{"id":41381,"date":"2016-03-14T22:54:54","date_gmt":"2016-03-15T02:54:54","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-medical-devices\/"},"modified":"2020-07-28T19:30:28","modified_gmt":"2020-07-28T19:30:28","slug":"fda-medical-devices","status":"publish","type":"page","link":"https:\/\/legacy.registrarcorp.com\/it\/fda-medical-devices\/","title":{"rendered":"Dispositivi Medici"},"content":{"rendered":"
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Dispositivi Medici<\/h1>\n
\n

Registrazione FDA (U.S. Food and Drug Administration)<\/strong><\/h2>\n[\/vc_column_text][vc_row_inner el_class=”row-content-center”][vc_column_inner]
Iniziare<\/span><\/div>
<\/div><\/a>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row el_class=”hero-footer”][vc_column][vc_raw_html]JTNDZGl2JTIwY2xhc3MlM0QlMjJzb2x1dGlvbnMtaGVyby1mb290ZXIlMjIlM0UlMEElM0NzcGFuJTIwY2xhc3MlM0QlMjJ0ZXh0JTIyJTNFTm9uJTIwc2FpJTIwZGElMjBkb3ZlJTIwaW5pemlhcmUlM0YlM0MlMkZzcGFuJTNFJTBBJTNDYSUyMGhyZWYlM0QlMjIlMjMlMjIlMjBjbGFzcyUzRCUyMmNoYXQtYnRuJTIwYnRuLWJsdWUtd2hpdGUlMjBidG4tZmxleCUyMiUzRSUwQSUzQ2ltZyUyMHNyYyUzRCUyMiUyRndwLWNvbnRlbnQlMkZ1cGxvYWRzJTJGMjAxOSUyRjEwJTJGQ2hhdF9idWJibGUucG5nJTIyJTIwJTJGJTNFJTBBJTNDc3BhbiUzRUFjY2VkaSUyMGFsbGElMjBjaGF0JTNDJTJGc3BhbiUzRSUwQSUzQyUyRmElM0UlMEElM0MlMkZkaXYlM0U=[\/vc_raw_html][\/vc_column][\/vc_row][\/vc_section][vc_section el_id=”featuredSolutions”][vc_row el_class=”side-by-side”][vc_column width=”1\/2″ el_class=”side-left align-right hasImage” css=”.vc_custom_1581878657161{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2018\/01\/guidance-on-medical-device.jpg?id=40116) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column_text el_class=”side-title-block”]\n

Registrazione FDA
\ne Listing<\/h2>\n[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ el_class=”side-right align-left”][vc_column_text el_class=”side-text-block”]I proprietari o gli operatori delle aziende coinvolte nella produzione e distribuzione di dispositivi medici destinati a essere utilizzati negli Stati Uniti sono tenuti a registrarsi presso la U.S. FDA ogni anno. Le imprese che producono, imballano, etichettano o ricondizionano dispositivi medici sono tenute al versamento di una quota annuale. Molte aziende che necessitano della registrazione U.S. FDA hanno l\u2019obbligo supplementare di elencare tutti i loro dispositivi destinati al mercato USA.[\/vc_column_text][vc_column_text el_class=”side-links”]Iniziare<\/a><\/p>\n

Costi<\/a>[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_class=”side-by-side mobile-reverse”][vc_column width=”1\/2″ el_class=”side-left align-left” css=”.vc_custom_1570054217097{background-color: #3b4254 !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column_text el_class=”side-text-block font-white”]La maggior parte dei dispositivi medici distribuiti negli Stati Uniti deve includere un codice numerico o alfanumerico come \u201cUnique Device Identifier\u201d (UDI). Inoltre, la FDA richiede la sottomissione di informazioni relative al dispositivo e al codice UDI attraverso il database GUDID.[\/vc_column_text][vc_column_text el_class=”side-links font-white”]Iniziare<\/a><\/p>\n

Costi<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ el_class=”side-right align-left hasImage” css=”.vc_custom_1581878635150{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2018\/06\/developments-in-udi.jpg?id=40031) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column_text el_class=”side-title-block”]\n

UDI e
\nGUDID<\/h2>\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_class=”side-by-side”][vc_column width=”1\/2″ el_class=”side-left align-right hasImage” css=”.vc_custom_1581878753081{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2019\/10\/VoluntaryMalfunctionSummary.jpg?id=39819) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column_text el_class=”side-title-block”]\n

Electronic Medical
\nDevice Reporting (eMDR)<\/h2>\n[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ el_class=”side-right align-left”][vc_column_text el_class=”side-text-block”]La FDA richiede che i produttori e gli importatori di dispositivi medici sottomettano i rapporti per gli eventi avversi in formato elettronico alla FDA. Tali rapporti devono essere inviati nel caso ci siano prove che il dispositivo possa aver contribuito al decesso del paziente o a gravi lesioni, o quando un malfunzionamento (o ricomparsa del malfunzionamento) potrebbero contribuire al decesso del paziente o a gravi lesioni.[\/vc_column_text][vc_column_text el_class=”side-links”]Iniziare<\/a><\/p>\n

Costi<\/a>[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_class=”side-by-side mobile-reverse”][vc_column width=”1\/2″ el_class=”side-left align-left” css=”.vc_custom_1570054217097{background-color: #3b4254 !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column_text el_class=”side-text-block font-white”]Un Medical Device Master File \u00e8 una documentazione da sottomettere alla U.S. FDA, che pu\u00f2 essere utilizzata a sostegno delle sottomissioni pre-market e che permette di fornire informazioni confidenziali dettagliate sugli stabilimenti, i processi o i prodotti utilizzati nella produzione, trasformazione, confezionamento e la conservazione di uno o pi\u00f9 dispositivi medici. Gli specialisti di Registrar Corp potranno fornire indicazioni in merito agli elementi richiesti, i formati, e le particolarit\u00e0 di presentazione di un Medical Device Master File.[\/vc_column_text][vc_column_text el_class=”side-links font-white”]Iniziare<\/a><\/p>\n

Costi<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ el_class=”side-right align-left hasImage” css=”.vc_custom_1581878724416{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2018\/09\/veterinary-master-files.jpg?id=39982) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column_text el_class=”side-title-block”]\n

Medical Device
\nMaster Files<\/h2>\n[\/vc_column_text][\/vc_column][\/vc_row][\/vc_section][vc_section css=”.vc_custom_1574176315943{background-color: #ececec !important;}”][vc_row equal_height=”yes” el_class=”grid-tiles”][vc_column width=”1\/2″ offset=”vc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1581976671879{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2019\/04\/9-of-medical-device.jpg?id=39918) !important;}” el_class=”grid-tile-title hasImage”]\n

Revisione Prodotto
\ned Etichettatura<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Gli errori di etichettatura sono una delle cause principali delle detenzioni in dogana da parte della FDA. Registrar Corp assiste le aziende alimentari a modificare le proprie etichette per i dispositivi medici affinch\u00e9 siano conformi alle normative della FDA. Registrar Corp fornisce un file grafico pronto per la stampa e un rapporto dettagliato sulla regolamentazione, le linee guida, le warning letter, le import alert e altri documenti emessi dalla FDA.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Iniziare<\/a><\/p>\n

Costi<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ offset=”vc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1582657607318{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/color-additive.jpg?id=41657) !important;}” el_class=”grid-tile-title hasImage”]\n

Requisiti Color Additive<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Un colorante per dispositivi medici \u00e9 qualsiasi tintura, pigmento o altra sostanza in grado di attribuire colore a un dispositivo medico. Tali coloranti additivi sono regolamentati dalla FDA.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Iniziare<\/a><\/p>\n

Costi<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ offset=”vc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1581976755946{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/detention-scaled.jpg?id=41099) !important;}” el_class=”grid-tile-title hasImage”]\n

Assistenza detenzioni<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Le aziende che esportano verso gli Stati Uniti possono trovarsi ad avere i propri prodotti denenuti senza previo controllo fisico dalla FDA. I prodotti soggetti a Detention Without Physical Examination (\u201cDWPE\u201d) sono trattenuti al porto di entrata mentre la FDA esegue controlli, analisi e test aggiuntivi. I ritardi causati dalla DWPE possono essere lunghi, specialmente per le aziende che hanno delle scadenze di consegna.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Iniziare<\/a><\/p>\n

Costi<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ offset=”vc_col-lg-offset-4 vc_col-lg-4 vc_col-md-offset-3 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1581976836646{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/export-certs-scaled.jpg?id=41085) !important;}” el_class=”grid-tile-title hasImage”]\n

Export Certificate per governi stranieri<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Gli stabilimenti statunitensi che esportano all\u2019estero ricevono spesso la richiesta dei propri clienti o dei governi extra-nazionali di poter fornire un \u201cExport Certificate\u201d, relativamente ai prodotti regolati dalla normativa U.S. FDA. L\u2019Export Certificate \u00e8 un documento preparato dalla U.S. FDA che contiene le informazioni relative alla normativa specifica applicabile al prodotto e allo status di commercializzazione.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Iniziare<\/a><\/p>\n

Costi<\/a>[\/vc_column_text][\/vc_column][\/vc_row][\/vc_section][vc_row][vc_column]

<\/i><\/i><\/div><\/div><\/div>
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[vc_section el_id=”pageHero” css=”.vc_custom_1581878044647{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/md-hero.jpg?id=41288) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}” el_class=”page-solutions”][vc_row el_class=”page-marquee”][vc_column][vc_column_text el_class=”half-width”] Dispositivi Medici Registrazione FDA (U.S. Food and Drug Administration) [\/vc_column_text][vc_row_inner el_class=”row-content-center”][vc_column_inner][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row el_class=”hero-footer”][vc_column][vc_raw_html]JTNDZGl2JTIwY2xhc3MlM0QlMjJzb2x1dGlvbnMtaGVyby1mb290ZXIlMjIlM0UlMEElM0NzcGFuJTIwY2xhc3MlM0QlMjJ0ZXh0JTIyJTNFTm9uJTIwc2FpJTIwZGElMjBkb3ZlJTIwaW5pemlhcmUlM0YlM0MlMkZzcGFuJTNFJTBBJTNDYSUyMGhyZWYlM0QlMjIlMjMlMjIlMjBjbGFzcyUzRCUyMmNoYXQtYnRuJTIwYnRuLWJsdWUtd2hpdGUlMjBidG4tZmxleCUyMiUzRSUwQSUzQ2ltZyUyMHNyYyUzRCUyMiUyRndwLWNvbnRlbnQlMkZ1cGxvYWRzJTJGMjAxOSUyRjEwJTJGQ2hhdF9idWJibGUucG5nJTIyJTIwJTJGJTNFJTBBJTNDc3BhbiUzRUFjY2VkaSUyMGFsbGElMjBjaGF0JTNDJTJGc3BhbiUzRSUwQSUzQyUyRmElM0UlMEElM0MlMkZkaXYlM0U=[\/vc_raw_html][\/vc_column][\/vc_row][\/vc_section][vc_section el_id=”featuredSolutions”][vc_row el_class=”side-by-side”][vc_column width=”1\/2″ el_class=”side-left align-right hasImage” css=”.vc_custom_1581878657161{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2018\/01\/guidance-on-medical-device.jpg?id=40116) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column_text el_class=”side-title-block”] Registrazione FDA e Listing [\/vc_column_text][\/vc_column][vc_column width=”1\/2″ el_class=”side-right align-left”][vc_column_text el_class=”side-text-block”]I proprietari o gli operatori<\/p>\n","protected":false},"author":2,"featured_media":402,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"full-width-page.php","meta":{"content-type":"","om_disable_all_campaigns":false,"inline_featured_image":false,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"class_list":{"0":"post-41381","1":"page","2":"type-page","3":"status-publish","4":"has-post-thumbnail","6":"entry"},"yoast_head":"\nDispositivi Medici - Registrar<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"it_IT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Dispositivi Medici\" \/>\n<meta property=\"og:description\" content=\"[vc_section el_id=”pageHero” css=”.vc_custom_1581878044647{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/md-hero.jpg?id=41288) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}” el_class=”page-solutions”][vc_row el_class=”page-marquee”][vc_column][vc_column_text el_class=”half-width”] Dispositivi Medici Registrazione FDA (U.S. Food and Drug Administration) [\/vc_column_text][vc_row_inner el_class=”row-content-center”][vc_column_inner][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row el_class=”hero-footer”][vc_column][vc_raw_html]JTNDZGl2JTIwY2xhc3MlM0QlMjJzb2x1dGlvbnMtaGVyby1mb290ZXIlMjIlM0UlMEElM0NzcGFuJTIwY2xhc3MlM0QlMjJ0ZXh0JTIyJTNFTm9uJTIwc2FpJTIwZGElMjBkb3ZlJTIwaW5pemlhcmUlM0YlM0MlMkZzcGFuJTNFJTBBJTNDYSUyMGhyZWYlM0QlMjIlMjMlMjIlMjBjbGFzcyUzRCUyMmNoYXQtYnRuJTIwYnRuLWJsdWUtd2hpdGUlMjBidG4tZmxleCUyMiUzRSUwQSUzQ2ltZyUyMHNyYyUzRCUyMiUyRndwLWNvbnRlbnQlMkZ1cGxvYWRzJTJGMjAxOSUyRjEwJTJGQ2hhdF9idWJibGUucG5nJTIyJTIwJTJGJTNFJTBBJTNDc3BhbiUzRUFjY2VkaSUyMGFsbGElMjBjaGF0JTNDJTJGc3BhbiUzRSUwQSUzQyUyRmElM0UlMEElM0MlMkZkaXYlM0U=[\/vc_raw_html][\/vc_column][\/vc_row][\/vc_section][vc_section el_id=”featuredSolutions”][vc_row el_class=”side-by-side”][vc_column width=”1\/2″ el_class=”side-left align-right hasImage” css=”.vc_custom_1581878657161{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2018\/01\/guidance-on-medical-device.jpg?id=40116) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column_text el_class=”side-title-block”] Registrazione FDA e Listing [\/vc_column_text][\/vc_column][vc_column width=”1\/2″ el_class=”side-right align-left”][vc_column_text el_class=”side-text-block”]I proprietari o gli operatori\" \/>\n<meta property=\"og:url\" content=\"https:\/\/legacy.registrarcorp.com\/it\/fda-medical-devices\/\" \/>\n<meta property=\"og:site_name\" content=\"Registrar\" \/>\n<meta property=\"article:modified_time\" content=\"2020-07-28T19:30:28+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2019\/08\/press_release.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1650\" \/>\n\t<meta property=\"og:image:height\" content=\"500\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"7 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/it\/fda-medical-devices\/\",\"url\":\"https:\/\/legacy.registrarcorp.com\/it\/fda-medical-devices\/\",\"name\":\"Dispositivi Medici - 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