CBPF vs. ISO 13485
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. However, ANVISA reserves the right to conduct an inspection of the foreign facility or require a Brazilian CBPF (issued to the importer/distributor in Brazil) for Class III and Class IV devices, and may require a CBPF for Class II devices depending on risk assessment.
Verify all information against official ANVISA sources before making regulatory decisions.