{"id":10017,"date":"2019-07-22T17:30:59","date_gmt":"2019-07-22T15:30:59","guid":{"rendered":"http:\/\/www.thema-med.com\/?page_id=10017"},"modified":"2023-06-23T10:20:35","modified_gmt":"2023-06-23T08:20:35","slug":"us-initial-importer-service","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/us-initial-importer-service\/","title":{"rendered":"US Initial Importer service"},"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-10008\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2019\/07\/US-initial-importer-1024x536.png\" alt=\"\"><figcaption><em>US Initial Importer service<\/em><\/figcaption><\/figure>\n<\/div>\n<\/p>\n<p>In the United States, the <strong><a href=\"https:\/\/www.thema-med.com\/en\/usa-are-you-confident-about-your-initial-importer\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"US Initial Importer (si apre in una nuova scheda)\">US Initial Importer<\/a><\/strong> assumes a strategic role not only in the import and customs clearance of the devices but also as responsible regulator for some activities. For example, the US initial Importer must:<\/p>\n<\/p>\n<ul class=\"wp-block-list\">\n<li>communicate to FDA all accidents or adverse events which caused (or contributed to) death or serious harm to the patient and which caused to the Manufacturer all malfunctions found on the imported device (<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=803.40\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"21 CFR 803.40 (si apre in una nuova scheda)\">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\" aria-label=\"21 CFR 803.42 (si apre in una nuova scheda)\">21 CFR 803.42<\/a>);<\/li>\n<li>record, communicate and archive all non-conformities and customer reports;<\/li>\n<li>collaborate with the Manufacturer in the management of the recalls;<\/li>\n<li>preserve the safety and effectiveness of the device during the storage and handling of imported devices (21 CFR 820);<\/li>\n<li>ensure the traceability of imported devices (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>Do you need support to sell your devices in the US?<\/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\/en\/contact-us-2\/\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">CONTACT US<\/span><\/a><\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":7094,"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-10017","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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