{"id":4827,"date":"2023-09-24T21:22:00","date_gmt":"2023-09-24T21:22:00","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?post_type=policy-training&#038;p=4827"},"modified":"2025-02-06T12:09:43","modified_gmt":"2025-02-06T12:09:43","slug":"conformity-assessment-of-medical-devices-in-brazil-and-the-in-u-s","status":"publish","type":"policy-training","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/policy-training\/conformity-assessment-of-medical-devices-in-brazil-and-the-in-u-s\/","title":{"rendered":"Conformity Assessment of Medical Devices in Brazil and the in U.S."},"content":{"rendered":"\n<p class=\"justified mb-3\">As a workstream under the Medical Device Regulatory Convergence Project (MDRC) and, on September 24, 2023, the MDRC hosted in Bras\u00edlia an Exchange of Information Workshop between ANVISA, INMETRO, USFDA and NIST. This workshop was part of the MDRC efforts to support good regulatory practices and medical device regulatory convergence. The objective was to review Medical Device Conformity Assessment in Brazil and the in U.S., to facilitate an exchange of related information, experiences and regulations between the authorities within the context of international practices, references, regulatory convergence and regulatory reliance.<\/p>\n\n\n\n<h2 class=\"wp-block-heading mb-0 has-accent-color has-text-color has-medium-font-size\">Agenda<\/h2>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2023\/12\/Workshop-INMETRO-ANVISA-NIST-FDA-Final.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading mb-0 has-accent-color has-text-color has-medium-font-size\">Presentations<\/h2>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong>ANVISA<\/strong><\/h5>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2023\/12\/Apresentacao-Anvisa-Workshop-ANVISA-INMETRO-USFDA-NIST-versao-Ingles.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong><strong>INMETRO<\/strong><\/strong><\/h5>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2023\/12\/Apresentacao-Workshop-AC-v3-INMETRO_site.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong><strong>USFDA<\/strong><\/strong><\/h5>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2023\/12\/FDA_2023-ANVISA-INMETRO-slides.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong><strong>NIST<\/strong><\/strong><\/h5>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2023\/12\/Brazil-Med-CA_NIST.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong><strong>MDRC Positioning<\/strong><\/strong><\/h5>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2023\/12\/MRDC_Inmetro_Anvisa_workstream_site_eng.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n\n\n\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2023\/12\/MDRC_Inmetro_Anvisa_workstream_site_port.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Portuguese<\/a><\/div>\n<\/div>\n","protected":false},"parent":0,"menu_order":0,"template":"","event_category":[],"class_list":["post-4827","policy-training","type-policy-training","status-publish","hentry","description-off"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - 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