Analysis of the impact of clinical evaluation on the submissions of high risk medical devices to the Brazilian Health Regulatory Agency
Autor(a) principal: | |
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Data de Publicação: | 2019 |
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/1231 |
Resumo: | Introduction: The clinical evaluation of medical devices is an important component in the evaluation of new technologies for sanitary registration purposes within the Brazilian Health Regulatory Agency and represents an important tool for regulatory decision-making to verify compliance with regulations that establish the need for proof of safety and efficacy of medical devices to perform sanitary registration. Objective: To evaluate and discuss the reasons for the rejection of registration requests motivated by deficiencies related to the clinical evaluation of high-risk medical devices. Methods: In the electronic system Datavisa, internal system for storage and analysis of data submitted to Anvisa, all the rejections occurred in 2017 within the scope of the General Office of Medical Devices (GGTPS) concerning the clinical evaluation of medical devices of risk class III and IV, both in the original cause of the refusal and related to the non-compliance with the legally established deadlines for meeting the requirements when at least one of the requirements involved clinical evaluation, were evaluated. Results: Data were collected from the expert opinion of the agency to construct the outline of the main characteristics related to the rejections in relation to the clinical evaluation offered in the registration dossiers by the companies responsible for the submission. The evaluations were divided according to the area responsible for the registry, involving implantable orthopedic materials submitted to the analysis of the Coordination of Implantable Materials in Orthopedics (CMIOR), materials for health use submitted to the analysis of the Office of Materials for Health Use (Gemat) and equipment submitted to the analysis of the Office of Equipment Technology (GQUIP) of Anvisa. Conclusions: Considering the sample of rejected health records, the findings suggest a heterogeneity in both the quality and the format of the data provided in clinical evaluations by companies submitting applications of medical devices, especially related to the methodological nature of the clinical trials presented, deficiencies in risk management, and other regulatory requirements connected to the clinical assessment scenario of medical devices and compliance with minimum design requirements. |
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Analysis of the impact of clinical evaluation on the submissions of high risk medical devices to the Brazilian Health Regulatory AgencyAnálise do impacto da avaliação clínica no registro sanitário de dispositivos médicos de alto riscoDispositivos MédicosAvaliação ClínicaRegistro SanitárioAnvisaEnsaios ClínicosMedical DevicesClinical EvaluationSanitary RegistrationAnvisaClinical TrialsIntroduction: The clinical evaluation of medical devices is an important component in the evaluation of new technologies for sanitary registration purposes within the Brazilian Health Regulatory Agency and represents an important tool for regulatory decision-making to verify compliance with regulations that establish the need for proof of safety and efficacy of medical devices to perform sanitary registration. Objective: To evaluate and discuss the reasons for the rejection of registration requests motivated by deficiencies related to the clinical evaluation of high-risk medical devices. Methods: In the electronic system Datavisa, internal system for storage and analysis of data submitted to Anvisa, all the rejections occurred in 2017 within the scope of the General Office of Medical Devices (GGTPS) concerning the clinical evaluation of medical devices of risk class III and IV, both in the original cause of the refusal and related to the non-compliance with the legally established deadlines for meeting the requirements when at least one of the requirements involved clinical evaluation, were evaluated. Results: Data were collected from the expert opinion of the agency to construct the outline of the main characteristics related to the rejections in relation to the clinical evaluation offered in the registration dossiers by the companies responsible for the submission. The evaluations were divided according to the area responsible for the registry, involving implantable orthopedic materials submitted to the analysis of the Coordination of Implantable Materials in Orthopedics (CMIOR), materials for health use submitted to the analysis of the Office of Materials for Health Use (Gemat) and equipment submitted to the analysis of the Office of Equipment Technology (GQUIP) of Anvisa. Conclusions: Considering the sample of rejected health records, the findings suggest a heterogeneity in both the quality and the format of the data provided in clinical evaluations by companies submitting applications of medical devices, especially related to the methodological nature of the clinical trials presented, deficiencies in risk management, and other regulatory requirements connected to the clinical assessment scenario of medical devices and compliance with minimum design requirements.Introdução: A avaliação clínica de dispositivos médicos é um componente importante na avaliação de novas tecnologias para fins de registro sanitário no âmbito da Agência Nacional de Vigilância Sanitária e representa uma ferramenta importante para a tomada de decisão regulatória para verificar a conformidade com as normativas que estabelecem a necessidade de comprovação de segurança e eficácia de dispositivos médicos para efetuar o registro sanitário. Objetivo: Avaliar e discutir as razões para o indeferimento de solicitações de registro motivadas por deficiências relacionadas à avaliação clínica dos dispositivos médicos de alto risco. Método: Foram avaliados no sistema eletrônico Datavisa, sistema interno para armazenamento e análise dedados de processos submetidos à Anvisa, todos os indeferimentos ocorridos em 2017 no âmbito da Gerência-Geral de Tecnologia de Produtos para Saúde (GGTPS), que tiveram como causa aspectos relativos à avaliação clínica de dispositivos médicos de classe de risco III e IV, tanto na causa original do indeferimento, quanto relacionadas ao não cumprimento dos prazos legalmente estabelecidos para o cumprimento dasexigências quando pelo menos uma das exigências envolvia a avaliação clínica. Resultados: Foram recolhidos dados dos pareceres construídos pelos especialistas da agência para construir o delineamento das principais características relacionadas aos indeferimentos em relação à avaliação clínica oferecida nos dossiês de registro pelas empresas responsáveis pela submissão. As avaliações foram discriminadas de acordo com a área responsável pelo registro, envolvendo materiais implantáveis em ortopedia submetidos à análise da Coordenação de Materiais Implantáveis em Ortopedia (CMIOR), materiais de uso em saúde submetidos à análise da Gerência de Tecnologia de Materiais de Uso em Saúde (Gemat) e equipamentos submetidos à análise da Gerência de Tecnologia em Equipamentos (GQUIP) da Anvisa. Conclusões: Considerando a amostra de indeferimentos de registro sanitário estudada, os achados sugerem uma heterogeneidade tanto na qualidade quanto no formato dos dados fornecidos em avaliações clínicas pelas empresas que submetem registros sanitários de dispositivos médicos, especialmente relacionado à natureza metodológica dos ensaios clínicos apresentados, deficiências no gerenciamento de risco e demais requisitos regulatórios relacionados ao cenário da avaliação clínica de dispositivos médicos e conformidade com os requisitos mínimos do projeto.Instituto Nacional de Controle de Qualidade em Saúde2019-05-31info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed article""Artículo revisado por pares""Artigo avaliado pelos pares"application/pdfapplication/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/123110.22239/2317-269x.01231Health Surveillance under Debate: Society, Science & Technology ; Vol. 7 No. 2 (2019): May; 37-45Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 7 Núm. 2 (2019): Puede; 37-45Vigil Sanit Debate, Rio de Janeiro; v. 7 n. 2 (2019): Maio; 37-452317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporenghttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1231/1010https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1231/1086Copyright (c) 2019 Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debatehttps://creativecommons.org/licenses/by-nc-nd/4.0info:eu-repo/semantics/openAccessNascimento, Alessandro Ferreira do2023-06-27T15:11:12Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/1231Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-06-27T15:11:12Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false |
dc.title.none.fl_str_mv |
Analysis of the impact of clinical evaluation on the submissions of high risk medical devices to the Brazilian Health Regulatory Agency Análise do impacto da avaliação clínica no registro sanitário de dispositivos médicos de alto risco |
title |
Analysis of the impact of clinical evaluation on the submissions of high risk medical devices to the Brazilian Health Regulatory Agency |
spellingShingle |
Analysis of the impact of clinical evaluation on the submissions of high risk medical devices to the Brazilian Health Regulatory Agency Nascimento, Alessandro Ferreira do Dispositivos Médicos Avaliação Clínica Registro Sanitário Anvisa Ensaios Clínicos Medical Devices Clinical Evaluation Sanitary Registration Anvisa Clinical Trials |
title_short |
Analysis of the impact of clinical evaluation on the submissions of high risk medical devices to the Brazilian Health Regulatory Agency |
title_full |
Analysis of the impact of clinical evaluation on the submissions of high risk medical devices to the Brazilian Health Regulatory Agency |
title_fullStr |
Analysis of the impact of clinical evaluation on the submissions of high risk medical devices to the Brazilian Health Regulatory Agency |
title_full_unstemmed |
Analysis of the impact of clinical evaluation on the submissions of high risk medical devices to the Brazilian Health Regulatory Agency |
title_sort |
Analysis of the impact of clinical evaluation on the submissions of high risk medical devices to the Brazilian Health Regulatory Agency |
author |
Nascimento, Alessandro Ferreira do |
author_facet |
Nascimento, Alessandro Ferreira do |
author_role |
author |
dc.contributor.author.fl_str_mv |
Nascimento, Alessandro Ferreira do |
dc.subject.por.fl_str_mv |
Dispositivos Médicos Avaliação Clínica Registro Sanitário Anvisa Ensaios Clínicos Medical Devices Clinical Evaluation Sanitary Registration Anvisa Clinical Trials |
topic |
Dispositivos Médicos Avaliação Clínica Registro Sanitário Anvisa Ensaios Clínicos Medical Devices Clinical Evaluation Sanitary Registration Anvisa Clinical Trials |
description |
Introduction: The clinical evaluation of medical devices is an important component in the evaluation of new technologies for sanitary registration purposes within the Brazilian Health Regulatory Agency and represents an important tool for regulatory decision-making to verify compliance with regulations that establish the need for proof of safety and efficacy of medical devices to perform sanitary registration. Objective: To evaluate and discuss the reasons for the rejection of registration requests motivated by deficiencies related to the clinical evaluation of high-risk medical devices. Methods: In the electronic system Datavisa, internal system for storage and analysis of data submitted to Anvisa, all the rejections occurred in 2017 within the scope of the General Office of Medical Devices (GGTPS) concerning the clinical evaluation of medical devices of risk class III and IV, both in the original cause of the refusal and related to the non-compliance with the legally established deadlines for meeting the requirements when at least one of the requirements involved clinical evaluation, were evaluated. Results: Data were collected from the expert opinion of the agency to construct the outline of the main characteristics related to the rejections in relation to the clinical evaluation offered in the registration dossiers by the companies responsible for the submission. The evaluations were divided according to the area responsible for the registry, involving implantable orthopedic materials submitted to the analysis of the Coordination of Implantable Materials in Orthopedics (CMIOR), materials for health use submitted to the analysis of the Office of Materials for Health Use (Gemat) and equipment submitted to the analysis of the Office of Equipment Technology (GQUIP) of Anvisa. Conclusions: Considering the sample of rejected health records, the findings suggest a heterogeneity in both the quality and the format of the data provided in clinical evaluations by companies submitting applications of medical devices, especially related to the methodological nature of the clinical trials presented, deficiencies in risk management, and other regulatory requirements connected to the clinical assessment scenario of medical devices and compliance with minimum design requirements. |
publishDate |
2019 |
dc.date.none.fl_str_mv |
2019-05-31 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion "Peer-reviewed article" "Artículo revisado por pares" "Artigo avaliado pelos pares" |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1231 10.22239/2317-269x.01231 |
url |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1231 |
identifier_str_mv |
10.22239/2317-269x.01231 |
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/1231/1010 https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1231/1086 |
dc.rights.driver.fl_str_mv |
https://creativecommons.org/licenses/by-nc-nd/4.0 info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
https://creativecommons.org/licenses/by-nc-nd/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. 7 No. 2 (2019): May; 37-45 Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 7 Núm. 2 (2019): Puede; 37-45 Vigil Sanit Debate, Rio de Janeiro; v. 7 n. 2 (2019): Maio; 37-45 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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1797042045301293056 |