{"id":4735,"date":"2024-01-12T17:13:14","date_gmt":"2024-01-12T09:13:14","guid":{"rendered":"https:\/\/regask.com\/?p=4735"},"modified":"2024-11-19T09:49:30","modified_gmt":"2024-11-19T01:49:30","slug":"reglamento-de-dispositivos-medicos-de-brasil","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/brazil-medical-device-regulations\/","title":{"rendered":"ANVISA publica reglamento para dispositivos m\u00e9dicos"},"content":{"rendered":"<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">La ANVISA emiti\u00f3 la Resoluci\u00f3n 837\/2023, el 15 de diciembre, que describe los procedimientos actualizados para las investigaciones cl\u00ednicas que respaldan el registro de Dispositivos M\u00e9dicos de mayor riesgo (Clases III y IV).<\/div>\n<div class=\"ewa-rteLine\"><\/div>\n<div class=\"ewa-rteLine\">Los principales objetivos del nuevo reglamento son\u2026<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\t<div id=\"gap-1718973128\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1718973128 {\n  padding-top: 60px;\n}\n<\/style>\n\t<\/div>\n\t\n\n\t<section class=\"section\" id=\"section_632339428\">\n\t\t<div class=\"section-bg fill\" >\n\t\t\t\t\t\t\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n<div class=\"row\"  id=\"row-573448262\">\n\n\t<div id=\"col-390355239\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\t<section class=\"section\" id=\"section_1290719368\">\n\t\t<div class=\"section-bg fill\" >\n\t\t\t\t\t\t\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n\n<div class=\"row\"  id=\"row-1176386298\">\n\n\n\t<div id=\"col-878469245\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<h2>Lo sentimos, este contenido premium es solo para clientes de RegASK.<\/h2>\n<p>\u00bfQuieres acceder a todo el contenido de la alerta o navegar por todas las noticias?\u00a0<\/p>\n<div class=\"row\"  id=\"row-773744150\">\n\n\n\t<div id=\"col-550812105\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<a href=\"https:\/\/app.RegASK.com\/#\/\" target=\"_blank\" class=\"button secondary is-outline\" rel=\"noopener\" >\n\t\t<span>Inicio de sesi\u00f3n del cliente<\/span>\n\t<\/a>\n\n\n<a href=\"https:\/\/regask.com\/es\/solicitar-una-demostracion\/\" class=\"button secondary lowercase\" style=\"border-radius:5px;\">\n\t\t<span>Reservar una demostraci\u00f3n<\/span>\n\t<\/a>\n\n\n<a href=\"https:\/\/regask.com\/es\/more-insights\/\" target=\"_blank\" class=\"button secondary is-outline\" rel=\"noopener\" >\n\t\t<span>Navegar por las noticias<\/span>\n\t<\/a>\n\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n<\/div>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n<\/div>\n\n\t\t<\/div>\n\n\t\t\n<style>\n#section_1290719368 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n  background-color: rgb(255,255,255);\n}\n<\/style>\n\t<\/section>\n\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t\t<\/div>\n\n\t\t\n<style>\n#section_632339428 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n  margin-bottom: -100px;\n  background-color: rgb(0, 49, 117);\n}\n<\/style>\n\t<\/section>\n\t\n\t<div id=\"gap-1197978684\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1197978684 {\n  padding-top: 60px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>ANVISA issued Resolution 837\/2023 on December 15, outlining updated procedures for clinical investigations supporting higher-risk Medical Devices (Classes III and IV) registration. The main objectives of the new regulation are&#8230; &nbsp;<\/p>","protected":false},"author":39,"featured_media":7731,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[56,269,271,273,275],"class_list":["post-4735","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-devices-insights","tag-premium-news","tag-medtech","tag-clinical-trial","tag-ctr","tag-gcp"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Brazil: Medical Device Regulation | RegASK<\/title>\n<meta name=\"description\" content=\"ANVISA publishes new regulations for medical devices in Brazil. 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Ensure compliance with RegASK&#039;s expert guidance.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/es\/reglamento-de-dispositivos-medicos-de-brasil\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2024-01-12T09:13:14+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-19T01:49:30+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2024\/01\/anvisa-published-regulation-medical-devices.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1600\" \/>\n\t<meta property=\"og:image:height\" content=\"1200\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2021\/12\/food-with-trans-fat-fop-labelling.png\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minuto\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/brazil-medical-device-regulations\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/brazil-medical-device-regulations\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"ANVISA Published Regulation For Medical Devices\",\"datePublished\":\"2024-01-12T09:13:14+00:00\",\"dateModified\":\"2024-11-19T01:49:30+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/brazil-medical-device-regulations\\\/\"},\"wordCount\":57,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/brazil-medical-device-regulations\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/01\\\/anvisa-published-regulation-medical-devices.png\",\"keywords\":[\"Premium News\",\"MedTech\",\"Clinical trial\",\"CTR\",\"GCP\"],\"articleSection\":[\"Medical Devices\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/brazil-medical-device-regulations\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/brazil-medical-device-regulations\\\/\",\"name\":\"Brazil: Medical Device Regulation | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/brazil-medical-device-regulations\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/brazil-medical-device-regulations\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/01\\\/anvisa-published-regulation-medical-devices.png\",\"datePublished\":\"2024-01-12T09:13:14+00:00\",\"dateModified\":\"2024-11-19T01:49:30+00:00\",\"description\":\"ANVISA publishes new regulations for medical devices in Brazil. 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