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.
Official resources
For domestic manufacturers, the CBPF is mandatory and cannot be substituted by ISO 13485. For foreign manufacturers, ISO 13485 certification may be accepted as evidence of GMP compliance, but ANVISA retains the discretion to require a direct CBPF inspection, particularly for Class III and Class IV devices or when there are compliance concerns.