Anvisa realizará audiência pública virtual sobre revisão da RDC 302/2005

Anvisa realizará audiência pública virtual sobre revisão da RDC 302/2005

Anvisa realizará audiência pública virtual sobre revisão da RDC 302/2005

O encontro acontece na próxima quarta-feira, dia 11 de janeiro, a partir das 14h30.

A próxima audiência pública promovida pela Agência Nacional de Vigilância Sanitária – Anvisa, tem o intuito de obter informações e subsídios sobre a proposta de minuta de Resolução da Diretoria Colegiada (RDC 302/2005), que estabelece os requisitos técnico-sanitários para o funcionamento de laboratórios clínicos, de anatomia patalógica e outros serviços relacionados a exames de análises clínicas.

O encontro pretende colher dos setores impactados pela norma, eventuais questões que tenham permanecido após todas as etapas de diálogo e consultas empreendidas ao longo do processo de revisão da RDC 302/2005. Vale lembrar que o tema já promoveu a Consulta Pública 912/2020 e a Audiência Pública 10/2022.

A audiência acontece no dia 11/01, às 14h30. Acesse este link por meio da plataforma Teams e participe! Você obtém mais informações pelo site da Anvisa.

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PRM 0009

Certified Reference Material Producer

Accredited by Coordenação-Geral de Acreditação do Inmetro

Controllab has been accredited as a Certified Reference Material (CRM) Producer since 2016 by Cgcre, under number PMR 0009. The conformity assessment is carried out in accordance with the requirements established in ABNT NBR ISO 17034 and Inmetro standards, ensuring competence for the production of CRMs, as defined in the Scope of Accreditation.

This accreditation attests to Controllab’s technical competence in producing CRMs according to international requirements and enables it to be recognized in other countries, under mutual recognition agreements, thereby reducing technical barriers between Brazil and other countries across continents.

Materiais de Referência Certificados - PMR 0009 - ABNT NBR ISO 17034-Controllab
Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).

CAL 0214

Calibration Laboratory

Accredited by Coordenação-Geral de Acreditação do Inmetro

In December 2002, the Calibration Laboratory was accredited by Cgcre. With this recognition, it became part of the Brazilian network of accredited laboratories, under number 214. Since then, it has been periodically evaluated for the maintenance and/or extension of its accreditation.

The Inmetro seal attests to Controllab’s technical competence, credibility, and operational capability for calibration services, in accordance with the requirements of ABNT NBR ISO/IEC 17025.

Calibração de Instrumentos - CAL 0214 - ABNT NBR ISO/IEC 17025 - Controllab
Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).

PEP 0003

Proficiency Test Provider

Accredited by Coordenação-Geral de Acreditação do Inmetro

In September 2011, Controllab was accredited by Cgcre as a proficiency test provider, under nº PEP0003. Initially as part of a pilot project by Inmetro, this accreditation was based on ILAC G13: 2007 and included several clinical and hemotherapy tests. In the periodic evaluations of this accreditation, new segments and tests are included and the evaluation is now conducted according to ABNT NBR ISO/IEC 17043.

This accreditation attests to Controllab’s technical competence to develop and conduct proficiency tests in accordance with international requirements and enables it to be recognized in other countries, in accordance with mutual recognition agreements signed by Brazil in Mercosur, the Americas and Europe.

PEP 0003 - ABNT NBR ISO-IEC 17043 - Controllab

Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).