation (MDR)<\/strong> 2017\/745<\/a> and <strong>In Vitro Diagnostic Medical Device Regulation (IVDR)<\/strong> 2017\/746. These regulations impose strict <strong>requirements<\/strong> on relabeling, repackaging, and translating device information to ensure compliance, which is essential for smooth cross-border <strong>medical device shipping<\/strong>.<\/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-1aab143 elementor-toc--minimized-on-tablet elementor-widget elementor-widget-table-of-contents\" data-id=\"1aab143\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;exclude_headings_by_selector&quot;:[],&quot;marker_view&quot;:&quot;bullets&quot;,&quot;icon&quot;:{&quot;value&quot;:&quot;fas fa-genderless&quot;,&quot;library&quot;:&quot;fa-solid&quot;},&quot;headings_by_tags&quot;:[&quot;h2&quot;,&quot;h3&quot;,&quot;h4&quot;,&quot;h5&quot;,&quot;h6&quot;],&quot;no_headings_message&quot;:&quot;No headings were found on this page.&quot;,&quot;minimize_box&quot;:&quot;yes&quot;,&quot;minimized_on&quot;:&quot;tablet&quot;,&quot;hierarchical_view&quot;:&quot;yes&quot;,&quot;min_height&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;min_height_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;min_height_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"table-of-contents.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-toc__header\">\n\t\t\t\t\t\t<h4 class=\"elementor-toc__header-title\">\n\t\t\t\tIn this blog we will go through the following topics:\t\t\t<\/h4>\n\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-toc__toggle-button elementor-toc__toggle-button--expand\" role=\"button\" tabindex=\"0\" aria-controls=\"elementor-toc__1aab143\" aria-expanded=\"true\" aria-label=\"Open table of contents\"><i aria-hidden=\"true\" class=\"fas fa-chevron-down\"><\/i><\/div>\n\t\t\t\t<div class=\"elementor-toc__toggle-button elementor-toc__toggle-button--collapse\" role=\"button\" tabindex=\"0\" aria-controls=\"elementor-toc__1aab143\" aria-expanded=\"true\" aria-label=\"Close table of contents\"><i aria-hidden=\"true\" class=\"fas fa-chevron-up\"><\/i><\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<div id=\"elementor-toc__1aab143\" class=\"elementor-toc__body\">\n\t\t\t<div class=\"elementor-toc__spinner-container\">\n\t\t\t\t<i class=\"elementor-toc__spinner eicon-animation-spin eicon-loading\" aria-hidden=\"true\"><\/i>\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-9e248c3 elementor-widget elementor-widget-image\" data-id=\"9e248c3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/customscomplete.com\/wp-content\/uploads\/elementor\/thumbs\/Medical-Device-Shipping-scaled-qwlp14wd9eyqao46akpv6irfi7sqjpyrhxjxmdihjm.jpg\" title=\"Medical Devices Shipping\" alt=\"Medical Devices Shipping\" loading=\"lazy\" \/>\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-c113461 elementor-widget elementor-widget-heading\" data-id=\"c113461\" 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\">MDR\/IVDR Article 16\n\n\n\n\n\n<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-dada352 elementor-widget elementor-widget-text-editor\" data-id=\"dada352\" 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 EU\u2019s <strong>Article 16<\/strong> of MDR\/IVDR defines actions that distributors and importers can take\u2014such as relabeling or repackaging\u2014without assuming manufacturer obligations, provided they meet regulatory compliance standards. For businesses involved in <strong>medical device shipping<\/strong>, adhering to these guidelines is critical for effective and compliant distribution.<\/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-238c653 elementor-widget elementor-widget-heading\" data-id=\"238c653\" 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\">Activities Allowed Under Article 16<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b5f121c elementor-widget elementor-widget-text-editor\" data-id=\"b5f121c\" 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><strong>Translation of Device Information<\/strong>: Importers and distributors may translate the manufacturer\u2019s information, including labels and instructions, to meet language requirements in EU Member States.<\/li><li><strong>Packaging Modifications<\/strong>: To align with market needs, companies may adjust outer packaging, such as resizing for specific healthcare requirements. These adjustments are allowed as long as they maintain the device\u2019s compliance.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-949b280 elementor-widget elementor-widget-heading\" data-id=\"949b280\" 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\">Repackaging and Relabeling<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6528088 elementor-widget elementor-widget-text-editor\" data-id=\"6528088\" 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>To meet <strong>Article 16 standards<\/strong>, importers and distributors involved in <strong>shipping medical devices<\/strong> must ensure:<\/p><ol><li><strong>Notification<\/strong>: Notify the manufacturer and the competent authority 28 days before introducing a relabeled or repackaged device. This notification should include samples to verify compliance.<\/li><li><strong>Certification<\/strong>: Obtain certification from a notified body to confirm compliance with MDR\/IVDR standards, especially for repackaging and relabeling.<\/li><li><strong>UDI and Traceability<\/strong>: Preserve the device\u2019s <strong>Unique Device Identification (UDI)<\/strong> and <strong>traceability<\/strong> to maintain regulatory standards and safeguard essential information.<\/li><li><strong>Quality Management System (QMS)<\/strong>: Implement a <strong>QMS<\/strong> to document and trace all procedures, supporting field safety and post-market surveillance.<\/li><\/ol>\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-f0847c0 elementor-widget elementor-widget-heading\" data-id=\"f0847c0\" 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\">Additional Considerations for Medical Devices Shipping <\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b5901c4 elementor-widget elementor-widget-text-editor\" data-id=\"b5901c4\" 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><strong>Streamlined Notifications<\/strong>: Notify only once for initial market introduction; batch-by-batch notifications aren\u2019t necessary unless significant changes are made.<\/li><li><strong>Post-Market Obligations<\/strong>: Continued communication with manufacturers and authorities, even if relabeling or repackaging has ceased, enhances transparency for post-market monitoring.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cee04c9 elementor-widget elementor-widget-heading\" data-id=\"cee04c9\" 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\">Practical Example<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d412342 elementor-widget elementor-widget-text-editor\" data-id=\"d412342\" 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>An importer may receive syringes in bulk and repackage them into smaller batches to meet local healthcare provider needs. Provided the primary sterile packaging remains intact, this practice aligns with <strong>Article 16<\/strong> without adding regulatory obligations.<\/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-c018512 elementor-widget elementor-widget-text-editor\" data-id=\"c018512\" 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><strong>Shipping medical devices<\/strong> within the EU requires a comprehensive understanding of <strong>MDR\/IVDR regulations<\/strong>.<\/p><p>At\u00a0<a href=\"https:\/\/customscomplete.com\/contact-us\/\"><strong>Customs Complete<\/strong><\/a>, we specialize in compliant <strong>medical device shipping<\/strong> to support efficient and effective cross-border distribution. Contact us for assistance with your <strong>logistics<\/strong> and <strong>regulatory compliance<\/strong> needs.<\/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-20dd755 elementor-widget elementor-widget-heading\" data-id=\"20dd755\" 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\">Get in touch<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c51b976 elementor-widget elementor-widget-wpforms\" data-id=\"c51b976\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wpforms-container \" id=\"wpforms-198\"><form id=\"wpforms-form-198\" class=\"wpforms-validate wpforms-form\" data-formid=\"198\" method=\"post\" 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class=\"choice-7 depth-1\"  >Logistics<\/option><option value=\"Supply Chain\"  class=\"choice-8 depth-1\"  >Supply Chain<\/option><\/select><\/div><div id=\"wpforms-198-field_2-container\" class=\"wpforms-field wpforms-field-textarea\" data-field-id=\"2\"><label class=\"wpforms-field-label\" for=\"wpforms-198-field_2\">Additional Comments<\/label><textarea id=\"wpforms-198-field_2\" class=\"wpforms-field-small\" name=\"wpforms[fields][2]\" ><\/textarea><\/div><\/div><!-- .wpforms-field-container --><div class=\"wpforms-field wpforms-field-hp\"><label for=\"wpforms-198-field-hp\" class=\"wpforms-field-label\">Comment<\/label><input type=\"text\" name=\"wpforms[hp]\" id=\"wpforms-198-field-hp\" class=\"wpforms-field-medium\"><\/div><div class=\"wpforms-recaptcha-container wpforms-is-recaptcha wpforms-is-recaptcha-type-invisible\" ><div class=\"g-recaptcha\" data-sitekey=\"6LdifI4fAAAAACNIvaJsAyYjc7SViYqtoKLgu6sY\" data-size=\"invisible\"><\/div><\/div><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"198\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/customscomplete.com\/es\/wp-json\/wp\/v2\/posts\/5128\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-198\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"SEND MESSAGE\" aria-live=\"assertive\" value=\"wpforms-submit\">SEND MESSAGE<\/button><\/div><\/form><\/div>  <!-- .wpforms-container -->\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>El env\u00edo de productos sanitarios para su procesamiento y ensayo implica un marco normativo complejo, en particular en virtud del Reglamento sobre productos sanitarios (MDR) 2017\/745 y el Reglamento sobre productos sanitarios para diagn\u00f3stico in vitro (IVDR) 2017\/746 de la UE. Estos reglamentos imponen requisitos estrictos sobre el reetiquetado, el reenvasado y la traducci\u00f3n de la informaci\u00f3n del producto para garantizar el cumplimiento, lo que es esencial para el env\u00edo transfronterizo de productos sanitarios sin problemas.<\/p>","protected":false},"author":1,"featured_media":5130,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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