GMP & Quality System (CBPF) — Overview
What is the CBPF?
The CBPF (Certificado de Boas Práticas de Fabricação — Certificate of Good Manufacturing Practices) is ANVISA's GMP certification for medical device manufacturers. It demonstrates that a manufacturer's quality management system and facilities comply with the Good Manufacturing Practices requirements set out in RDC 752/2022.
The CBPF is required for:
- All domestic manufacturers applying for a Registro or Cadastro;
- Foreign manufacturers whose devices are being registered in Brazil (the CBPF or an equivalent GMP certificate is submitted with the registration dossier); and
- Importers who perform certain manufacturing activities (repackaging, relabelling) in Brazil.
GMP vs. ISO 13485
RDC 752/2022 is closely aligned with ISO 13485:2016 (Medical devices — Quality management systems) and adopts many of its requirements. For foreign manufacturers, a current ISO 13485 certificate from an accredited certification body is generally accepted by ANVISA as evidence of GMP compliance in place of the CBPF — however, ANVISA may still require a CBPF inspection for certain high-risk devices.
See CBPF vs. ISO 13485 for a detailed comparison.