{"id":32706,"date":"2024-06-21T09:59:57","date_gmt":"2024-06-21T07:59:57","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/06\/21\/brasile-programma-reliance-accesso-accelerato-per-dispositivi-medici-gia-registrati-in-altri-paesi\/"},"modified":"2024-06-21T10:04:30","modified_gmt":"2024-06-21T08:04:30","slug":"brasile-programma-reliance-accesso-accelerato-per-dispositivi-medici-gia-registrati-in-altri-paesi","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2024\/06\/21\/brasile-programma-reliance-accesso-accelerato-per-dispositivi-medici-gia-registrati-in-altri-paesi\/","title":{"rendered":"BRASIL: Reliance Programme Accelerated Access for Medical Devices Already Registered in Other Countries"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><h2>As of <strong>June 3, 2024<\/strong>, it will be possible to place one&#8217;s <strong>high-risk medical devices in Brazil<\/strong>, relying on authorisations from other selected countries worldwide. This path significantly accelerates registration procedures and can only be welcomed with enthusiasm by the industry.<\/h2>\n<p>The important news has been formalised by <strong>ANVISA<\/strong>, the Brazilian Regulatory Agency, with <strong>Regulatory Instruction 290\/2024<\/strong> of April 8, 2024, which defines the optimised procedures for the analysis and approval of applications for registration of medical devices, the criteria to be used in the evaluations conducted by the <strong>Equivalent Foreign Regulatory Authorities (<\/strong>known as <strong>AREE)<\/strong>.<\/p>\n<p>The measure is an important step in the <strong>Regulatory Reliance<\/strong> <strong>Programme<\/strong>, encouraged by the World Health Organisation (WHO), which defines <strong>Regulatory Reliance<\/strong> as such: &#8216;an act by which the national regulatory authority of a jurisdiction, in reaching its own decision, takes into account the assessment made by another authority or trusted institution or additional relevant information. <strong>The authority adopting this approach remains independent, responsible for its decisions <\/strong>and accountable for those decisions, even if it relies on decisions and information from other authorities.<\/p>\n<p><strong>Equivalent Foreign Regulatory Authorities (AREE)<\/strong><\/p>\n<p>The Equivalent Foreign Regulatory Authorities (AREE) represent <strong>four <\/strong>of the five former founding countries of the Global Harmonisation Task Force (GHTF). The GHTF is a voluntary group of representatives of national medical device regulators and industry established to encourage regulatory harmonisation and convergence between different countries worldwide to foster the deployment of safe and effective devices.<\/p>\n<p>The authorised AREE include:<\/p>\n<ul>\n<li>TGA &#8211; Australian Register of Therapeutic Goods (ARTG)<\/li>\n<li>Health Canada &#8211; Medical Device Licence<\/li>\n<li>US FDA &#8211; 510(k) Clearance, Premarket Approval (PMA) or 513(f)(2) &#8216;De Novo&#8217;<\/li>\n<li>Japanese MHLW &#8211; Pre-market approval (Shonin)<\/li>\n<\/ul>\n<p><strong>How does the optimised entry of medical devices in Brazil work?<\/strong><\/p>\n<p>First, it should be noted that 290\/2024 only applies to <strong>class<\/strong> <strong>III and IV<\/strong> <strong>medical devices and IVDs<\/strong> that normally have to go through the registration procedure.<\/p>\n<p>Such devices, if they have already been authorised by one of the four AREE, can be released in Brazil much more quickly. A main AREE must be identified and, if several authorisations have been obtained, additional AREE can be reported.<\/p>\n<p><strong>Documents <\/strong>must be presented to prove that the products intended for the Brazilian market have the same production characteristics, indications and intended use approved by the recognised regulatory authority.<\/p>\n<p>To apply for a marketing authorisation, it is necessary to submit:<\/p>\n<ul>\n<li>A declaration signed by the technical director and legal officer;<\/li>\n<li>A proof of authorisation received from the identified Equivalent Foreign Regulatory Authority;<\/li>\n<li>The instructions for use (IFU).<\/li>\n<\/ul>\n<p>The Reliance route accelerates entry to the Brazilian market but <strong>does not exclude certain steps, <\/strong>such as the submission of the <strong>technical dossier<\/strong> at the application stage and compliance with <strong>other specific registration requirements<\/strong>, such as the submission of INCQS, B-GMP, INMETRO or ANTEL certificates.<\/p>\n<p>It is estimated that the Reliance pathway would reduce ANVISA review times by at least 30%, with a substantial decrease in waiting times for registrations, allowing the population faster access to medical devices important for public health.<\/p>\n<p>&gt;&gt; Thema can accompany you on the Brazilian market with <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/consulenza-strategico-regolatoria-dispositivi-medici-medical-devices\/\"><strong>strategic-regulatory consulting services <\/strong><\/a><strong>\u00a0<\/strong>assisting you in the <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/registrazioni-internazionali-extra-ue-dispositivi-medici-dm-e-medico-diagnostici-in-vitro-ivd\/\"><strong>registration of your medical devices in Brazil<\/strong><\/a> either through the Reliance route or in case you have never registered your medical devices in Australia, Canada, U.S.A. or Japan.<\/p>\n<p><strong>Source<\/strong><strong>:<\/strong><br \/>\n<a href=\"https:\/\/www.in.gov.br\/web\/dou\/-\/instrucao-normativa-in-n-290-de-4-de-abril-de-2024-552512770\">INSTRU\u00c7\u00c3O NORMATIVA &#8211; IN N\u00b0 290, DE 4 DE ABRIL DE 2024 &#8211; INSTRU\u00c7\u00c3O NORMATIVA &#8211; IN N\u00b0 290, DE 4 DE ABRIL DE 2024 &#8211; DOU &#8211; Imprensa Nacional<\/a><\/p>\n<p><a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/assuntos\/noticias-anvisa\/2024\/anvisa-ira-utilizar-analises-de-autoridades-estrangeiras-para-registro-de-dispositivos-medicos\">Anvisa ir\u00e1 utilizar an\u00e1lises de autoridades estrangeiras para registro de dispositivos m\u00e9dicos \u2014 Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria &#8211; Anvisa (www.gov.br)<\/a><\/p>\n<p>&nbsp;<\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":32692,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-32706","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>BRASIL: Reliance Programme Accelerated Access for Medical Devices Already Registered in Other Countries<\/title>\n<meta name=\"description\" content=\"Il Medical Device Coordination Group (MDCG) ha aggiornato la linea 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