CBPF vs. ISO 13485
BR-unique
The CBPF is Brazil's national GMP certificate for medical device manufacturers. For foreign manufacturers, ANVISA generally accepts a current ISO 13485 certificate from an accredited certification body as equivalent evidence of GMP compliance — but important differences exist.
| Feature | CBPF | ISO 13485 certificate |
|---|---|---|
| Issuer | ANVISA (federal) or state VISA | Accredited certification body (e.g., BSI, TÜV, DNV) |
| Inspection basis | ANVISA inspectors conduct the inspection | Third-party auditors from the CB conduct the audit |
| Scope | Brazil-specific requirements (RDC 752/2022) | International standard (ISO 13485:2016) |
| Accepted by ANVISA | Always | Generally accepted for foreign manufacturers |
| Accepted by foreign authorities | Not directly | Widely accepted internationally |
| Validity | Specified in the certificate | Typically 3 years (with surveillance audits) |
For domestic Brazilian manufacturers, a CBPF issued by ANVISA is required. For foreign manufacturers importing devices into Brazil, an ISO 13485 certificate is typically accepted with the registration dossier, but ANVISA reserves the right to conduct an inspection or require a CBPF for Class IV devices.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.