{"id":15299,"date":"2019-07-22T17:30:59","date_gmt":"2019-07-22T15:30:59","guid":{"rendered":"https:\/\/www.thema-med.com\/?page_id=15299"},"modified":"2023-06-23T17:18:18","modified_gmt":"2023-06-23T15:18:18","slug":"servicio-de-us-initial-importer","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/es\/servicios\/representante-local\/servicio-de-us-initial-importer\/","title":{"rendered":"SERVICIO DE US INITIAL IMPORTER"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><\/p>\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter\"><img decoding=\"async\" class=\"wp-image-10010\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2019\/07\/US-initial-importer-1024x536.png\" alt=\"US initial importer\"><figcaption><em>Servicio de US Initial Importer <\/em><\/figcaption><\/figure>\n<\/div>\n<\/p>\n<p>En los Estados Unidos, el <strong><a href=\"https:\/\/www.thema-med.com\/es\/ee-uu-estas-cierto-de-tu-initial-importer\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"US Initial Importer  (si apre in una nuova scheda)\">US Initial Importer <\/a><\/strong>asume un papel estrat\u00e9gico no solo en la importaci\u00f3n y en el despacho aduanero de los dispositivos, sino tambi\u00e9n como responsable regulador de algunas actividades. Por ejemplo el US Initial Importer tiene que:<\/p>\n<\/p>\n<ul class=\"wp-block-list\">\n<li>informar a la FDA de todos los incidentes o acontecimientos adversos que hayan causado (o contribuido a la) muerte o da\u00f1o grave al paciente e informar al Fabricante de todos los casos de mal funcionamiento detectados en el dispositivo importado (<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=803.40\" target=\"_blank\" rel=\"noreferrer noopener\">21 CFR 803.40<\/a>, <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=803.42\" target=\"_blank\" rel=\"noreferrer noopener\">21 CFR 803.42<\/a>);<\/li>\n<li>registrar, comunicar y archivar todas las no conformidades e informes de cliente;<\/li>\n<li>colaborar con el Fabricante en la gesti\u00f3n de recall;<\/li>\n<li>preservar seguridad y eficacia del dispositivo durante las actividades de almacenamiento y manipulaci\u00f3n de dispositivos importados (21 CFR 820);<\/li>\n<li>garantizar la trazabilidad de los dispositivos importados (21 CFR 821).<\/li>\n<\/ul><\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-padding-top:20px;--awb-padding-bottom:20px;--awb-padding-right-small:20px;--awb-padding-left-small:20px;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:10px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-2\" style=\"--awb-content-alignment:center;--awb-text-color:var(--awb-color1);\"><p>\u00bfNecesita ayuda para vender sus dispositivos en U.S.A?<\/p>\n<\/div><div style=\"text-align:center;\"><a class=\"fusion-button button-flat fusion-button-default-size button-custom fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"--button_accent_color:#ffffff;--button_accent_hover_color:var(--awb-custom12);--button_border_hover_color:var(--awb-color1);--button-border-radius-top-left:10px;--button-border-radius-top-right:10px;--button-border-radius-bottom-right:10px;--button-border-radius-bottom-left:10px;--button_gradient_top_color:var(--awb-custom12);--button_gradient_bottom_color:var(--awb-custom12);--button_gradient_top_color_hover:var(--awb-color1);--button_gradient_bottom_color_hover:var(--awb-color1);--button_text_transform:var(--awb-typography4-text-transform);--button_font_size:var(--awb-typography4-font-size);--button_line_height:var(--awb-typography4-line-height);--button_typography-letter-spacing:var(--awb-typography4-letter-spacing);--button_typography-font-family:&quot;Montserrat&quot;;--button_typography-font-style:normal;--button_typography-font-weight:700;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/es\/contactanos\/\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">CONT\u00c1CTENOS<\/span><\/a><\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":7095,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-15299","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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