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.
Verify all information against official ANVISA sources before making regulatory decisions.
The CBPF is valid for 2 years from the date of issuance. Manufacturers must submit renewal applications at least 90 days before expiry to ensure continuity of certification. A lapse in CBPF validity may result in suspension of device sales and regulatory action by ANVISA.
The CBPF application must include comprehensive quality system documentation demonstrating compliance with RDC 752/2022, including the quality policy, organizational structure, management responsibilities, design and development procedures, production controls, purchasing controls, personnel training records, and post-market surveillance procedures.
The CBPF is typically valid for 2 years from the date of issuance. Manufacturers should submit renewal applications at least 90 days before the current CBPF expires to avoid a lapse in certification.