{"id":41380,"date":"2016-03-14T22:54:54","date_gmt":"2016-03-15T02:54:54","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-medical-devices\/"},"modified":"2020-07-07T16:31:36","modified_gmt":"2020-07-07T16:31:36","slug":"fda-medical-devices","status":"publish","type":"page","link":"https:\/\/legacy.registrarcorp.com\/de\/fda-medical-devices\/","title":{"rendered":"Medizinische Ger\u00e4te"},"content":{"rendered":"
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Medizinische Ger\u00e4te<\/h1>\n
\n

Registrieren Sie sich bei der U.S. Food and Drug Administration (FDA)<\/strong><\/h2>\n[\/vc_column_text][vc_row_inner el_class=”row-content-center”][vc_column_inner]
Beginnen<\/span><\/div>
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FDA Registrierung
\nund Auflistung<\/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”]Inhaber oder Betreiber von Einrichtungen, die an der Herstellung und dem Vertrieb von zur Verwendung in den USA bestimmten medizinischen Ger\u00e4ten beteiligt sind, m\u00fcssen sich j\u00e4hrlich bei der FDA registrieren. Unternehmen, die an der Herstellung, Verpackung, Etikettierung oder Wiederaufbereitung von Ger\u00e4ten beteiligt sind, m\u00fcssen eine j\u00e4hrliche Geb\u00fchr entrichten. Viele Einrichtungen, die sich bei der FDA registrieren m\u00fcssen, m\u00fcssen auch ihre Ger\u00e4te auflisten.[\/vc_column_text][vc_column_text el_class=”side-links”]Beginnen<\/a><\/p>\n

Preisgestaltung<\/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”]Die meisten in den USA vertriebenen medizinischen Ger\u00e4te m\u00fcssen einen numerischen oder alphanumerischen Code als eindeutige Ger\u00e4tekennung (UDI) enthalten. Die FDA erfordert auch die \u00dcbermittlung von Ger\u00e4te- und UDI-Informationen an die GUDID (Global Unique Device Identifier Database).[\/vc_column_text][vc_column_text el_class=”side-links font-white”]Beginnen<\/a><\/p>\n

Preisgestaltung<\/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 und
\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

Elektronische
\nMedizinger\u00e4t-Berichterstattung (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”]Die FDA verlangt nun, dass Hersteller und Importeure von Medizinprodukten Berichte \u00fcber unerw\u00fcnschte Ereignisse (adverse events reports) in elektronischer Form vorlegen m\u00fcssen. Ger\u00e4tehersteller und Importeure von Ger\u00e4ten m\u00fcssen der FDA Berichte \u00fcber unerw\u00fcnschte Ereignisse vorlegen, wenn Anhaltspunkte daf\u00fcr vorliegen, dass ein Ger\u00e4t zum Tod oder zu schweren Verletzungen des Patienten beigetragen hat oder wenn Fehlfunktionen und Wiederauftreten der Fehlfunktion eines Ger\u00e4ts wahrscheinlich zum Tod oder zu schweren Verletzungen f\u00fchren.[\/vc_column_text][vc_column_text el_class=”side-links”]Beginnen<\/a><\/p>\n

Preisgestaltung<\/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”]Eine Master-Datei f\u00fcr medizinische Ger\u00e4te (Medical Device Master File (MAF)) ist eine Einreichung bei der FDA, die zur Unterst\u00fctzung von Premarket-Einreichungen verwendet werden kann, um vertrauliche, detaillierte Informationen \u00fcber Einrichtungen, Prozesse oder Artikel bereitzustellen, die bei der Herstellung, Verarbeitung, Verpackung und Lagerung von einem oder mehreren medizinischen Ger\u00e4ten verwendet werden. Das Experten-Team f\u00fcr Registrierungen medizinischer Ger\u00e4te bietet Anleitungen zu den erforderlichen Elementen, Formaten und Besonderheiten f\u00fcr die \u00dcbermittlung von Medical Device Master Files (MAF).[\/vc_column_text][vc_column_text el_class=”side-links font-white”]Beginnen<\/a><\/p>\n

Preisgestaltung<\/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_1581976271397{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

Etikettierung und Produkt\u00fcberpr\u00fcfung<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Fehler bei der Kennzeichnung sind eine der Hauptursachen f\u00fcr die Zur\u00fcckhaltung durch die FDA. Registrar Corp hilft Unternehmen, die Etikettierung von Medizinprodukten an die FDA Vorschriften anzupassen. Registrar Corp stellt \u00fcberarbeitete Grafikdateien bereit, die zum Drucken oder Bearbeiten bereitstehen, sowie einen Bericht, in dem die Vorschriften, Compliance-Richtlinien, Warnschreiben, Importwarnungen und andere Anleitungen der FDA aufgef\u00fchrt sind.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Beginnen<\/a><\/p>\n

Preisgestaltung<\/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_1582657592566{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/color-additive.jpg?id=41656) !important;}” el_class=”grid-tile-title hasImage”]\n

Anforderungen f\u00fcr Farbadditive<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Ein Farbstoffadditiv f\u00fcr ein Medizinprodukt ist ein Farbstoff, Pigment oder eine andere Substanz, die einem Medizinprodukt Farbe verleihen kann. Farbadditive f\u00fcr medizinische Ger\u00e4te werden von der FDA reguliert.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Beginnen<\/a><\/p>\n

View Pricing<\/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_1581976365655{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

Hilfe bei Beschlagnahmung<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Unternehmen, die Produkte in die Vereinigten Staaten versenden, k\u00f6nnen feststellen, dass ihre Sendungen von der FDA der Zur\u00fcckhaltung ohne physische Untersuchung (DWPE) unterliegen. Produkte, die DWPE unterliegen, werden am Einfuhrhafen angehalten, w\u00e4hrend die FDA zus\u00e4tzliche Pr\u00fcfungen, Tests und Analysen durchf\u00fchrt. Verz\u00f6gerungen durch DWPE k\u00f6nnen f\u00fcr Unternehmen, die ihre Produkte termingerecht liefern m\u00f6chten, unagenehm lange dauern.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Beginnen<\/a><\/p>\n

Preisgestaltung<\/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_1581976410071{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

Exportzertifikate an ausl\u00e4ndische Regierungen<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Unternehmen, die Produkte aus den USA exportieren, werden h\u00e4ufig von ausl\u00e4ndischen Kunden oder ausl\u00e4ndischen Regierungen aufgefordert, ein \u201cExport Certificate\u201d f\u00fcr von der FDA regulierte Produkte vorzulegen. Ein Exportzertifikat ist ein von der FDA erstelltes Dokument, das Informationen zum regulatorischen oder Vermarktungs-Status eines Produkts enth\u00e4lt.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Beginnen<\/a><\/p>\n

Preisgestaltung<\/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”] Medizinische Ger\u00e4te Registrieren Sie sich bei der U.S. Food and Drug Administration (FDA) [\/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]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[\/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”] FDA Registrierung und Auflistung [\/vc_column_text][\/vc_column][vc_column width=”1\/2″ el_class=”side-right align-left”][vc_column_text el_class=”side-text-block”]Inhaber<\/p>\n","protected":false},"author":2,"featured_media":401,"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":["post-41380","page","type-page","status-publish","has-post-thumbnail","entry"],"yoast_head":"\nMedizinische Ger\u00e4te - 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=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medizinische Ger\u00e4te\" \/>\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”] Medizinische Ger\u00e4te Registrieren Sie sich bei der U.S. Food and Drug Administration (FDA) [\/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]JTNDZGl2JTIwY2xhc3MlM0QlMjJzb2x1dGlvbnMtaGVyby1mb290ZXIlMjIlM0UlMEElM0NzcGFuJTIwY2xhc3MlM0QlMjJ0ZXh0JTIyJTNFTmljaHQlMjBzaWNoZXIlMjB3byUyMFNpZSUyMHN0YXJ0ZW4lMjBzb2xsZW4lM0YlM0MlMkZzcGFuJTNFJTBBJTNDYSUyMGhyZWYlM0QlMjIlMjMlMjIlMjBjbGFzcyUzRCUyMmNoYXQtYnRuJTIwYnRuLWJsdWUtd2hpdGUlMjBidG4tZmxleCUyMiUzRSUwQSUzQ2ltZyUyMHNyYyUzRCUyMiUyRndwLWNvbnRlbnQlMkZ1cGxvYWRzJTJGMjAxOSUyRjEwJTJGQ2hhdF9idWJibGUucG5nJTIyJTIwJTJGJTNFJTBBJTNDc3BhbiUzRUNoYXR0ZW4lMjBTaWUlMjBqZXR6dCUzQyUyRnNwYW4lM0UlMEElM0MlMkZhJTNFJTBBJTNDJTJGZGl2JTNF[\/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”] FDA Registrierung und Auflistung [\/vc_column_text][\/vc_column][vc_column width=”1\/2″ el_class=”side-right align-left”][vc_column_text el_class=”side-text-block”]Inhaber\" \/>\n<meta property=\"og:url\" content=\"https:\/\/legacy.registrarcorp.com\/de\/fda-medical-devices\/\" \/>\n<meta property=\"og:site_name\" content=\"Registrar\" \/>\n<meta property=\"article:modified_time\" content=\"2020-07-07T16:31:36+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\/de\/fda-medical-devices\/\",\"url\":\"https:\/\/legacy.registrarcorp.com\/de\/fda-medical-devices\/\",\"name\":\"Medizinische Ger\u00e4te - 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