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Brazilian Regulatory System – News Roundup

Date: 10/25/2019

Our team has compiled a few important news from the past days concerning medical device’s regulation and the Brazilian regulatory system:

 

Field safety correction action information is now submitted to ANVISA by electronic system 

 

Since the 22th of July manufacturers must submit field safety correction action information via ANVISA’s electronic system – called Solicita. Before that, the information was submitted to ANVISA by e-mail or hard copies.

 

Field safety correction actions are actions taken by manufacturers and medical devices’ registry holders to reduce the risk of adverse events and other incidents related to products marketed in Brazil.

 

By making all the information electronic ANVISA aims to organize the documentation received by the agency, give transparency to the actions taken and better manage the work flow.

 

QMI-SAI Canada new Notified Body recognized by ANVISA to perform MDSAP Audits

 

ANVISA recently (August 6) published the Resolution RE Nº 2.138, DE 5 DE AGOSTO DE 2019 granting QMI-SAI Canada Limited the status of notified body able to perform MDSAP on-site audits for medical devices’ manufacturers.

 

ANVISA is a member of the IMDRF and along with four other countries – Australia, Canada, Japan and the United States – compose the MDSAP participating regulators.

 

BGMP (Brazilian Good Manufacturing Practices) inspection requests for foreign manufacturers must be applied by a Brazilian Registration Holder, who will also be the holder of the certificate issued by ANVISA.

 

INMETRO is working on reducing the average time to issue Import Permits

 

INMETRO is working alongside with Global Alliance for Trade Facilitation and developing a project to reduce the deadline to issue Import Permits from 5 to 2 days by automating 70% of the requests. The results will start to show by the end of the year, informs INMETRO.

 

INMETRO gets through approximately 200 thousands of processes requesting Import Permits every year.  Low risk products’ Permits will be issued by an automatized, simple process which will allow INMETRO’s specialists to focus on high-risk products – improving the safety for importers and consumers. The risk level will be periodically reevaluated.

 

The action is a part of INMETRO’s effort to propose a new regulatory model aiming to create a less bureaucratic and more simple system. (link para o nosso post sobre o novo modelo que está sendo proposto pelo INMETRO)

 

INMETRO’s new Ordinance makes the approval of  measuring instruments faster

 

INMETRO’s Ordinance 302/2019 published by the end of June has altered  altered modified? changed? the procedures that must be taken in order to approve measuring instruments such as  blood pressure meters and clinical thermometers.

 

Before, the manufacturer or importer had to open a process with INMETRO, submit the instrument for INMETRO’s lab evaluation, wait for INMETRO´s reply, then send the instrument to an accredited lab and wait approximately 3 months for  the lab to provide a test report to be evaluated by INMETRO. Waiting time could be up to 145 days.

 

Now, the company can submit the sample directly to the lab and the report, issued by the accredited lab, can be submitted directly to INMETRO thus making the process up to 3 months faster. The changes increase the process predictability and efficiency making it easier for the manufacturer to plan his entrance in the market.

 

INMETRO also published, on July 15th, the Ordinance 336/2019 concerning measuring instruments. Manufacturers and importers of certain measuring instruments can now obtain authorization to issue a declaration of conformity  instead of the initial verification that needs to be done to every instrument before they can be marketed in Brazil. Before the ordinance, the initial verification could only be carried by Brazilian Metrology and Industrial Quality Bodies.

 

Follow us on social media to get an update on the top news regarding the Brazilian regulatory system.

 

DOMO Salute Team

 

Ronda regulatória DOMO Salute

 

Nossa equipe  preparou um resumo das principais notícias recentes referentes à área regulatória de produtos para saúde no Brasil. Confira abaixo:

 

Informações referentes às ações de campo de produtos para a saúde  devem ser encaminhadas para ANVISA via Solicita

 

Desde 22 de julho as ações de campo devem ser encaminhadas para a Anvisa por meio do sistema de peticionamento eletrônico Solicita. Com isso, as empresas deixam de encaminhar a documentação fisicamente ou via e-mail, como ocorria anteriormente.

 

As ações de campo são realizadas pelos detentores de registro de produtos para a saúde com o objetivo de reduzir o risco de ocorrência de eventos adversos relacionados ao uso de produtos que já são comercializados. São exemplos das principais ações de campo realizadas pelas empresas: recolhimento de produtos, correção em campo, atualização de software e encaminhamento de cartas aos clientes com instruções referentes aos problemas detectados.

 

Com a migração das ações de campo para o sistema Solicita, a Anvisa pretende organizar a documentação encaminhada para a área técnica, dar transparência às ações e melhorar os fluxos internos. Além disso, busca-se melhorar as informações e ferramentas para o encaminhamento de documentos pelo setor regulado.

 

ANVISA reconhece novo organismo auditor – QMI-SAI Canada Limited

 

A Resolução-RE Nº 2.138, de 5 de agosto de 2019 da ANVISA reconheceu a QMI-SAI Canada Limited como organismo auditor para realização de Auditorias Regulatórias no formato MDSAP em estabelecimentos fabris de produtos para saúde.

 

A ANVISA é membro do Fórum Internacional de Reguladores de Produtos para Saúde, conhecido como IMDRF, e em conjunto com Austrália, Canadá, Japão e Estados Unidos integra o Programa de Auditoria Única em Produtos para a Saúde – MDSAP.

 

INMETRO quer reduzir tempo médio para emissão de licenças de importação

 

Para impulsionar o comércio internacional, o INMETRO, em parceria com a Global Alliance for Trade Facilitation, está desenvolvendo um projeto que objetiva diminuir de cinco para dois dias o prazo de emissão de licenças de importação, automatizando a análise de 70% dos pedidos. Os resultados já poderão ser percebidos no final de 2019.

 

Anualmente, o Inmetro analisa cerca de 200 mil processos de anuência para liberação de importação de produtos regulamentados. Para lidar com a grande demanda, o projeto é baseado em dois pilares: a modernização de sistemas de TI e a utilização de princípios de gestão de riscos, a partir na análise de dados e do histórico do importador. Assim, processos de licença de baixo risco serão feitos de forma simplificada e automática e os servidores do Inmetro poderão concentrar suas análises nos processos de médio e alto risco, aumentando a proteção ao consumidor e a transparência aos importadores. O grau de risco atribuído será reavaliado ciclicamente, a partir do resultado das ações de fiscalização, monitoramento e controle realizadas pelo Inmetro no mercado brasileiro.

 

De acordo com o coordenador da Diretoria de Avaliação da Conformidade (Dconf), Paulo Coscarelli, os novos procedimentos que serão estabelecidos vão ao encontro da reforma regulatória que está em curso no Inmetro (link para o nosso post sobre o novo modelo que está sendo proposto pelo INMETRO). “O projeto de modernização do licenciamento de importações está completamente alinhado às diretrizes de simplificação e de desburocratização, ao mesmo tempo que amplia a capacidade do Inmetro de controlar as importações de maneira mais inteligente e ágil e menos onerosa para as empresas. Nosso objetivo é se alinhar às melhores práticas internacionais e conseguir realizar inspeções físicas em cargas, em cooperação com a Receita Federal, quando nossas análises assim indicarem como necessidade”, afirmou.

 

Portaria do INMETRO facilita aprovação de instrumentos de medição

 

Aprovar instrumentos de medição no Instituto Nacional de Metrologia, Qualidade e Tecnologia (Inmetro) ficou mais rápido. O Diário Oficial da União (DOU) publicou, no dia 26 de junho, a Portaria Nº 302/2019, que altera os procedimentos de avaliação de modelo de instrumentos de medição como balanças, termômetros clínicos, medidores de pressão arterial (esfigmomanômetros), entre outros.

 

Até então, o fabricante ou o importador precisava abrir um processo na Diretoria de Metrologia Legal do Inmetro; encaminhar o instrumento de medição para a Dimel, para avaliação nos laboratórios do Instituto; e aguardar na fila de espera de realização dos ensaios em laboratórios externos, para posterior análise do relatório de ensaio e emissão da portaria de aprovação para sua comercialização. Essa dinâmica superava três meses de espera por parte do fabricante ou importador.

 

Pelo novo regulamento, os requisitos para uso de laboratórios acreditados serão mais simples e o detentor do instrumento poderá levar diretamente os relatórios de ensaios de laboratórios acreditados à Diretoria de Metrologia Legal (Dimel) do Inmetro. Assim, o tempo em fila para análise do pedido de aprovação de modelo diminuirá em, aproximadamente três meses. Até então, o período de espera chegava a 145 dias. Com a mudança, haverá, ainda, melhor previsibilidade para o planejamento financeiro do empresário e comercialização dos produtos no mercado.

 

O INMETRO também publicou, no dia 15 de Julho, a Portaria 336/2019. Considerando a crescente demanda de verificação inicial de instrumentos de medição e a limitação do capital humano para operacionalizar essa atividade executada pelos órgãos da RBMLQ-I, resolveu permitir que importadores e fabricantes de instrumentos de medição obtenham autorização para emitir declaração de conformidade em substituição à verificação inicial realizada pelos órgãos da RBMLQ-I, nos termos da Portaria Inmetro nº 400, de 12 de agosto de 2013. Confira a lista de instrumentos de medição para os quais a Portaria se aplica. 

 

Siga nossas redes sociais e acompanhe as principais notícias referentes ao sistema regulatório brasileiro. 

 

Equipe DOMO Salute

 

Links:

 

Tópico 1  Solicita ANVISA

http://portal.anvisa.gov.br/noticias?p_p_id=101_INSTANCE_FXrpx9qY7FbU&p_p_col_id=column-2&p_p_col_pos=1&p_p_col_count=2&_101_INSTANCE_FXrpx9qY7FbU_groupId=219201&_101_INSTANCE_FXrpx9qY7FbU_urlTitle=conheca-os-codigos-para-acoes-de-campo-no-solicita&_101_INSTANCE_FXrpx9qY7FbU_struts_action=%2Fasset_publisher%2Fview_content&_101_INSTANCE_FXrpx9qY7FbU_assetEntryId=5562561&_101_INSTANCE_FXrpx9qY7FbU_type=content

 

https://www.emergobyul.com/blog/2019/07/brazils-anvisa-now-requires-electronic-submissions-medical-device-fscas?fbclid=IwAR0v2w3nEj3xgXrlK4N9Yx_4fPmSvDN6HmdXcXhuE1wGXxBtgtWKiRFT8eA

 

Tópico 2 Novo auditor MDSAP

http://www.latinigroup.com/pt-br/blog/noticias-todas/621-mdsap-qmi-sai.html?fbclid=IwAR05qETV1RPWZKF0TMdS5aAi4ujNt8tt-VIUdaIZTZzLO3AIh-1qlUsYt1c

 

http://www.in.gov.br/web/dou/-/resolucao-re-n-2.138-de-5-de-agosto-de-2019-208990028

 

Tópico 3  Licença de Importação INMETRO

http://www4.inmetro.gov.br/noticia/Inmetro-quer-reduzir-tempo-medio-para-emissao-de-licencas-de-importacao

 

Tópico 4 Portaria 302/2019 INMETRO

http://www4.inmetro.gov.br/noticias/portaria-do-inmetro-facilita-aprovacao-de-instrumentos-de-medicao

 

Tópico 5 Portaria 336/2019 INMETRO

http://www.in.gov.br/web/dou/-/portaria-n-336-de-15-de-julho-de-2019-197102353

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