GMP for Domestic Manufacturers
Brazilian manufacturers of medical devices must comply with RDC 752/2022 and obtain a CBPF issued by ANVISA or the state VISA body where the manufacturing facility is located.
The CBPF inspection process
- Application — submit a CBPF application via Peticionamento Eletrônico.
- Documentation review — ANVISA reviews the quality system documentation.
- Inspection — ANVISA or state VISA inspectors conduct a physical site inspection, reviewing facilities, processes, documentation, and records.
- Inspection report — inspectors issue a report identifying any non-conformities.
- Corrective action — the manufacturer must address non-conformities within the specified timeframe.
- CBPF issuance — upon satisfactory resolution, ANVISA issues the CBPF.
The CBPF must be kept current — it has a defined validity period and must be renewed before expiry.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.