A decade of improvement of health legislation for medical devices and its impacts on the health regulation cycle
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Data de Publicação: | 2022 |
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Tipo de documento: | Artigo |
Idioma: | por eng |
Título da fonte: | Vigilância Sanitária em Debate |
Texto Completo: | https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2104 |
Resumo: | Introduction: The sanitary regulation of medical devices was improved with a focus on sanitary risk, through the simplification of regulatory steps and the reduction of the administrative burden. Objective: To evaluate the impacts of the improvement of health legislation during the decade 2012-2021 by three indicators representing government, company, and product. Method: The indicators developed to evaluate the health regulation cycle are 1) Anvisa’s regulatory performance (by median evaluation time of medical devices); 2) companies’ performance in complying with health legislation (by proportion of medical devices not authorized for sale); and 3) evidence of medical device health risk (due to adverse events, technical complaints, health alerts and preventive/cautionary measures). Influence analyses were carried out with variables associated with regulatory process, company size and medical device characteristics as predictors of the indicators. Results: The first indicator shows that the Agency’s timing has improved across all risk classes of medical devices. In 2012, the indicator was measured in 73 days (interquartile range 56–111), while in 2021 in 9 days (interquartile range 6–15). The second indicator showed improvement only for medical devices in the low/medium risk classes. The third indicator did not show an increase in health risk for medical devices with the regulatory simplifications adopted in the last decade. The influence analysis indicates that the need for a certificate of good manufacturing practices, company size and need for additional information are the most relevant predictor variables. Conclusions: The regulatory results from the legislation on medical devices in the last decade were positive. |
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A decade of improvement of health legislation for medical devices and its impacts on the health regulation cycleUna Década de Mejora de la Legislación Sanitaria de Dispositivos Médicos y sus Impactos en el Ciclo de Regulación SanitariaUma década de aperfeiçoamento da legislação sanitária de dispositivos médicos e os impactos no ciclo da regulação sanitáriaDispositivos MédicosRegulação SanitáriaAnvisaMedical DeviceSanitary RegulationAnvisaregulación sanitariadispositivos médicosAnvisaIntroduction: The sanitary regulation of medical devices was improved with a focus on sanitary risk, through the simplification of regulatory steps and the reduction of the administrative burden. Objective: To evaluate the impacts of the improvement of health legislation during the decade 2012-2021 by three indicators representing government, company, and product. Method: The indicators developed to evaluate the health regulation cycle are 1) Anvisa’s regulatory performance (by median evaluation time of medical devices); 2) companies’ performance in complying with health legislation (by proportion of medical devices not authorized for sale); and 3) evidence of medical device health risk (due to adverse events, technical complaints, health alerts and preventive/cautionary measures). Influence analyses were carried out with variables associated with regulatory process, company size and medical device characteristics as predictors of the indicators. Results: The first indicator shows that the Agency’s timing has improved across all risk classes of medical devices. In 2012, the indicator was measured in 73 days (interquartile range 56–111), while in 2021 in 9 days (interquartile range 6–15). The second indicator showed improvement only for medical devices in the low/medium risk classes. The third indicator did not show an increase in health risk for medical devices with the regulatory simplifications adopted in the last decade. The influence analysis indicates that the need for a certificate of good manufacturing practices, company size and need for additional information are the most relevant predictor variables. Conclusions: The regulatory results from the legislation on medical devices in the last decade were positive.IntroducciónSe mejoró la regulación sanitaria de dispositivos médicos con enfoque de riesgo sanitario, a través de la simplificación de trámites regulatorios y la reducción de la carga administrativa.objetivoEvaluar los impactos de la mejora de la legislación sanitaria durante la década 2012-2021 mediante tres indicadores que representen al gobierno, la empresa y el producto.MétodoLos indicadores desarrollados para evaluar el ciclo de regulación sanitaria son 1) el desempeño regulatorio de la Anvisa (por tiempo medio de evaluación de dispositivos médicos); 2) desempeño de las empresas en el cumplimiento de la legislación sanitaria (por proporción de dispositivos médicos no autorizados para la venta); y 3) evidencia de riesgo para la salud del dispositivo médico (debido a eventos adversos, quejas técnicas, alertas de salud y medidas preventivas/cautelares). Se realizaron análisis de influencia con variables asociadas al proceso regulatorio, el tamaño de la empresa y las características del dispositivo médico como predictores de los indicadores.ResultadosEl primer indicador muestra que el tiempo de la Agencia ha mejorado en todas las clases de riesgo de dispositivos médicos. En 2012, el indicador se midió en 73 días (rango intercuartílico 56-111), mientras que en 2021 fue de 9 días (rango intercuartílico 6-15). El segundo indicador mostró una mejora solo para dispositivos médicos en las clases de riesgo bajo/medio. El tercer indicador no mostró un aumento en el riesgo para la salud de los dispositivos médicos con las simplificaciones regulatorias adoptadas en la última década. El análisis de influencia indica que la necesidad de un certificado de buenas prácticas de manufactura, el tamaño de la empresa y la necesidad de información adicional son las variables predictoras más relevantes.Introdução: O regramento sanitário de dispositivos médicos foi aperfeiçoado com foco no risco sanitário, por meio da simplificação de etapas regulatórias e da redução da carga administrativa. Objetivo: Avaliar os impactos do aperfeiçoamento da legislação sanitária durante a década 2012-2021 por três indicadores que representam governo, empresa e produto. Método: Os indicadores desenvolvidos para avaliar o ciclo de regulação sanitária são: 1) desempenho regulatório da Anvisa (por mediana de tempo de avaliação dos dispositivos médicos); 2) desempenho das empresas no cumprimento da legislação sanitária (por porcentagem de dispositivos médicos não autorizados para comercialização); e 3) evidências de risco sanitário do dispositivo médico (por eventos adversos, queixas técnicas, alertas sanitários e medidas preventivas/cautelares). Foram realizadas análises de influência com variáveis associadas ao processo regulatório, porte da empresa e características do dispositivo médico como preditoras dos indicadores. Resultados: O primeiro indicador evidencia que os tempos da Agência foram aperfeiçoados em todas as classes de risco de dispositivos médicos. Em 2012, o indicador foi mensurado em 73 dias (intervalo interquartil 56–111), ao passo que, em 2021, foi de 9 dias (intervalo interquartil 6–15). O segundo indicador apresentou melhora apenas para os dispositivos médicos das classes de risco baixo/médio. O terceiro indicador não demonstrou incremento de risco sanitário para os dispositivos médicos com as simplificações regulatórias adotadas na última década. A análise de influência indica que a necessidade de certificado de boas práticas de fabricação, porte da empresa e a necessidade de informações complementares são as variáveis preditoras mais relevantes. Conclusões: Os resultados regulatórios oriundos da legislação sobre dispositivos médicos na última década foram positivos.Instituto Nacional de Controle de Qualidade em Saúde2022-11-30info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Guest Article""Artigo de convidado""Artigo de convidado"application/pdfapplication/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/210410.22239/2317-269x.02104Health Surveillance under Debate: Society, Science & Technology ; Vol. 10 No. 4 (2022): November - Commemorative Edition: 10 Years of Visa in Debate; 32-43Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 10 Núm. 4 (2022): Noviembre - Edición Conmemorativa: 10 Años de Visa en Debate; 32-43Vigil Sanit Debate, Rio de Janeiro; v. 10 n. 4 (2022): Novembro - Edição comemorativa: 10 anos da Visa em Debate; 32-432317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporenghttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2104/1462https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2104/1500Copyright (c) 2022 Leidy Anne Alves Teixeira, Hélio Bomfim de Macêdo Filho (Autor)https://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessTeixeira, Leidy Anne Alves Macêdo Filho, Hélio Bomfim de2023-12-14T14:28:38Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/2104Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-12-14T14:28:38Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false |
dc.title.none.fl_str_mv |
A decade of improvement of health legislation for medical devices and its impacts on the health regulation cycle Una Década de Mejora de la Legislación Sanitaria de Dispositivos Médicos y sus Impactos en el Ciclo de Regulación Sanitaria Uma década de aperfeiçoamento da legislação sanitária de dispositivos médicos e os impactos no ciclo da regulação sanitária |
title |
A decade of improvement of health legislation for medical devices and its impacts on the health regulation cycle |
spellingShingle |
A decade of improvement of health legislation for medical devices and its impacts on the health regulation cycle Teixeira, Leidy Anne Alves Dispositivos Médicos Regulação Sanitária Anvisa Medical Device Sanitary Regulation Anvisa regulación sanitaria dispositivos médicos Anvisa |
title_short |
A decade of improvement of health legislation for medical devices and its impacts on the health regulation cycle |
title_full |
A decade of improvement of health legislation for medical devices and its impacts on the health regulation cycle |
title_fullStr |
A decade of improvement of health legislation for medical devices and its impacts on the health regulation cycle |
title_full_unstemmed |
A decade of improvement of health legislation for medical devices and its impacts on the health regulation cycle |
title_sort |
A decade of improvement of health legislation for medical devices and its impacts on the health regulation cycle |
author |
Teixeira, Leidy Anne Alves |
author_facet |
Teixeira, Leidy Anne Alves Macêdo Filho, Hélio Bomfim de |
author_role |
author |
author2 |
Macêdo Filho, Hélio Bomfim de |
author2_role |
author |
dc.contributor.author.fl_str_mv |
Teixeira, Leidy Anne Alves Macêdo Filho, Hélio Bomfim de |
dc.subject.por.fl_str_mv |
Dispositivos Médicos Regulação Sanitária Anvisa Medical Device Sanitary Regulation Anvisa regulación sanitaria dispositivos médicos Anvisa |
topic |
Dispositivos Médicos Regulação Sanitária Anvisa Medical Device Sanitary Regulation Anvisa regulación sanitaria dispositivos médicos Anvisa |
description |
Introduction: The sanitary regulation of medical devices was improved with a focus on sanitary risk, through the simplification of regulatory steps and the reduction of the administrative burden. Objective: To evaluate the impacts of the improvement of health legislation during the decade 2012-2021 by three indicators representing government, company, and product. Method: The indicators developed to evaluate the health regulation cycle are 1) Anvisa’s regulatory performance (by median evaluation time of medical devices); 2) companies’ performance in complying with health legislation (by proportion of medical devices not authorized for sale); and 3) evidence of medical device health risk (due to adverse events, technical complaints, health alerts and preventive/cautionary measures). Influence analyses were carried out with variables associated with regulatory process, company size and medical device characteristics as predictors of the indicators. Results: The first indicator shows that the Agency’s timing has improved across all risk classes of medical devices. In 2012, the indicator was measured in 73 days (interquartile range 56–111), while in 2021 in 9 days (interquartile range 6–15). The second indicator showed improvement only for medical devices in the low/medium risk classes. The third indicator did not show an increase in health risk for medical devices with the regulatory simplifications adopted in the last decade. The influence analysis indicates that the need for a certificate of good manufacturing practices, company size and need for additional information are the most relevant predictor variables. Conclusions: The regulatory results from the legislation on medical devices in the last decade were positive. |
publishDate |
2022 |
dc.date.none.fl_str_mv |
2022-11-30 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion "Guest Article" "Artigo de convidado" "Artigo de convidado" |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2104 10.22239/2317-269x.02104 |
url |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2104 |
identifier_str_mv |
10.22239/2317-269x.02104 |
dc.language.iso.fl_str_mv |
por eng |
language |
por eng |
dc.relation.none.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2104/1462 https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2104/1500 |
dc.rights.driver.fl_str_mv |
Copyright (c) 2022 Leidy Anne Alves Teixeira, Hélio Bomfim de Macêdo Filho (Autor) https://creativecommons.org/licenses/by/4.0 info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
Copyright (c) 2022 Leidy Anne Alves Teixeira, Hélio Bomfim de Macêdo Filho (Autor) https://creativecommons.org/licenses/by/4.0 |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf application/pdf |
dc.publisher.none.fl_str_mv |
Instituto Nacional de Controle de Qualidade em Saúde |
publisher.none.fl_str_mv |
Instituto Nacional de Controle de Qualidade em Saúde |
dc.source.none.fl_str_mv |
Health Surveillance under Debate: Society, Science & Technology ; Vol. 10 No. 4 (2022): November - Commemorative Edition: 10 Years of Visa in Debate; 32-43 Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 10 Núm. 4 (2022): Noviembre - Edición Conmemorativa: 10 Años de Visa en Debate; 32-43 Vigil Sanit Debate, Rio de Janeiro; v. 10 n. 4 (2022): Novembro - Edição comemorativa: 10 anos da Visa em Debate; 32-43 2317-269X reponame:Vigilância Sanitária em Debate instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ |
instname_str |
Fundação Oswaldo Cruz (FIOCRUZ) |
instacron_str |
FIOCRUZ |
institution |
FIOCRUZ |
reponame_str |
Vigilância Sanitária em Debate |
collection |
Vigilância Sanitária em Debate |
repository.name.fl_str_mv |
Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ) |
repository.mail.fl_str_mv |
incqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br |
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