Transcription of Brazil - who.int
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Brazil - who.int
BrazilWorld Bank income group: Upper middle incomeLegal Legal framework: Ye sAuthorizing legislation: Law No. 6,360 (23 Sept. 1976) Cadastro Procedures, RDC 24/2009 (2009) Clinical Trials, RDC 10/2015 (2015) Classification and Registration Requirements for Medical Products, RDC 185/2001 (2001) Technical regulation on in-vitro diagnostic products, RDC 206/2006 Field Action Requirements, RDC 23/2012 (2012) Post-market surveillance, RDC 67/2009 +67-2009+ : N /ANotes: Brazil is a member of Mercosur: MERCOSUR/GMC/RES. N 72/98: Reglamento T cnico Requisitos Esenciales de Seguridad y Eficacia de los Productos M dicos MERCOSUR/GMC/RES N 37/96: Registro Armonizado de Productos Medicos Regulatory AuthorityNational Regulatory Authority present: Ye sName: Brazilian Health Surveillance Agency of the NRA: N /AMedical device definitionMedical device defined: Ye
WHO Region of the Americas Clinical investigation Clinical investigation controls: Yes Details: RDC 10/2015 details clinical trial controls, including applications for permission to conduct
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