{"id":42711,"date":"2020-03-06T16:39:59","date_gmt":"2020-03-06T16:39:59","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/us-buyers-seek-surgical-mask-suppliers-here-are-the-regulatory-requirements-for-helping-to-meet-the-demand\/"},"modified":"2020-03-26T16:55:27","modified_gmt":"2020-03-26T16:55:27","slug":"us-buyers-seek-surgical-mask-suppliers-here-are-the-regulatory-requirements-for-helping-to-meet-the-demand","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/pt\/us-buyers-seek-surgical-mask-suppliers-here-are-the-regulatory-requirements-for-helping-to-meet-the-demand\/","title":{"rendered":"Compradores dos EUA Procuram Fornecedores de M\u00e1scaras Cir\u00fargicas; Estes s\u00e3o os Requisitos Regulamentares para Satisfazer a Demanda"},"content":{"rendered":"<p>O COVID-19 chegou aos Estados Unidos e causou uma escassez nacional de m\u00e1scaras cir\u00fargicas. Registrar Corp recebeu muitos pedidos de fabricantes ao redor do mundo para receber assist\u00eancia com as regula\u00e7\u00f5es da Administra\u00e7\u00e3o de Alimentos e Medicamentos dos Estados Unidos (FDA) para exportar m\u00e1scaras e outros dispositivos de controle de infe\u00e7\u00f5es aos EE. UU.<\/p>\n<p>Apesar dos an\u00fancios e pedidos para que os americanos evitem comprar m\u00e1scaras desnecessariamente, os varejistas precisam de mais suprimentos. &#8220;As lojas em todo o pa\u00eds ficaram sem m\u00e1scaras&#8221;, <a href=\"https:\/\/www.cnn.com\/2020\/02\/29\/health\/face-masks-coronavirus-surgeon-general-trnd\/index.html\">\u00a0informou a CNN<\/a> na segunda-feira. &#8220;Quanto \u00e0s compras on-line, muitos pedidos est\u00e3o atrasados&#8221;. De acordo com aqueles que nos consultam, os compradores americanos parecem estar procurando novos fornecedores para complementar os pedidos existentes e atender \u00e0 crescente demanda.<\/p>\n<p><strong>Requerimentos da FDA para M\u00e1scaras Cir\u00fargicas<\/strong><\/p>\n<p>O primeiro passo para exportar m\u00e1scaras para os Estados Unidos \u00e9 identificar o c\u00f3digo do produto, pois esse \u00e9 o fator determinante para a necessidade de autoriza\u00e7\u00e3o da FDA e da aprova\u00e7\u00e3o do NIOSH.<\/p>\n<p><em>C\u00f3digos de Produto que Requerem Autoriza\u00e7\u00e3o da FDA<\/em><\/p>\n<p><strong>\u00a0<\/strong>M\u00e1scaras ou respiradores que alegam prevenir infec\u00e7\u00f5es ou t\u00eam propriedades antivirais ou antimicrobianas s\u00e3o considerados dispositivos de classe II e requerem autoriza\u00e7\u00e3o da FDA. Exemplos de c\u00f3digos de produto que se encaixam nessas categorias s\u00e3o <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfPCD\/classification.cfm?id=2846\">FXX<\/a>, <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfPCD\/classification.cfm?id=2874\">OUK<\/a>, ou <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfPCD\/classification.cfm?id=2757\">ORW<\/a>.\u00a0 Como o c\u00f3digo do produto ORW \u00e9 usado para os respiradores N95, os produtos listados sob este c\u00f3digo devem ser certificados pelo NIOSH para filtrar pelo menos 95% das part\u00edculas no ar.<\/p>\n<p><em>C\u00f3digos de Produto que N\u00e3o Requerem de Autoriza\u00e7\u00e3o da FDA<\/em><\/p>\n<p>As m\u00e1scaras que n\u00e3o pretendem prevenir a infec\u00e7\u00e3o nem t\u00eam propriedades antivirais ou antimicrobianas n\u00e3o precisam da autoriza\u00e7\u00e3o da FDA. Por exemplo, as m\u00e1scaras listadas como respiradores cir\u00fargicos sob o c\u00f3digo de produto <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfPCD\/classification.cfm?id=2864\">MSH<\/a> est\u00e3o isentas da libera\u00e7\u00e3o da FDA, sempre que n\u00e3o apresentem tais alega\u00e7\u00f5es e demonstrem a capacidade de resistir \u00e0 penetra\u00e7\u00e3o de fluidos (como sangue e fluidos corporais) a uma velocidade consistente com a do uso pretendido do dispositivo. Tenha em conta que o MSH tamb\u00e9m \u00e9 usado para respiradores N95, portanto, embora as m\u00e1scaras listadas neste c\u00f3digo n\u00e3o precisem da autoriza\u00e7\u00e3o da FDA, elas ainda precisam ser aprovadas pelo NIOSH.<\/p>\n<p>Aqueles fabricantes de m\u00e1scaras que n\u00e3o requeiram de autoriza\u00e7\u00e3o da FDA somente precisar\u00e3o <a href=\"https:\/\/regstaging.wpengine.com\/fda-medical-devices\/registration\/?lead_source=blog\">registrar seu estabelecimento na FDA<\/a> e listar seus produtos.<\/p>\n<p><strong>Como Obter Autoriza\u00e7\u00e3o da FDA<\/strong><\/p>\n<p>Os fabricantes podem obter uma carta de autoriza\u00e7\u00e3o da FDA apresentando uma notifica\u00e7\u00e3o de pr\u00e9-mercado, conhecida como 510 (k). Os 510(k)s destinam-se a provar \u00e0 FDA que um produto \u00e9 substancialmente equivalente (mesmo uso pretendido e igualmente seguro e eficaz) a um j\u00e1 existente no mercado.<\/p>\n<p>Entre outras coisas, a apresenta\u00e7\u00e3o desta notifica\u00e7\u00e3o deve incluir a classe do dispositivo e a rotulagem proposta. O <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?CFRPart=807&amp;showFR=1&amp;subpartNode=21:8.0.1.1.5.5\">21 CFR 807<\/a> descreve todos os requisitos de uma apresenta\u00e7\u00e3o 510(k). Ap\u00f3s de receber a autoriza\u00e7\u00e3o da FDA, voc\u00ea deve <a href=\"https:\/\/regstaging.wpengine.com\/fda-medical-devices\/registration\/?lead_source=blog\">registrar seu estabelecimento na FDA<\/a> e listar seus produtos antes da exporta\u00e7\u00e3o.<\/p>\n<p>Tenha em conta que a FDA estabeleceu as <a href=\"https:\/\/www.fda.gov\/medical-devices\/emergency-situations-medical-devices\/emergency-use-authorizations#coronavirus2019\">Autoriza\u00e7\u00f5es de Usos de Emerg\u00eancia<\/a> devido ao Coronav\u00edrus e est\u00e1 exercendo o poder de aplica\u00e7\u00e3o de determinadas regulamenta\u00e7\u00f5es de dispositivos. Em resposta \u00e0 pandemia, a Ag\u00eancia declarou que pode considerar uma revis\u00e3o acelerada das altera\u00e7\u00f5es no local de fabrica\u00e7\u00e3o ou nas apresenta\u00e7\u00f5es de pr\u00e9-mercado para ajudar a aliviar as press\u00f5es no fornecimento.<\/p>\n<p><strong>Outros Dispositivos de Controle de Infe\u00e7\u00f5es<\/strong><\/p>\n<p>Luvas e ventiladores m\u00e9dicos destinados a evitar a contamina\u00e7\u00e3o entre m\u00e9dico e paciente exigem 510(k), mas nem todos os dispositivos de controle de infec\u00e7\u00e3o em alta demanda exigem uma revis\u00e3o t\u00e3o rigorosa. <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpcd\/classification.cfm?id=5364\">\u00d3culos de prote\u00e7\u00e3o<\/a> e <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfPCD\/classification.cfm?id=2843\">roupas cir\u00fargicas<\/a> (que n\u00e3o devem ser confundidos com aventais cir\u00fargicos, que s\u00e3o de classe II) s\u00e3o considerados dispositivos de classe I e n\u00e3o requerem 510(k). Os fabricantes de dispositivos com exce\u00e7\u00e3o dessa apresenta\u00e7\u00e3o ainda precisam <a href=\"https:\/\/regstaging.wpengine.com\/fda-medical-devices\/registration\/?lead_source=blog\">se registrar na FDA<\/a> e listar seus produtos.<\/p>\n<p>A empresa de consultoria FDA, Registrar Corp, pode ajudar os fabricantes a identificar os c\u00f3digos de produto e os requisitos da FDA espec\u00edficos para seus dispositivos. Voc\u00ea pode entrar em contato com a Registrar Corp pelo e-mail <a href=\"mailto:info@registrarcorp.com\">info@registrarcorp.com<\/a> ou ligando para qualquer um dos nossos <a href=\"https:\/\/regstaging.wpengine.com\/offices\/\">20 escrit\u00f3rios globais<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>O COVID-19 chegou aos Estados Unidos e causou uma escassez nacional de m\u00e1scaras cir\u00fargicas. Registrar Corp recebeu muitos pedidos de fabricantes ao redor do mundo para receber assist\u00eancia com as regula\u00e7\u00f5es da Administra\u00e7\u00e3o de Alimentos e Medicamentos dos Estados Unidos (FDA) para exportar m\u00e1scaras e outros dispositivos de controle de infe\u00e7\u00f5es aos EE. UU. Apesar<\/p>\n","protected":false},"author":2,"featured_media":42698,"comment_status":"open","ping_status":"open","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-42711","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>Compradores dos EUA Procuram Fornecedores de M\u00e1scaras Cir\u00fargicas; Estes s\u00e3o os Requisitos Regulamentares para Satisfazer a Demanda - 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=\"Compradores dos EUA Procuram Fornecedores de M\u00e1scaras Cir\u00fargicas; Estes s\u00e3o os Requisitos Regulamentares para Satisfazer a Demanda\" \/>\n<meta property=\"og:description\" content=\"O COVID-19 chegou aos Estados Unidos e causou uma escassez nacional de m\u00e1scaras cir\u00fargicas. Registrar Corp recebeu muitos pedidos de fabricantes ao redor do mundo para receber assist\u00eancia com as regula\u00e7\u00f5es da Administra\u00e7\u00e3o de Alimentos e Medicamentos dos Estados Unidos (FDA) para exportar m\u00e1scaras e outros dispositivos de controle de infe\u00e7\u00f5es aos EE. UU. 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