{"id":5344,"date":"2025-07-10T16:02:11","date_gmt":"2025-07-10T19:02:11","guid":{"rendered":"https:\/\/baptistaluz.com.br\/privacyhub\/?page_id=5344"},"modified":"2025-08-14T15:06:54","modified_gmt":"2025-08-14T18:06:54","slug":"equipamentosmedicos","status":"publish","type":"page","link":"https:\/\/baptistaluz.com.br\/privacyhub\/legislacoes\/setor-saude\/equipamentosmedicos\/","title":{"rendered":"Equipamentos M\u00e9dicos"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"5344\" class=\"elementor elementor-5344\" data-elementor-settings=\"{&quot;ha_cmc_init_switcher&quot;:&quot;no&quot;}\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fb3fe7a e-flex e-con-boxed e-con e-parent\" data-id=\"fb3fe7a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-813d94a e-con-full e-flex e-con e-child\" data-id=\"813d94a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5785df0 elementor-widget elementor-widget-heading\" data-id=\"5785df0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><a href=\"https:\/\/baptistaluz.com.br\/privacyhub\/legislacoes\/\">Mapeamento de legisla\u00e7\u00f5es \/<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-65624dc elementor-widget elementor-widget-heading\" data-id=\"65624dc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><a href=\"https:\/\/baptistaluz.com.br\/privacyhub\/legislacoes\/setor-saude\/\">Sa\u00fade<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-91102f8 elementor-widget elementor-widget-heading\" data-id=\"91102f8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">\/ Equipamentos M\u00e9dicos<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0d5b473 elementor-widget elementor-widget-heading\" data-id=\"0d5b473\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Equipamentos M\u00e9dicos<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4d7ca05 elementor-widget elementor-widget-text-editor\" data-id=\"4d7ca05\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\tFabricantes e distribuidores de dispositivos utilizados no monitoramento, diagn\u00f3stico e tratamento de condi\u00e7\u00f5es de sa\u00fade. Englobam desde aparelhos de imagem at\u00e9 dispositivos implant\u00e1veis de uso prolongado.\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b9d1869 elementor-widget elementor-widget-text-editor\" data-id=\"b9d1869\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h3>Conselho Federal de Medicina (CFM)<\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-34345fa elementor-widget elementor-widget-text-editor\" data-id=\"34345fa\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h5><strong>C\u00f3digo de Conduta \u00c9tica<\/strong><\/h5>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-145b4f7 elementor-widget elementor-widget-n-accordion\" data-id=\"145b4f7\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2130\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2130\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> <p style=\"font-size: 16px\">Compartilhamento de informa\u00e7\u00f5es confidenciais aos empregadores<\/p> <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"huge huge-arrow-up-01-round\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"huge huge-arrow-down-01-round\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2130\" class=\"elementor-element elementor-element-4222c31 e-con-full e-flex e-con e-child\" data-id=\"4222c31\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2130\" class=\"elementor-element elementor-element-01a49ed e-flex e-con-boxed e-con e-child\" data-id=\"01a49ed\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d93fe15 elementor-widget elementor-widget-text-editor\" data-id=\"d93fe15\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Art. 76<br \/><\/strong>O C\u00f3digo de \u00c9tica veda expressamente o compartilhamento, pelo m\u00e9dico, de informa\u00e7\u00f5es confidenciais . Revelar informa\u00e7\u00f5es confidenciais obtidas quando do exame m\u00e9dico de trabalhadores, inclusive por exig\u00eancia dos dirigentes de empresas ou de institui\u00e7\u00f5es, salvo se o sil\u00eancio puser em risco a sa\u00fade dos empregados ou da comunidade.<\/p>\t\t\t\t\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\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4b531ca elementor-widget elementor-widget-button\" data-id=\"4b531ca\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/portal.cfm.org.br\/images\/PDF\/cem2019.pdf\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Acesse o C\u00f3digo completo<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-38a0e8f elementor-widget elementor-widget-text-editor\" data-id=\"38a0e8f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h3>Congresso Nacional<\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-442bcfb elementor-widget elementor-widget-text-editor\" data-id=\"442bcfb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h5><strong>Lei n\u00ba 8.159\/1991<\/strong><\/h5>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-aaa4e56 elementor-widget elementor-widget-n-accordion\" data-id=\"aaa4e56\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1780\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1780\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> <p style=\"font-size: 16px\">San\u00e7\u00e3o para quem destr\u00f3i ou desfigura documentos de interesse p\u00fablico ou social, incluindo prontu\u00e1rio m\u00e9dico<\/p> <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"huge huge-arrow-up-01-round\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"huge huge-arrow-down-01-round\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1780\" class=\"elementor-element elementor-element-69a65c4 e-con-full e-flex e-con e-child\" data-id=\"69a65c4\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1780\" class=\"elementor-element elementor-element-e6fe164 e-flex e-con-boxed e-con e-child\" data-id=\"e6fe164\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3e1af56 elementor-widget elementor-widget-text-editor\" data-id=\"3e1af56\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Art. 25<\/strong><\/p><p>Essa lei, que disp\u00f5e sobre a pol\u00edtica nacional de arquivos p\u00fablicos e privados, aplicando-se aqui tamb\u00e9m prontu\u00e1rios m\u00e9dicos, prev\u00ea que ficar\u00e1 sujeito \u00e0 responsabilidade penal, civil e administrativa, na forma da legisla\u00e7\u00e3o em vigor, aquele que desfigurar ou destruir documentos de valor permanente ou considerado como de interesse p\u00fablico e social.<\/p>\t\t\t\t\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\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7960a5d elementor-widget elementor-widget-button\" data-id=\"7960a5d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/www.planalto.gov.br\/ccivil_03\/leis\/l8159.htm\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Acesse a Lei completa<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d875470 elementor-widget elementor-widget-text-editor\" data-id=\"d875470\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h3>Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria<\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9552847 elementor-widget elementor-widget-text-editor\" data-id=\"9552847\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h5><strong>RDC N\u00b0 657\/2022<\/strong><\/h5>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a147480 elementor-widget elementor-widget-n-accordion\" data-id=\"a147480\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1690\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1690\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> <p style=\"font-size: 16px\">Requisitos para a regulariza\u00e7\u00e3o de softwares como dispositivos m\u00e9dicos (Software as a Medical Device - SaMD)<\/p> <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"huge huge-arrow-up-01-round\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"huge huge-arrow-down-01-round\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1690\" class=\"elementor-element elementor-element-913affa e-con-full e-flex e-con e-child\" data-id=\"913affa\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1690\" class=\"elementor-element elementor-element-e2751ba e-flex e-con-boxed e-con e-child\" data-id=\"e2751ba\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-910bd7c elementor-widget elementor-widget-text-editor\" data-id=\"910bd7c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Art. 12; Art. 17<\/strong><br \/>Requer um relat\u00f3rio t\u00e9cnico abrangente para o registro de Sistemas de Assist\u00eancia M\u00e9dica Digital (SaMD) de classe de risco III e IV. Esse relat\u00f3rio deve incluir informa\u00e7\u00f5es sobre a arquitetura de software e hardware, plataforma, seguran\u00e7a da informa\u00e7\u00e3o, gerenciamento de risco, avalia\u00e7\u00e3o cl\u00ednica, interoperabilidade, e outros aspectos t\u00e9cnicos e cl\u00ednicos relevantes para a efic\u00e1cia e seguran\u00e7a do SaMD.<\/p>\t\t\t\t\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\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-493155d elementor-widget elementor-widget-button\" data-id=\"493155d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/anvisalegis.datalegis.net\/action\/UrlPublicasAction.php?acao=abrirAtoPublico&#038;num_ato=00000657&#038;sgl_tipo=RDC&#038;sgl_orgao=RDC\/DC\/ANVISA\/MS&#038;vlr_ano=2022&#038;seq_ato=000&#038;cod_modulo=310&#038;cod_menu=9434\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Acesse a Resolu\u00e7\u00e3o completa<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3853f08 elementor-widget elementor-widget-text-editor\" data-id=\"3853f08\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h5><strong>RDC N\u00ba 546\/2021<\/strong><\/h5>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-65afb6f elementor-widget elementor-widget-n-accordion\" data-id=\"65afb6f\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1060\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1060\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> <p style=\"font-size: 16px\">Requisitos essenciais de seguran\u00e7a e efic\u00e1cia aplic\u00e1veis aos produtos para sa\u00fade<\/p> <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"huge huge-arrow-up-01-round\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"huge huge-arrow-down-01-round\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1060\" class=\"elementor-element elementor-element-b632d00 e-con-full e-flex e-con e-child\" data-id=\"b632d00\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1060\" class=\"elementor-element elementor-element-6d00c77 e-flex e-con-boxed e-con e-child\" data-id=\"6d00c77\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c859b82 elementor-widget elementor-widget-text-editor\" data-id=\"c859b82\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Art. 39<br \/><\/strong>Estabelece que os produtos para sa\u00fade que incorporem sistemas eletr\u00f4nicos program\u00e1veis devem ser projetados de forma que se garanta a repetibilidade, confiabilidade e efic\u00e1cia destes sistemas, em conson\u00e2ncia com a utiliza\u00e7\u00e3o a que se destinam.<\/p>\t\t\t\t\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\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cbc1934 elementor-widget elementor-widget-button\" data-id=\"cbc1934\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/bvsms.saude.gov.br\/bvs\/saudelegis\/anvisa\/2020\/rdc0546_30_08_2021.pdf\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Acesse a Resolu\u00e7\u00e3o completa<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\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\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Mapeamento de legisla\u00e7\u00f5es \/ Sa\u00fade \/ Equipamentos M\u00e9dicos Equipamentos M\u00e9dicos Fabricantes e distribuidores de dispositivos utilizados no monitoramento, diagn\u00f3stico e tratamento de condi\u00e7\u00f5es de sa\u00fade. Englobam desde aparelhos de imagem at\u00e9 dispositivos implant\u00e1veis de uso prolongado. Conselho Federal de Medicina (CFM) C\u00f3digo de Conduta \u00c9tica Compartilhamento de informa\u00e7\u00f5es confidenciais aos empregadores Art. 76O C\u00f3digo de [&hellip;]<\/p>\n","protected":false},"author":17,"featured_media":0,"parent":2828,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-5344","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Equipamentos M\u00e9dicos - PrivacyHub<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/baptistaluz.com.br\/privacyhub\/legislacoes\/setor-saude\/equipamentosmedicos\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Equipamentos M\u00e9dicos - PrivacyHub\" \/>\n<meta property=\"og:description\" content=\"Mapeamento de legisla\u00e7\u00f5es \/ Sa\u00fade \/ Equipamentos M\u00e9dicos Equipamentos M\u00e9dicos Fabricantes e distribuidores de dispositivos utilizados no monitoramento, diagn\u00f3stico e tratamento de condi\u00e7\u00f5es de sa\u00fade. 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