{"id":7727,"date":"2026-06-09T15:57:44","date_gmt":"2026-06-09T10:27:44","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=7727"},"modified":"2026-06-09T15:57:44","modified_gmt":"2026-06-09T10:27:44","slug":"anvisa","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/br-en\/anvisa\/","title":{"rendered":"ANVISA Changes for Low-risk Medical Devices"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7727\" class=\"elementor elementor-7727\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-181c6ed9 e-flex e-con-boxed e-con e-parent\" data-id=\"181c6ed9\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-374541a9 elementor-widget elementor-widget-heading\" data-id=\"374541a9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">ANVISA Changes for Low-risk Medical Devices<\/h1>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-29eb2a67 e-flex e-con-boxed e-con e-parent\" data-id=\"29eb2a67\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-4812920a e-con-full e-flex e-con e-child\" data-id=\"4812920a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5c29215a elementor-widget elementor-widget-text-editor\" data-id=\"5c29215a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>\u00a0<\/p><p><span style=\"font-weight: 400;\">The National Health Surveillance Agency or ANVISA (Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria) is the Brazilian regulatory agency that is responsible for the approval and supervision of food, cosmetics, tobacco, pharmaceuticals, health services, and medical devices, among others. The agency is connected to the Ministry of Health, which manages ANVISA through a management contract signed periodically.<\/span><\/p><p><span style=\"font-weight: 400;\">Brazilian medical device regulators have approved plans to amend registration requirements for low-risk devices to more closely align with International Medical Device Regulators Forum (<\/span><span style=\"font-weight: 400;\">IMDRF<\/span><span style=\"font-weight: 400;\">) recommendations.<\/span><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"font-weight: 400;\">Anvisa\u2019s role is to promote the protection of the population\u2019s health by executing sanitary control of the production, marketing, and use of products and services subject to health regulation, including related environments, processes, ingredients, and technologies, as well as the control in ports, airports, and borders.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-70dcc829 e-con-full e-flex e-con e-child\" data-id=\"70dcc829\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-2dd5bc7a e-con-full e-flex e-con e-child\" data-id=\"2dd5bc7a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-59420e elementor-widget elementor-widget-heading\" data-id=\"59420e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Regulatory Excellence for Global Medical Device Markets<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1eb8f9f9 elementor-widget elementor-widget-wpforms\" data-id=\"1eb8f9f9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wpforms-container 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aria-hidden=\"true\">*<\/span><\/label><textarea id=\"wpforms-6203-field_4\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][4]\" placeholder=\"Message\" aria-errormessage=\"wpforms-6203-field_4-error\" required><\/textarea><\/div><script>\n\t\t\t\t( function() {\n\t\t\t\t\tconst style = document.createElement( 'style' );\n\t\t\t\t\tstyle.appendChild( document.createTextNode( '#wpforms-6203-field_5-container { position: absolute !important; overflow: hidden !important; display: inline !important; height: 1px !important; width: 1px !important; z-index: -1000 !important; padding: 0 !important; } #wpforms-6203-field_5-container input { visibility: hidden; } #wpforms-conversational-form-page #wpforms-6203-field_5-container label { counter-increment: none; }' ) );\n\t\t\t\t\tdocument.head.appendChild( style );\n\t\t\t\t\tdocument.currentScript?.remove();\n\t\t\t\t} )();\n\t\t\t<\/script><\/div><!-- .wpforms-field-container --><div class=\"wpforms-recaptcha-container wpforms-is-recaptcha wpforms-is-recaptcha-type-v3\" ><input type=\"hidden\" name=\"wpforms[recaptcha]\" value=\"\"><\/div><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"6203\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/posts\/7727\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-6203\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Submit\" aria-live=\"assertive\" value=\"wpforms-submit\">Submit<\/button><img decoding=\"async\" src=\"https:\/\/operonstrategist.com\/wp-content\/plugins\/wpforms\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-71aca3b3 e-flex e-con-boxed e-con e-parent\" data-id=\"71aca3b3\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1ac8557f elementor-widget elementor-widget-text-editor\" data-id=\"1ac8557f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Brazil\u2019s medical device market regulator ANVISA will issue a 60-day consultation for a proposal to change the agency\u2019s cadastro registration pathway for Class I devices to a notification pathway, with implications for premarket review requirements for affected manufacturers.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bbfcdb6 elementor-widget elementor-widget-heading\" data-id=\"bbfcdb6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Current Anvisa Cadastro Registration Requirements\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1d8ba80 elementor-widget elementor-widget-text-editor\" data-id=\"1d8ba80\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Under ANVISA\u2019s existing requirements for cadastro registration, lower-risk device manufacturers must submit applications and legal documentation to the regulator for premarket review, as well as provide their Brazil Registration Holders (BRH) with technical dossiers, labels, and indications for use documentation in case of National Health Surveillance Agency audits.<\/span><\/p><p><span style=\"font-weight: 400;\">The National Health Surveillance Agency will publish its public consultation on the proposed notification pathway for low-risk devices.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-08df1b5 elementor-widget elementor-widget-heading\" data-id=\"08df1b5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">The Medical Device Registration Process in Brazil\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a634aec elementor-widget elementor-widget-text-editor\" data-id=\"a634aec\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The medical device registration process in Brazil is overseen by the Brazilian Health Regulatory Agency (ANVISA). Here\u2019s a brief overview of the process:<\/span><\/p><ol><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Local Representation: For foreign manufacturers, it is mandatory to appoint a local Brazilian representative (Legal Representative) with an established office in Brazil.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Technical Documentation: Prepare the required technical documentation, including device specifications, manufacturing processes, safety data, and performance studies. It is crucial to meet the specific requirements outlined by ANVISA.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Application Submission: Submit the registration application through ANVISA\u2019s online system. Include all necessary documentation and pay the applicable fees.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">ANVISA Evaluation: ANVISA will review the submitted documents, perform technical assessments, and evaluate the safety and efficacy of the medical device.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Good Manufacturing Practices (GMP) Inspection: For certain device classes, ANVISA may conduct an on-site inspection to ensure compliance with Good Manufacturing Practices.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Approval and Registration: If the application meets all requirements, ANVISA will grant the registration certificate, allowing the medical device to be marketed and sold in Brazil.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Post-Market Surveillance: After registration, manufacturers must comply with post-market surveillance requirements, including reporting adverse events, updates to labeling, and ongoing compliance with regulations.<\/span><\/li><\/ol>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ed8d246 elementor-widget elementor-widget-heading\" data-id=\"ed8d246\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Operon Strategist - Medical Device Consultants\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-64658ac elementor-widget elementor-widget-text-editor\" data-id=\"64658ac\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">It\u2019s important to note that the medical device registration process in Brazil can be complex and time-consuming. Seeking the guidance of a specialized regulatory consultant can help navigate the process smoothly and ensure compliance with Brazilian regulations.<\/span><\/p><p><span style=\"font-weight: 400;\">Operon Strategist is a <\/span><a href=\"https:\/\/operonstrategist.com\/\"><span style=\"font-weight: 400;\">medical device consulting company<\/span><\/a><span style=\"font-weight: 400;\"> that provides regulatory guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers.<\/span><\/p><p><a href=\"https:\/\/operonstrategist.com\/contact-us\/\"><span style=\"font-weight: 400;\">Contact Us<\/span><\/a> <a href=\"https:\/\/api.whatsapp.com\/send\/?phone=%2B919403892834&amp;text&amp;type=phone_number&amp;app_absent=0\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">WhatsApp<\/span><\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>The National Health Surveillance Agency or ANVISA (Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria) is the Brazilian regulatory agency that is responsible for the approval and supervision of food, cosmetics, tobacco, pharmaceuticals, health services, and medical devices, among others. The agency is connected to the Ministry of Health, which manages ANVISA through a management contract signed periodically. [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":11182,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[55],"tags":[],"class_list":["post-7727","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/posts\/7727","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/comments?post=7727"}],"version-history":[{"count":1,"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/posts\/7727\/revisions"}],"predecessor-version":[{"id":11183,"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/posts\/7727\/revisions\/11183"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/media\/11182"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/media?parent=7727"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/categories?post=7727"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/tags?post=7727"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}