Transcription of Brazil - WHO
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Brazil - WHO
Brazil Medical devices regulatory systems at country level World Bank income group: Upper middle income Legal Legal framework: Yes Authorizing legislation: Law No. 6,360 (23 Sept. 1976) Cadastro Procedures, RDC 24/2009 (2009) Clinical Trials, RDC 10/2015 (2015) 03/03/2015&jornal=1&pagina=73&totalArqui vos=140. Classification and Registration Requirements for Medical Products, RDC 185/2001 (2001) http://. Technical regulation on in-vitro diagnostic products, RDC 206/2006 upload/ Field Action Requirements, RDC 23/2012 (2012) legislacao/2012/52604 Post-market surveillance, RDC 67/2009 c52e168846bc0a466faa84/RDC+67-2009+ Guidelines: N/A. Notes: 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 Resoluciones/ES/Res_072_098_RT_Req-Esenc _Seg-Eficacia_Prod-M%C3%A9dicos_Acta%20.
WHO Region of the Americas Clinical investigation Clinical investigation controls: Yes Details: RDC 10/2015 details clinical trial controls, including applications for …
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