{"id":41383,"date":"2016-03-14T22:54:54","date_gmt":"2016-03-15T02:54:54","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-medical-devices\/"},"modified":"2020-07-07T16:32:42","modified_gmt":"2020-07-07T16:32:42","slug":"fda-medical-devices","status":"publish","type":"page","link":"https:\/\/legacy.registrarcorp.com\/es\/fda-medical-devices\/","title":{"rendered":"Dispositivos m\u00e9dicos"},"content":{"rendered":"
[vc_section el_id=\u00bbpageHero\u00bb css=\u00bb.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;}\u00bb el_class=\u00bbpage-solutions\u00bb][vc_row el_class=\u00bbpage-marquee\u00bb][vc_column][vc_column_text el_class=\u00bbhalf-width\u00bb]\n

Dispositivos m\u00e9dicos<\/h1>\n
\n

Registro con la administraci\u00f3n de alimentos y medicamentos de los estados unidos (FDA)<\/strong><\/h2>\n[\/vc_column_text][vc_row_inner el_class=\u00bbrow-content-center\u00bb][vc_column_inner]
Iniciar<\/span><\/div>
<\/div><\/a>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row el_class=\u00bbhero-footer\u00bb][vc_column][vc_raw_html]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[\/vc_raw_html][\/vc_column][\/vc_row][\/vc_section][vc_section el_id=\u00bbfeaturedSolutions\u00bb][vc_row el_class=\u00bbside-by-side\u00bb][vc_column width=\u00bb1\/2″ el_class=\u00bbside-left align-right hasImage\u00bb css=\u00bb.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;}\u00bb][vc_column_text el_class=\u00bbside-title-block\u00bb]\n

Registro FDA
\ny Listado<\/h2>\n[\/vc_column_text][\/vc_column][vc_column width=\u00bb1\/2″ el_class=\u00bbside-right align-left\u00bb][vc_column_text el_class=\u00bbside-text-block\u00bb]Propietarios o titulares de los establecimientos que participan en la producci\u00f3n y distribuci\u00f3n de dispositivos m\u00e9dicos para uso en los Estados Unidos deben registrarse anualmente con FDA. Las empresas dedicadas a la fabricaci\u00f3n, envasado, etiquetado, o el reprocesamiento de los dispositivos deben pagar una cuota anual. Muchos establecimientos que est\u00e1n obligados a registrarse con FDA tambi\u00e9n est\u00e1n obligados a la lista de sus dispositivos.[\/vc_column_text][vc_column_text el_class=\u00bbside-links\u00bb]Iniciar<\/a><\/p>\n

Honorarios<\/a>[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_class=\u00bbside-by-side mobile-reverse\u00bb][vc_column width=\u00bb1\/2″ el_class=\u00bbside-left align-left\u00bb css=\u00bb.vc_custom_1570054217097{background-color: #3b4254 !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}\u00bb][vc_column_text el_class=\u00bbside-text-block font-white\u00bb]Muchos de los dispositivos m\u00e9dicos distribuidos en los EE.UU. requieren incluir un c\u00f3digo num\u00e9rico o alfanum\u00e9rico como un Identificador \u00danico de Dispositivo (Unique Device Identifier \u2013 UDI). Adicionalmente FDA requiere la presentaci\u00f3n de la informaci\u00f3n del dispositivo y del UDI a la Base de Datos Global de Identificadores \u00danicos de Dispositivos (Global Unique Device Identifier Database -GUDID).[\/vc_column_text][vc_column_text el_class=\u00bbside-links font-white\u00bb]Iniciar<\/a><\/p>\n

Honorarios<\/a>[\/vc_column_text][\/vc_column][vc_column width=\u00bb1\/2″ el_class=\u00bbside-right align-left hasImage\u00bb css=\u00bb.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;}\u00bb][vc_column_text el_class=\u00bbside-title-block\u00bb]\n

UDI y
\nGUDID<\/h2>\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_class=\u00bbside-by-side\u00bb][vc_column width=\u00bb1\/2″ el_class=\u00bbside-left align-right hasImage\u00bb css=\u00bb.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;}\u00bb][vc_column_text el_class=\u00bbside-title-block\u00bb]\n

Informe electr\u00f3nico U.S. FDA
\nde dispositivo m\u00e9dico (eMDR)<\/h2>\n[\/vc_column_text][\/vc_column][vc_column width=\u00bb1\/2″ el_class=\u00bbside-right align-left\u00bb][vc_column_text el_class=\u00bbside-text-block\u00bb]FDA ahora requiere que fabricantes e importadores de dispositivos m\u00e9dicos presente reportes de eventos adversos en formato electr\u00f3nico. Fabricantes e importadores de dispositivos deben presentar estos reportes a FDA cuando la evidencia sugiere que un dispositivo pudo haber contribuido al deceso o da\u00f1o severo de un paciente, o cuando el funcionamiento incorrecto o recurrencia de este mal funcionamiento del dispositivo pudo haber contribuido al deceso o da\u00f1o severo de un paciente.[\/vc_column_text][vc_column_text el_class=\u00bbside-links\u00bb]Iniciar<\/a><\/p>\n

Honorarios<\/a>[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_class=\u00bbside-by-side mobile-reverse\u00bb][vc_column width=\u00bb1\/2″ el_class=\u00bbside-left align-left\u00bb css=\u00bb.vc_custom_1570054217097{background-color: #3b4254 !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}\u00bb][vc_column_text el_class=\u00bbside-text-block font-white\u00bb]Un Archivo Maestro de dispositivos m\u00e9dicos es una sumisi\u00f3n a FDA que se puede utilizar en apoyo a las sumisiones previas a la comercializaci\u00f3n para facilitar informaci\u00f3n confidencial detallada sobre los establecimientos, procesos, o art\u00edculos usados en la fabricaci\u00f3n, elaboraci\u00f3n, envasado y almacenamiento de uno o m\u00e1s dispositivos m\u00e9dicos. El equipo de expertos de Registrar Corp en regulaciones para dispositivos m\u00e9dicos proporciona orientaci\u00f3n sobre los elementos requeridos, formatos y particularidades de las sumisiones de Archivos Maestros de dispositivos m\u00e9dicos.[\/vc_column_text][vc_column_text el_class=\u00bbside-links font-white\u00bb]Iniciar<\/a><\/p>\n

Honorarios<\/a>[\/vc_column_text][\/vc_column][vc_column width=\u00bb1\/2″ el_class=\u00bbside-right align-left hasImage\u00bb css=\u00bb.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;}\u00bb][vc_column_text el_class=\u00bbside-title-block\u00bb]\n

Archivos Maestros de
\ndispositivos m\u00e9dicos<\/h2>\n[\/vc_column_text][\/vc_column][\/vc_row][\/vc_section][vc_section css=\u00bb.vc_custom_1574176315943{background-color: #ececec !important;}\u00bb][vc_row equal_height=\u00bbyes\u00bb el_class=\u00bbgrid-tiles\u00bb][vc_column width=\u00bb1\/2″ offset=\u00bbvc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=\u00bb.vc_custom_1581974719219{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2019\/04\/9-of-medical-device.jpg?id=39918) !important;}\u00bb el_class=\u00bbgrid-tile-title hasImage\u00bb]\n

Revisi\u00f3n de Producto y Etiquetado<\/h2>\n[\/vc_column_text][vc_column_text el_class=\u00bbgrid-tile-block\u00bb]Los errores de etiquetado son la principal causa de detenciones por parte de FDA. Registrar Corp ayuda a las empresas modificar el etiquetado de los dispositivos m\u00e9dicos para cumplir con regulaciones de FDA. Registrar Corp provee archivos gr\u00e1ficos revisados listos para ser impresos o editados, y un informe que detalla las normas, el cumplimiento de las gu\u00edas, cartas de advertencia, las alertas de importaci\u00f3n, y otros documentos de orientaci\u00f3n de FDA.[\/vc_column_text][vc_column_text el_class=\u00bbgrid-tile-links\u00bb]Iniciar<\/a><\/p>\n

Honorarios<\/a>[\/vc_column_text][\/vc_column][vc_column width=\u00bb1\/2″ offset=\u00bbvc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=\u00bb.vc_custom_1582657631758{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/color-additive-scaled.jpg?id=41652) !important;}\u00bb el_class=\u00bbgrid-tile-title hasImage\u00bb]\n

Requisitos para Colorantes<\/h2>\n[\/vc_column_text][vc_column_text el_class=\u00bbgrid-tile-block\u00bb]Un aditivo colorante de dispositivos m\u00e9dicos es cualquier colorante, pigmento, u otra sustancia que puede dar color a un dispositivo m\u00e9dico. Estos aditivos est\u00e1n regulados por FDA. Para determinar la forma en que las regulaciones de los aditivos colorantes de FDA se aplican a los dispositivos m\u00e9dicos[\/vc_column_text][vc_column_text el_class=\u00bbgrid-tile-links\u00bb]Iniciar<\/a><\/p>\n

Honorarios<\/a>[\/vc_column_text][\/vc_column][vc_column width=\u00bb1\/2″ offset=\u00bbvc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=\u00bb.vc_custom_1581974711528{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/detention-scaled.jpg?id=41099) !important;}\u00bb el_class=\u00bbgrid-tile-title hasImage\u00bb]\n

Asistencia con Detenciones<\/h2>\n[\/vc_column_text][vc_column_text el_class=\u00bbgrid-tile-block\u00bb]Las compa\u00f1\u00edas que exportan productos a los Estados Unidos pueden encontrar sus env\u00edos sometidos a una \u201cdetenci\u00f3n sin examen f\u00edsico\u201d por FDA. Los productos sujetos a detenci\u00f3n sin examen f\u00edsico son retenidos en el puerto de entrada, mientras que FDA realiza escrutinios, pruebas y an\u00e1lisis adicionales. Los retrasos por estas detenciones pueden resultar largos para las empresas deseosas de entregar productos a tiempo.[\/vc_column_text][vc_column_text el_class=\u00bbgrid-tile-links\u00bb]Iniciar<\/a><\/p>\n

Honorarios<\/a>[\/vc_column_text][\/vc_column][vc_column width=\u00bb1\/2″ offset=\u00bbvc_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=\u00bb.vc_custom_1581974770183{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/export-certs-scaled.jpg?id=41085) !important;}\u00bb el_class=\u00bbgrid-tile-title hasImage\u00bb]\n

Certificados de Exportaci\u00f3n para Gobiernos Extranjeros<\/h2>\n[\/vc_column_text][vc_column_text el_class=\u00bbgrid-tile-block\u00bb]Compa\u00f1\u00edas que exportar productos desde los Estados Unidos a menudo requieren presentar, ante agentes aduanales extranjeros o agencias gubernamentales extranjeras, un \u201cCertificado de Exportaci\u00f3n\u201d para productos regulados por FDA. Un Certificado de Exportaci\u00f3n es un documento preparado por FDA y contienen informaci\u00f3n sobre el estado regulatorio o comercial del producto.[\/vc_column_text][vc_column_text el_class=\u00bbgrid-tile-links\u00bb]Iniciar<\/a><\/p>\n

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

<\/i><\/i><\/div><\/div><\/div>
[vc_row_inner][vc_column_inner][vc_raw_html]JTNDaDIlM0UlM0NzcGFuJTIwY2xhc3MlM0QlMjJmZWUtc2VydmljZS1uYW1lJTIyJTNFJTNDJTJGc3BhbiUzRSUzQyUyRmgyJTNFJTBBJTNDdWwlM0UlM0MlMkZ1bCUzRQ==[\/vc_raw_html][\/vc_column_inner][\/vc_row_inner]<\/div><\/div><\/div>
<\/div>[\/vc_column][\/vc_row]\n<\/div>","protected":false},"excerpt":{"rendered":"

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