Portaria nº 384, de 18 de dezembro de 2020
Páginas | 167-167 |
Data | 18 Dezembro 2020 |
Data de publicação | 21 Dezembro 2020 |
Órgão | Ministério da Economia,Instituto Nacional de Metrologia, Qualidade e Tecnologia |
Seção | DO1 |
Portaria nº 384, de 18 de dezembro de 2020
Aprova os Requisitos de Avaliação da Conformidade para Equipamentos sob Regime de Vigilância Sanitária - Consolidado.
O PRESIDENTE DO INSTITUTO NACIONAL DE METROLOGIA, QUALIDADE E TECNOLOGIA - INMETRO, no exercício da competência que lhe foi outorgada pelos artigos 4º, § 2º, da Lei nº 5.966, de 11 de dezembro de 1973, e 3º, incisos I e IV, da Lei nº 9.933, de 20 de dezembro de 1999, combinado com o disposto nos artigos 18, inciso V, do Anexo I ao Decreto nº 6.275, de 28 de novembro de 2007, e 105, inciso V, do Anexo à Portaria nº 2, de 4 de janeiro de 2017, do então Ministério da Indústria, Comércio Exterior e Serviços, considerando o que determina o Decreto nº 10.139, de 28 de novembro de 2019, e o que consta no Processo SEI nº 0052600.006080/2019-60, resolve:
Objeto e âmbito de aplicação
Art. 1º Ficam aprovados os Requisitos de Avaliação da Conformidade e as Especificações para o Selo de Identificação da Conformidade para Equipamentos sob Regime de Vigilância Sanitária - Consolidado, fixados, respectivamente, nos Anexos I e II disponíveis em http://www.inmetro.gov.br/legislacao.
§ 1º A avaliação da conformidade, por meio do mecanismo de certificação, deve ser realizada por Organismo de Certificação de Produto - OCP, estabelecido no Brasil e acreditado pelo Inmetro, consoante os Requisitos ora aprovados.
§ 2º Aplicam-se os presentes Requisitos a equipamentos, inclusive suas partes e acessórios, com finalidade médica, odontológica, laboratorial ou fisioterápica, utilizados direta ou...
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