Exported Devices — Regulatory Obligations in Brazil
Medical devices manufactured in Brazil for export may be exempt from ANVISA product registration if not intended for sale in Brazil, but the manufacturing facility must hold a valid AFE and comply with GMP (CBPF) requirements under RDC 752/2022.
Certificado de Exportação (CFG)
BR-unique
The Certificado de Exportação (CFG — Certificate of Free Sale) is issued by ANVISA to demonstrate that a product is legally manufactured and/or sold in Brazil. Importing countries often require a CFG as part of their registration dossier — particularly for MERCOSUL, Africa, Middle East and Asia submissions.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.