A importância dos dispositivos médicos na prevenção e combate ao SARS-CoV-2 e da cooperação entre reguladores, academia e indústria nacional : perspetivas da realidade portuguesa
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Data
2020
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Edições Universitárias Lusófonas
Resumo
Face à crise instalada com o deflagrar da pandemia associada ao novo coronavírus SARS-CoV-2, ao nível de propagação do vírus e à escassez de dispositivos médicos necessários ao seu combate, foi estabelecido um regime excecional relativamente aos procedimentos de avaliação da conformidade e de fiscalização do mercado, aplicável a estes dispositivos, através da Recomendação (UE) 2020/403 da Comissão Europeia de13 março, que foi adotada por Portugal através da publicação do Decreto-Lei n.º 14-E/2020 de 13 de abril. É importante que a regular produção de orientações emanadas pelo INFARMED durante a pandemia e a cooperação de outras entidades nacionais (Ministério da Economia, Ministério da Ciência, Tecnologia e Ensino Superior e Indústria Nacional e Direção Geral de Saúde), de apoio aos fabricantes e importadores, se reflitam no desenvolvimento do sistema produtivo português, permitindo promover o reconhecimento internacional da indústria nacional e o fácil acesso a outros mercados. Uma análise detalhada de todas as variáveis que incluí neste artigo de opinião e a apresentação de propostas, na perspetiva da definição de uma visão estratégica nacional, na área do desenvolvimento e produção de dispositivos médicos, de forma a potenciar as ideias e ganhos que resultaram da resposta à crise, será objeto de estudo a publicar oportunamente. Palavras-chave: INFARMED. Legislação Dispositivos Médicos, COVID-19, SARS-CoV-2
In view of the scarcity of medical devices necessary to combat the outbreak crisis caused by the new SARS-CoV-2 coronavirus pandemic, an exceptional regime regarding applicable device conformity assessment procedures and market surveillance was established through Recommendation (EU) 2020/403 of the European Commission of 13 March. This was adopted by Portugal through the publication of Decree-Law no. 14-E / 2020 of 13 April. Many guidelines were issued during the pandemic by INFARMED and with the cooperation of other national entities (Ministry of Economy, Ministry of Science, Technology and Higher Education, national Industry and General Directorate of Health) to support medical device manufacturers and importers. It is important that these guidelines are reflected in the development of the Portuguese medical device industry in order to promote its international recognition and to ease access to other medical markets. A detailed analysis of all variables here included in this opinion article, together with some proposals, aims to promote a national strategic vision in the area of the development and production of medical devices, in order to enhance ideas and gains that resulted from these responses to the crisis, serving for future analysis to be published in due course. Keywords: INFARMED, Medical Devices Legislation, COVID-19,SARS-CoV-2
In view of the scarcity of medical devices necessary to combat the outbreak crisis caused by the new SARS-CoV-2 coronavirus pandemic, an exceptional regime regarding applicable device conformity assessment procedures and market surveillance was established through Recommendation (EU) 2020/403 of the European Commission of 13 March. This was adopted by Portugal through the publication of Decree-Law no. 14-E / 2020 of 13 April. Many guidelines were issued during the pandemic by INFARMED and with the cooperation of other national entities (Ministry of Economy, Ministry of Science, Technology and Higher Education, national Industry and General Directorate of Health) to support medical device manufacturers and importers. It is important that these guidelines are reflected in the development of the Portuguese medical device industry in order to promote its international recognition and to ease access to other medical markets. A detailed analysis of all variables here included in this opinion article, together with some proposals, aims to promote a national strategic vision in the area of the development and production of medical devices, in order to enhance ideas and gains that resulted from these responses to the crisis, serving for future analysis to be published in due course. Keywords: INFARMED, Medical Devices Legislation, COVID-19,SARS-CoV-2
Descrição
Biomedical and biopharmaceutical research : jornal de investigação biomédica e biofarmacêutica
Palavras-chave
MEDICINA, INFARMED, LEGISLAÇÃO, DISPOSITIVOS MÉDICOS, COVID-19, BIOMEDICINA, MEDICINE, LEGISLATION, COVID-19, BIOMEDICINE
Citação
Abreu, I M M P D 2020, 'A importância dos dispositivos médicos na prevenção e combate ao SARS-CoV-2 e da cooperação entre reguladores, academia e indústria nacional : perspetivas da realidade portuguesa', Biomedical and biopharmaceutical research : jornal de investigação biomédica e biofarmacêutica.