{"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":"brasilianische-vorschriften-fur-medizinprodukte","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/brazil-medical-device-regulations\/","title":{"rendered":"ANVISA ver\u00f6ffentlicht Verordnung f\u00fcr Medizinprodukte"},"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\">ANVISA hat am 15. Dezember die Resolution 837\/2023 herausgegeben, in der aktualisierte Verfahren f\u00fcr klinische Untersuchungen zur Unterst\u00fctzung der Registrierung von Medizinprodukten mit h\u00f6herem Risiko (Klassen III und IV) dargelegt werden.<\/div>\n<div class=\"ewa-rteLine\"><\/div>\n<div class=\"ewa-rteLine\">Die Hauptziele der neuen Verordnung sind\u2026<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\t<div id=\"gap-1681642527\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1681642527 {\n  padding-top: 60px;\n}\n<\/style>\n\t<\/div>\n\t\n\n\t<section class=\"section\" id=\"section_1461162707\">\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-1892868140\">\n\n\t<div id=\"col-1665007635\" 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_1483843485\">\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-230707754\">\n\n\n\t<div id=\"col-664071533\" 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>Entschuldigung, dieser Premium-Inhalt ist nur f\u00fcr RegASK-Kunden.<\/h2>\n<p>M\u00f6chten Sie auf den gesamten Inhalt der Warnung zugreifen oder alle Nachrichten durchsuchen?\u00a0<\/p>\n<div class=\"row\"  id=\"row-1007624489\">\n\n\n\t<div id=\"col-282890989\" 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>Kunden-Login<\/span>\n\t<\/a>\n\n\n<a href=\"https:\/\/regask.com\/de\/demo-anfordern\/\" class=\"button secondary lowercase\" style=\"border-radius:5px;\">\n\t\t<span>Demo buchen<\/span>\n\t<\/a>\n\n\n<a href=\"https:\/\/regask.com\/de\/more-insights\/\" target=\"_blank\" class=\"button secondary is-outline\" rel=\"noopener\" >\n\t\t<span>Durchsuchen Sie die Nachrichten<\/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_1483843485 {\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_1461162707 {\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-244312898\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-244312898 {\n  padding-top: 60px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>ANVISA ver\u00f6ffentlichte am 15. Dezember die Resolution 837\/2023, in der aktualisierte Verfahren f\u00fcr klinische Pr\u00fcfungen zur Registrierung von Medizinprodukten mit h\u00f6herem Risiko (Klassen III und IV) dargelegt werden. Die Hauptziele der neuen Verordnung sind\u2026 &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 v27.6 (Yoast SEO v27.7) - 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. Ensure compliance with RegASK&#039;s expert guidance.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/de\/brasilianische-vorschriften-fur-medizinprodukte\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ANVISA Published Regulation For Medical Devices\" \/>\n<meta property=\"og:description\" content=\"ANVISA publishes new regulations for medical devices in Brazil. Ensure compliance with RegASK&#039;s expert guidance.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/de\/brasilianische-vorschriften-fur-medizinprodukte\/\" \/>\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\u00a0Minute\" \/>\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\":\"de\"},{\"@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. Ensure compliance with RegASK's expert guidance.\",\"inLanguage\":\"de\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/brazil-medical-device-regulations\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"de\",\"@id\":\"https:\\\/\\\/regask.com\\\/brazil-medical-device-regulations\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/01\\\/anvisa-published-regulation-medical-devices.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/01\\\/anvisa-published-regulation-medical-devices.png\",\"width\":1600,\"height\":1200,\"caption\":\"Anvisa Published Regulation Medical Devices\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/regask.com\\\/#website\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"name\":\"RegASK\",\"description\":\"The Regulatory AI Operating System for High-Performing Teams\",\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/regask.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"de\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\",\"name\":\"Benoit Trouwaert\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Brasilien: Verordnung \u00fcber Medizinprodukte | RegASK","description":"ANVISA ver\u00f6ffentlicht neue Vorschriften f\u00fcr Medizinprodukte in Brasilien. Stellen Sie die Einhaltung mit den Expertenrichtlinien von RegASK sicher.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/regask.com\/de\/brasilianische-vorschriften-fur-medizinprodukte\/","og_locale":"de_DE","og_type":"article","og_title":"ANVISA Published Regulation For Medical Devices","og_description":"ANVISA publishes new regulations for medical devices in Brazil. Ensure compliance with RegASK's expert guidance.","og_url":"https:\/\/regask.com\/de\/brasilianische-vorschriften-fur-medizinprodukte\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2024-01-12T09:13:14+00:00","article_modified_time":"2024-11-19T01:49:30+00:00","og_image":[{"width":1600,"height":1200,"url":"https:\/\/regask.com\/wp-content\/uploads\/2024\/01\/anvisa-published-regulation-medical-devices.png","type":"image\/png"}],"author":"Benoit Trouwaert","twitter_card":"summary_large_image","twitter_image":"https:\/\/regask.com\/wp-content\/uploads\/2021\/12\/food-with-trans-fat-fop-labelling.png","twitter_creator":"@ASKRegASK","twitter_site":"@ASKRegASK","twitter_misc":{"Written by":"Benoit Trouwaert","Est. reading time":"1\u00a0Minute"},"schema":{"@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":"de"},{"@type":"WebPage","@id":"https:\/\/regask.com\/brazil-medical-device-regulations\/","url":"https:\/\/regask.com\/brazil-medical-device-regulations\/","name":"Brasilien: Verordnung \u00fcber Medizinprodukte | 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 ver\u00f6ffentlicht neue Vorschriften f\u00fcr Medizinprodukte in Brasilien. Stellen Sie die Einhaltung mit den Expertenrichtlinien von RegASK sicher.","inLanguage":"de","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/brazil-medical-device-regulations\/"]}]},{"@type":"ImageObject","inLanguage":"de","@id":"https:\/\/regask.com\/brazil-medical-device-regulations\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2024\/01\/anvisa-published-regulation-medical-devices.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2024\/01\/anvisa-published-regulation-medical-devices.png","width":1600,"height":1200,"caption":"Anvisa Published Regulation Medical Devices"},{"@type":"WebSite","@id":"https:\/\/regask.com\/#website","url":"https:\/\/regask.com\/","name":"RegASK","description":"Das regulatorische KI-Betriebssystem f\u00fcr leistungsstarke Teams","publisher":{"@id":"https:\/\/regask.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/regask.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"de"},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/c1d261e8dcf7b1c30b2c4f2c119df42d","name":"Benoit Trouwaert"}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/posts\/4735","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/users\/39"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/comments?post=4735"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/posts\/4735\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/media\/7731"}],"wp:attachment":[{"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/media?parent=4735"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/categories?post=4735"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/tags?post=4735"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}