{"id":55788,"date":"2022-10-07T08:41:44","date_gmt":"2022-10-07T12:41:44","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-announces-new-medical-device-user-fees-for-fy-2023\/"},"modified":"2022-10-19T13:08:41","modified_gmt":"2022-10-19T17:08:41","slug":"fda-announces-new-medical-device-user-fees-for-fy-2023","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/pt\/fda-announces-new-medical-device-user-fees-for-fy-2023\/","title":{"rendered":"A FDA Anuncia Novas Taxas de Usu\u00e1rios de Dispositivos M\u00e9dicos Para o Ano Fiscal de 2023"},"content":{"rendered":"<p>A Administra\u00e7\u00e3o de Alimentos e Medicamentos nos EUA (FDA) anunciou as taxas para o Ano Fiscal (FY) 2023 sob as Emendas \u00e0s Taxas de Uso de Dispositivos M\u00e9dicos (MDUFA).<\/p>\n<p>O ano fiscal come\u00e7a em 1 de outubro de 2022 e termina em 30 de setembro de 2023. As instala\u00e7\u00f5es de dispositivos m\u00e9dicos devem pagar as taxas para manter seu status de conformidade com a FDA.<\/p>\n<p><strong>Taxas de Produtos M\u00e9dicos<\/strong><\/p>\n<p>A FDA exige taxas das instala\u00e7\u00f5es de dispositivos m\u00e9dicos cobrindo:<\/p>\n<ul>\n<li>Algumas aplica\u00e7\u00f5es de dispositivos m\u00e9dicos<\/li>\n<li>Relat\u00f3rios peri\u00f3dicos sobre dispositivos de Classe III<\/li>\n<li>Registro anual dos estabelecimentos<\/li>\n<\/ul>\n<p>Empresas com vendas totais inferiores a 100 milh\u00f5es de d\u00f3lares no ano fiscal mais recente podem se qualificar como pequenas empresas por uma taxa reduzida nas solicita\u00e7\u00f5es. As empresas com vendas totais inferiores a 30 milh\u00f5es de d\u00f3lares podem receber uma isen\u00e7\u00e3o de registros pela primeira vez ou de relat\u00f3rios de pr\u00e9-comercializa\u00e7\u00e3o. Se voc\u00ea se qualificou para uma taxa reduzida ou isenta no AF2022, voc\u00ea deve apresentar novamente suas informa\u00e7\u00f5es durante a renova\u00e7\u00e3o do FDA para continuar a se qualificar.<\/p>\n<p>Os registros de estabelecimento s\u00e3o consistentes em todos os tamanhos de empresas e devem ser pagos para completar os registros. Para a taxa de registro do estabelecimento, n\u00e3o h\u00e1 isen\u00e7\u00f5es ou redu\u00e7\u00f5es para pequenos estabelecimentos, empresas ou grupos. As empresas devem pagar a taxa de registro do estabelecimento para cada local f\u00edsico que possui a empresa e que cuida de certas fun\u00e7\u00f5es dos dispositivos m\u00e9dicos.<\/p>\n<p>As taxas de produtos m\u00e9dicos para o <a href=\"https:\/\/www.fda.gov\/industry\/fda-user-fee-programs\/medical-device-user-fee-amendments-mdufa\">ano fiscal de 2023<\/a> foram aumentadas em compara\u00e7\u00e3o ao ano fiscal de 2022. A FDA menciona que isto se deve ao fato de levar em conta a infla\u00e7\u00e3o do ano passado.<\/p>\n<p><strong>Ano fiscal 2023 Taxas MDUFA<\/strong><\/p>\n<table class=\"feeTable statistics\" style=\"border: 1px solid grey; border-spacing: 0px !important;\" border=\"1\" width=\"100%\">\n<tbody>\n<tr>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"229\"><strong>Tipo de Tarifa<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" colspan=\"2\" width=\"196\"><strong>2022<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" colspan=\"2\" width=\"213\"><strong>2023<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"229\">Registro Anual de Estabelecimentos<\/td>\n<td colspan=\"2\" width=\"196\">$5,546<\/td>\n<td colspan=\"2\" width=\"213\">$6,493<\/td>\n<\/tr>\n<tr>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"229\"><strong>Taxas de Aplica\u00e7\u00e3o<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"90\"><strong>Normal<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"106\"><strong>Pequenas Empresas<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"106\"><strong>Normal<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"106\"><strong>Pequenas Empresas<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"229\">510(k)<\/td>\n<td width=\"90\">$12,745<\/td>\n<td width=\"106\">$3,186<\/td>\n<td width=\"106\">$19,870<\/td>\n<td width=\"106\">$4,967<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">513(g)<\/td>\n<td width=\"90\">$5,061<\/td>\n<td width=\"106\">$2,530<\/td>\n<td width=\"106\">$5,961<\/td>\n<td width=\"106\">$2,980<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">Nova Classifica\u00e7\u00e3o<\/td>\n<td width=\"90\">$112,457<\/td>\n<td width=\"106\">$28,114<\/td>\n<td width=\"106\">$441,547<\/td>\n<td width=\"106\">$110,387<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">PMA, PDP, PMR, BLA<\/td>\n<td width=\"90\">$374,858<\/td>\n<td width=\"106\">$93,714<\/td>\n<td width=\"106\">$132,464<\/td>\n<td width=\"106\">$33,116<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">Suplemento de Painel<\/td>\n<td width=\"90\">$281,143<\/td>\n<td width=\"106\">$70,286<\/td>\n<td width=\"106\">$353,238<\/td>\n<td width=\"106\">$88,309<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">Suplemento de 180 dias<\/td>\n<td width=\"90\">$56,229<\/td>\n<td width=\"106\">$14,057<\/td>\n<td width=\"106\">$66,232<\/td>\n<td width=\"106\">$16,558<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">Suplemento em Tempo Real<\/td>\n<td width=\"90\">$26,240<\/td>\n<td width=\"106\">$6,560<\/td>\n<td width=\"106\">$30,908<\/td>\n<td width=\"106\">$7,727<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">Suplemento de efici\u00eancia BLA<\/td>\n<td width=\"90\">$374,858<\/td>\n<td width=\"106\">$93,714<\/td>\n<td width=\"106\">$441,547<\/td>\n<td width=\"106\">$110,387<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">Reporte Anual PMA<\/td>\n<td width=\"90\">$13,120<\/td>\n<td width=\"106\">$3,280<\/td>\n<td width=\"106\">$15,454<\/td>\n<td width=\"106\">$3,864<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>A FDA n\u00e3o considerar\u00e1 os registros de dispositivos m\u00e9dicos completos a menos que todos os pagamentos necess\u00e1rios tenham sido submetidos. Se os pagamentos n\u00e3o tiverem sido recebidos pela FDA at\u00e9 o prazo final de 31 de dezembro, suas instala\u00e7\u00f5es poder\u00e3o ser removidas do banco de dados da FDA, tornando seu registro inv\u00e1lido. A Registrar Corp pode ajud\u00e1-lo a determinar as taxas a que seu estabelecimento est\u00e1 sujeito e facilitar o pagamento \u00e0 FDA.<\/p>\n<div class=\"callout-row text-center margin-bottom\">\n<h3>Obtenha assist\u00eancia para conformidade com a FDA<\/h3>\n<p>Os especialistas em regulamenta\u00e7\u00e3o da Registrar Corp podem ajud\u00e1-lo a cumprir os regulamentos da FDA para dispositivos m\u00e9dicos.<\/p>\n<p>Para mais assist\u00eancia com as exig\u00eancias regulat\u00f3rias da FDA, ligue: +1-757-224-0177, ou envie um e-mail para: <a href=\"mailto:info@registrarcorp.com\">info@registrarcorp.com<\/a>, ou converse 24 horas por dia com um Consultor Regulat\u00f3rio: <a href=\"https:\/\/regstaging.wpengine.com\/livechat\">regstaging.wpengine.com\/livechat<\/a>.<\/p>\n<p class=\"btn-row\"><a class=\"btn btn-red-white\" href=\"https:\/\/regstaging.wpengine.com\/pt\/fda-medical-devices\/?lead_source=blog\">Obtenha Assist\u00eancia<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>A Administra\u00e7\u00e3o de Alimentos e Medicamentos nos EUA (FDA) anunciou as taxas para o Ano Fiscal (FY) 2023 sob as Emendas \u00e0s Taxas de Uso de Dispositivos M\u00e9dicos (MDUFA). O ano fiscal come\u00e7a em 1 de outubro de 2022 e termina em 30 de setembro de 2023. As instala\u00e7\u00f5es de dispositivos m\u00e9dicos devem pagar as<\/p>\n","protected":false},"author":31,"featured_media":55642,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","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":""},"categories":[99],"tags":[],"class_list":{"0":"post-55788","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medical-devices-pt","8":"entry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.9 (Yoast SEO v25.5) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>A FDA Anuncia Novas Taxas de Usu\u00e1rios de Dispositivos M\u00e9dicos Para o Ano Fiscal de 2023 - 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=\"pt_PT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"A FDA Anuncia Novas Taxas de Usu\u00e1rios de Dispositivos M\u00e9dicos Para o Ano Fiscal de 2023\" \/>\n<meta property=\"og:description\" content=\"A Administra\u00e7\u00e3o de Alimentos e Medicamentos nos EUA (FDA) anunciou as taxas para o Ano Fiscal (FY) 2023 sob as Emendas \u00e0s Taxas de Uso de Dispositivos M\u00e9dicos (MDUFA). O ano fiscal come\u00e7a em 1 de outubro de 2022 e termina em 30 de setembro de 2023. As instala\u00e7\u00f5es de dispositivos m\u00e9dicos devem pagar as\" \/>\n<meta property=\"og:url\" content=\"https:\/\/legacy.registrarcorp.com\/pt\/fda-announces-new-medical-device-user-fees-for-fy-2023\/\" \/>\n<meta property=\"og:site_name\" content=\"Registrar\" \/>\n<meta property=\"article:published_time\" content=\"2022-10-07T12:41:44+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-10-19T17:08:41+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2022\/10\/flat-lay-health-still-life-arrangement-with-copy-space-scaled-e1665146316410.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1440\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Ashley Lambert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ashley Lambert\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/pt\/fda-announces-new-medical-device-user-fees-for-fy-2023\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/pt\/fda-announces-new-medical-device-user-fees-for-fy-2023\/\"},\"author\":{\"name\":\"Ashley Lambert\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/pt\/#\/schema\/person\/15b1dcde8983ff58d1caac513cd1002e\"},\"headline\":\"A FDA Anuncia Novas Taxas de Usu\u00e1rios de Dispositivos M\u00e9dicos Para o Ano Fiscal de 2023\",\"datePublished\":\"2022-10-07T12:41:44+00:00\",\"dateModified\":\"2022-10-19T17:08:41+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/pt\/fda-announces-new-medical-device-user-fees-for-fy-2023\/\"},\"wordCount\":516,\"publisher\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/pt\/#organization\"},\"image\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/pt\/fda-announces-new-medical-device-user-fees-for-fy-2023\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2022\/10\/flat-lay-health-still-life-arrangement-with-copy-space-scaled-e1665146316410.jpg\",\"articleSection\":[\"Medical Devices\"],\"inLanguage\":\"pt\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/pt\/fda-announces-new-medical-device-user-fees-for-fy-2023\/\",\"url\":\"https:\/\/legacy.registrarcorp.com\/pt\/fda-announces-new-medical-device-user-fees-for-fy-2023\/\",\"name\":\"A FDA Anuncia Novas Taxas de Usu\u00e1rios de Dispositivos M\u00e9dicos Para o Ano Fiscal de 2023 - 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