{"id":41382,"date":"2016-03-14T22:54:54","date_gmt":"2016-03-15T02:54:54","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-medical-devices\/"},"modified":"2020-07-07T16:32:25","modified_gmt":"2020-07-07T16:32:25","slug":"fda-medical-devices","status":"publish","type":"page","link":"https:\/\/legacy.registrarcorp.com\/pt\/fda-medical-devices\/","title":{"rendered":"Dispositivos M\u00e9dicos"},"content":{"rendered":"
[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”]\n

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

Registre-se com a Food and Drug Administration (FDA) dos EUA<\/strong><\/h2>\n[\/vc_column_text][vc_row_inner el_class=”row-content-center”][vc_column_inner]
Iniciar<\/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]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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”]\n

Registro e
\nListagem<\/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”]Os propriet\u00e1rios ou operadores de locais envolvidos na produ\u00e7\u00e3o e distribui\u00e7\u00e3o de dispositivos m\u00e9dicos destinados aos Estados Unidos devem registrar-se na FDA anualmente. As empresas envolvidas na fabrica\u00e7\u00e3o, embalagem, rotulagem ou reprocessamento ou dispositivos devem pagar uma taxa anual. Muitos estabelecimentos que s\u00e3o obrigados a se registrar na FDA s\u00e3o obrigados a listar seus dispositivos.[\/vc_column_text][vc_column_text el_class=”side-links”]Iniciar<\/a><\/p>\n

Pre\u00e7os<\/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”]A maioria dos dispositivos m\u00e9dicos distribu\u00eddos nos EUA s\u00e3o obrigados a incluir um c\u00f3digo num\u00e9rico ou alfanum\u00e9rico como um identificador \u00fanico de dispositivo (UDI). A FDA tamb\u00e9m exige o envio de informa\u00e7\u00f5es de dispositivo e UDI para o banco de dados global de identificadores exclusivos de dispositivos (GUDID).[\/vc_column_text][vc_column_text el_class=”side-links font-white”]Iniciar<\/a><\/p>\n

Pre\u00e7os<\/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

Relat\u00f3rio de Dispositivos
\nM\u00e9dicos Eletr\u00f4nicos (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”]A FDA agora requer que fabricantes e importadores de dispositivos m\u00e9dicos enviem relat\u00f3rios de eventos adversos em formato eletr\u00f4nico. Os fabricantes e importadores de dispositivos devem enviar relat\u00f3rios de eventos adversos \u00e0 FDA quando a evid\u00eancia sugerir que um dispositivo pode ter contribu\u00eddo para a morte do paciente ou ferimentos graves, ou quando um mau funcionamento do dispositivo em recorr\u00eancia de mau funcionamento provavelmente contribuiriam para morte ou ferimentos graves.[\/vc_column_text][vc_column_text el_class=”side-links”]Iniciar<\/a><\/p>\n

Pre\u00e7os<\/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”]Um arquivo principal de dispositivo m\u00e9dico \u00e9 uma submiss\u00e3o \u00e0 FDA que pode ser usada no suporte de envios de pr\u00e9-comercializa\u00e7\u00e3o para fornecer informa\u00e7\u00f5es confidenciais detalhadas sobre estabelecimentos, processos ou artigos usados \u200b\u200bna fabrica\u00e7\u00e3o, processamento, empacotamento e armazenamento de um ou mais dispositivos m\u00e9dicos. A equipe de especialistas em regulamenta\u00e7\u00f5es de dispositivos m\u00e9dicos da Registrar Corp fornece orienta\u00e7\u00f5es sobre os elementos, formatos e particularidades exigidos dos envios do arquivo principal de dispositivos m\u00e9dicos.[\/vc_column_text][vc_column_text el_class=”side-links font-white”]Iniciar<\/a><\/p>\n

Pre\u00e7os<\/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

Arquivos principais
\ndo dispositivo m\u00e9dico<\/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_1581977217946{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

Revis\u00e3o de Rotulagem
\ne Produtos<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Erros de rotulagem s\u00e3o uma das principais causas de deten\u00e7\u00f5es por parte da FDA. A Registrar Corp ajuda as empresas a modificar a rotulagem de dispositivos m\u00e9dicos para cumprir os regulamentos da FDA. A Registrar Corp fornece gr\u00e1ficos revisados \u200b\u200bprontos para serem impressos ou editados, al\u00e9m de relat\u00f3rios sobre as regulamenta\u00e7\u00f5es, guias de conformidade, cartas de alerta, alertas de importa\u00e7\u00e3o e outros documentos de orienta\u00e7\u00e3o da FDA.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Iniciar<\/a><\/p>\n

Pre\u00e7os<\/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_1582657619847{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/color-additive.jpg?id=41658) !important;}” el_class=”grid-tile-title hasImage”]\n

Requerimentos para Aditivos de Cor<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Um aditivo de colora\u00e7\u00e3o de dispositivo m\u00e9dico \u00e9 qualquer corante, pigmento ou outra subst\u00e2ncia que possa transmitir cor a um dispositivo m\u00e9dico. Os aditivos de cor para dispositivos m\u00e9dicos s\u00e3o regulados pela FDA.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Iniciar<\/a><\/p>\n

Pre\u00e7os<\/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_1581977303503{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

Assist\u00eancia com Deten\u00e7\u00f5es<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Empresas enviando produtos para os Estados Unidos podem encontrar seus envios sujeitos \u00e0 Deten\u00e7\u00e3o sem Avalia\u00e7\u00e3o F\u00edsica (DWPE) pela FDA. Produtos sujeitos \u00e0 DWPE s\u00e3o retidos no porto de entrada enquanto a FDA realiza fiscaliza\u00e7\u00e3o adicional, testes e an\u00e1lises. Atrasos devido a DWPE podem prolongar a apreens\u00e3o para entregar os produtos dentro do prazo.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Iniciar<\/a><\/p>\n

Pre\u00e7os<\/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_1581977346126{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

Certificados de exporta\u00e7\u00e3o para Governos estrangeiros<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Empresas que exportam produtos dos Estados Unidos s\u00e3o frequentemente solicitadas por clientes estrangeiros ou governos estrangeiros a fornecer e \u201cCertificado de Exporta\u00e7\u00e3o\u201d para produtos regulados pela FDA. Um Certificado de Exporta\u00e7\u00e3o \u00e9 um documento preparado pela FDA contendo informa\u00e7\u00f5es sobre regulamenta\u00e7\u00f5es de produtos ou status comercial.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Iniciar<\/a><\/p>\n

Pre\u00e7os<\/a>[\/vc_column_text][\/vc_column][\/vc_row][\/vc_section][vc_row][vc_column]

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

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